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Positive Psychology for Acute Coronary Syndrome Patients (PEACE-IV)

6. května 2020 aktualizováno: Jeff C. Huffman, MD, Massachusetts General Hospital

Positive Psychology for Acute Coronary Syndrome Patients: a Randomized, Controlled Pilot Trial

This is a randomized controlled pilot trial in approximately 50 acute coronary syndrome patients to determine if a 12 week, telephone-delivered, combined positive psychology-motivational interviewing intervention is feasible and more effective than a motivational interviewing health education program at improving health behaviors and other outcomes. The investigators hypothesize that the intervention will be associated with better mental and physical health outcomes and better health behavior adherence compared to the motivational interviewing health education program.

Přehled studie

Postavení

Dokončeno

Podmínky

Intervence / Léčba

Detailní popis

The initial study visit will occur in-person two weeks after discharge from the hospital. Participants will meet with a member of the study staff (the study "trainer") and complete self-report questionnaires assessing health behavior adherence and mental and physical health. Then, participants will be randomized to receive the positive psychology + motivational interviewing or the motivational interviewing health education interventions. A study interventionist will provide a treatment manual specific to their condition, review the rationale for the initial exercise, and assign the first exercise. If the participant is in the positive psychology + motivational interviewing condition, the trainer will explain the rationale for both the positive psychology and goal-setting portions of the program, and will be assigned the first exercise. Similarly, if the participant is randomized into the motivational interviewing health education program, the interventionist will introduce them to the program and assign the first exercise. Participants in both groups will then be given an accelerometer, which they will be asked to wear for 7 days to ensure that they are comfortable with the device and that useable data can be obtained from the participant. Participants in both groups will then complete twelve 30-minute weekly phone sessions with a study trainer. The phone sessions primarily will include a review of the prior week's session content and a discussion of the rationale and assignment of the next week's exercise/assignment. Upon the completion of these calls, and again at a final follow-up timepoint at 24 weeks, a blinded member of the study staff will call participants to administer self-report outcome measures. Participants will also be asked to wear an accelerometer at each of these follow-up timepoints as an objective measure of physical activity, which they will return by mail to the study staff.

Typ studie

Intervenční

Zápis (Aktuální)

69

Fáze

  • Nelze použít

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní místa

  • Spojené státy
    • Massachusetts
      • Boston, Massachusetts, Spojené státy, 02114
        • Massachusetts General Hospital

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

18 let a starší (Dospělý, Starší dospělý)

Přijímá zdravé dobrovolníky

Ne

Pohlaví způsobilá ke studiu

Všechno

Popis

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

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Léčba
  • Přidělení: Randomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Singl

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: Pozitivní psychologie + motivační rozhovor
Účastníci absolvují týdenní cvičení pozitivní psychologie a budou si systematicky stanovovat cíle související s pohybovou aktivitou. Studijní školitelé budou každý týden opakovat cvičení pozitivní psychologie po telefonu a budou používat techniky motivačních rozhovorů k usnadnění stanovení cílů.
Behaviorální: Pozitivní psychologie + motivační rozhovor
U části intervence zaměřené na pozitivní psychologii školitel studie (a) zopakuje týdenní cvičení pozitivní psychologie, (b) prodiskutuje zdůvodnění pozitivního psychologického cvičení příštího týdne prostřednictvím řízené revize příručky pozitivní psychologie a (c) zadat cvičení pozitivní psychologie na další týden. U části motivačního rozhovoru účastníci (a) zhodnotí svůj cíl fyzické aktivity z předchozího týdne, (b) prodiskutují techniky pro zlepšení fyzické aktivity a (c) stanoví cíl fyzické aktivity na příští týden. Studijní školitelé budou používat techniky motivačních pohovorů k usnadnění stanovení cílů.
Aktivní komparátor: 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.
Behaviorální: Motivational Interviewing Health Education
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).

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Feasibility of the PP-MI Based Health Behavior Intervention
Časové okno: 24 weeks
Feasibility will be measured by examining the number of completed exercises.
24 weeks
Acceptability of the PP-MI Exercises: Utility Score
Časové okno: Weeks 1-12
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.
Weeks 1-12
Acceptability of the PP-MI Exercises: Ease Score
Časové okno: Weeks 1-12
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.
Weeks 1-12

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Minutes of Moderate to Vigorous Physical Activity (Actigraph)
Časové okno: MVPA at 12 weeks and 24 weeks
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.
MVPA at 12 weeks and 24 weeks
Change in Medication Adherence
Časové okno: Change in score from Baseline to 12 weeks, 24 weeks
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.
Change in score from Baseline to 12 weeks, 24 weeks
Change in Dietary Adherence
Časové okno: Change in score from Baseline to 12 weeks, 24 weeks
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.
Change in score from Baseline to 12 weeks, 24 weeks
Change in Positive Affect
Časové okno: Change in score from Baseline to 12 weeks, 24 weeks
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.
Change in score from Baseline to 12 weeks, 24 weeks
Change in Trait Optimism
Časové okno: Change in score from baseline to 12 week, 24 week
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.
Change in score from baseline to 12 week, 24 week
Change in State Optimism
Časové okno: Change of score from Baseline to 12 weeks, 24 weeks
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.
Change of score from Baseline to 12 weeks, 24 weeks
Changes in HADS-A Scores
Časové okno: Change in score from Baseline to 12 week, 24 week
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.
Change in score from Baseline to 12 week, 24 week
Change in HADS-D Scores
Časové okno: Change in score from Baseline to 12 week, 24 week
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).
Change in score from Baseline to 12 week, 24 week
Change in Physical Function
Časové okno: Change of score from Baseline to 12 week, 24 week
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.
Change of score from Baseline to 12 week, 24 week
Change in SF-12 Scores (Physical)
Časové okno: Change of score from Baseline to 12 week, 24 week
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.
Change of score from Baseline to 12 week, 24 week
Change in SF-12 Scores (Mental)
Časové okno: Change of score from baseline to 12 and 24 weeks.
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.
Change of score from baseline to 12 and 24 weeks.
Change in Adherence to Health Behaviors
Časové okno: Change of score from Baseline to 12 week, 24 week
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.
Change of score from Baseline to 12 week, 24 week
Change in Cardiac Symptoms
Časové okno: Change of score from Baseline to 12 week, 24 week
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.
Change of score from Baseline to 12 week, 24 week
Change in Physical Activity
Časové okno: Change of score from Baseline to 12 week, 24 week
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.
Change of score from Baseline to 12 week, 24 week
Change in Perceived Stress
Časové okno: Change of score from Baseline to 12 week, 24 week
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.
Change of score from Baseline to 12 week, 24 week

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Massachusetts General Hospital

Vyšetřovatelé

  • Vrchní vyšetřovatel: Jeff Huffman, MD, Massachusetts General Hospital

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Aktuální)

1. května 2017

Primární dokončení (Aktuální)

10. července 2018

Dokončení studie (Aktuální)

26. listopadu 2018

Termíny zápisu do studia

První předloženo

6. dubna 2017

První předloženo, které splnilo kritéria kontroly kvality

17. dubna 2017

První zveřejněno (Aktuální)

20. dubna 2017

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

14. května 2020

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

6. května 2020

Naposledy ověřeno

1. května 2020

Více informací

Termíny související s touto studií

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • R01HL113272 (Grant/smlouva NIH USA)

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

NE

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

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