Stepped care versus center-based cardiopulmonary rehabilitation for older frail adults living in rural MA

Ended Project Grant Awarded Last action

Award ID
R34HL156920
Recipient
Awarding agency
Obligated
$760,767

Award facts

Assistance listing
93.837 Cardiovascular Diseases Research
Completion date
Originally
Place of performance
Massachusetts, USA

Award details come from USAspending.gov.

Description

As the agency reported it.

Abstract
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. If the feasibility trial is successful, we will proceed to conduct a parallel, 2-arm, single blind, multi-site superiority RCT to compare the EFFECTIVENESS and value (COST-EFFECTIVENESS) of SC versus TAU (CBR) in older frail adults living rural counties. Our long-term objective is to provide hospital systems with high quality evidence on how best to optimize uptake of CR and PR for older frail adults living in rural communities.

Transactions

Action Obligated Date
Amendment -$16,025
Amendment $148,176
Amendment $232,982
Amendment $232,982
Original award $162,652

Subawards

Subrecipient Amount Awarded
Berkshire Healthcare Systems, Inc. Liana Fraenkel, MD (1.8 calendar months, years 1-3). As Co-PI, Dr. Fraenkel will have primary responsibility for the day-to-day operation of the study,… $358,664

Quick answers

Who received award R34HL156920?

R34HL156920 was awarded to Baystate Medical Center, Inc. by National Heart Lung and Blood Institute (National Institutes of Health) on March 15, 2022.

How much is award R34HL156920 worth?

$760,767 has been obligated on R34HL156920.

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