Clinical trial NCT02778165: My Cardiac Recovery (MyCaRe): A Pilot RCT.
Official title: 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.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Postoperative; Dysfunction Following Cardiac Surgery
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
Collaborators: name: Toronto General Hospital
First posted: 2016-05-19
Enrollment: 40
Sex: ALL
Minimum age (years): 35
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Enrolment in cardiac rehabilitation
timeFrame: 8 weeks post operative discharge
Secondary outcomes:
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Cardiac Rehabilitation, Rumsey Centre, TRI-UHN
state: Ontario
Study officials:
affiliation: University Health Network, Toronto
name: Tracey J Colella, PhD
role: PRINCIPAL_INVESTIGATOR
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