Clinical Trials Logo

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:

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.

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
See also
  Status Clinical Trial Phase
Recruiting NCT06030596 - SPECT Myocardial Blood Flow Quantification for Diagnosis of Ischemic Heart Disease Determined by Fraction Flow Reserve
Completed NCT04080700 - Korean Prospective Registry for Evaluating the Safety and Efficacy of Distal Radial Approach (KODRA)
Recruiting NCT03810599 - Patient-reported Outcomes in the Bergen Early Cardiac Rehabilitation Study N/A
Recruiting NCT06002932 - Comparison of PROVISIONal 1-stent Strategy With DEB Versus Planned 2-stent Strategy in Coronary Bifurcation Lesions. N/A
Not yet recruiting NCT06032572 - Evaluation of the Safety and Effectiveness of the VRS100 System in PCI (ESSENCE) N/A
Recruiting NCT05308719 - Nasal Oxygen Therapy After Cardiac Surgery N/A
Recruiting NCT04242134 - Drug-coating Balloon Angioplasties for True Coronary Bifurcation Lesions N/A
Completed NCT04556994 - Phase 1 Cardiac Rehabilitation With and Without Lower Limb Paddling Effects in Post CABG Patients. N/A
Recruiting NCT05846893 - Drug-Coated Balloon vs. Drug-Eluting Stent for Clinical Outcomes in Patients With Large Coronary Artery Disease N/A
Recruiting NCT06027788 - CTSN Embolic Protection Trial N/A
Recruiting NCT05023629 - STunning After Balloon Occlusion N/A
Completed NCT04941560 - Assessing the Association Between Multi-dimension Facial Characteristics and Coronary Artery Diseases
Completed NCT04006288 - Switching From DAPT to Dual Pathway Inhibition With Low-dose Rivaroxaban in Adjunct to Aspirin in Patients With Coronary Artery Disease Phase 4
Completed NCT01860274 - Meshed Vein Graft Patency Trial - VEST N/A
Recruiting NCT06174090 - The Effect of Video Education on Pain, Anxiety and Knowledge Levels of Coronary Bypass Graft Surgery Patients N/A
Terminated NCT03959072 - Cardiac Cath Lab Staff Radiation Exposure
Completed NCT03968809 - Role of Cardioflux in Predicting Coronary Artery Disease (CAD) Outcomes
Recruiting NCT05065073 - Iso-Osmolar vs. Low-Osmolar Contrast Agents for Optical Coherence Tomography Phase 4
Recruiting NCT04566497 - Assessment of Adverse Outcome in Asymptomatic Patients With Prior Coronary Revascularization Who Have a Systematic Stress Testing Strategy Or a Non-testing Strategy During Long-term Follow-up. N/A
Completed NCT05096442 - Compare the Safety and Efficacy of Genoss® DCB and SeQuent® Please NEO in Korean Patients With Coronary De Novo Lesions N/A