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

Chronic Obstructive Pulmonary Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05562037
• Other study ID #: R34HL156920
• Status: Recruiting
• Phase: N/A
• Start date: September 8, 2022
• Est. completion date: February 28, 2025

Study information

• Verified date: March 2023
• Source: Baystate Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: February 28, 2025
• Est. primary completion date: December 28, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Angina, Stable
• Chronic Obstructive Pulmonary Disease
• Congestive Heart Failure
• Heart Failure
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Other:
• Stepped Care
Patients meeting a non-response criterion will be stepped up to the next step

Locations

Country	Name	City	State
United States	Berkshire Medical Center, Inc	Pittsfield	Massachusetts
United States	Baystate Health	Springfield	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Peter Lindenauer, MD	Berkshire Medical Center

Country where clinical trial is conducted

United States, 

References & Publications (20)

American Academy of Family Physicians; American Academy of Hospice and Palliative Medicine; American Nurses Association; American Society of Health-System Pharmacists; Heart Rhythm Society; Society of Hospital Medicine; Bonow RO, Ganiats TG, Beam CT, Blak — View Citation

Anderson JL, Adams CD, Antman EM, Bridges CR, Califf RM, Casey DE Jr, Chavey WE 2nd, Fesmire FM, Hochman JS, Levin TN, Lincoff AM, Peterson ED, Theroux P, Wenger NK, Wright RS, Smith SC Jr, Jacobs AK, Adams CD, Anderson JL, Antman EM, Halperin JL, Hunt SA — View Citation

Anderson L, Thompson DR, Oldridge N, Zwisler AD, Rees K, Martin N, Taylor RS. Exercise-based cardiac rehabilitation for coronary heart disease. Cochrane Database Syst Rev. 2016 Jan 5;2016(1):CD001800. doi: 10.1002/14651858.CD001800.pub3. — View Citation

Arena R, Williams M, Forman DE, Cahalin LP, Coke L, Myers J, Hamm L, Kris-Etherton P, Humphrey R, Bittner V, Lavie CJ; American Heart Association Exercise, Cardiac Rehabilitation and Prevention Committee of the Council on Clinical Cardiology, Council on E — View Citation

Drozda J Jr, Messer JV, Spertus J, Abramowitz B, Alexander K, Beam CT, Bonow RO, Burkiewicz JS, Crouch M, Goff DC Jr, Hellman R, James T 3rd, King ML, Machado EA Jr, Ortiz E, O'Toole M, Persell SD, Pines JM, Rybicki FJ, Sadwin LB, Sikkema JD, Smith PK, To — View Citation

Galati A, Piccoli M, Tourkmani N, Sgorbini L, Rossetti A, Cugusi L, Bellotto F, Mercuro G, Abreu A, D'Ascenzi F; Working Group on Cardiac Rehabilitation of the Italian Society of Cardiology. Cardiac rehabilitation in women: state of the art and strategies — View Citation

Garvey C, Bayles MP, Hamm LF, Hill K, Holland A, Limberg TM, Spruit MA. Pulmonary Rehabilitation Exercise Prescription in Chronic Obstructive Pulmonary Disease: Review of Selected Guidelines: AN OFFICIAL STATEMENT FROM THE AMERICAN ASSOCIATION OF CARDIOVA — View Citation

Keating A, Lee A, Holland AE. What prevents people with chronic obstructive pulmonary disease from attending pulmonary rehabilitation? A systematic review. Chron Respir Dis. 2011;8(2):89-99. doi: 10.1177/1479972310393756. — View Citation

Lindenauer PK, Stefan MS, Pekow PS, Mazor KM, Priya A, Spitzer KA, Lagu TC, Pack QR, Pinto-Plata VM, ZuWallack R. Association Between Initiation of Pulmonary Rehabilitation After Hospitalization for COPD and 1-Year Survival Among Medicare Beneficiaries. J — View Citation

Long L, Mordi IR, Bridges C, Sagar VA, Davies EJ, Coats AJ, Dalal H, Rees K, Singh SJ, Taylor RS. Exercise-based cardiac rehabilitation for adults with heart failure. Cochrane Database Syst Rev. 2019 Jan 29;1(1):CD003331. doi: 10.1002/14651858.CD003331.pu — View Citation

Nishi SP, Zhang W, Kuo YF, Sharma G. Pulmonary Rehabilitation Utilization in Older Adults With Chronic Obstructive Pulmonary Disease, 2003 to 2012. J Cardiopulm Rehabil Prev. 2016 Sep-Oct;36(5):375-82. doi: 10.1097/HCR.0000000000000194. — View Citation

O'Gara PT, Kushner FG, Ascheim DD, Casey DE Jr, Chung MK, de Lemos JA, Ettinger SM, Fang JC, Fesmire FM, Franklin BA, Granger CB, Krumholz HM, Linderbaum JA, Morrow DA, Newby LK, Ornato JP, Ou N, Radford MJ, Tamis-Holland JE, Tommaso CL, Tracy CM, Woo YJ, — View Citation

Puhan MA, Gimeno-Santos E, Cates CJ, Troosters T. Pulmonary rehabilitation following exacerbations of chronic obstructive pulmonary disease. Cochrane Database Syst Rev. 2016 Dec 8;12(12):CD005305. doi: 10.1002/14651858.CD005305.pub4. — View Citation

Ritchey MD, Maresh S, McNeely J, Shaffer T, Jackson SL, Keteyian SJ, Brawner CA, Whooley MA, Chang T, Stolp H, Schieb L, Wright J. Tracking Cardiac Rehabilitation Participation and Completion Among Medicare Beneficiaries to Inform the Efforts of a Nationa — View Citation

Rochester CL, Vogiatzis I, Holland AE, Lareau SC, Marciniuk DD, Puhan MA, Spruit MA, Masefield S, Casaburi R, Clini EM, Crouch R, Garcia-Aymerich J, Garvey C, Goldstein RS, Hill K, Morgan M, Nici L, Pitta F, Ries AL, Singh SJ, Troosters T, Wijkstra PJ, Ya — View Citation

Rubin R. Although Cardiac Rehab Saves Lives, Few Eligible Patients Take Part. JAMA. 2019 Aug 6;322(5):386-388. doi: 10.1001/jama.2019.8604. No abstract available. — View Citation

Spitzer KA, Stefan MS, Priya A, Pack QR, Pekow PS, Lagu T, Pinto-Plata VM, ZuWallack RL, Lindenauer PK. Participation in Pulmonary Rehabilitation after Hospitalization for Chronic Obstructive Pulmonary Disease among Medicare Beneficiaries. Ann Am Thorac S — View Citation

Valencia HE, Savage PD, Ades PA. Cardiac rehabilitation participation in underserved populations. Minorities, low socioeconomic, and rural residents. J Cardiopulm Rehabil Prev. 2011 Jul-Aug;31(4):203-10. doi: 10.1097/HCR.0b013e318220a7da. — View Citation

Vercammen-Grandjean C, Schopfer DW, Zhang N, Whooley MA. Participation in Pulmonary Rehabilitation by Veterans Health Administration and Medicare Beneficiaries After Hospitalization for Chronic Obstructive Pulmonary Disease. J Cardiopulm Rehabil Prev. 201 — View Citation

Yoo BW, Wenger NK. Gender Disparities in Cardiac Rehabilitation Among Older Women: Key Opportunities to Improve Care. Clin Geriatr Med. 2019 Nov;35(4):587-594. doi: 10.1016/j.cger.2019.07.012. Epub 2019 Jul 12. — View Citation

* Note: There are 20 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Secondary Feasibility Outcomes	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.	3 years
Primary	Recruitment	Average number of eligible patients randomized per month	3 years
Primary	Adherence	Proportion of older frail adults randomized to SC attending prescribed rehabilitation sessions	8 weeks
Primary	Adherence	Average number of sessions attended in SC arm	8 weeks
Primary	Retention	Proportion in SC arm completing outcome measures	8 weeks
Primary	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	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
Secondary	PROMIS Dyspnea functional limitation	NIH PROMIS CAT to assess dyspnea functional limitation.	1 week prior to start and 1 week after completion of rehabilitation
Secondary	PROMIS Physical function	NIH PROMIS ACT to assess physical function.	1 week prior to start and 1 week after completion of rehabilitation
Secondary	PROMIS Social isolation	NIH PROMIS CAT to assess social isolation.	1 week prior to start and 1 week after completion of rehabilitation
Secondary	PROMIS anxiety	NIH PROMIS CAT to assess anxiety.	1 week prior to start and 1 week after completion of Rehabilitation
Secondary	PROMIS Depression/Sadness	NIH PROMIS CAT to assess Depression/Sadness.	1 week prior to start and 1 week after completion of rehabilitation
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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