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Empowering Patients to Participate in Health Care Decisions

19. September 2022 aktualisiert von: Vastra Gotaland Region

Empowering Patients With Long-term Impaired Work Ability to Participate in Health Related Decisions

The study aims to evaluate whether an intervention with patient education in study circles, aiming to empower patients to participate in health care an rehabilitation by increasing health literacy and sense of coherence, may have a causal effect on perceived health, ability and function as well as independence and quality of life for patients with long-term health-related disabilities and passive coping strategies.

Studienübersicht

Status

Aktiv, nicht rekrutierend

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

Chronic poor health and impaired work ability entails both personal suffering and considerable social costs. Poverty, homelessness, difficulties to handle complex issues, and maltreatment may affect health outcomes in the long run. Both sense of coherence (SOC) and the ability to understand health-related information (health literacy) influences personal coping strategies and thus the motivation to participate in health care and rehabilitation, which is known to have a positive impact on health outcome. The purpose of this study is to evaluate whether an intervention with patient education in study circles, aiming to empower patients to participate in health care and rehabilitation by increasing health literacy and sense of coherence, may have a causal effect on perceived health, ability and function as well as independence and quality of life for patients with long-term health-related disabilities and passive coping strategies. The study design is a cluster randomized controlled study comparing the intervention in addition to treatment as usual (TAU) with TAU. Follow-up is performed with validated questionnaires after 3, 6 and 12 months. Primary outcome is net inactivity days (net days without employment or rehabilitation) and secondary outcome variables are the number of net and gross days with sick leave during the follow-up period, sense of coherence, health literacy, health-related quality of life, confidence in own problem solving ability, work ability and work satisfaction, social function and health habits, symptoms of depression, anxiety, and exhaustion as well as pain and catastrophization. Randomization will be performed at Primary Care Center (PCC) level. Around 30 Primary Care Centers and 400 patients will be included in the study. The intervention consists of patient education with study circles meeting half a day per week for eight following weeks. The study is expected to show whether patient education in study circles aiming to increase health literacy and sense of coherence has a causal effect on perceived health, ability and function, independence and quality of life for patients with long-term health-related disabilities and passive coping strategies compared to TAU.

The research subjects will answer all questionnaires in a web based tool approved for storing research data, esMaker (Entergate AB) on their mobile phone, iPad or computer. Individual web links to the questionnaires will be distributed via e-mail. Research subject identity is replaced with individual codes in esMaker. The research assistant will be in charge of the CodeKey and responsible for distributing the web links and for reminding the research subjects to fill in the questionnaires.

Studientyp

Interventionell

Einschreibung (Tatsächlich)

400

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

  • Schweden
    • Region Vastra Gotaland
      • Gothenburg, Region Vastra Gotaland, Schweden, S-40530
        • Dominique Hange

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

18 Jahre bis 64 Jahre (Erwachsene)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Beschreibung

Inclusion Criteria:

Patients attending primary care centers included in the study.

  • Aged 18-64 years
  • Health-related impaired work ability > 60 net days last 6 months

Exclusion Criteria:• Acute crisis

  • Serious mental disorder needing psychiatric specialist care
  • Serious somatic disease a definite barrier to rehabilitation for a foreseeable future
  • Cognitive impairment or not speaking /understanding Swedish

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Unterstützende Pflege
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Single

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: Intervention group - experimental TAU + intervention
Patient education in study circles, aiming to empower patients to participate in health care and rehabilitation by increasing health literacy and sense of coherence. The study circles will meet half a day each week for eight following weeks.
Verhalten: Learn-to-Cope
Patient education in study circles, aiming to empower patients to participate in health care and rehabilitation by increasing health literacy and sense of coherence. The study circles will meet half a day each week for eight following weeks.
Kein Eingriff: TAU - no intervention
Treatment as usual following local routines on each primary care center

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Net days with sceduled activity
Zeitfenster: Change from base-line net days with scedulded activity at 6 months
What is the effect of interactive patient education in supervised study groups on net days with scheduled activity in patients of working age with long-term health-related work impairment (measured as change in net days with work / scheduled work preparatory rehabilitation (unemployed) / scheduled work preparatory rehabilitation during sick leave (on sick leave) from baseline to 6 months after baseline).
Change from base-line net days with scedulded activity at 6 months

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Net days with sceduled activity
Zeitfenster: Change from base-line net days with scedulded activity at 3 months
What is the effect of interactive patient education in supervised study groups on net days with scheduled activity in patients of working age with long-term health-related work impairment (measured as change in net days with work / scheduled work preparatory rehabilitation (unemployed) / scheduled work preparatory rehabilitation during sick leave (on sick leave) from baseline to 3 months after baseline).
Change from base-line net days with scedulded activity at 3 months
Net days with sceduled activity
Zeitfenster: Change from base-line net days with scedulded activity at 12 months
What is the effect of interactive patient education in supervised study groups on net days with scheduled activity in patients of working age with long-term health-related work impairment (measured as change in net days with work / scheduled work preparatory rehabilitation (unemployed) / scheduled work preparatory rehabilitation during sick leave (on sick leave) from baseline to 12 months after baseline).
Change from base-line net days with scedulded activity at 12 months
Health-related quality of life
Zeitfenster: Change from base-line scores EQ-5D at 3 months
What is the effect of interactive patient education in supervised study groups on participants' health-related quality of life (measured by change in scores in EQ-5D from baseline to 3 months after baseline). The EQ-5D-3L descriptive system comprises the following five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results into a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state.
Change from base-line scores EQ-5D at 3 months
Health-related quality of life
Zeitfenster: Change from base-line scores EQ-5D at 6 months
What is the effect of interactive patient education in supervised study groups on participants' health-related quality of life (measured by change in scores in EQ-5D from baseline to 6 months after baseline). The EQ-5D-3L descriptive system comprises the following five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results into a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state.
Change from base-line scores EQ-5D at 6 months
Health-related quality of life
Zeitfenster: Change from base-line scores EQ-5D at 12 months
What is the effect of interactive patient education in supervised study groups on participants' health-related quality of life (measured by change in scores in EQ-5D from baseline to 12 months after baseline). The EQ-5D-3L descriptive system comprises the following five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results into a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state.
Change from base-line scores EQ-5D at 12 months
Sense of coherence (SOC)
Zeitfenster: Change from base-line scores SOC-13 scale at 3 months
What is the effect of interactive patient education in supervised study groups on the participants' sense of coherence (measured by changes in scores in SOC-13 scale in Swedish9 from baseline to 3 months after baseline). Antonovsky developed the 29 item Orientation to Life Questionnaire to measure the sense of coherence, having 11 items measuring comprehensibility, 10 items measuring manageability, and 8 items measuring meaningfulness. The response alternatives are a semantic scale of 1 point to 7 points. The questionnaire yields a summed score with a range from 29 to 203. A shorter version of 13 questions of the original form was developed by Antonovsky, where the score ranges between 13 and 91 points,
Change from base-line scores SOC-13 scale at 3 months
Sense of coherence (SOC)
Zeitfenster: Change from base-line scores SOC-13 scale at 6 months
What is the effect of interactive patient education in supervised study groups on the participants' sense of coherence (measured by changes in scores in SOC-13 scale in Swedish9 from baseline to 6 months after baseline). Antonovsky developed the 29 item Orientation to Life Questionnaire to measure the sense of coherence, having 11 items measuring comprehensibility, 10 items measuring manageability, and 8 items measuring meaningfulness. The response alternatives are a semantic scale of 1 point to 7 points. The questionnaire yields a summed score with a range from 29 to 203. A shorter version of 13 questions of the original form was developed by Antonovsky, where the score ranges between 13 and 91 points,
Change from base-line scores SOC-13 scale at 6 months
Sense of coherence (SOC)
Zeitfenster: Change from base-line scores SOC-13 scale at 12 months
What is the effect of interactive patient education in supervised study groups on the participants' sense of coherence (measured by changes in scores in SOC-13 scale in Swedish9 from baseline to 12 months after baseline). Antonovsky developed the 29 item Orientation to Life Questionnaire to measure the sense of coherence, having 11 items measuring comprehensibility, 10 items measuring manageability, and 8 items measuring meaningfulness. The response alternatives are a semantic scale of 1 point to 7 points. The questionnaire yields a summed score with a range from 29 to 203. A shorter version of 13 questions of the original form was developed by Antonovsky, where the score ranges between 13 and 91 points,
Change from base-line scores SOC-13 scale at 12 months
Health literacy
Zeitfenster: Change from base-line scores HLS-EU-Q16-SE scale at 3 months
What is the effect of interactive patient education in supervised study groups on participants' health literacy (measured by change in scores in HLS-EU-Q16-SE from baseline to 3 months after baseline). The instrument consists of 16 items focusing on four HL dimensions reflecting perceived ease or difficulty in an individual's ability to access/obtain health information, understand health information (not only in written form), process/appraise health information, and apply/use health information. More specifically, the 16 items include perceived skills for understanding health information, where to seek consultation and health information on prevention, early detection, and health care, health warnings, advice given by family and friends, how to seek a second opinion, and how to apply advice given by care providers. Response options include "very easy," "easy," "difficult," and "very difficult."
Change from base-line scores HLS-EU-Q16-SE scale at 3 months
Health literacy
Zeitfenster: Change from base-line scores HLS-EU-Q16-SE scale at 6 months
What is the effect of interactive patient education in supervised study groups on participants' health literacy (measured by change in scores in HLS-EU-Q16-SE from baseline to 6 months after baseline). The instrument consists of 16 items focusing on four HL dimensions reflecting perceived ease or difficulty in an individual's ability to access/obtain health information, understand health information (not only in written form), process/appraise health information, and apply/use health information. More specifically, the 16 items include perceived skills for understanding health information, where to seek consultation and health information on prevention, early detection, and health care, health warnings, advice given by family and friends, how to seek a second opinion, and how to apply advice given by care providers. Response options include "very easy," "easy," "difficult," and "very difficult."
Change from base-line scores HLS-EU-Q16-SE scale at 6 months
Health literacy
Zeitfenster: Change from base-line scores HLS-EU-Q16-SE scale at 12 months
What is the effect of interactive patient education in supervised study groups on participants' health literacy (measured by change in scores in HLS-EU-Q16-SE from baseline to 12 months after baseline). The instrument consists of 16 items focusing on four HL dimensions reflecting perceived ease or difficulty in an individual's ability to access/obtain health information, understand health information (not only in written form), process/appraise health information, and apply/use health information. More specifically, the 16 items include perceived skills for understanding health information, where to seek consultation and health information on prevention, early detection, and health care, health warnings, advice given by family and friends, how to seek a second opinion, and how to apply advice given by care providers. Response options include "very easy," "easy," "difficult," and "very difficult."
Change from base-line scores HLS-EU-Q16-SE scale at 12 months
General self-efficacy
Zeitfenster: Change from base-line scores S-GSE scale at 3 months

What is the effect of interactive patient education in supervised study groups on participants' general self-efficacy (measured as change in scores in S-GSE from baseline to 3 months after baseline). About: This scale is a self-report measure of self-efficacy.

Items: 10 Reliability:

Internal reliability for GSE = Cronbach's alphas between .76 and .90

Validity:

The General Self-Efficacy Scale is correlated to emotion, optimism, work satisfaction. Negative coefficients were found for depression, stress, health complaints, burnout, and anxiety.

Scoring:

All questions 1 2 3 4 The total score is calculated by finding the sum of the all items. For the GSE, the total score ranges between 10 and 40, with a higher score indicating more self-efficacy.
Change from base-line scores S-GSE scale at 3 months
General self-efficacy
Zeitfenster: Change from base-line scores S-GSE scale at 6 months

What is the effect of interactive patient education in supervised study groups on participants' general self-efficacy (measured as change in scores in S-GSE from baseline to 6 months after baseline). About: This scale is a self-report measure of self-efficacy.

Items: 10 Reliability:

Internal reliability for GSE = Cronbach's alphas between .76 and .90

Validity:

The General Self-Efficacy Scale is correlated to emotion, optimism, work satisfaction. Negative coefficients were found for depression, stress, health complaints, burnout, and anxiety.

Scoring:

All questions 1 2 3 4 The total score is calculated by finding the sum of the all items. For the GSE, the total score ranges between 10 and 40, with a higher score indicating more self-efficacy.
Change from base-line scores S-GSE scale at 6 months
General self-efficacy
Zeitfenster: Change from base-line scores S-GSE scale at 12 months

What is the effect of interactive patient education in supervised study groups on participants' general self-efficacy (measured as change in scores in S-GSE from baseline to 12 months after baseline). About: This scale is a self-report measure of self-efficacy.

Items: 10 Reliability:

Internal reliability for GSE = Cronbach's alphas between .76 and .90

Validity:

The General Self-Efficacy Scale is correlated to emotion, optimism, work satisfaction. Negative coefficients were found for depression, stress, health complaints, burnout, and anxiety.

Scoring:

All questions 1 2 3 4 The total score is calculated by finding the sum of the all items. For the GSE, the total score ranges between 10 and 40, with a higher score indicating more self-efficacy.
Change from base-line scores S-GSE scale at 12 months
Social function
Zeitfenster: Change from base-line scores sub scale "Social function" of RAND-36 at 3 months
What is the effect of interactive patient education in supervised study groups on participants' social function (measured as change in scores in the two questions used in the sub scale "Social function" of RAND-36 from baseline to 3 months after baseline). The RAND 36-Item Health Survey laps eight concepts: physical functioning, bodily pain, role limitations due to physical health problems, role limitations due to personal or emotional problems, emotional well-being, social functioning, energy/fatigue, and general health perceptions. It also includes a single item that provides an indication of perceived change in health. Scoring the RAND 36-Item Health Survey is a two-step process. First, precoded numeric values are recoded per the scoring key. Note that all items are scored so that a high score defines a more favourable health state.
Change from base-line scores sub scale "Social function" of RAND-36 at 3 months
Social function
Zeitfenster: Change from base-line scores sub scale "Social function" of RAND-36 at 6 months
What is the effect of interactive patient education in supervised study groups on participants' social function (measured as change in scores in the two questions used in the sub scale "Social function" of RAND-36 from baseline to 6 months after baseline). The RAND 36-Item Health Survey (Version 1.0) laps eight concepts: physical functioning, bodily pain, role limitations due to physical health problems, role limitations due to personal or emotional problems, emotional well-being, social functioning, energy/fatigue, and general health perceptions. It also includes a single item that provides an indication of perceived change in health. Scoring the RAND 36-Item Health Survey is a two-step process. First, precoded numeric values are recoded per the scoring key given. Note that all items are scored so that a high score defines a more favourable health state. I
Change from base-line scores sub scale "Social function" of RAND-36 at 6 months
Social function
Zeitfenster: Change from base-line scores sub scale "Social function" of RAND-36 at 12 months
What is the effect of interactive patient education in supervised study groups on participants' social function (measured as change in scores in the two questions used in the sub scale "Social function" of RAND-36 from baseline to 12 months after baseline). The RAND 36-Item Health Survey (Version 1.0) laps eight concepts: physical functioning, bodily pain, role limitations due to physical health problems, role limitations due to personal or emotional problems, emotional well-being, social functioning, energy/fatigue, and general health perceptions. It also includes a single item that provides an indication of perceived change in health. Scoring the RAND 36-Item Health Survey is a two-step process. First, precoded numeric values are recoded per the scoring key given. Note that all items are scored so that a high score defines a more favourable health state.
Change from base-line scores sub scale "Social function" of RAND-36 at 12 months
Work ability
Zeitfenster: Change from base-line scores WAI scale at 3 months
What is the effect of interactive patient education in supervised study groups on participants' work ability (measured as change in scores in WAI from baseline to 3 months after baseline). Work ability was measured by means of the Work Ability Index (WAI) which consists in a 7-part self-assessment: current ability, work ability in relation to physical and mental demands of the job, reported diagnosed diseases, estimated impairment due to health status, sick leave over the last 12 months, self-prognosis of work ability in the 2 years to come and mental resources of the individual. The WAI measured in this way ranges from 7 to 49 points and 4 categories have been suggested to describe WAI levels: poor (7-27), moderate (28-36), good (37-43) and excellent (44-49).
Change from base-line scores WAI scale at 3 months
Work ability
Zeitfenster: Change from base-line scores WAI scale at 6 months
What is the effect of interactive patient education in supervised study groups on participants' work ability (measured as change in scores in WAI from baseline to 6 months after baseline). Work ability was measured by means of the Work Ability Index (WAI) which consists in a 7-part self-assessment: current ability, work ability in relation to physical and mental demands of the job, reported diagnosed diseases, estimated impairment due to health status, sick leave over the last 12 months, self-prognosis of work ability in the 2 years to come and mental resources of the individual. The WAI measured in this way ranges from 7 to 49 points and 4 categories have been suggested to describe WAI levels: poor (7-27), moderate (28-36), good (37-43) and excellent (44-49).
Change from base-line scores WAI scale at 6 months
Work ability
Zeitfenster: Change from base-line scores WAI scale at 12 months
What is the effect of interactive patient education in supervised study groups on participants' work ability (measured as change in scores in WAI from baseline to 12 months after baseline). Work ability was measured by means of the Work Ability Index (WAI) which consists in a 7-part self-assessment: current ability, work ability in relation to physical and mental demands of the job, reported diagnosed diseases, estimated impairment due to health status, sick leave over the last 12 months, self-prognosis of work ability in the 2 years to come and mental resources of the individual. The WAI measured in this way ranges from 7 to 49 points and 4 categories have been suggested to describe WAI levels: poor (7-27), moderate (28-36), good (37-43) and excellent (44-49).
Change from base-line scores WAI scale at 12 months
Job content
Zeitfenster: Change from base-line scores Karasek Job Content Questionnaire scale at 3 months
What is the effect of interactive patient education in supervised study groups on participants' job content (measured as change in score in Karasek Job Content Questionnaire from baseline to 3 months after baseline). Designed to measure scales assessing psychological demands, decision latitude, social support, physical demands, and job insecurity.
Change from base-line scores Karasek Job Content Questionnaire scale at 3 months
Job content
Zeitfenster: Change from base-line scores Karasek Job Content Questionnaire scale at 6 months
What is the effect of interactive patient education in supervised study groups on participants' job content (measured as change in score in Karasek Job Content Questionnaire from baseline to 6 months after baseline). Designed to measure scales assessing psychological demands, decision latitude, social support, physical demands, and job insecurity.
Change from base-line scores Karasek Job Content Questionnaire scale at 6 months
Job content
Zeitfenster: Change from base-line scores Karasek Job Content Questionnaire scale at 12 months
What is the effect of interactive patient education in supervised study groups on participants' job content (measured as change in score in Karasek Job Content Questionnaire from baseline to 12 months after baseline). Designed to measure scales assessing psychological demands, decision latitude, social support, physical demands, and job insecurity.
Change from base-line scores Karasek Job Content Questionnaire scale at 12 months
Total number of net and gross sick leave days
Zeitfenster: Change from base-line total number of net and gross sick leave days at 3 months
What is the effect of interactive patient education in supervised study groups on the total number of net and gross sick leave days during the follow-up period (measured as change in measures defined by the Swedish Social Insurance Agency from baseline to 3 months after baseline).
Change from base-line total number of net and gross sick leave days at 3 months
Total number of net and gross sick leave days
Zeitfenster: Change from base-line total number of net and gross sick leave days at 6 months
What is the effect of interactive patient education in supervised study groups on the total number of net and gross sick leave days during the follow-up period (measured as change in measures defined by the Swedish Social Insurance Agency from baseline to 6 months after baseline).
Change from base-line total number of net and gross sick leave days at 6 months
Total number of net and gross sick leave days
Zeitfenster: Change from base-line total number of net and gross sick leave days at 12 months
What is the effect of interactive patient education in supervised study groups on the total number of net and gross sick leave days during the follow-up period (measured as change in measures defined by the Swedish Social Insurance Agency from baseline to 12 months after baseline).
Change from base-line total number of net and gross sick leave days at 12 months
Physical activity
Zeitfenster: Change from base-line scores LTPA (level of physical activity) scale at 3 months
What is the effect of interactive patient education in supervised study groups on participants' level of physical activity (measured as change in time spent on physical activities during leisure time according to LTPAI from baseline to 3 months after baseline).
Change from base-line scores LTPA (level of physical activity) scale at 3 months
Physical activity
Zeitfenster: Change from base-line scores LTPAI (level of physical activity) scale at 6 months
What is the effect of interactive patient education in supervised study groups on participants' level of physical activity (measured as change in time spent on physical activities during leisure time according to LTPAI from baseline to 6 months after baseline).
Change from base-line scores LTPAI (level of physical activity) scale at 6 months
Physical activity
Zeitfenster: Change from base-line scores LTPAI (level of physical activity) scale at 12 months
What is the effect of interactive patient education in supervised study groups on participants' level of physical activity (measured as change in time spent on physical activities during leisure time according to LTPAI from baseline to 12 months after baseline).
Change from base-line scores LTPAI (level of physical activity) scale at 12 months
BMI
Zeitfenster: Change from base-line scores BMI at 3 months
What is the effect of interactive patient education in supervised study groups on participants' Body Mass Index, BMI (measured as change in BMI from baseline to 3 months after baseline).
Change from base-line scores BMI at 3 months
BMI
Zeitfenster: Change from base-line scores BMI at 6 months
What is the effect of interactive patient education in supervised study groups on participants' Body Mass Index, BMI (measured as change in BMI from baseline to 6 months after baseline).
Change from base-line scores BMI at 6 months
BMI
Zeitfenster: Change from base-line scores BMI at 12 months
What is the effect of interactive patient education in supervised study groups on participants' Body Mass Index, BMI (measured as change in BMI from baseline to 12 months after baseline).
Change from base-line scores BMI at 12 months
Symptoms of depression
Zeitfenster: Change from base-line scores MADRS-S scale at 3 months

What is the effect of interactive patient education in supervised study groups on participants' symptoms of depression (measured as change in score in MADRS-S from baseline to 3 months after baseline).

Scale:

0 to 6 - normal/symptom absent 7 to 19 - mild depression 20 to 34 - moderate depression >34 - severe depression
Change from base-line scores MADRS-S scale at 3 months
Symptoms of depression
Zeitfenster: Change from base-line scores MADRS-S scale at 6 months

What is the effect of interactive patient education in supervised study groups on participants' symptoms of depression (measured as change in score in MADRS-S from baseline to 6 months after baseline).

Scale:

0 to 6 - normal/symptom absent 7 to 19 - mild depression 20 to 34 - moderate depression >34 - severe depression
Change from base-line scores MADRS-S scale at 6 months
Symptoms of depression
Zeitfenster: Change from base-line scores MADRS-S scale at 12 months

What is the effect of interactive patient education in supervised study groups on participants' symptoms of depression (measured as change in score in MADRS-S from baseline to 12 months after baseline).

Scale:

0 to 6 - normal/symptom absent 7 to 19 - mild depression 20 to 34 - moderate depression >34 - severe depression
Change from base-line scores MADRS-S scale at 12 months
Symptoms of anxiety
Zeitfenster: Change from base-line scores GAD-7 scale at 3 months

What is the effect of interactive patient education in supervised study groups on participants' symptoms of anxiety (measured change in score in GAD-7 from baseline to 3 months after baseline).

Management Scores ≥10: Further assessment (including diagnostic interview and mental status examination) and/or referral to a mental health professional recommended.

Score Symptom Severity Comments 5-9 Mild Monitor 10*-14 Moderate Possible clinically significant condition >15 Severe Active treatment probably warranted
Change from base-line scores GAD-7 scale at 3 months
Symptoms of anxiety
Zeitfenster: Change from base-line scores GAD-7 scale at 6 months

What is the effect of interactive patient education in supervised study groups on participants' symptoms of anxiety (measured change in score in GAD-7 from baseline to 6 months after baseline).

Score Symptom Severity Comments 5-9 Mild Monitor 10*-14 Moderate Possible clinically significant condition >15 Severe Active treatment probably warranted
Change from base-line scores GAD-7 scale at 6 months
Symptoms of anxiety
Zeitfenster: Change from base-line scores GAD-7 scale at 12 months

What is the effect of interactive patient education in supervised study groups on participants' symptoms of anxiety (measured change in score in GAD-7 from baseline to 12 months after baseline).

Score Symptom Severity Comments 5-9 Mild Monitor 10*-14 Moderate Possible clinically significant condition >15 Severe Active treatment probably warranted
Change from base-line scores GAD-7 scale at 12 months
Symptoms of exhaustion
Zeitfenster: Change from base-line scores KEDS scale at 3 months

What is the effect of interactive patient education in supervised study groups on participants' symptoms of exhaustion (measured as change in score in KEDS from baseline to 3 months after baseline). items

9 items/symptoms Scoring 0-6/item Total 0-54

=/>19 p exhaustion
Change from base-line scores KEDS scale at 3 months
Symptoms of exhaustion
Zeitfenster: Change from base-line scores KEDS scale at 6 months

What is the effect of interactive patient education in supervised study groups on participants' symptoms of exhaustion (measured as change in score in KEDS from baseline to 6 months after baseline).

9 items/symptoms Scoring 0-6/item Total 0-54

=/>19 p exhaustion
Change from base-line scores KEDS scale at 6 months
Symptoms of exhaustion
Zeitfenster: Change from base-line scores KEDS scale at 12 months

What is the effect of interactive patient education in supervised study groups on participants' symptoms of exhaustion (measured as change in score in KEDS from baseline to 12 months after baseline).

9 items/symptoms Scoring 0-6/item Total 0-54

=/>19 p exhaustion
Change from base-line scores KEDS scale at 12 months
Pain catastrophizing
Zeitfenster: Change from base-line scores pain catastrophizing scale at 3 months

What is the effect of interactive patient education in supervised study groups on participant pain catastrophizing (measured as change in score in PCS from baseline to 3 months after baseline).

13 items Degree 0 - not at all

  1. - to a slight degree
  2. - to a moderate degree
  3. - to a great degree
  4. - all the time
Change from base-line scores pain catastrophizing scale at 3 months
Pain catastrophizing
Zeitfenster: Change from base-line scores pain catastrophizing scale at 6 months

What is the effect of interactive patient education in supervised study groups on participant pain catastrophizing (measured as change in score in PCS from baseline to 6 months after baseline).

13 items Degree 0 - not at all

  1. - to a slight degree
  2. - to a moderate degree
  3. - to a great degree
  4. - all the time
Change from base-line scores pain catastrophizing scale at 6 months
Pain catastrophizing
Zeitfenster: Change from base-line scores pain catastrophizing scale at 12 months

What is the effect of interactive patient education in supervised study groups on participant pain catastrophizing (measured as change in score in PCS from baseline to 12 months after baseline).

13 items Degree 0 - not at all

  1. - to a slight degree
  2. - to a moderate degree
  3. - to a great degree
  4. - all the time
Change from base-line scores pain catastrophizing scale at 12 months
Participant pain
Zeitfenster: Change from base-line scores OMPSQ scale at 3 months
What is the effect of interactive patient education in supervised study groups on participant pain (measured as change in score in OMPSQ from baseline to 3 months after baseline). A higher score indicates a higher disability. Maximum score is 210 points; a score of < 105 points indicates a low disability, that between 105 and 130 points indicates a moderate disability and that > 130 points indicates a high disability
Change from base-line scores OMPSQ scale at 3 months
Participant pain
Zeitfenster: Change from base-line scores OMPSQ scale at 6 months

What is the effect of interactive patient education in supervised study groups on participant pain (measured as change in score in OMPSQ from baseline to 6 months after baseline).

Maximum score is 210 points; a score of < 105 points indicates a low disability, that between 105 and 130 points indicates a moderate disability and that > 130 points indicates a high disability
Change from base-line scores OMPSQ scale at 6 months
Participant pain
Zeitfenster: Change from base-line scores OMPSQ scale at 12 months

What is the effect of interactive patient education in supervised study groups on participant pain (measured as change in score in OMPSQ from baseline to 12 months after baseline).

Maximum score is 210 points; a score of < 105 points indicates a low disability, that between 105 and 130 points indicates a moderate disability and that > 130 points indicates a high disability
Change from base-line scores OMPSQ scale at 12 months
Pain spreading
Zeitfenster: Change from base-line scores in number of painful body regions at 3 months
What is the effect of interactive patient education in supervised study groups on participant pain spreading (measured as change in number of painful body regions from baseline to 3 months after baseline). The diagram documents pain in 19 anatomic areas. Based on the distribution of the anatomic areas, we established six different body regions. Generalized linear regression was used to evaluate the association between the number of painful nonindex body regions (categorized as 0; 1-2; or 3-6) with our measures of interest. Participants reporting no body pain, low (1-2 regions) and high (≥ 3 regions).
Change from base-line scores in number of painful body regions at 3 months
Pain spreading
Zeitfenster: Change from base-line scores in number of painful body regions at 6 months
What is the effect of interactive patient education in supervised study groups on participant pain spreading (measured as change in number of painful body regions from baseline to 6 months after baseline). The diagram documents pain in 19 anatomic areas. Based on the distribution of the anatomic areas, we established six different body regions. Generalized linear regression was used to evaluate the association between the number of painful nonindex body regions (categorized as 0; 1-2; or 3-6) with our measures of interest. Participants reporting no body pain, low (1-2 regions) and high (≥ 3 regions).
Change from base-line scores in number of painful body regions at 6 months
Pain spreading
Zeitfenster: Change from base-line scores in number of painful body regions at 12 months
What is the effect of interactive patient education in supervised study groups on participant pain spreading (measured as change in number of painful body regions from baseline to 12 months after baseline). The diagram documents pain in 19 anatomic areas. Based on the distribution of the anatomic areas, we established six different body regions. Generalized linear regression was used to evaluate the association between the number of painful nonindex body regions (categorized as 0; 1-2; or 3-6) with our measures of interest. Participants reporting no body pain, low (1-2 regions) and high (≥ 3 regions).
Change from base-line scores in number of painful body regions at 12 months
Trust in own know-how
Zeitfenster: Change from base-line scores in questions about trust in own know-how and ability to improving health at 3 months
What is the effect of interactive patient education in supervised study groups on participant trust in own know-how and ability related to improving health (measured as change in score in questions about trust in own know-how and ability to improving health from baseline to 3 months after baseline).
Change from base-line scores in questions about trust in own know-how and ability to improving health at 3 months
Trust in own know-how
Zeitfenster: Change from base-line scores in questions about trust in own know-how and ability to improving health at 6 months
What is the effect of interactive patient education in supervised study groups on participant trust in own know-how and ability related to improving health (measured as change in score in questions about trust in own know-how and ability to improving health from baseline to 6 months after baseline).
Change from base-line scores in questions about trust in own know-how and ability to improving health at 6 months
Trust in own know-how
Zeitfenster: Change from base-line scores in questions about trust in own know-how and ability to improving health at 12 months
What is the effect of interactive patient education in supervised study groups on participant trust in own know-how and ability related to improving health (measured as change in score in questions about trust in own know-how and ability to improving health from baseline to 12 months after baseline).
Change from base-line scores in questions about trust in own know-how and ability to improving health at 12 months
Partners in health care
Zeitfenster: Change from base-line scores in questions about informed as a patient and being a partner in health care at 3 months
What is the effect of interactive patient education in supervised study groups on participants being informed as patients and being a partners in health care (measured as change in score in questions about informed as a patient and being a partner in health care from baseline to 3 months after baseline).
Change from base-line scores in questions about informed as a patient and being a partner in health care at 3 months
Partners in health care
Zeitfenster: Change from base-line scores in questions about informed as a patient and being a partner in health care at 6 months
What is the effect of interactive patient education in supervised study groups on participants being informed as patients and being a partners in health care (measured as change in score in questions about informed as a patient and being a partner in health care from baseline to 6 months after baseline).
Change from base-line scores in questions about informed as a patient and being a partner in health care at 6 months
Partners in health care
Zeitfenster: Change from base-line scores in questions about informed as a patient and being a partner in health care at 12 months
What is the effect of interactive patient education in supervised study groups on participants being informed as patients and being a partners in health care (measured as change in score in questions about informed as a patient and being a partner in health care from baseline to 12 months after baseline).
Change from base-line scores in questions about informed as a patient and being a partner in health care at 12 months
Visits to primary health care
Zeitfenster: Change from base-line proportion if they had to visit the primary health care center during the preceding two months, at 3 months
What is the effect of interactive patient education in supervised study groups on participant visits to primary health care (research subjects are asked at baseline if they had to visit the primary health care center during the preceding two months. The same question is asked at 3 months. The measurement is the change in proportion of research subjects who visited the primary health care center).
Change from base-line proportion if they had to visit the primary health care center during the preceding two months, at 3 months
Visits to primary health care
Zeitfenster: Change from base-line proportion if they had to visit the primary health care center during the preceding two months, at 6 months
What is the effect of interactive patient education in supervised study groups on participant visits to primary health care (research subjects are asked at baseline if they had to visit the primary health care center during the preceding two months. The same question is asked at 6 months. The measurement is the change in proportion of research subjects who visited the primary health care center).
Change from base-line proportion if they had to visit the primary health care center during the preceding two months, at 6 months
Visits to primary health care
Zeitfenster: Change from base-line proportion if they had to visit the primary health care center during the preceding two months, at 12 months
What is the effect of interactive patient education in supervised study groups on participant visits to primary health care (research subjects are asked at baseline if they had to visit the primary health care center during the preceding two months. The same question is asked at 12 months. The measurement is the change in proportion of research subjects who visited the primary health care center).
Change from base-line proportion if they had to visit the primary health care center during the preceding two months, at 12 months

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Vastra Gotaland Region

Mitarbeiter

Göteborg University

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

14. Februar 2020

Primärer Abschluss (Tatsächlich)

14. März 2020

Studienabschluss (Voraussichtlich)

30. Juni 2023

Studienanmeldedaten

Zuerst eingereicht

21. Januar 2020

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

31. Januar 2020

Zuerst gepostet (Tatsächlich)

5. Februar 2020

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

21. September 2022

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

19. September 2022

Zuletzt verifiziert

1. September 2022

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Andere Studien-ID-Nummern

  • Learn-to-Cope

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

NEIN

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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