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

COPD Exacerbation Clinical Trial

Official title:

Increasing Adherence to Pulmonary Rehabilitation After COPD Related Hospitalizations

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04521608
• Other study ID #: 18-002453
• Secondary ID: R61HL142933-02St
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 30, 2020
• Est. completion date: November 2024

Study information

• Verified date: April 2024
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 296
• Est. completion date: November 2024
• Est. primary completion date: November 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• COPD Exacerbation

Intervention

Behavioral:
• Intervention- Home-based Pulmonary Rehabilitation
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).

Locations

Country	Name	City	State
United States	Health Partners Institute	Bloomington	Minnesota
United States	Mayo Clinic in Rochester	Rochester	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
Mayo Clinic	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adherence to Pulmonary Rehabilitation	Percentage of Patients completing PR	baseline to 3 months
Secondary	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
Secondary	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
Secondary	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
Secondary	Health Care Utilization	Number of ER and Hospital visits/days	baseline to 3 months
Secondary	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
Secondary	Qualitative interviews	Investigate barriers and facilitators to PR adherence	After intervention (3 months)