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

6. mai 2020 oppdatert av: 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.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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.

Studietype

Intervensjonell

Registrering (Faktiske)

69

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Forente stater
    • Massachusetts
      • Boston, Massachusetts, Forente stater, 02114
        • Massachusetts General Hospital

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Enkelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Positiv psykologi + motiverende intervju
Deltakerne skal gjennomføre ukentlige positive psykologiøvelser og vil systematisk sette mål knyttet til fysisk aktivitet. Studietrenere vil gjennomgå de positive psykologiøvelsene på telefonen hver uke og vil bruke motiverende intervjuteknikker for å lette målsettingen.
Atferdsmessig: Positiv psykologi + motiverende intervju
For den positive psykologi-delen av intervensjonen, vil studietreneren (a) gjennomgå ukens positive psykologi-øvelse, (b) diskutere begrunnelsen for neste ukes positiv-psykologi-øvelse gjennom en veiledet gjennomgang av positiv psykologi-manualen, og (c) tilordne neste ukes positiv psykologiøvelse. For den motiverende intervjudelen vil deltakerne (a) gjennomgå sitt fysiske aktivitetsmål fra forrige uke, (b) diskutere teknikker for å forbedre fysisk aktivitet og (c) sette et fysisk aktivitetsmål for neste uke. Studietrenere vil bruke motiverende intervjuteknikker for å lette målsettingen.
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.
Atferdsmessig: 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).

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Feasibility of the PP-MI Based Health Behavior Intervention
Tidsramme: 24 weeks
Feasibility will be measured by examining the number of completed exercises.
24 weeks
Acceptability of the PP-MI Exercises: Utility Score
Tidsramme: 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
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Minutes of Moderate to Vigorous Physical Activity (Actigraph)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Massachusetts General Hospital

Etterforskere

  • Hovedetterforsker: Jeff Huffman, MD, Massachusetts General Hospital

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

1. mai 2017

Primær fullføring (Faktiske)

10. juli 2018

Studiet fullført (Faktiske)

26. november 2018

Datoer for studieregistrering

Først innsendt

6. april 2017

Først innsendt som oppfylte QC-kriteriene

17. april 2017

Først lagt ut (Faktiske)

20. april 2017

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

14. mai 2020

Siste oppdatering sendt inn som oppfylte QC-kriteriene

6. mai 2020

Sist bekreftet

1. mai 2020

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • R01HL113272 (U.S. NIH-stipend/kontrakt)

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

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Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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