International CR Registry

NCT04676100 | Enrolling By Invitation DMC

• 2 other identifiers: York U ethics e2020-359215
• Study Type: observational
• Target: 7,000
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Acute Coronary Syndrome; Heart Failure; Coronary Artery Disease

Keywords

registry; cardiac rehabilitation; mortality; equity; quality of care; patient engagement; audit and feedback; health behavior; patient-reported outcomes; depression

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (9)

• Cardiac Symptoms

  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

• Functional capacity

  pre and post-CR program (dependent upon program length, but globally the median is 8 weeks)

• Low-density lipoprotein

  pre and post-CR program (dependent upon program length, but globally the median is 8 weeks)

• Body mass index

  pre and post-CR program (dependent upon program length, but globally the median is 8 weeks)

• Blood pressure

  pre and post-CR program (dependent upon program length, but globally the median is 8 weeks)

Other Outcomes (4)

• Physical activity

  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

• Diet

  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

• Medication adherence

  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

Interventions

Cardiac rehabilitation OTHER

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.

Also known as: quality improvement initiatives, feedback

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Coronary heart disease patients who are indicated for CR are eligible for registry inclusion (e.g., acute coronary syndrome +/- revascularization, heart failure, stable coronary artery disease +/- valve or rhythm conditions); there are some exclusions to CR eligibility such as inability to ambulate.

You may qualify if:

• SITES:
• CR program (defined in intervention section)
• in low-resource setting (i.e., low or middle-income country according to World Bank, or in region within a higher-income country where there is under-development of CR related to financial resources, lack of healthcare system resources, lack of patient and provider awareness, and/or patient disadvantage \[e.g., limited social resources, geographic barriers\])

You may not qualify if:

• SITES:
• program cannot enter data in English
• PATIENTS:
• not capable to understand the registry information letter for cognitive or mental reasons (although they would also likely be excluded from CR).
• not proficient in the language of the local ethics-approved registry information letter /consent form.

Sponsors & Collaborators

• University Health Network, Toronto: lead
• International Council of Cardiovascular Prevention and Rehabilitation (ICCPR: collaborator
• York University: collaborator
• Qatar University: collaborator

Study Sites (1)

Hamad Medical Corporation

Doha, Qatar

Location

Related Publications (4)

• 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.

  PMID: 28762761 BACKGROUND

• 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/

  PMID: 24945055 BACKGROUND

• 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.

  PMID: 35174042 BACKGROUND

• 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.

  PMID: 36038174 BACKGROUND

Related Links

• Registry page for interested programs and the CR community. Patient website to be developed

MeSH Terms

Conditions

Acute Coronary Syndrome; Heart Failure; Coronary Artery Disease; Patient Participation; Health Behavior; Depression

Interventions

Cardiac Rehabilitation

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Coronary Disease; Arteriosclerosis; Arterial Occlusive Diseases; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Behavior; Behavioral Symptoms

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Sherry L Grace

  York University & University Health Network

  PRINCIPAL INVESTIGATOR

• Karam Turk-Adawi, PhD

  Qatar University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Faculty of Health & Sr. Scientist, KITE University Health Network

Study Record Dates

• First Submitted: December 9, 2020
• First Posted: December 19, 2020
• Study Start: September 27, 2021
• Primary Completion (Estimated): June 30, 2036
• Study Completion (Estimated): June 30, 2041
• Last Updated: December 4, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: to be announced
• Access Criteria: The research sub-committee will develop a policy. Once approved, it will be posted at the website below

Locations

QA (1)