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

Home-based Pulmonary Rehabilitation and Health Coaching in Bronchiectasis

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

Study Overview

• Status: Completed
• Conditions: Bronchiectasis
• Intervention / Treatment: Behavioral: Home Rehabilitation Monitoring System; Behavioral: Health coaching calls

Detailed 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.

• Study Type: Observational
• Enrollment (Actual): 35

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic in Rochester

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Subjects with a medical diagnosis of bronchiectasis being see in the Mayo Clinic Bronchiectasis Clinic in Rochester, MN.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Home-based Pulmonary Rehabilitation and Health Coaching; Subjects with symptomatic bronchiectasis (CAT score ≥10) will receive a 12-week intervention with home-based pulmonary rehab (PR).

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.; Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Physical activity	As measured by number of steps per 24-hr period.	12 weeks

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
• Investigators: Principal Investigator: Roberto Benzo, MD, Mayo Clinic

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): August 25, 2022
• Primary Completion (Actual): July 30, 2023
• Study Completion (Actual): July 30, 2023

Study Registration Dates

• First Submitted: September 21, 2022
• First Submitted That Met QC Criteria: September 21, 2022
• First Posted (Actual): September 23, 2022

Study Record Updates

• Last Update Posted (Actual): September 7, 2023
• Last Update Submitted That Met QC Criteria: September 6, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Bronchial Diseases; Bronchiectasis
• Other Study ID Numbers: 22-004626; 5K24HL138150-05 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No