Positive Psychology for Acute Coronary Syndrome Patients (PEACE-IV)
Positive Psychology for Acute Coronary Syndrome Patients: a Randomized, Controlled Pilot Trial
Studieoversigt
Status
Status
Betingelser
Betingelser
Intervention / Behandling
Intervention / Behandling
Detaljeret beskrivelse
Undersøgelsestype
Undersøgelsestype
Tilmelding (Faktiske)
Tilmelding
Fase
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
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Massachusetts
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Boston, Massachusetts, Forenede Stater, 02114
- Massachusetts General Hospital
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Deltagelseskriterier
Berettigelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Adult patients admitted to Massachusetts General Hospital or Brigham and Women's Hospital inpatient units
- Diagnosis of acute coronary syndrome (using established criteria for myocardial infarction or unstable angina; confirmed via medical record and/or patient's treatment team)
- Age 18 or older
- Suboptimal adherence on MOS-SAS: Score < 15 OR Score = 15 with physical activity < 6
Exclusion Criteria:
- Cognitive deficits, assessed via a 6-item cognitive screen used to assess appropriate participation of medically ill patients in research studies.
- Medical conditions precluding interviews or likely to lead to death within 6 months, determined in consultation with the primary treatment team and cardiology co-investigator.
- Inability to perform moderate to vigorous physical activity, as defined by an inability to walk without aid of an assistive device such as a walker or cane, OR inability to walk at a steady pace for at least 5 minutes without stopping.
- Inability to communicate in English.
- Inability to participate in physical activity
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Antal våben
Våben og indgreb
Deltagergruppe / ArmDeltagergruppe / Arm |
Intervention / BehandlingIntervention / Behandling |
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Eksperimentel: Positiv psykologi + motiverende samtale
Deltagerne vil gennemføre ugentlige positive psykologiske øvelser og vil systematisk sætte mål relateret til fysisk aktivitet.
Studietrænere vil gennemgå de positive psykologiske øvelser på telefonen hver uge og vil bruge motiverende samtaleteknikker til at lette målsætningen.
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For den positive psykologi-del af interventionen vil studietræneren (a) gennemgå ugens positive psykologi-øvelse, (b) diskutere begrundelsen for den næste uges positive psykologi-øvelse gennem en guidet gennemgang af manualen for positiv psykologi og (c) tildele næste uges positiv psykologi øvelse.
Til den motiverende interviewdel vil deltagerne (a) gennemgå deres fysiske aktivitetsmål fra den foregående uge, (b) diskutere teknikker til at forbedre fysisk aktivitet og (c) sætte et fysisk aktivitetsmål for den næste uge.
Studietrænere vil bruge motiverende samtaleteknikker for at lette målsætningen.
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Aktiv komparator: Motivational Interviewing Health Education
Participants will speak on the telephone each week with a study trainer.
During these calls, the trainer will provide education about a health behavior (physical activity, medication adherence, diet, stress reduction) and assign an activity related to one health behavior each week.
Motivational interviewing techniques will be used throughout to facilitate health behavior changes.
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Each week, participants will learn about a different health behavior topic related to cardiac health.
They will also be introduced to motivational interviewing topics in concert with the health behavior education topics.
The intervention is divided into five sections, focusing on five different important cardiac health-related topics (recovery from an acute cardiac illness, physical activity, a heart-healthy diet, medication adherence, and stress reduction).
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Hvad måler undersøgelsen?
Primære resultatmål
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Feasibility of the PP-MI Based Health Behavior Intervention
Tidsramme: 24 weeks
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Feasibility will be measured by examining the number of completed exercises.
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24 weeks
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Acceptability of the PP-MI Exercises: Utility Score
Tidsramme: Weeks 1-12
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Participants will provide ratings of utility after each exercise, measured on a 10-point Likert scale (0=not at all helpful; 10=very helpful).
Weekly utility ratings were averaged to provide an overall utility score of the exercises.
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Weeks 1-12
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Acceptability of the PP-MI Exercises: Ease Score
Tidsramme: Weeks 1-12
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Participants will provide ratings of ease after each exercise, measured on a 10-point Likert scale (0=very difficult; 10=very easy).
Weekly ratings were averaged to provide an overall ease of the exercises.
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Weeks 1-12
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Sekundære resultatmål
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Minutes of Moderate to Vigorous Physical Activity (Actigraph)
Tidsramme: MVPA at 12 weeks and 24 weeks
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ActiGraph GT3X+ step counters are validated as measures of physical activity and have been used in numerous studies of physical activity in patients with medical illness.
In this trial, participants will wear the accelerometer for one week at 12 weeks, and another week at 24 weeks to assess the feasibility of doing so and to ensure adequate capture of physical activity.
In our analysis, data on pre-ACS activity was collected using the International Physical Activity Questionnaire (IPAQ) to control for baseline activity.
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MVPA at 12 weeks and 24 weeks
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Change in Medication Adherence
Tidsramme: Change in score from Baseline to 12 weeks, 24 weeks
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Measured by Self-Reported Medication Adherence (SRMA), a two-item self-report medication adherence scale measuring percentage of time (in 10% increments) patients report taking their heart medications in the past one and two weeks.
Minimum: 0, Maximum:100.
Change was calculated by subtracting the score at baseline from the score at 12 weeks and 24 weeks.
Higher score indicates greater levels of medication adherence.
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Change in score from Baseline to 12 weeks, 24 weeks
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Change in Dietary Adherence
Tidsramme: Change in score from Baseline to 12 weeks, 24 weeks
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Measured by the MEDFICTS scale, a National Cholesterol Education Program-developed scale inquiring about saturated fat.
Minimum= 0; Maximum= 216.
Change was calculated by subtracting the score at baseline from the score at 12 and 24 weeks.
Higher scores indicate lower levels of dietary adherence.
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Change in score from Baseline to 12 weeks, 24 weeks
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Change in Positive Affect
Tidsramme: Change in score from Baseline to 12 weeks, 24 weeks
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The positive affect items on the Positive and Negative Affect Schedule (PANAS), a well-validated scale used in other intervention trials and in patients with medical illnesses, will be used to measure positive affect.
(Range: 10-50).
Change was calculated by subtracting the score at baseline from the score at 12 and 24 weeks.
Higher scores indicate higher levels of positive affect.
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Change in score from Baseline to 12 weeks, 24 weeks
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Change in Trait Optimism
Tidsramme: Change in score from baseline to 12 week, 24 week
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Life Orientation Test-Revised is a well-validated 6-item instrument used to measure dispositional optimism.
(Range: 0-24) Change was calculated by subtracting the score at baseline from the score at 12 and 24 weeks.
Higher scores indicate higher levels of optimism.
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Change in score from baseline to 12 week, 24 week
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Change in State Optimism
Tidsramme: Change of score from Baseline to 12 weeks, 24 weeks
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Measured by the State Optimism Scale developed by our team (SOM), which aims to capture the changeable nature of optimism based on time and situation.
Minimum:7, Maximum:35.
The higher number indicates a greater level of optimism.
Change was calculated by subtracting the score at baseline from the score at 12 and 24 weeks.
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Change of score from Baseline to 12 weeks, 24 weeks
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Changes in HADS-A Scores
Tidsramme: Change in score from Baseline to 12 week, 24 week
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The Hospital Anxiety and Depression Scale will be used to measure depression and anxiety.
This is a well-validated scale with few somatic symptom items that can confound mood/anxiety assessment in medically-ill patients.
(Range: 0-21) Change was calculated by subtracting the score at baseline from the score at 12 and 24 weeks.
Higher scores indicate higher levels of anxiety.
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Change in score from Baseline to 12 week, 24 week
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Change in HADS-D Scores
Tidsramme: Change in score from Baseline to 12 week, 24 week
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The Hospital Anxiety and Depression Scale will be used to measure depression and anxiety.
This is a well-validated scale with few somatic symptom items that can confound mood/anxiety assessment in medically-ill patients.(Range:
0-21).
Change was calculated by subtracting the score at baseline from the score at 12 and 24 weeks.
Higher scores indicate worse outcome (i.e.
greater levels of depression).
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Change in score from Baseline to 12 week, 24 week
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Change in Physical Function
Tidsramme: Change of score from Baseline to 12 week, 24 week
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Measured by the Duke Activity Status Index (DASI), a 12-item questionnaire that inquires about activities of daily living, basic physical activity, and more strenuous physical function to gauge overall functional capacity.
Minimum: 0, Maximum: 58.2.
Change was calculated by subtracting the score at baseline from the score at 12 and 24 weeks.
Higher scores indicate greater levels of functional capacity.
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Change of score from Baseline to 12 week, 24 week
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Change in SF-12 Scores (Physical)
Tidsramme: Change of score from Baseline to 12 week, 24 week
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The Medical Outcomes Study Short Form-12 (SF-12) will be used to measure quality of life.
This is an instrument which has been used in multiple cardiac studies in the past.
(SF-12 Mental Composite Score and Physical Composite Score Range: 0-100 each).
Change was calculated by subtracting the score at baseline from the score at 12 and 24 weeks.
Higher scores indicate higher level of health related QoL.
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Change of score from Baseline to 12 week, 24 week
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Change in SF-12 Scores (Mental)
Tidsramme: Change of score from baseline to 12 and 24 weeks.
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The Medical Outcomes Study Short Form-12 (SF-12) will be used to measure quality of life.
This is an instrument which has been used in multiple cardiac studies in the past.
(SF-12 Mental Composite Score and Physical Composite Score Range: 0-100 each).
Change was calculated by subtracting the score at baseline from the score at 12 and 24 weeks.
Higher scores indicate higher level of health related QoL.
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Change of score from baseline to 12 and 24 weeks.
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Change in Adherence to Health Behaviors
Tidsramme: Change of score from Baseline to 12 week, 24 week
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Three Medical Outcomes Study Specific Adherence Scale (MOS SAS) items assessing medication, diet, and exercise, will be measured individually and as a composite score.
(Range: 3-18) Change was calculated by subtracting the score at baseline from the score at 12 and 24 weeks.
Higher scores indicate better adherence to health behaviors.
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Change of score from Baseline to 12 week, 24 week
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Change in Cardiac Symptoms
Tidsramme: Change of score from Baseline to 12 week, 24 week
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Measured by a checklist taken from the Women and Ischemia Syndrome Evaluation Study (WISE) to assess the presence and intensity of ten cardiac symptoms felt to best capture the range of symptoms experienced by ACS patients.
Minimum: 0, Maximum: 30.
Change was calculated by subtracting the score at baseline from the score at 12 and 24 weeks.
Higher scores indicate greater levels of cardiac symptoms.
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Change of score from Baseline to 12 week, 24 week
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Change in Physical Activity
Tidsramme: Change of score from Baseline to 12 week, 24 week
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Measured by the self-report International Physical Activity Questionnaire (IPAQ).
The measure asseses the types of intensity of physical activity that people do as part of their daily lives.
All activities are converted to multiples of resting energy expenditure (MET) minutes per week.
Change was calculated by subtracting the score at baseline from the score at 12 and 24 weeks.
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Change of score from Baseline to 12 week, 24 week
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Change in Perceived Stress
Tidsramme: Change of score from Baseline to 12 week, 24 week
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Measured by the Perceived Stress Scale (PSS-4) measure.
Minimum: 0, Maximum: 16.
Change was calculated by subtracting the score at baseline from the score at 12 and 24 weeks Higher scores indicate greater levels of stress.
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Change of score from Baseline to 12 week, 24 week
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Samarbejdspartnere og efterforskere
Sponsor
Sponsor
Efterforskere
Efterforskere
- Ledende efterforsker: Jeff Huffman, MD, Massachusetts General Hospital
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Studiestart
Primær færdiggørelse (Faktiske)
Primær færdiggørelse
Studieafslutning (Faktiske)
Studieafslutning
Datoer for studieregistrering
Først indsendt
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Først opslået
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering sendt
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
Andre undersøgelses-id-numre
- R01HL113272 (U.S. NIH-bevilling/kontrakt)
Plan for individuelle deltagerdata (IPD)
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