International CR Registry (ICRR)
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| ClinicalTrials.gov Identifier: NCT04676100 |
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Recruitment Status :
Enrolling by invitation
First Posted : December 19, 2020
Last Update Posted : October 4, 2021
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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.
| Condition or disease | Intervention/treatment |
|---|---|
| Acute Coronary Syndrome Heart Failure Coronary Artery Disease | Other: Cardiac rehabilitation |
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 |
| Estimated Enrollment : | 7000 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Official Title: | International Cardiac Rehabilitation Registry (ICRR) Protocol |
| Actual Study Start Date : | September 27, 2021 |
| Estimated Primary Completion Date : | June 30, 2036 |
| Estimated Study Completion Date : | June 30, 2041 |
- 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.
Other Names:- quality improvement initiatives
- feedback
- Mortality [ Time Frame: 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 ]all-cause mortality, assessed via phone call
- Morbidity [ Time Frame: 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 ]CV event or procedure, emergency department visit for cardiac cause, or any cause hospitalization, and/or other new health condition assessed via self-report
- Cardiac Symptoms [ Time Frame: 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 ]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/)
- Functional capacity [ Time Frame: pre and post-CR program (dependent upon program length, but globally the median is 8 weeks) ]peak METs, which could be calculated based on exercise test (treadmill or bike), Duke Activity Status Index, or 6-minute walk test
- Low-density lipoprotein [ Time Frame: pre and post-CR program (dependent upon program length, but globally the median is 8 weeks) ]in mmol/L or mg/dL from lab report
- Body mass index [ Time Frame: pre and post-CR program (dependent upon program length, but globally the median is 8 weeks) ]weight and height will be combined to report BMI in kg/m^2
- Blood pressure [ Time Frame: pre and post-CR program (dependent upon program length, but globally the median is 8 weeks) ]systolic and diastolic (mmHg), assessed manually or with a validated automated device
- Work status [ Time Frame: 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 ]return-to-work, if applicable, assessed via self-report of work status
- Psychosocial well-being [ Time Frame: 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) & depressive symptoms (PHQ-2)
- Quality of life [ Time Frame: 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 ]Cantril's ladder of life (10 rungs)
- Depressive symptoms [ Time Frame: 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 ]PHQ-2
- Physical activity [ Time Frame: 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 ]self-report of minutes per week active to being at least slightly short of breath, assessed via self-report
- Diet [ Time Frame: 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 ]average number of fruits and vegetables per day, via self-report
- Medication adherence [ Time Frame: 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 ]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
- Tobacco use [ Time Frame: 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 ]self-report of never, current (last month), or former (use of tobacco more than 1 month prior)
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04676100
| Qatar | |
| Hamad Medical Corporation | |
| Doha, Qatar | |
| Principal Investigator: | Sherry L Grace | York University & University Health Network | |
| Principal Investigator: | Karam Turk-Adawi, PhD | Qatar University |
Publications:
| Responsible Party: | Sherry Grace, Professor, Faculty of Health & Sr. Scientist, KITE University Health Network, York University |
| ClinicalTrials.gov Identifier: | NCT04676100 |
| Other Study ID Numbers: |
York U ethics e2020-359 215 ( Other Grant/Funding Number: Qatar University International Research Collaboration Co-Fund 2020 ) |
| First Posted: | December 19, 2020 Key Record Dates |
| Last Update Posted: | October 4, 2021 |
| Last Verified: | September 2021 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Yes |
| 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. |
| Supporting Materials: |
Study Protocol Statistical Analysis Plan (SAP) Informed Consent Form (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 |
| URL: | https://globalcardiacrehab.com/International-CR-Registry-(ICRR) |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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registry cardiac rehabilitation mortality equity quality of care |
patient engagement audit and feedback health behavior patient-reported outcomes depression |
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Coronary Artery Disease Acute Coronary Syndrome Heart Diseases Cardiovascular Diseases Coronary Disease |
Myocardial Ischemia Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases |