Angina, Stable, Congestive Heart Failure, Chronic Obstructive Pulmonary Disease
Conditions
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. 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.
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. 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.
Interventions
OTHERStepped Care
Patients meeting a non-response criterion will be stepped up to the next step
Sponsors
Berkshire Medical Center
Peter Lindenauer, MD
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Masking description
Outcome measures will be obtained by a blinded research assistant over the phone within 1 week of completing the 8 week rehabilitation program
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No
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 * referral to cardiac rehab after coronary artery bypass graph (CABG) and valvular surgery
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Burden of Data Collection | 8 weeks | Baseline Measurement Completion- The investigators need to reach \>80% of baseline data to move forward with this study |
| Retention | 8 weeks | Proportion in SC arm completing outcome measures |
| Recruitment | 3 years | Average number of eligible patients randomized per month |
| Adherence | 8 weeks | Proportion of older frail adults randomized to SC attending prescribed rehabilitation sessions |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PROMIS Social isolation | 1 week prior to start and 1 week after completion of rehabilitation | NIH PROMIS CAT to assess social isolation. |
| PROMIS anxiety | 1 week prior to start and 1 week after completion of Rehabilitation | NIH PROMIS CAT to assess anxiety. |
| PROMIS Depression/Sadness | 1 week prior to start and 1 week after completion of rehabilitation | NIH PROMIS CAT to assess Depression/Sadness. |
| EuroQol (EQ-5D-5L) | 1 week prior to start and 1 week after completion of rehabilitation | 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. |
| Smoking | 1 week prior to start and 1 week after completion of rehabilitation | Smoking will be quantified by self-report (number of cigarettes smoked per day) |
| 6 Minute walk test (6-MWT) | 1 week prior to start and 1 week after completion of rehabilitation | 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. |
| Short Physical Performance Battery (SPPB) | 1 week prior to start and 1 week after completion of rehabilitation | 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. |
| PASE | 1 week prior to start and 1 week after completion of rehabilitation | 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. |
| PROMIS Dyspnea severity | 1 week prior to start and 1 week after completion of rehabilitation | NIH PROMIS computer adaptive test (CAT) to assess dyspnea severity. |
| PROMIS Dyspnea functional limitation | 1 week prior to start and 1 week after completion of rehabilitation | NIH PROMIS CAT to assess dyspnea functional limitation. |
| PROMIS Physical function | 1 week prior to start and 1 week after completion of rehabilitation | NIH PROMIS ACT to assess physical function. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Secondary Feasibility Outcomes | 3 years | The investigators will look at data already obtained in the research project to determine the number of non-response criteria and average number of days on each step to develop a new protocol for a randomized clinical trial. |
| Qualitative feasibility measure | 14 months from the time of first patient enrollment | Semi-structured telephone interviews of randomly selected 15 participants to evaluate feasibility of study interventions. Interviews will elicit participants' views and experiences with all aspects of the intervention including personnel, components of the rehabilitation program, data collection procedures, their likes and dislikes about the SC program, and when relevant, reasons for non-adherence. The research staff will also interview the CHW and feedback from RNs to determine the factors that facilitated or impeded the delivery of the intervention and to identify procedures in the protocol which could be improved upon for the full-scale trial. |
Countries
United States
Outcome results
None listed