- ICH GCP
- Register voor klinische proeven in de VS.
- Klinische proef NCT02721758
Understanding and Promoting Health Behaviour Change Amid Transition to Cardiac Rehabilitation (UPBeAT-CR)
Design and Evaluation of a Brief Motivational Intervention to Promote Enrolment in Outpatient Cardiac Rehabilitation
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
Studietype
Inschrijving (Werkelijk)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
-
-
Alberta
-
Calgary, Alberta, Canada, T2N1N4
- Department of Psychology, University of Calgary
-
-
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
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
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
Sponsor
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Andere studie-ID-nummers
- REB14-1213
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .
Klinische onderzoeken op Naleving van de patiënt
-
Mersin UniversityNog niet aan het wervenPatient resultaten
-
University of AarhusCentral Denmark RegionActief, niet wervendMedisch onderwijs | Kindergeneeskunde | Patient resultatenDenemarken
-
Vance Thompson Vision - MTOnbekendVoorkeur van de patiënt | Postoperatieve ontsteking | Patient resultaten | Graad van postoperatief cystoïd maculair oedeem | Snelheid van postoperatief cystoïd maculair oedeemVerenigde Staten
Klinische onderzoeken op Brief Motivational Intervention
-
University of North Carolina, Chapel HillNational Institute on Drug Abuse (NIDA); National Institute of Mental Health...Voltooid
-
Ruth Masterson-CreberUniversity of Pennsylvania; Edna G Kynett Memorial FoundationVoltooidHartfalenVerenigde Staten
-
University of SheffieldVoltooidHuisartsenpraktijk, instellingen voor eerstelijnszorgVerenigd Koninkrijk
-
The Behavioural Insights TeamOnbekendVermijdbare bezoeken aan de afdeling spoedeisende hulp
-
Veerle SnijdersCroatian Institute of Public Health; Andrija Štampar School of Public HealthWervingColorectale kanker | GedragsveranderingKroatië
-
Public Health EnglandNational Health Service, United KingdomVoltooid
-
Unity Health TorontoVoltooidKanker | Sociaaleconomische status | Vroege detectie van kankerCanada
-
The University of Texas Health Science Center,...National Center for Advancing Translational Sciences (NCATS)Actief, niet wervend
-
Office of Evaluation SciencesVoltooid
-
Henry Ford Health SystemBlue Cross Blue Shield of Michigan FoundationVoltooidDiabetes mellitus, type 2Verenigde Staten