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

16 maja 2022 zaktualizowane przez: 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.

Przegląd badań

Status

Zakończony

Warunki

Interwencja / Leczenie

Szczegółowy opis

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.

Typ studiów

Interwencyjne

Zapisy (Rzeczywisty)

100

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Lokalizacje studiów

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

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

18 lat i starsze (Dorosły, Starszy dorosły)

Akceptuje zdrowych ochotników

Nie

Płeć kwalifikująca się do nauki

Wszystko

Opis

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

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie podtrzymujące
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Brak (otwarta etykieta)

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: Brief Motivational Intervention
Single, 60-minute, manualized behavioural intervention designed to support cardiac rehabilitation enrollment, informed by principles of motivational interviewing
Behawioralne: Brief Motivational Intervention
Brak interwencji: Usual Care
Standard encouragement to enroll in cardiac rehabilitation, and meeting with a researcher to complete study questionnaires

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Intention to Attend Cardiac Rehabilitation Scale (adapted from Blanchard et al., 2002)
Ramy czasowe: 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)

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Cardiac Rehabilitation Enrollment (attendance at ≥1 appointment; chart review)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)

Inne miary wyników

Miara wyniku
Opis środka
Ramy czasowe
ENRICHD Social Support Instrument (ESSI; Mitchell et al., 2003)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

University of Calgary

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

1 czerwca 2015

Zakończenie podstawowe (Rzeczywisty)

1 maja 2016

Ukończenie studiów (Rzeczywisty)

1 kwietnia 2017

Daty rejestracji na studia

Pierwszy przesłany

18 marca 2016

Pierwszy przesłany, który spełnia kryteria kontroli jakości

22 marca 2016

Pierwszy wysłany (Oszacować)

29 marca 2016

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

18 maja 2022

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

16 maja 2022

Ostatnia weryfikacja

1 maja 2022

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Inne numery identyfikacyjne badania

  • REB14-1213

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