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

16 mei 2022 bijgewerkt door: 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.

Studie Overzicht

Toestand

Voltooid

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Werkelijk)

100

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

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

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Ondersteunende zorg
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Brief Motivational Intervention
Single, 60-minute, manualized behavioural intervention designed to support cardiac rehabilitation enrollment, informed by principles of motivational interviewing
Geen tussenkomst: Usual Care
Standard encouragement to enroll in cardiac rehabilitation, and meeting with a researcher to complete study questionnaires

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Intention to Attend Cardiac Rehabilitation Scale (adapted from Blanchard et al., 2002)
Tijdsspanne: 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)

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Cardiac Rehabilitation Enrollment (attendance at ≥1 appointment; chart review)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)

Andere uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
ENRICHD Social Support Instrument (ESSI; Mitchell et al., 2003)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

1 juni 2015

Primaire voltooiing (Werkelijk)

1 mei 2016

Studie voltooiing (Werkelijk)

1 april 2017

Studieregistratiedata

Eerst ingediend

18 maart 2016

Eerst ingediend dat voldeed aan de QC-criteria

22 maart 2016

Eerst geplaatst (Schatting)

29 maart 2016

Updates van studierecords

Laatste update geplaatst (Werkelijk)

18 mei 2022

Laatste update ingediend die voldeed aan QC-criteria

16 mei 2022

Laatst geverifieerd

1 mei 2022

Meer informatie

Termen gerelateerd aan deze studie

Andere studie-ID-nummers

  • REB14-1213

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