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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT04676100
Other study ID # York U ethics e2020-359
Secondary ID 215
Status Enrolling by invitation
Phase
First received
Last updated
Start date September 27, 2021
Est. completion date June 30, 2041

Study information

Verified date November 2023
Source University Health Network, Toronto
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The ICRR is a health services registry to establish the quality of CR delivery, and the effectiveness in terms of patient outcomes, in low-resource settings. The purposes of the registry are care optimization, evidentiary support for CR advocacy / policy, and research. All programs in low-resource settings will be welcome to participate at no cost. Programs will follow procedures approved by their local ethics board for collection of program and patient-reported variables. Assessments occur pre-cardiac rehabilitation (CR), post-CR and annually thereafter.


Description:

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Study Design


Intervention

Other:
Cardiac rehabilitation
A CR program is defined as one that offers initial assessment, structured exercise (can be supervised or unsupervised) and at least one other strategy to control risk factors. The registry pertains to phase II CR. Quality of care and patient outcomes are benchmarked with other countries anonymously, through 2 registry dashboards (real-time). The dashboards will also show change over time in 6-month increments; Sites will be encouraged to continue to provide data on new patients until all indicators show quality as possible. Sites will be supported in quality improvement by the ICRR user sub-committee. High-performing programs will be recognized on ICRR's website and ICCPR's social media accounts. This mechanism may be used in future to support program accreditation.

Locations

Country Name City State
Qatar Hamad Medical Corporation Doha

Sponsors (4)

Lead Sponsor Collaborator
University Health Network, Toronto International Council of Cardiovascular Prevention and Rehabilitation (ICCPR, Qatar University, York University

Country where clinical trial is conducted

Qatar, 

References & Publications (4)

Abukhadijah HJ, Turk-Adawi KI, Dewart N, Grace SL. Qualitative study measuring the usability of the International Cardiac Rehabilitation Registry. BMJ Open. 2022 Aug 29;12(8):e064255. doi: 10.1136/bmjopen-2022-064255. — View Citation

Chowdhury MI, Turk-Adawi K, Babu AS, de Melo Ghisi GL, Seron P, Yeo TJ, Uddin J, Heine M, Saldivia MG, Kouidi E, Sadeghi M, Aljehani R, Grace SL. Development of the International Cardiac Rehabilitation Registry Including Variable Selection and Definition Process. Glob Heart. 2022 Jan 11;17(1):1. doi: 10.5334/gh.1091. eCollection 2022. — View Citation

Gliklich RE, Dreyer NA, Leavy MB, editors. Registries for Evaluating Patient Outcomes: A User's Guide [Internet]. 3rd edition. Rockville (MD): Agency for Healthcare Research and Quality (US); 2014 Apr. Report No.: 13(14)-EHC111. Available from http://www.ncbi.nlm.nih.gov/books/NBK208616/ — View Citation

Poffley A, Thomas E, Grace SL, Neubeck L, Gallagher R, Niebauer J, O'Neil A. A systematic review of cardiac rehabilitation registries. Eur J Prev Cardiol. 2017 Oct;24(15):1596-1609. doi: 10.1177/2047487317724576. Epub 2017 Aug 1. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Other Physical activity self-report of minutes per week active to being at least slightly short of breath, assessed via self-report pre and post-CR program (dependent upon program length, but globally the median is 8 weeks) & annual until patient expiry or withdrawal; there is no planned end date to registry but we estimate this will be assessed at 5 years
Other Diet average number of fruits and vegetables per day, via self-report pre and post-CR program (dependent upon program length, but globally the median is 8 weeks) & annual until patient expiry or withdrawal; there is no planned end date to registry but we estimate this will be assessed at 5 years
Other Medication adherence frequency of taking heart pills as directed by physician in last month (5 point Likert scale from all the time to never), assessed via self-report pre and post-CR program (dependent upon program length, but globally the median is 8 weeks) & annual until patient expiry or withdrawal; there is no planned end date to registry but we estimate this will be assessed at 5 years
Other Tobacco use self-report of never, current (last month), or former (use of tobacco more than 1 month prior) pre and post-CR program (dependent upon program length, but globally the median is 8 weeks) & annual until patient expiry or withdrawal; there is no planned end date to registry but we estimate this will be assessed at 5 years
Primary Mortality all-cause mortality, assessed via phone call assessed annually from initial assessment date until patient expiry or withdrawal; there is no planned end date to registry but we estimate this will be assessed at 5 years
Primary Morbidity CV event or procedure, emergency department visit for cardiac cause, or any cause hospitalization, and/or other new health condition assessed via self-report assessed annually from initial assessment date until patient expiry or withdrawal; there is no planned end date to registry but we estimate this will be assessed at 5 years
Secondary Cardiac Symptoms frequency of shortness of breath, dizziness, or chest pain in past month, assessed via self-report item (investigator-generated item based on https://www.ichom.org/portfolio/coronary-artery-disease/) assessed annually from initial assessment date until patient expiry or withdrawal; there is no planned end date to registry but we estimate this will be assessed at 5 years
Secondary Functional capacity peak METs, which could be calculated based on exercise test (treadmill or bike), Duke Activity Status Index, or 6-minute walk test pre and post-CR program (dependent upon program length, but globally the median is 8 weeks)
Secondary Low-density lipoprotein in mmol/L or mg/dL from lab report pre and post-CR program (dependent upon program length, but globally the median is 8 weeks)
Secondary Body mass index weight and height will be combined to report BMI in kg/m^2 pre and post-CR program (dependent upon program length, but globally the median is 8 weeks)
Secondary Blood pressure systolic and diastolic (mmHg), assessed manually or with a validated automated device pre and post-CR program (dependent upon program length, but globally the median is 8 weeks)
Secondary Work status return-to-work, if applicable, assessed via self-report of work status pre and post-CR program (dependent upon program length, but globally the median is 8 weeks) & annually until patient expiry or withdrawal; there is no planned end date to registry but we estimate this will be assessed at 5 yea
Secondary Psychosocial well-being quality of life (Cantril's ladder) & depressive symptoms (PHQ-2) pre and post-CR program (dependent upon program length, but globally the median is 8 weeks) & annual until patient expiry or withdrawal; there is no planned end date to registry but we estimate this will be assessed at 5 years
Secondary Quality of life Cantril's ladder of life (10 rungs) pre and post-CR program (dependent upon program length, but globally the median is 8 weeks) & annual until patient expiry or withdrawal; there is no planned end date to registry but we estimate this will be assessed at 5 years
Secondary Depressive symptoms PHQ-2 pre and post-CR program (dependent upon program length, but globally the median is 8 weeks) & annual until patient expiry or withdrawal; there is no planned end date to registry but we estimate this will be assessed at 5 years
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