Stepped Care vs Center-based Cardiopulmonary Rehabilitation for Older Frail Adults Living in Rural MA

Study Overview
=================
Brief Summary
-----------------
This feasibility trial will focus on older adults 60+ who are candidates for cardiac or pulmonary rehabilitation and who are vulnerable, mildly or moderately frail. We will randomize older frail adults living in rural regions of the county to Treatment as usual (TAU) or Stepped care (SC). TAU refers to center-based rehabilitation (CBR). Patients randomized to SC will be enrolled in traditional CBR and based on prespecified non-response criteria, will step up to three services: 1) Transportation-subsidized CBR, 2) Home-based telerehabilitation (TR), and 3) Community health worker-(CHW) supported home-based TR.

Detailed Description
-----------------
Cardiac rehabilitation (CR) decreases mortality and both CR and pulmonary rehabilitation (PR) improve function, quality of life, and decrease readmission rates. Despite their proven efficacy, both programs are grossly underutilized, with fewer than 20% of eligible persons participating. Patients with heart and lung disease living in rural communities have even lower rates of participation. The objective of this proposal is to test the feasibility of performing a full-scale randomized controlled trial (RCT) to compare the effectiveness and value of a stepped care (SC) model versus treatment as usual (TAU) in older frail adults living rural counties. TAU refers to center-based rehabilitation (CBR). The SC model includes initial enrollment into CBR followed by possible step up to three interventions based on prespecified non-response criteria: 1) Transportation-subsidized CBR, 2) Home-based telerehabilitation (TR), and 3) Community health worker-(CHW) supported home-based TR. Unlike traditional SC models, the initial treatment in this model, i.e. CBR, is not the least resource intensive. CBR was chosen as the initial option because it is currently considered the standard of care. We will conduct a parallel, 2-arm, randomized controlled feasibility trial. Eligible participants will be randomized to TAU (CBR) or SC. Because of the urgent need to address underuse of both CR and PR in rural regions, the proposed feasibility trial will enroll patients referred to either CR or PR. Both arms include an in-person intake evaluation conducted by a certified rehabilitation nurse in the rehabilitation center to determine exercise tolerance and design a tailored 8-week rehabilitation program. Patients randomized to TAU participate in two weekly sessions at the center and are encouraged to exercise at home in between sessions. Patients randomized to the SC arm will also be enrolled in the CBR program. Those who meet prespecified non-response criteria will be stepped up to transportation-subsidized CBR. Providing transportation may not be sufficient for frail older adults who are reluctant to leave their homes in the winter, unfamiliar with exercising, or do not want to exercise in a group setting. Thus, non-responders, will be stepped up to home-based TR. Home-based rehabilitation will be supported by Chanl Health, a virtual platform that supports education and self-management, remote monitoring, and coaching by rehabilitation specialists. Non-responders will be stepped up to CHW-supported home-based TR. The CHW will be help participants use the mobile app, access educational materials, clarify educational content, and exercise during biweekly in-person visits. Purpose: Heart and lung disease are the first and third leading causes of mortality in the US, respectively. Cardiac rehabilitation (CR) decreases mortality and both CR and pulmonary rehabilitation (PR) improve function, quality of life, and decrease readmission rates. Despite their proven efficacy, both programs are grossly underutilized, with fewer than 20% of eligible persons participating. Patients living in rural communities have even lower rates of participation. Home-based CR and PR has been developed with the goal of improving uptake, and low to moderate strength evidence indicates that these programs are as effective as center-based programs. Further work is needed, however, to examine how best to increase utilization of CR and PR in rural communities. While several studies have examined approaches to improve referral and enrollment, there is little evidence on how to optimize adherence to CR, and no evidence how to optimize adherence to PR.

Official Title
-----------------
Stepped Care vs Center-based Cardiopulmonary Rehabilitation for Older Frail Adults Living in Rural MA

Conditions
-----------------
Angina, Stable, Congestive Heart Failure, Chronic Obstructive Pulmonary Disease

Intervention / Treatment
-----------------
* Other: Stepped Care


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Older adults (greater than 60 years of age) Live in a Level 1 or 2 state designated rural area in Berkshire County Has a condition qualifying for reimbursement (by government or private insurance) for cardiac or pulmonary rehabilitation Score of 4, 5 or 6 on the Clinical Frailty Scale(24) (corresponding to vulnerable, mildly frail, and moderately frail) Exclusion Criteria: Attended pulmonary or cardiac rehabilitation within the previous two years Resting pulse oximetry < 85% on room air or while breathing the prescribed level of supplemental oxygen Unstable asthma with hospital admission or ED visit within previous three months Severe exercise-induced hypoxemia, not correctable with oxygen supplementation Acute systemic illness or fever Complex ventricular arrhythmias Resting systolic blood pressure greater than 200mmhg Resting diastolic blood pressure greater than 100mmhg Orthostatic blood pressure (BP) drop of >20 mm Hg with symptoms History of arrhythmia with syncope Severe symptomatic valvular disease Unstable angina Uncontrolled atrial or ventricular arrhythmias Uncontrolled sinus tachycardia (>120 BPM) Uncompensated congestive heart failure Third degree heart block without a pacemaker Active pericarditis or myocarditis Acute cor pulmonale, severe pulmonary hypertension Resting ST displacement > 2mm Uncontrolled diabetes (resting blood glucose >400 mg/dl) Conditions other than pulmonary or cardiac that prohibit exercise (e.g., arthritis, severe neurologic, hepatic or renal disease) Planned surgery or transplantation Hearing impairment limiting ability to participate in data collection by telephone Life expectancy less than one year Significant cognitive deficit and/or psychiatric illness that interferes with ability to provide consent, follow directions, or adhere to study procedures

Ages Eligible for Study
-----------------
Minimum Age: 60 Years

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

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

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

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The planned research is to improve enrollment, adherence and completion of CR and PR using stepped care (SC). The proposed SC model enables a patient-centered approach by matching intensity of treatment with individual patient needs.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Treatment as usual<br>Patients referred to CR or PR are initially telephoned by a RN,RC or RA who describes the program and schedules the initial intake evaluation. The intake evaluation reflects usual care practices at both BMC and Fairview Hospital. The purpose of this initial session is to obtain the data required to design an individualized effective and safe rehabilitation program. It is performed by a RN, RC, or RA and includes performing a medical history, physical examination, and testing. Reminder telephone calls are placed prior to the initial intake and formal reassessments visits. | |
| Active Comparator: Stepped Care<br>The SC arm will be offered Center Based Rehabilitation (CBR) and subsequently stepped up to transportation-subsidized CBR, home-based TR, and CHW-supported home-based TR based on prespecified non-response criteria/poor adherence. Standard of Care. Patients meeting a non-response criterion will be stepped up to transportation-subsidized CBR. Step 1. Transportation-Subsidized CBR. Step 2. Home-Based TR. Step 3. CHW-Supported Home-Based TR. | Other: Stepped Care<br>* Patients meeting a non-response criterion will be stepped up to the next step<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recruitment | Average number of eligible patients randomized per month | 3 years | 
| Adherence | Proportion of older frail adults randomized to SC attending prescribed rehabilitation sessions | 8 weeks | 
| Adherence | Average number of sessions attended in SC arm | 8 weeks | 
| Retention | Proportion in SC arm completing outcome measures | 8 weeks | 
| Burden of Data Collection | Baseline Measurement Completion- The investigators need to reach >80% of baseline data to move forward with this study | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PROMIS Dyspnea severity | NIH PROMIS computer adaptive test (CAT) to assess dyspnea severity. | 1 week prior to start and 1 week after completion of rehabilitation | 
| PROMIS Dyspnea functional limitation | NIH PROMIS CAT to assess dyspnea functional limitation. | 1 week prior to start and 1 week after completion of rehabilitation | 
| PROMIS Physical function | NIH PROMIS ACT to assess physical function. | 1 week prior to start and 1 week after completion of rehabilitation | 
| PROMIS Social isolation | NIH PROMIS CAT to assess social isolation. | 1 week prior to start and 1 week after completion of rehabilitation | 
| PROMIS anxiety | NIH PROMIS CAT to assess anxiety. | 1 week prior to start and 1 week after completion of Rehabilitation | 
| PROMIS Depression/Sadness | NIH PROMIS CAT to assess Depression/Sadness. | 1 week prior to start and 1 week after completion of rehabilitation | 
| PASE | Physical Activity Scale for the elderly. The PASE is a brief, 12-item, reliable, validated questionnaire used to measure physical activity in older adults. Activities are scored using frequency, duration and intensity parameters over the previous week. | 1 week prior to start and 1 week after completion of rehabilitation | 
| EuroQol (EQ-5D-5L) | Health-related quality of life will be measured using the EuroQol (EQ-5D-5L). The EQ-5D-5L is a well-validated and widely used generic health status questionnaire that measures amount of difficulty with mobility, self-care, usual activities, pain/discomfort and anxiety/depression. | 1 week prior to start and 1 week after completion of rehabilitation | 
| Smoking | Smoking will be quantified by self-report (number of cigarettes smoked per day) | 1 week prior to start and 1 week after completion of rehabilitation | 
| 6 Minute walk test (6-MWT) | The 6-MWT is a widely used and well-validated measure of functional exercise capacity. The 6-MWT measures the distance that a patient can walk quickly on a flat, hard surface over six minutes. It is self-paced and assesses sub-maximal aerobic capacity and endurance. | 1 week prior to start and 1 week after completion of rehabilitation | 
| Short Physical Performance Battery (SPPB) | Physical Function and Mobility will be measured using SPPB which includes a walking speed test, a hierarchal balance test (feet side by side, semi tandem stance, tandem stance), and a 5-times sit to stand test, each scored on a 0-4 scale. | 1 week prior to start and 1 week after completion of rehabilitation |