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My Cardiac Recovery (MyCaRe): A Pilot RCT.

My Cardiac Recovery (MyCaRe): A Pilot RCT to Examine the Effect of MyCaRe Android Application on Recovery Outcomes and Enrolment in Cardiac Rehab Post Cardiac Surgery.

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02778165
Acronym
MyCaRe
Enrollment
40
Registered
2016-05-19
Start date
2022-10-01
Completion date
2024-06-30
Last updated
2023-05-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative; Dysfunction Following Cardiac Surgery

Brief summary

MyCardiacRecovery (MyCaRe) is an interactive platform that includes a standardized educational format and interactive tracking (wound healing and activity progression using photo capabilities and Fitbit Inspire 2 accelerometer) support during the first 6 to 8 weeks post hospital discharge. This android application will help patients and family navigate their way through the continuum of care by providing an: a) integrated link between acute care and outpatient cardiac rehab (CR) for efficient coordination of information and reduction in duplication of services; b) patient care and education materials designed to address salient recovery questions; c) improved communication between the patient and care providers and, d) ensure streamlined systematic referral to CR. This innovative strategy has the potential to positively impact patient satisfaction, improve patient outcomes and possibly minimize financial constraints placed on the health care system. Phase 1 (preliminary usability testing) of prototype 1.0 is complete. Phase 2 will focus on testing MyCaRe 2.0 in a sample of post cardiac surgery patients using a pilot randomized controlled trial (RCT) design.

Detailed description

The early transition period post coronary artery bypass graft surgery is one associated with intense physiological and psychosocial adjustment that requires patients make sustainable long-term lifestyle changes. Cardiac rehabilitation (CR) is an evidence-based risk reduction program that has been shown to improve overall fitness and quality of life as well as lower morbidity and mortality in patients with coronary artery disease. Therefore, the development of supportive strategies to bridge the gap from acute care in to CR through early intervention for cardiac surgery patients is essential. MyCardiacRecovery (MyCaRe) is an interactive platform that includes a standardized educational format and interactive tracking (wound healing and activity progression using photo capabilities and Fitbit Inspire 2 accelerometer) support during the first 6 to 8 weeks post hospital discharge. This application will help patients and family navigate their way through the continuum of care by providing an: a) integrated link between acute care and outpatient cardiac rehab for efficient coordination of information and reduction in duplication of services; b) patient care and education materials designed to address salient recovery questions; c) improved communication between the patient and care providers and, d) ensure streamlined systematic referral to CR. This innovative strategy has the potential to positively impact patient satisfaction, improve patient outcomes and possibly minimize financial constraints placed on the health care system. Phase 1 (preliminary usability testing) of prototype 1.0 is complete. Phase 2 will focus on testing MyCaRe 2.0 in a sample of post cardiac surgery patients using a pilot randomized controlled trial design. Protocol Summary: App Study Phase 2 - Pilot Randomized Controlled Trial N= 40 (20 usual care + intervention; 20 usual care) Study Population: Post cardiac surgery patient population at 1 acute care cardiac centre in Toronto Study Design Pilot Randomized controlled trial Study Duration March 2022 - Dec 2022 Study Agent/ Intervention MyCaRe prototype (mobile application) Primary Objectives: 1) To examine the effect of MyCaRe application on enrolment in CR post cardiac surgery in comparison to usual care (assessing effectiveness of intervention); Secondary Objectives: 2\) To examine the impact of MyCaRe application on patient recovery and satisfaction (i.e. knowledge level, perceptions of recovery outcomes such as activity progression, quality of life, anxiety and depression) 3) To examine the effect of MyCaRe application on health services use. 4) To examine patient and clinician satisfaction, specifically user ease, usability and comfort with MyCaRe application.

Interventions

OTHERMyCaRe (my cardiac recovery Android application)

Android application & Fitbit Inspire 2 activity monitor

Sponsors

Toronto General Hospital
CollaboratorOTHER
University Health Network, Toronto
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
35 Years to No maximum
Healthy volunteers
No

Inclusion criteria

The inclusion criteria for the sample includes: 1. comprehend/understand instructions for study and use of app/Fitbit, 2. \> 35 years of age, 3. undergoing traditional (sternotomy approach) coronary artery bypass graft (CABG) surgery, 4. an uncomplicated postoperative course, 5. standard length of hospital stay (four to eight days), 6. access to wifi internet in their home, 7. able to hear telephone conversation, 8. reside within the greater Toronto region (GTA) or if outside GTA willing to return devices via mail upon completion of study.

Exclusion criteria

* The

Design outcomes

Primary

MeasureTime frameDescription
Enrolment in cardiac rehabilitation8 weeks post operative dischargeThe number of individuals who attend their initial cardiac rehab intake appointment will be the primary outcome measure of enrollment. Enrollment is defined in accordance with Canadian Cardiovascular Society data definitions (http://bridge.ccs.ca/index.php/en/), as patient having attended their scheduled cardiac rehab intake appointment (i.e., risk factor assessment, goal-setting). Enrollment will be verified with patient as well as with the CR program in which they are enrolled.

Countries

Canada

Contacts

Primary ContactTracey J Colella, PhD
tracey.colella@uhn.ca4165973422
Backup ContactAnam Tahsinul
MDtahsinul.anam@uhn.ca4165973422

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026