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Understanding and Promoting Health Behaviour Change Amid Transition to Cardiac Rehabilitation (UPBeAT-CR)

16 maj 2022 uppdaterad av: Tavis S. Campbell, University of Calgary

Design and Evaluation of a Brief Motivational Intervention to Promote Enrolment in Outpatient Cardiac Rehabilitation

The purpose of this study was to test whether a brief motivational intervention is associated with enrollment in cardiac rehabilitation.

Studieöversikt

Status

Avslutad

Betingelser

Detaljerad beskrivning

Cardiac rehabilitation programs help reduce morbidity and mortality following a cardiac event, but only a subset of referred patients chooses to participate. An intervention based on principles of motivational interviewing may help resolve individuals' ambivalence about cardiac rehabilitation. The primary aim is to evaluate the efficacy of a brief motivational intervention (MI) for enhancing intention to enroll in cardiac rehabilitation compared to a usual care (UC) control condition among patients referred to cardiac rehabilitation. It is hypothesized that patients in the MI condition will report greater intention to enroll in cardiac rehabilitation compared to patients in UC. A small-scale feasibility trial will include patients (n = 100) with acute coronary syndrome who are referred to a standard 12-week exercise-based cardiac rehabilitation program in Calgary, Canada. Patients will be randomly assigned to MI or UC. The primary outcome will be self-reported intention to attend cardiac rehabilitation. Secondary outcomes will include beliefs about cardiac rehabilitation, exercise self-efficacy, perceived barriers, and cardiac rehabilitation enrollment.

Studietyp

Interventionell

Inskrivning (Faktisk)

100

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

    • Alberta
      • Calgary, Alberta, Kanada, T2N1N4
        • Department of Psychology, University of Calgary

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

Inclusion Criteria:

  • Referred to and eligible for outpatient, exercise-based cardiac rehabilitation; confirmed acute coronary syndrome; English-speaking; able to complete study prior to first scheduled cardiac rehabilitation appointment

Exclusion Criteria:

  • Cognitive or hearing impairment that would interfere with study participation

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Stödjande vård
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: Brief Motivational Intervention
Single, 60-minute, manualized behavioural intervention designed to support cardiac rehabilitation enrollment, informed by principles of motivational interviewing
Inget ingripande: Usual Care
Standard encouragement to enroll in cardiac rehabilitation, and meeting with a researcher to complete study questionnaires

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Intention to Attend Cardiac Rehabilitation Scale (adapted from Blanchard et al., 2002)
Tidsram: At least 1 day after receiving MI or UC but prior to enrollment in cardiac rehabilitation (average 7 days)

Intention to attend cardiac rehabilitation will be assessed using the average of two self-report items: (1) "My goal is to attend ___ exercise classes at cardiac rehabilitation" with responses ranging from 1 (no exercise classes) to 7 (some exercise classes) and (2) "I intend to attend scheduled classes during cardiac rehabilitation" with responses ranging from 1 (strongly disagree) to 7 (strongly agree).

Blanchard, C. M., Courneya, K. S., Rodgers, W. M., Daub, B., & Knapik, G. (2002). Determinants of exercise intention and behavior during and after phase 2 cardiac rehabilitation: An application of the theory of planned behavior. Rehabilitation Psychology, 47(3), 308-323.

At least 1 day after receiving MI or UC but prior to enrollment in cardiac rehabilitation (average 7 days)

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Cardiac Rehabilitation Enrollment (attendance at ≥1 appointment; chart review)
Tidsram: 60 days after initial referral to cardiac rehabilitation program
Participation in cardiac rehabilitation will be confirmed by chart review 60 days after referral. Non-enrollment will be defined as (a) explicitly declining interest in CR participation, (b) not attending the initial scheduled exercise appointment within 60 days of referral, or (c) inability to be contacted by program staff within 60 days of referral to cardiac rehabilitation.
60 days after initial referral to cardiac rehabilitation program
Beliefs About Cardiac Rehabilitation Scale (BACR; Cooper et al., 2007)
Tidsram: At least 1 day after receiving MI or UC but prior to enrollment in cardiac rehabilitation (average 7 days)

The BACR is a 13-item questionnaire that evaluates patients' beliefs regarding CR. Items are rated on a 5-point Likert-type scale, ranging from "strongly disagree" to "strongly agree." Items are summed to provide a score on each of four subscales: perceived necessity, concerns about exercise, practical barriers, and perceived suitability.

Cooper, A. F., Weinman, J., Hankins, M., Jackson, G., & Horne, R. (2007). Assessing patients' beliefs about cardiac rehabilitation as a basis for predicting attendance after acute myocardial infarction. Heart (British Cardiac Society), 93(1), 53-8. doi:10.1136/hrt.2005.081299

At least 1 day after receiving MI or UC but prior to enrollment in cardiac rehabilitation (average 7 days)
Multidimensional Self-Efficacy for Exercise Scale (Rodgers et al., 2008)
Tidsram: At least 1 day after receiving MI or UC but prior to enrollment in cardiac rehabilitation (average 7 days)

The MSES is a 9-item questionnaire that evaluates exercise self-efficacy in three domains: task (e.g., ability to follow directions to complete exercise), coping (e.g., ability to exercise when feeling discomfort from exercise), and scheduling (e.g. ability to fit exercise into daily routine). Items are rated from 0 (not at all confident) to 100 (completely confident), and averaged in each domain.

Rodgers, W. M., Wilson, P. M., Hall, C. R., Fraser, S. N., & Murray, T. C. (2008). Evidence for a multidimensional self-efficacy for exercise scale. Research Quarterly for Exercise and Sport, 79(2), 222-34.

At least 1 day after receiving MI or UC but prior to enrollment in cardiac rehabilitation (average 7 days)
Cardiac Rehabilitation Barriers Scale (CRBS; Shanmugasegaram et al., 2012)
Tidsram: At least 1 day after receiving MI or UC but prior to enrollment in cardiac rehabilitation (average 7 days)

The CRBS is a 21-item questionnaire designed to assess perceptions of patient, provider, and health system barriers to CR participation. Items are rated on 5-point Likert-type scales ranging from "strongly disagree" to "strongly agree," and are averaged to provide a total score, with higher scores indicating greater perceived barriers. Totals are also calculated for four subscales: perceived need/healthcare factors, logistical factors, work/time conflicts, and comorbidities/functional status.

Shanmugasegaram, S., Gagliese, L., Oh, P., Stewart, D. E., Brister, S. J., Chan, V., & Grace, S. L. (2012). Psychometric validation of the Cardiac Rehabilitation Barriers Scale. Clinical Rehabilitation, 26(2), 152-64. doi:10.1177/0269215511410579

At least 1 day after receiving MI or UC but prior to enrollment in cardiac rehabilitation (average 7 days)

Andra resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
ENRICHD Social Support Instrument (ESSI; Mitchell et al., 2003)
Tidsram: At least 1 day after receiving MI or UC but prior to enrollment in cardiac rehabilitation (average 7 days)

The ESSI is a 7-item questionnaire designed to assess social support in patients post-myocardial infarction. Items are rated from 1 (none of the time) to 5 (all of the time), and are summed to provide a total score, with higher scores indicating more social support.

Mitchell, P. H., Powell, L., Blumenthal, J., Norten, J., Ironson, G., Pitula, C. R., ... & Berkman, L. F. (2003). A short social support measure for patients recovering from myocardial infarction: the ENRICHD Social Support Inventory. Journal of Cardiopulmonary Rehabilitation and Prevention, 23(6), 398-403.

At least 1 day after receiving MI or UC but prior to enrollment in cardiac rehabilitation (average 7 days)
Brief Illness Perceptions Questionnaire (BIPQ; Broadbent et al., 2006)
Tidsram: At least 1 day after receiving MI or UC but prior to enrollment in cardiac rehabilitation (average 7 days)

The BIPQ is an 8-item questionnaire that assesses cognitive and emotional representations of illness. It evaluates perceived consequences, timelines, personal/treatment control, symptoms, concern, understanding, and emotional consequences associated with the illness. Items are summed to provide a total score, with higher scores indicating greater perceived threat of the illness.

Broadbent, E., Petrie, K. J., Main, J., & Weinman, J. (2006). The brief illness perception questionnaire. Journal of Psychosomatic Research, 60(6), 631-7. doi:10.1016/j.jpsychores.2005.10.020

At least 1 day after receiving MI or UC but prior to enrollment in cardiac rehabilitation (average 7 days)
Cardiac rehabilitation adherence (# of cardiac rehabilitation sessions attended; chart review)
Tidsram: Following a 12-week cardiac rehabilitation program
Number of cardiac rehabilitation sessions attended (out of a total possible 24 scheduled sessions)
Following a 12-week cardiac rehabilitation program

Samarbetspartners och utredare

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Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

1 juni 2015

Primärt slutförande (Faktisk)

1 maj 2016

Avslutad studie (Faktisk)

1 april 2017

Studieregistreringsdatum

Först inskickad

18 mars 2016

Först inskickad som uppfyllde QC-kriterierna

22 mars 2016

Första postat (Uppskatta)

29 mars 2016

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

18 maj 2022

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

16 maj 2022

Senast verifierad

1 maj 2022

Mer information

Termer relaterade till denna studie

Andra studie-ID-nummer

  • REB14-1213

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