Home-based Pulmonary Rehabilitation and Health Coaching in Fibrotic Interstitial Lung Disease

NCT05130034 | Completed

• 1 other identifier: 21-006804
• Study Type: interventional
• Target: 81
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to gather information on the effectiveness of a home-based pulmonary rehabilitation program with health coaching and tele-monitoring for improving patient-reported respiratory-related quality of life and physical activity in patients with fibrotic Interstitial Lung Diseases (f-ILD).

Conditions

Fibrotic Interstitial Lung Disease

Outcome Measures

Primary Outcomes (3)

• Change in patient-reported respiratory-related quality of life CRQ Physical Summary score

  Measured using the Chronic Respiratory Questionnaire (CRQ) survey which is a validated tool for measuring health status in patients with chronic lung disease divided into four domains of dyspnea, fatigue, emotion, and mastery. The Physical Summary score combines dyspnea and fatigue dimensions, a lower score suggests a greater degree of dysfunction on a 7-point scale. A difference of 0.5 in any domain is considered clinically significant (the minimal clinically important difference (MCID)). Higher total scores represent relatively better or improved patient-reported quality of life.

  Baseline, 12 weeks

• Change in patient-reported respiratory-related quality of life CRQ Emotional score

  Measured using the Chronic Respiratory Questionnaire (CRQ) survey which is a validated tool for measuring health status in patients with chronic lung disease divided into four domains of dyspnea, fatigue, emotion, and mastery. The emotional domain score is measured by a lower score suggests a greater degree of dysfunction on a 7-point scale. A difference of 0.5 in any domain is considered clinically significant (the minimal clinically important difference (MCID)). Higher total scores represent relatively better or improved patient-reported quality of life.

  Baseline, 12 weeks

• Physical activity

  Measured by mean number of steps per 24-hour period as assessed by Actigraphy, pre- and post-intervention

  Baseline, 12 weeks

Secondary Outcomes (2)

• Qualitative assessment of patient-reported efficacy

  12 weeks

• Self-reported tolerance of directed medical management

  Baseline, 12 weeks

Other Outcomes (3)

• Change in self-management ability

  Baseline, 12 weeks

• Change in mood or affect

  Baseline, 12 weeks

• Change in self-reported dyspnea

  Baseline, 12 weeks

Study Arms (1)

Home-based pulmonary rehab for fibrotic interstitial lung disease

EXPERIMENTAL

Subjects diagnosed with fibrotic interstitial lung disease will participate in a home-rehab program that promotes more physical activity in daily life.

Behavioral: Home-based pulmonary rehabilitation

Interventions

Home-based pulmonary rehabilitation BEHAVIORAL

Home-based tablet-assisted pulmonary rehabilitation with monitoring technology and telephonic health coach calls using motivational interviewing techniques

Home-based pulmonary rehab for fibrotic interstitial lung disease

Eligibility Criteria

• Age: 18 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of idiopathic pulmonary fibrosis (IPF) or other fibrotic interstitial lung disease, with a minimum of \> 10% fibrosis on computed tomography imaging.
• Clinically meaningful breathlessness: modified Medical Research Council (mMRC) dyspnea score \>1.

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.

Sponsors & Collaborators

• Mayo Clinic: lead
• Boehringer Ingelheim: collaborator

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Links

• Mayo Clinic Clinical Trials

Study Officials

• Teng Moua, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 10, 2021
• First Posted: November 22, 2021
• Study Start: December 13, 2021
• Primary Completion: April 15, 2025
• Study Completion: April 15, 2025
• Last Updated: May 6, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)