International CR Registry (ICRR)

International Cardiac Rehabilitation Registry (ICRR) Protocol

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Coronary Artery Disease; Heart Failure; Acute Coronary Syndrome
• Intervention / Treatment: Other: Cardiac rehabilitation

Detailed Description

The user sub-committee has a formal site on-boarding process. Participating sites will be encouraged to enter data on all patients meeting inclusion / exclusion criteria to reduce bias. Prospective / concurrent data collection will be encouraged, to support quality improvement activities.

The company Dendrite will host the registry and ensure data security. Privacy protections will be in place, and no identifying information such as names will be entered into the registry. Data entered from sites into the registry is secured through encryption added to secure HTTP, done using Transport Layer Security. Stored data is also encrypted using InterSystems Cache database software.

There is an ICRR program survey assessing structural CR indicators. The registry variable list for patient-level data was developed based on recommendations of the Core Outcome Set-STAndards for Development (COS-STAD), through a delphi process. The final variable list and data dictionary can be found here: https://globalcardiacrehab.com/ICRR-Governance.

There are 10 program-reported variables and 16 patient-reported variables (some variables are assessed at multiple time points), assessed pre-program, post-program (dependent upon duration of each program) and each year from initial assessment (until patients expire or are unable to complete the assessments, which is ascertained by the program, or patient opt-out/withdrawal). Sites can arrange electronic data capture for the program-reported variables to contribute data to the registry, rather than manual electronic entry.

Descriptive statistics (i.e. means and standard deviations for continuous variables and frequencies with percentages for categorical variables) will be used to describe the quality of care (outcomes below). For testing change in patient outcomes pre to post-program, paired t-tests will also be used for continuous variables and chi-square test for categorical variables.

Univariate and multivariate approaches will be used to identify factors associated with outcomes, including the use of guideline-indicated therapies. Associations between patient characteristics and outcomes tested via logistic regression will be reported with odds ratios and 95% confidence intervals. Associations will be considered statistically significant when 2-sided α is <0.05. Appropriate statistical corrections for repeated measures will be performed. To limit the influence of confounding, multivariate adjustment will be used, including propensity weighting, or other techniques. Risk adjustment (e.g., socioeconomic status, indication, comorbidities, age) will be undertaken.

The registry has a data quality dashboard which displays by site completeness of data entry at each assessment point, to help reduce bias. The registry has in-built minimum and maximum values for continuous variables to reduce data entry errors. The data dictionary clearly defines each variable, and new sites are trained prior to start. The registry is being usability tested prior to launch, and piloted in Qatar. The research sub-committee will oversee a data quality process; Data audits may be supported by a registry database analyst / professional statistician.

Patient perspectives were considered in the development of the variable list and outcomes. A registry page for patients is in development (https://globalcardiacrehab.com/ICRR-for-Patients). Patients have a voice on ICRR's user sub-committee. Patients providing data pre and post-program may receive a lay summary of their progress. Lay summaries of annual registry reports may be shared with interested patients.

• Study Type: Observational
• Enrollment (Estimated): 7000

Contacts and Locations

Study Locations

• Qatar
  • Doha, Qatar
    • Hamad Medical Corporation

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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.

Description

Inclusion Criteria:

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])

Exclusion Criteria:

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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)
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)
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)
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)
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
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
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
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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

Collaborators and Investigators

• Sponsor: University Health Network, Toronto
• Collaborators: Qatar University; York University; International Council of Cardiovascular Prevention and Rehabilitation (ICCPR
• Investigators: Principal Investigator: Sherry L Grace, York University & University Health Network; Principal Investigator: Karam Turk-Adawi, PhD, Qatar University

Publications and helpful links

General Publications

• 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/
• 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.
• 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.
• 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.

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Actual): September 27, 2021
• Primary Completion (Estimated): June 30, 2036
• Study Completion (Estimated): June 30, 2041

Study Registration Dates

• First Submitted: December 9, 2020
• First Submitted That Met QC Criteria: December 17, 2020
• First Posted (Actual): December 19, 2020

Study Record Updates

• Last Update Posted (Estimated): December 4, 2023
• Last Update Submitted That Met QC Criteria: November 28, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: depression; quality of care; mortality; patient-reported outcomes; registry; health behavior; cardiac rehabilitation; patient engagement; audit and feedback; equity
• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Coronary Artery Disease; Acute Coronary Syndrome
• Other Study ID Numbers: York U ethics e2020-359; 215 (Other Grant/Funding Number: Qatar University International Research Collaboration Co-Fund 2020)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

The ICCR will explore potential public posting of anonymous registry data in a repository in future, to augment utility of the data through availability to the scientific community.

Specific sites may also apply for ethics approval for administrative data linkage (e.g., clinical databases, imaging or lab data, government databases or surveys), which could enable cost-effectiveness analysis for example. Contributing sites may also apply for ethics approval to survey patients over and above registry assessments.

Any secondary use of the data for research purposes will go through separate ethical review. Requests will be vetted by the ICRR research sub-committee. No data will be released that could identify patients. This may include sharing of aggregate data on common variables with other CR registries. This research may be published in peer-reviewed journals and presented at scholarly conferences.

• IPD Sharing Time Frame: to be announced
• IPD Sharing Access Criteria: The research sub-committee will develop a policy. Once approved, it will be posted at the website below
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No