Clinical trial NCT04521608: Increasing Adherence to Pulmonary Rehabilitation After COPD Related Hospitalizations (Study 2)
Official title: Increasing Adherence to Pulmonary Rehabilitation After COPD Related Hospitalizations
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: COPD Exacerbation
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2020-08-20
Enrollment: 296
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is being done to test the comparative effectiveness of participating in a Pulmonary Rehabilitation Program at home using new technology and health coaching following dismissal from the hospital compared to the referral to a center based pulmonary rehabilitation that may include the choice of center based or telehealth.

Detailed description: Despite proven benefits, the proportion of people with COPD who receive Pulmonary Rehabilitation (PR) is very small. The current model of a center-based PR program fails to address the needs of many patients with COPD. After the COVID epidemic, telehealth is an option for individuals referred to patients referred to center based rehabilitation.

The direct referral to home-based, unsupervised PR has been proposed as an alternative model to hospital-based programs and has been found to be safe and effective. The refined home-based PR program from the pilot portion of the study supported by a separate grant mechanism (R61HL142933/NCT03865329) will be tested in this second part randomized control study.

Subjects with a COPD-related hospitalization (exacerbation or pneumonia) will be randomized after hospital discharge to either home-based PR or Choice (referral to conventional center-based PR or telehealth-based PR).

Eligibility criteria: Inclusion Criteria:

* COPD related hospitalization and eligible for PR
* Age 40+
* Confidence (score \> 5 in a self-efficacy question (1-10 scale): how confident you feel to use this system on a daily basis)

Exclusion Criteria:

- Inability to walk (orthopedic-neurologic problems or confined to bed)

Primary outcomes:
measure: Adherence to Pulmonary Rehabilitation
timeFrame: baseline to 3 months
Secondary outcomes:
measure: Health Related Quality of Life as measured by the Chronic Respiratory Questionnaire (CRQ).
timeFrame: baseline to 3 months
measure: Self Management
timeFrame: baseline to 3 months
measure: Daily Physical Activity
timeFrame: baseline to 3 months
measure: Health Care Utilization
timeFrame: baseline to 3 months
measure: Duke-UNC Functional Social Support Questionnaire (FSSQ)
timeFrame: baseline to 3 months
measure: Qualitative interviews
timeFrame: After intervention (3 months)
Other outcomes:
Locations:
city: Bloomington
country: United States
facility: Health Partners Institute
state: Minnesota
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Roberto P Benzo, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cox NS, Dal Corso S, Hansen H, McDonald CF, Hill CJ, Zanaboni P, Alison JA, O'Halloran P, Macdonald H, Holland AE. Telerehabilitation for chronic respiratory disease. Cochrane Database Syst Rev. 2021 Jan 29;1(1):CD013040. doi: 10.1002/14651858.CD013040.pub2.