Rehabilitation at Home Using Mobile Health In Older Adults After Hospitalization for Ischemic Heart Disease

Study Overview
=================
Brief Summary
-----------------
RESILIENT is a phase II, multi-center, prospective, pragmatic randomized clinical trial with blinded assessment of the primary endpoint. This study aims to evaluate whether mHealth-CR improves functional capacity in older adults (age ≥65) with IHD compared with standard traditional cardiac rehabilitation care. A total of 400 eligible patients will be randomized in 3:1 manner to mHealth-CR versus usual care for assessment of primary endpoint. Enrollment will occur over approximately 42 months with an expected minimum of 3 months follow-up per participant.

Detailed Description
-----------------
The primary objective of RESILIENT is to evaluate whether mobile health cardiac rehab (mHealth-CR) improves functional capacity in older adults (age ≥65) with ischemic heart disease (IHD), identified at the time of acute myocardial infarction (AMI), percutaneous coronary intervention (PCI), or coronary artery bypass graft (CABG), compared with usual care. Our central hypotheses related to efficacy are that mHealth-CR will (1) improve functional capacity (primary outcome), (2) improve goal attainment, health status, and activities of daily living, and (3) lower rates of hospital readmission and death (secondary outcomes). Our central hypothesis related to engagement is that we will identify distinct trajectories of engagement and characteristics that predict membership in each category.

Official Title
-----------------
REhabilitation at Home uSIng mobiLe Health In oldEr Adults After hospitalizatioN for Ischemic hearT Disease

Conditions
-----------------
Ischemic Heart Disease

Intervention / Treatment
-----------------
* Other: mHealth-CR


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age ≥65 Currently hospitalized for AMI, PCI, or CABG or Hospitalized for AMI, PCI or CABG within prior 2 weeks. Capable of self-consent. Understand and are able to perform study procedures (i.e. 6-minute walk test, use mHealth in English or Spanish). Exclusion Criteria: Non-ambulatory. Moderate or severe cognitive impairment. Unable/unwilling to consent. PCI-related groin hematoma that precludes brisk walking. Incarcerated. Unable to use mHealth software in English or Spanish. Severe osteoarthritis, or joint replacement within last 3 months. Parkinson's disease or other progressive movement disorder. Regular use of walker for ambulation. Projected life expectancy <3 months. Clinical judgment concerning other safety or nonadherence issues. Participants admitted from long-term care facility. Currently listed for heart transplant. Left ventricular assist device recipient. Completion of ambulatory cardiac rehabilitation program within prior 3 months.

Ages Eligible for Study
-----------------
Minimum Age: 65 Years
Maximum Age: 110 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: mHealth-CR<br> | Other: mHealth-CR<br>* Study participants randomized to the intervention (mHealth-CR) arm during the (in-hospital) baseline visit will receive 3 components for their home activity: (1) communication with exercise therapist (in-hospital assessment/counseling followed by regular communication post-discharge), (2) mHealth-CR software, and (3) wearable activity monitoring device.<br>|
| No Intervention: Usual Care<br> | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in 6-minute walking distance (6MWD) | Change in 6MWD, reflective of functional capacity, is measured by the 6-minute walk test (6MWT). The 6-minute walk test (6MWT) is a submaximal exercise test in which the pace is self-selected by the participant. The 6MWT will be performed during baseline hospitalization and at the 3-month follow-up visit by a blinded research nurse. | 3 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Goal Attainment measured using a 5-point goal attainment scale (GAS) | Using the SMART goal framework, GAS describes the person's expected level of goal achievement over 3 months, ranging from no change (scored as -2) to much better than expected (scored as +2) out of a 5 point-scale. Scales are dynamically set according to a person's needs, while measurement of attainment is standardized. Overall score is calculated by incorporating the goal of outcomes scores into an aggregated t-score. Goal attainment, through goal setting, is an especially important outcome in older adults who may begin an intervention with a variety of deficits (therefore necessitating individualized therapy towards realistic goals). | 3 month | 
| Participant reported health status - measured using the SF-12 | Health status encompasses a person's functional status, symptoms, and wellbeing, and is increasingly recognized as an important patient-centered outcome. Both the SF-12 and SAQ-7 have been validated and are convenient for participants (<5 minutes to administer). For the SF-12, we will analyze change from baseline to 3 months using a threshold of 5 points in SF-12 physical component score (PCS) as a clinically meaningful change | 3 month | 
| Participant reported health status - measured Seattle Angina Questionnaire 7 (SAQ-7) (disease-specific health status). | Health status encompasses a person's functional status, symptoms, and wellbeing, and is increasingly recognized as an important patient-centered outcome. Both the SF-12 and SAQ-7 have been validated and are convenient for participants (<5 minutes to administer). For SAQ-7, we will analyze at a single time point (3 months) the number of participants who have residual angina (SAQ-7<100) vs. no angina (SAQ-7=100). | 3 month | 
| Change in Basic Activities of Daily Living (BADLs) | defined as any improvement or worsening in basic (BADLs) over 3 months. BADLs are basic self-care behaviors: feeding, toileting, bathing, dressing, and ambulating. I | 3 month | 
| Change in Activities of Daily Living (ADLs) | defined as any improvement or worsening in instrumental (IADLs) activities of daily living over 3 months. ADLs are activities that allow a person to live independently (e.g. food preparation, medication management, transportation, shopping, managing finances, using the telephone, and housekeeping). | 3 months. | 
| Hospital readmissions evaluated at 3, 6 and 12 Months | Defined as number of participants who were readmitted into the hospital with an overnight stay (including observation) in any hospital within 3, 6, and 12 months of hospitalization. Data are obtainable via the electronic health record (EHR). | 1 Year | 
| Death | is defined by number of participants who died from any cause within 3, 6, and 12 months of enrollment. Data are obtainable via the electronic health record (EHR). | 1 Year |