My Cardiac Recovery (MyCaRe): A Pilot RCT. (MyCaRe)

May 24, 2023 updated by: Tracey JF Colella, University Health Network, Toronto

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.

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M4G1R7
        • Recruiting
        • Cardiac Rehabilitation, Rumsey Centre, TRI-UHN
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 exclusion criteria will include those persons who:

    1. have cardiac surgery procedures other than CABG,
    2. reside in a nursing home or long term care facility,
    3. have any neurological or psychiatric disorder that may impede their ability to self reflect or communicate,
    4. sustained in-hospital post surgical complications of major significance (such as stroke, deep wound infections, pericardial effusion, etc.), 5) inability to ambulate (i.e. walk unaided at 2 mph).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Usual Care
Patients receiving usual care are typically referred to CR at the time of discharge from the acute care center via paper or electronic systematic referral (completed by a physician or nurse practitioner). Additionally, a conversation with the patient regarding CR by a healthcare provider may occur, however this communication is not always a consistent occurrence. Once referred, patients will await contact from a CR program in their region/area and if actual program enrollment occurs, this usually happens between 8 to 10 weeks post discharge.
Experimental: MyCaRe Android Application
The MyCaRe mobile application (education and symptom monitoring which includes pain, mood scales, wound monitoring) and Fitbit accelerometer (steps walked, distance) will be provided to patients receiving intervention group allocation for the initial 6 to 8 weeks recovery post cardiac surgery. The patients will be provided a temporary loan mobile device loaded with MyCaRe and Fitbit Inspire 2 before leaving hospital. They will be asked to input data (pain, mood, wounds, activity, blood sugar, blood pressure) daily if possible in first 2 weeks and once weekly thereafter until 6 to 8 weeks or until entry to a cardiac rehabilitation program.
Other: MyCaRe (my cardiac recovery Android application)
Android application & Fitbit Inspire 2 activity monitor
Other Names:
  • MyCaRe

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Enrolment in cardiac rehabilitation
Time Frame: 8 weeks post operative discharge
The 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.
8 weeks post operative discharge

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Health Network, Toronto

Collaborators

Toronto General Hospital

Investigators

  • Principal Investigator: Tracey J Colella, PhD, University Health Network, Toronto

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2022

Primary Completion (Estimated)

December 31, 2023

Study Completion (Estimated)

June 30, 2024

Study Registration Dates

First Submitted

May 18, 2016

First Submitted That Met QC Criteria

May 18, 2016

First Posted (Estimated)

May 19, 2016

Study Record Updates

Last Update Posted (Actual)

May 26, 2023

Last Update Submitted That Met QC Criteria

May 24, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • 15-9520

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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