Increasing Adherence to Pulmonary Rehabilitation After COPD Related Hospitalizations (Study 2)

Study Overview
=================
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).

Official Title
-----------------
Increasing Adherence to Pulmonary Rehabilitation After COPD Related Hospitalizations

Conditions
-----------------
COPD Exacerbation

Intervention / Treatment
-----------------
* Behavioral: Intervention- Home-based Pulmonary Rehabilitation


Participation Criteria
=================
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)

Ages Eligible for Study
-----------------
Minimum Age: 40 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention- Home Pulmonary Rehabilitation<br>Participants enrolled in the intervention arm will be offered a Home-based pulmonary rehabilitation program with health coaching. | Behavioral: Intervention- Home-based Pulmonary Rehabilitation<br>* Home-based Pulmonary Rehabilitation (PR) with health coaching using a remote system that will allow patients to complete PR at home. The program involves upper and lower extremity exercises, self-report of symptoms (fatigue, breathlessness, physical activity and overall well-being).<br>|
| No Intervention: Control- Choice<br>This arm receives the standard of care which includes the choice of PR at a facility or through telehealth. Center based PR involves attending a medical center gym where they can do exercises and receive disease specific education. Telehealth PR is delivered virtually through the computer or telephone. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adherence to Pulmonary Rehabilitation | Percentage of Patients completing PR | baseline to 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Health Related Quality of Life as measured by the Chronic Respiratory Questionnaire (CRQ). | The CRQ will be completed by participants several times during the study. The questionnaire measures health related quality of life and is a validated tool. This questionnaire measures both physical and emotional aspects of chronic respiratory disease. Higher scores indicate better health related quality of life. (numerical, 1-7 point Likert Scale, emotional and physical summary scores will be reported ) | baseline to 3 months | 
| Self Management | The Self-Management Ability Scale (30) item questionnaire that measures ability and function. A higher score indicates more ability and function in everyday life. Scores on the subscales and the total score are transformed into scores ranging from 0 to 100 (higher number is best). Each question has a range from 1-5. | baseline to 3 months | 
| Daily Physical Activity | Actigraph Activity Monitor will be worn for one week to measure daily steps, and time in sedentary mode, mild to moderate and vigorous physical activity. | baseline to 3 months | 
| Health Care Utilization | Number of ER and Hospital visits/days | baseline to 3 months | 
| Duke-UNC Functional Social Support Questionnaire (FSSQ) | 8 item questionnaire that measures the amount of social support and availability of help from family and friends. The answers range from 1 Much less than I would like to 5  As much as I would like. The scores from all 8 questions are summed (maximum 40) and then divided by 8 to get an average score. The higher the average score, the greater the perceived social support. | baseline to 3 months | 
| Qualitative interviews | Investigate barriers and facilitators to PR adherence | After intervention (3 months) |