NCT05553119

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 25, 2022

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

September 21, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 23, 2022

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2023

Completed
Last Updated

September 7, 2023

Status Verified

September 1, 2023

Enrollment Period

11 months

First QC Date

September 21, 2022

Last Update Submit

September 6, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Physical activity

    12 weeks

Study Arms (1)

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 SystemBehavioral: Health coaching calls

Interventions

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.

Home-based Pulmonary Rehabilitation and Health Coaching

Coaching calls based on motivational interviewing principles will occur weekly for twelve weeks following a standard protocol, lasting no more than 5-10 minutes.

Home-based Pulmonary Rehabilitation and Health Coaching

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • Ability to communicate in English.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Links

MeSH Terms

Conditions

Bronchiectasis

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract Diseases

Study Officials

  • Roberto Benzo, MD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 21, 2022

First Posted

September 23, 2022

Study Start

August 25, 2022

Primary Completion

July 30, 2023

Study Completion

July 30, 2023

Last Updated

September 7, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations