Recruiting

MyCaRe

Sponsor:

University Health Network, Toronto

Code:

NCT02778165

Conditions

Postoperative; Dysfunction Following Cardiac Surgery

Eligibility Criteria

Sex: All

Age: 35+

Healthy Volunteers: Not accepted

Interventions

MyCaRe (my cardiac recovery Android application)

Study Details

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.

Conditions

Postoperative; Dysfunction Following Cardiac Surgery

Study ID

NCT02778165

Start date

Oct 1, 2022

Status verified date

May, 2023

Completion date

Jun 30, 2024

Anticipated

Primary completion date

Dec 31, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 35+

Healthy Volunteers: Not accepted

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 Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

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.

Interventions

MyCaRe (my cardiac recovery Android application)

Android application \& Fitbit Inspire 2 activity monitor

Primary outcome measure

  • Enrolment in cardiac rehabilitation [ Time Frame: 8 weeks post operative discharge ]

Central Contacts and Locations

Central contacts

Tracey J Colella, PhD

4165973422tracey.colella@uhn.ca

Anam Tahsinul

4165973422MDtahsinul.anam@uhn.ca

Locations

Cardiac Rehabilitation, Rumsey Centre, TRI-UHN

Recruiting

Toronto, Ontario, Canada, M4G1R7

Contacts

Tracey Colella, RN, PhD

416-597-3422tracey.colella@uhn.ca

Anam Tahsinul, MBBS, MPH

4165408383mdtahsinul.anam@uhn.ca

More Information

Sponsor

University Health Network, Toronto

Last update posted

May 26, 2023

Last verified

May, 2023

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University Health Network, Toronto on 2023-05-26.