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.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Enrolment in cardiac rehabilitation
研究概览
简要总结
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.
详细描述
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:
- 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 35 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The inclusion criteria for the sample includes:
- •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.
排除标准
- •The exclusion criteria will include those persons who:
- •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).
结局指标
主要结局
Enrolment in cardiac rehabilitation
时间窗: 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.
次要结局
未报告次要终点
研究者
Tracey JF Colella
Scientist
University Health Network, Toronto
