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

16. mai 2022 oppdatert 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.

Studieoversikt

Status

Fullført

Detaljert beskrivelse

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

Intervensjonell

Registrering (Faktiske)

100

Fase

  • Ikke aktuelt

Kontakter og plasseringer

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

Studiesteder

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

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:

  • 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

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

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Støttende omsorg
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

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

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Intention to Attend Cardiac Rehabilitation Scale (adapted from Blanchard et al., 2002)
Tidsramme: 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)

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Cardiac Rehabilitation Enrollment (attendance at ≥1 appointment; chart review)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)

Andre resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
ENRICHD Social Support Instrument (ESSI; Mitchell et al., 2003)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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

Samarbeidspartnere og etterforskere

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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. juni 2015

Primær fullføring (Faktiske)

1. mai 2016

Studiet fullført (Faktiske)

1. april 2017

Datoer for studieregistrering

Først innsendt

18. mars 2016

Først innsendt som oppfylte QC-kriteriene

22. mars 2016

Først lagt ut (Anslag)

29. mars 2016

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

18. mai 2022

Siste oppdatering sendt inn som oppfylte QC-kriteriene

16. mai 2022

Sist bekreftet

1. mai 2022

Mer informasjon

Begreper knyttet til denne studien

Andre studie-ID-numre

  • REB14-1213

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