iCBT para idosos com depressão: um RCT pragmático de cuidados primários
A nova geração da Internet: tratamento iCBT para idosos com depressão leve a moderada - um ensaio pragmático randomizado controlado no contexto da atenção primária
This clinical trial aims to evaluate the potential benefits of internet cognitive behavioural therapy (iCBT) for elderly patients with mild/moderate depression and compare its effectiveness with the current treatment as usual (TAU) at primary care centres (PCCs).
The specific aims are to study if:
iCBT is as effective as TAU in reducing depressive symptoms iCBT is as effective as TAU in increasing quality of life iCBT is as effective as TAU in increasing the function in patients >65 years and older with mild/moderate depression attending primary care, with the perspective of 36 months.
Participants will:
Work with the iCBT program (10-12 weeks) or become TAU at their PCCs. Followed-up at 3, 6, 12, 24 and 36 months of their symptoms, quality of life and function.
Visão geral do estudo
Status
Status
Condições
Condições
Intervenção / Tratamento
Intervenção / Tratamento
Descrição detalhada
Study Objective:
The primary aim is to determine if iCBT is as effective for treating mild-moderate depression in older adults (<65) as it is for younger age groups. The study will assess various outcomes throughout 3, 6, 12, 24, and 36 months, including depressive symptoms, quality of life, workability, relationships, activities of daily living, and social participation.
Trial Design:
It's a randomised controlled trial (RCT) with two groups: intervention (iCBT) and control (TAU). The pragmatic design closely resembles real-world primary care conditions to ensure the results apply to routine clinical practice.
Population:
Participants will be recruited from primary care centres (PCCs) in Sweden, targeting individuals over 65 years diagnosed with mild to moderate depressive symptoms. The study aims to include all eligible patients from participating PCCs, ensuring a broad representation of the target population.
Intervention and Control:
Intervention:
iCBT program with minimal therapist contact, initiated promptly after inclusion and lasting 10-12 weeks. Weekly therapist/nurse contact via email or telephone is part of the intervention.
Control:
TAU according to Swedish National Guidelines may include guided self-help, face-to-face CBT (excluding iCBT), and/or antidepressants provided by GPs or nurses at the PCCs.
Patient Selection and Randomization:
Patients will be screened using standardised guidelines (NICE guidelines for depression), diagnosed via the MINI diagnostic interview (Mini International Neuropsychiatric Interview), and randomised centrally to avoid bias. Due to the nature of the intervention, blinding at the patient level isn't feasible, but efforts will be made to blind researchers during data analysis.
Follow-up and Data Collection:
Multiple follow-up points up to 36 months will allow the researchers to assess the longer-term effects of iCBT compared to TAU. Quantitative outcomes will be supplemented by qualitative data from focus group interviews with patients and staff, exploring their experiences with iCBT.
Focus Group Interviews:
These will involve patients and staff separately, aiming to gather insights into the acceptability, feasibility, and perceived effectiveness of iCBT in a primary care setting. Qualitative analysis methods will be used to interpret and contextualise the findings from these interviews.
Tipo de estudo
Tipo de estudo
Inscrição (Estimado)
Inscrição
Estágio
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
-
-
-
Gothenburg, Suécia
- University of Gothenburg
-
-
Critérios de participação
Critérios de elegibilidade
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
- All patients >65, attending PCCs engaged in the trial, with mood as well as somatic complaints will be asked about depressive symptoms during the last 2 weeks by NICE guidelines for depression.
- All patients diagnosed with minor/major depression and not belonging to exclusion criteria and willing to take part in the trial will be diagnosed via the Mini International Neuropsychiatric Interview (M.I.N.I.) by a psychologist/specially trained nurse and have a General Practitioner (GP) somatic consultation
Exclusion Criteria:
Patients diagnosed with:
- severe depression
- prior suicide attempt or currently at medium to high risk of suicide (MADRS-S question 9>3 points or MINI suicide >9)
- bipolar disorder
- psychosis
- addiction
- cognitive impairment
- not speaking or understanding Swedish.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Solteiro
Número de braços
Armas e Intervenções
Grupo de Participantes / BraçoGrupo de Participantes / Braço |
Intervenção / TratamentoIntervenção / Tratamento |
|---|---|
|
Experimental: iCBT Senior
iCBT depression program with minimal therapist contact offered within 14 days from inclusion and with a duration of 10-12 weeks. Contact via email or telephone every week (therapist/nurse) |
iCBT depression program with minimal therapist contact offered within 14 days from inclusion and with a duration of 10-12 weeks. Contact via email or telephone every week (therapist/nurse) |
|
Comparador Ativo: Depression treatment-as-usual Senior
Depression treatment-as-usual for patient >65 years |
iCBT depression program with minimal therapist contact offered within 14 days from inclusion and with a duration of 10-12 weeks. Contact via email or telephone every week (therapist/nurse) |
O que o estudo está medindo?
Medidas de resultados primários
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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MADRS-S (Montgomery and Asberg Depression Rating Scale)
Prazo: Change from baseline scores MADRS-S scale at 3 months
|
What is the effect of iCBT on participants' symptoms of depression (measured as a 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 baseline scores MADRS-S scale at 3 months
|
|
MADRS-S (Montgomery and Asberg Depression Rating Scale)
Prazo: Change from baseline scores MADRS-S scale at 6 months
|
What is the effect of iCBT on participants' symptoms of depression (measured as a 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 baseline scores MADRS-S scale at 6 months
|
|
MADRS-S (Montgomery and Asberg Depression Rating Scale)
Prazo: Change from baseline scores MADRS-S scale at 12 months
|
What is the effect of iCBT on participants' symptoms of depression (measured as a 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 baseline scores MADRS-S scale at 12 months
|
|
MADRS-S (Montgomery and Asberg Depression Rating Scale)
Prazo: Change from baseline scores MADRS-S scale at 24 months
|
What is the effect of iCBT on participants' symptoms of depression (measured as a change in score in MADRS-S from baseline to 24 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 baseline scores MADRS-S scale at 24 months
|
|
MADRS-S (Montgomery and Asberg Depression Rating Scale)
Prazo: Change from baseline scores MADRS-S scale at 36 months
|
What is the effect of iCBT on participants' symptoms of depression (measured as a change in score in MADRS-S from baseline to 36 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 baseline scores MADRS-S scale at 36 months
|
Medidas de resultados secundários
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
The 5-level EQ-5D version (EQ-5D-5L) EuroQol 5-Dimension
Prazo: Change from baseline scores EQ-5D scale at 3 months
|
Scale Title: EQ-5D-5L. The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. 1 = no difficulties and 5 = very large difficulties. These single-digit codes can be combined into a five-digit code that corresponds to a specific health profile. 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 in 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. What is the effect of iCBT on participants' health-related quality of life (measured by the change in scores in EQ-5D from baseline to 3 months after baseline)? |
Change from baseline scores EQ-5D scale at 3 months
|
|
The 5-level EQ-5D version (EQ-5D-5L)
Prazo: Change from baseline scores EQ-5D scale at 6 months
|
What is the effect of iCBT on participants' health-related quality of life (measured by the change in scores in EQ-5D from baseline to 6 months after baseline? The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has five levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate their health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in 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 baseline scores EQ-5D scale at 6 months
|
|
The 5-level EQ-5D version (EQ-5D-5L)
Prazo: Change from baseline scores EQ-5D scale at 12 months
|
What is the effect of iCBT on participants' health-related quality of life (measured by the change in scores in EQ-5D from baseline to 12 months after baseline? The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has five levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate their health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in 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 baseline scores EQ-5D scale at 12 months
|
|
The 5-level EQ-5D version (EQ-5D-5L)
Prazo: Change from baseline scores EQ-5D scale at 24 months
|
What is the effect of iCBT on participants' health-related quality of life (measured by the change in scores in EQ-5D from baseline to 24 months after baseline? The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has five levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate their health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in 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 baseline scores EQ-5D scale at 24 months
|
|
The 5-level EQ-5D version (EQ-5D-5L)
Prazo: Change from baseline scores EQ-5D scale at 36 months
|
What is the effect of iCBT on participants' health-related quality of life (measured by the change in scores in EQ-5D from baseline to 36 months after baseline? The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has five levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate their health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in 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 baseline scores EQ-5D scale at 36 months
|
|
Work ability
Prazo: Change from baseline scores WAI scale at 3 months
|
Scale Title: Work Ability Index (WAI) Minimum Value: 7 Maximum Value: 49 Higher Scores Mean: A better outcome. The WAI is used to assess an individual's work ability based on their health and work capacity.What is the effect of iCBT 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 baseline scores WAI scale at 3 months
|
|
Work ability
Prazo: Change from base-line scores WAI scale at 6 months
|
What is the effect of iCBT 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
Prazo: Change from base-line scores WAI scale at 12 months
|
What is the effect of iCBT 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
|
|
Work ability
Prazo: Change from base-line scores WAI scale at 24 months
|
What is the effect of iCBT on participants' work ability (measured as change in scores in WAI from baseline to 24 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 24 months
|
|
Work ability
Prazo: Change from base-line scores WAI scale at 36 months
|
What is the effect of iCBT on participants' work ability (measured as change in scores in WAI from baseline to 36 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 36 months
|
|
WHODAS 12 2.0 (WORLD HEALTH ORGANIZATION DISABILITY ASSESSMENT SCHEDULE 2.0), 12-item version, self-administered
Prazo: Change from base-line scores WHODAS scale at 3 months
|
What is the effect of iCBT on participants' disability work (measured as a change in scores in WHODAS from baseline to 3 months after baseline)? This questionnaire asks about difficulties due to health conditions. Health conditions include diseases or illnesses, other health problems that may be short or long-lasting, injuries, mental or emotional problems, and problems with alcohol or drugs. Review the past 30 days and answer these questions, thinking about how difficult participant had to do the following activities. WHODAS 2.0 covers 6 Domains of Functioning, including Cognition - understanding & communicating; mobility- moving & getting around; self-care- hygiene, dressing, eating & staying alone; getting along- interacting with other people; life activities- domestic responsibilities, leisure, work & school, Participation- joining in community activities |
Change from base-line scores WHODAS scale at 3 months
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WHODAS 12 2.0 (WORLD HEALTH ORGANIZATION DISABILITY ASSESSMENT SCHEDULE 2.0), 12-item version, self-administered
Prazo: Change from base-line scores WHODAS scale at 6 months
|
What is the effect of iCBT on participants' disability work (measured as a change in scores in WHODAS from baseline to 6 months after baseline)? This questionnaire asks about difficulties due to health conditions. Health conditions include diseases or illnesses, other health problems that may be short or long-lasting, injuries, mental or emotional problems, and problems with alcohol or drugs. Review the past 30 days and answer these questions, thinking about how difficult participant had to do the following activities. WHODAS 2.0 covers 6 Domains of Functioning, including Cognition - understanding & communicating; mobility- moving & getting around; self-care- hygiene, dressing, eating & staying alone; getting along- interacting with other people; life activities- domestic responsibilities, leisure, work & school, Participation- joining in community activities |
Change from base-line scores WHODAS scale at 6 months
|
|
WHODAS 12 2.0 (WORLD HEALTH ORGANIZATION DISABILITY ASSESSMENT SCHEDULE 2.0), 12-item version, self-administered
Prazo: Change from base-line scores WHODAS scale at 12 months
|
What is the effect of iCBT on participants' disability work (measured as a change in scores in WHODAS from baseline to 12 months after baseline)? This questionnaire asks about difficulties due to health conditions. Health conditions include diseases or illnesses, other health problems that may be short or long-lasting, injuries, mental or emotional problems, and problems with alcohol or drugs. Review the past 30 days and answer these questions, thinking about how difficult participant had to do the following activities. WHODAS 2.0 covers 6 Domains of Functioning, including Cognition - understanding & communicating; mobility- moving & getting around; self-care- hygiene, dressing, eating & staying alone; getting along- interacting with other people; life activities- domestic responsibilities, leisure, work & school, Participation- joining in community activities |
Change from base-line scores WHODAS scale at 12 months
|
|
WHODAS 12 2.0 (WORLD HEALTH ORGANIZATION DISABILITY ASSESSMENT SCHEDULE 2.0), 12-item version, self-administered
Prazo: Change from base-line scores WHODAS scale at 24 months
|
What is the effect of iCBT on participants' disability work (measured as a change in scores in WHODAS from baseline to 24 months after baseline)? This questionnaire asks about difficulties due to health conditions. Health conditions include diseases or illnesses, other health problems that may be short or long-lasting, injuries, mental or emotional problems, and problems with alcohol or drugs. Review the past 30 days and answer these questions, thinking about how difficult participant had to do the following activities. WHODAS 2.0 covers 6 Domains of Functioning, including Cognition - understanding & communicating; mobility- moving & getting around; self-care- hygiene, dressing, eating & staying alone; getting along- interacting with other people; life activities- domestic responsibilities, leisure, work & school, Participation- joining in community activities |
Change from base-line scores WHODAS scale at 24 months
|
|
WHODAS 12 2.0 (WORLD HEALTH ORGANIZATION DISABILITY ASSESSMENT SCHEDULE 2.0), 12-item version, self-administered
Prazo: Change from base-line scores WHODAS scale at 36 months
|
What is the effect of iCBT on participants' disability work (measured as a change in scores in WHODAS from baseline to 36 months after baseline)? This questionnaire asks about difficulties due to health conditions. Health conditions include diseases or illnesses, other health problems that may be short or long-lasting, injuries, mental or emotional problems, and problems with alcohol or drugs. Review the past 30 days and answer these questions, thinking about how difficult participant had to do the following activities. WHODAS 2.0 covers 6 Domains of Functioning, including Cognition - understanding & communicating; mobility- moving & getting around; self-care- hygiene, dressing, eating & staying alone; getting along- interacting with other people; life activities- domestic responsibilities, leisure, work & school, Participation- joining in community activities |
Change from base-line scores WHODAS scale at 36 months
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Use of Antidepressants
Prazo: Antidepressant use will be assessed at baseline and after 12 months of participation in the study.
|
The use of antidepressants will be assessed as a secondary outcome measure in this study to understand its impact on the treatment of mild to moderate depression in individuals aged 66 and above. Antidepressant use will be compared between the intervention group (receiving iCBT) and the control group (receiving Treatment-As-Usual, TAU) over a 12-month period. |
Antidepressant use will be assessed at baseline and after 12 months of participation in the study.
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General Self-Efficacy Scale (GSE)
Prazo: Change from base-line scores GSE scale at 3 months
|
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: Not at all true, Hardly true, Moderately true, Exactly true, 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 GSE scale at 3 months
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General Self-Efficacy Scale (GSE)
Prazo: Change from base-line scores GSE scale at 6 months
|
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: Not at all true, Hardly true, Moderately true, Exactly true, 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 GSE scale at 6 months
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General Self-Efficacy Scale (GSE)
Prazo: Change from base-line scores GSE scale at 12 months
|
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: Not at all true, Hardly true, Moderately true, Exactly true, 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 GSE scale at 12 months
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General Self-Efficacy Scale (GSE)
Prazo: Change from base-line scores GSE scale at 24 months
|
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: Not at all true, Hardly true, Moderately true, Exactly true, 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 GSE scale at 24 months
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General Self-Efficacy Scale (GSE)
Prazo: Change from base-line scores GSE scale at 36 months
|
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: Not at all true, Hardly true, Moderately true, Exactly true, 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 GSE scale at 36 months
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The Health Literacy Survey European Questionnaire (HLS-EU-Q16)
Prazo: Change from base-line scores HLSE-EU-Q16 scale at 3 months
|
The HLS-EU-Q16, or the Health Literacy Survey European Questionnaire (short version with 16 questions), is a standardized tool designed to measure health literacy in populations. Health literacy refers to an individual's ability to access, understand, appraise, and apply information to make informed decisions regarding their health. Each question in the HLS-EU-Q16 is answered on a Likert scale with four response options: Very difficult (1 point), Fairly difficult (2 points), Fairly easy (3 points), Very easy (4 points). To calculate the total score, sum the points for all 16 questions. The total score can range from 16 to 64 points. Low points are Inadequate Health Literacy. |
Change from base-line scores HLSE-EU-Q16 scale at 3 months
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The Health Literacy Survey European Questionnaire (HLS-EU-Q16)
Prazo: Change from base-line scores HLSE-EU-Q16 scale at 6 months
|
The HLS-EU-Q16, or the Health Literacy Survey European Questionnaire (short version with 16 questions), is a standardized tool designed to measure health literacy in populations. Health literacy refers to an individual's ability to access, understand, appraise, and apply information to make informed decisions regarding their health. Each question in the HLS-EU-Q16 is answered on a Likert scale with four response options: Very difficult (1 point), Fairly difficult (2 points), Fairly easy (3 points), Very easy (4 points). To calculate the total score, sum the points for all 16 questions. The total score can range from 16 to 64 points. Low points are Inadequate Health Literacy. |
Change from base-line scores HLSE-EU-Q16 scale at 6 months
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The Health Literacy Survey European Questionnaire (HLS-EU-Q16)
Prazo: Change from base-line scores HLSE-EU-Q16 scale at 12 months
|
The HLS-EU-Q16, or the Health Literacy Survey European Questionnaire (short version with 16 questions), is a standardized tool designed to measure health literacy in populations. Health literacy refers to an individual's ability to access, understand, appraise, and apply information to make informed decisions regarding their health. Each question in the HLS-EU-Q16 is answered on a Likert scale with four response options: Very difficult (1 point), Fairly difficult (2 points), Fairly easy (3 points), Very easy (4 points). To calculate the total score, sum the points for all 16 questions. The total score can range from 16 to 64 points. Low points are Inadequate Health Literacy. |
Change from base-line scores HLSE-EU-Q16 scale at 12 months
|
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The Health Literacy Survey European Questionnaire (HLS-EU-Q16)
Prazo: Change from base-line scores HLSE-EU-Q16 scale at 24 months
|
The HLS-EU-Q16, or the Health Literacy Survey European Questionnaire (short version with 16 questions), is a standardized tool designed to measure health literacy in populations. Health literacy refers to an individual's ability to access, understand, appraise, and apply information to make informed decisions regarding their health. Each question in the HLS-EU-Q16 is answered on a Likert scale with four response options: Very difficult (1 point), Fairly difficult (2 points), Fairly easy (3 points), Very easy (4 points). To calculate the total score, sum the points for all 16 questions. The total score can range from 16 to 64 points. Low points are Inadequate Health Literacy. |
Change from base-line scores HLSE-EU-Q16 scale at 24 months
|
|
The Health Literacy Survey European Questionnaire (HLS-EU-Q16)
Prazo: Change from base-line scores HLSE-EU-Q16 scale at 36 months
|
The HLS-EU-Q16, or the Health Literacy Survey European Questionnaire (short version with 16 questions), is a standardized tool designed to measure health literacy in populations. Health literacy refers to an individual's ability to access, understand, appraise, and apply information to make informed decisions regarding their health. Each question in the HLS-EU-Q16 is answered on a Likert scale with four response options: Very difficult (1 point), Fairly difficult (2 points), Fairly easy (3 points), Very easy (4 points). To calculate the total score, sum the points for all 16 questions. The total score can range from 16 to 64 points. Low points are Inadequate Health Literacy. |
Change from base-line scores HLSE-EU-Q16 scale at 36 months
|
Colaboradores e Investigadores
Patrocinador
Patrocinador
Colaboradores
Colaboradores
Investigadores
Investigadores
- Investigador principal: Dominique Hange, Ass Prof, Göteborg University
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Início do estudo
Conclusão Primária (Estimado)
Conclusão Primária
Conclusão do estudo (Estimado)
Conclusão do estudo
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Primeira postagem
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última Atualização Postada
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Última verificação
Mais Informações
Termos relacionados a este estudo
Outros números de identificação do estudo
Outros números de identificação do estudo
- iCBT-Senior-DEP-2024-PRCT
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Informações sobre medicamentos e dispositivos, documentos de estudo
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