International CR Registry

Coronary Artery Disease Clinical Trial

— ICRR  

Official title:

International Cardiac Rehabilitation Registry (ICRR) Protocol

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
• 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
• 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:

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 7000
• Est. completion date: June 30, 2041
• Est. primary completion date: June 30, 2036
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Coronary Artery Disease
• Heart Failure

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

External Links

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