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. The investigators 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.
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. The investigators 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Enrollment
139
Patients meeting a non-response criterion will be stepped up to the next step
Berkshire Medical Center, Inc
Pittsfield, Massachusetts, United States
Baystate Health
Springfield, Massachusetts, United States
Recruitment
Average number of eligible patients randomized per month
Time frame: 3 years
Adherence
Proportion of older frail adults randomized to SC attending prescribed rehabilitation sessions
Time frame: 8 weeks
Adherence
Average number of sessions attended in SC arm
Time frame: 8 weeks
Retention
Proportion in SC arm completing outcome measures
Time frame: 8 weeks
Burden of Data Collection
Baseline Measurement Completion- The investigators need to reach \>80% of baseline data to move forward with this study
Time frame: 8 weeks
PROMIS Dyspnea severity
NIH PROMIS computer adaptive test (CAT) to assess dyspnea severity.
Time frame: 1 week prior to start and 1 week after completion of rehabilitation
PROMIS Dyspnea functional limitation
NIH PROMIS CAT to assess dyspnea functional limitation.
Time frame: 1 week prior to start and 1 week after completion of rehabilitation
PROMIS Physical function
NIH PROMIS ACT to assess physical function.
Time frame: 1 week prior to start and 1 week after completion of rehabilitation
PROMIS Social isolation
NIH PROMIS CAT to assess social isolation.
Time frame: 1 week prior to start and 1 week after completion of rehabilitation
PROMIS anxiety
NIH PROMIS CAT to assess anxiety.
Time frame: 1 week prior to start and 1 week after completion of Rehabilitation
PROMIS Depression/Sadness
NIH PROMIS CAT to assess Depression/Sadness.
Time frame: 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.
Time frame: 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.
Time frame: 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)
Time frame: 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.
Time frame: 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.
Time frame: 1 week prior to start and 1 week after completion of rehabilitation
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