My Cardiac Recovery (MyCaRe): A Pilot RCT.

NCT02778165 | Unknown

• 1 other identifier: 15-9520
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Enrolment in cardiac rehabilitation

  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

Study Arms (2)

Usual Care

NO INTERVENTION

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.

MyCaRe Android Application

EXPERIMENTAL

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)

Interventions

MyCaRe (my cardiac recovery Android application) OTHER

Android application \& Fitbit Inspire 2 activity monitor

Also known as: MyCaRe

MyCaRe Android Application

Eligibility Criteria

• Age: 35 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• have cardiac surgery procedures other than CABG,
• reside in a nursing home or long term care facility,
• have any neurological or psychiatric disorder that may impede their ability to self reflect or communicate,
• 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).

Sponsors & Collaborators

• University Health Network, Toronto: lead
• Toronto General Hospital: collaborator

Study Sites (1)

Cardiac Rehabilitation, Rumsey Centre, TRI-UHN

Toronto, Ontario, M4G1R7, Canada

RECRUITING

Related Publications (56)

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• Dibben G, Faulkner J, Oldridge N, Rees K, Thompson DR, Zwisler AD, Taylor RS. Exercise-based cardiac rehabilitation for coronary heart disease. Cochrane Database Syst Rev. 2021 Nov 6;11(11):CD001800. doi: 10.1002/14651858.CD001800.pub4.

  PMID: 34741536 DERIVED

Study Officials

• Tracey J Colella, PhD

  University Health Network, Toronto

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tracey J Colella, PhD

CONTACT

4165973422; tracey.colella@uhn.ca

Anam Tahsinul

CONTACT

4165973422; MDtahsinul.anam@uhn.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Scientist

Study Record Dates

• First Submitted: May 18, 2016
• First Posted: May 19, 2016
• Study Start: October 1, 2022
• Primary Completion: December 31, 2023
• Study Completion: June 30, 2024
• Last Updated: May 26, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)