A Study of Home-based Pulmonary Rehabilitation and Health Coaching to Treat Bronchiectasis

Bronchiectasis Clinical Trial

Official title:

Home-based Pulmonary Rehabilitation and Health Coaching in Bronchiectasis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05553119
• Other study ID #: 22-004626
• Secondary ID: 5K24HL138150-05
• Status: Completed
• Start date: August 25, 2022
• Est. completion date: July 30, 2023

Study information

• Verified date: September 2023
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to gather information on the effectiveness on a home-based pulmonary rehabilitation in patients with bronchiectasis.

Description:

The purpose of this study is to gather information on the effectiveness on a home-based pulmonary rehabilitation in patients with bronchiectasis. We hope that by participating in home-rehab that patients with bronchiectasis will become more physically active in their daily lives.

Pulmonary Rehabilitation in a medical center has proven to have a positive impact on physical activity and shortness of breath in patients with chronic lung disease. However, travel and access can make going to a center difficult.

Study participation involves completing gentle flexibility exercises and walking practice using a provided computer tablet, pulse oximeter and an activity tracker for 12 weeks. During that time, you will talk to a health coach once a week on the phone. At the end of the 12 weeks, someone will call you and ask you questions about your experience with the home-based rehab. Health Coaching calls will be recorded so that it can later be transcribed. All identifying information will be removed and the answers will be lumped together.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: July 30, 2023
• Est. primary completion date: July 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Having a diagnosis of non-cystic fibrosis bronchiectasis (primary inclusion criteria) ,confirmed by records, that are symptomatic.

• Ability to communicate in English.

Exclusion Criteria:

• Inability to walk (orthopedic/neurologic/cardiac limitation causing immobility).

• Cognitive impairment or inability to understand and follow instructions.

• Traditional PR completed within 3 months of study recruitment.

• Hospice or end-of-life care at the time of screening.

• Acute exacerbation at the time of screening.

Related Conditions & MeSH terms

• Bronchiectasis

Intervention

Behavioral:
• Home Rehabilitation Monitoring System
Established home-based pulmonary rehab system consists of three commercial devices (Garmin Vívofit™ activity monitor, Nonin 3150 WristOx2® Pulse Oximeter, Android tablet) and two software applications for telemonitored home pulmonary rehabilitation.
• Health coaching calls
Coaching calls based on motivational interviewing principles will occur weekly for twelve weeks following a standard protocol, lasting no more than 5-10 minutes.

Locations

Country	Name	City	State
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	Change in patient-reported quality of life	As defined by the COPD Assessment Test (CAT). The CAT is a validated tool for measuring health status in patients with bronchiectasis and is divided into eight domains of cough, mucous production, chest tightness, shortness of breath with activity, activity limitation at home, confidence leaving home, sleep quality, and energy. A lower score suggests no health-related quality of life (HRQL) impairment, while the maximum score of 40 represents significant impact.	Baseline, after completion of the 12-week intervention.
Secondary	Physical activity	As measured by number of steps per 24-hr period.	12 weeks

External Links

•   Mayo Clinic Clinical Trials