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

Primary Purpose

Fibrotic Interstitial Lung Disease

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Home-based pulmonary rehabilitation
Sponsored by
Mayo Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Fibrotic Interstitial Lung Disease

Eligibility Criteria

18 Years - 95 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.

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.

Sites / Locations

  • Mayo Clinic in RochesterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Home-based pulmonary rehab for fibrotic interstitial lung disease

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Qualitative assessment of patient-reported efficacy
Measured at the end of study through qualitative interviews using structured interview guide, combined with primary outcomes using mixed-methods analysis. Potential themes of relevance being sought include changes in patient perception of disease severity, overcoming emotional and physical burden of disease, and feasibility and long-term utility of the intervention.
Self-reported tolerance of directed medical management
Pre and post-intervention assessment of patient-reported side-effect severity from medical management

Full Information

First Posted
November 10, 2021
Last Updated
March 14, 2023
Sponsor
Mayo Clinic
Collaborators
Boehringer Ingelheim
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1. Study Identification

Unique Protocol Identification Number
NCT05130034
Brief Title
Home-based Pulmonary Rehabilitation and Health Coaching in Fibrotic Interstitial Lung Disease
Official Title
Home-based Pulmonary Rehabilitation and Health Coaching to Improve Respiratory-related Quality of Life and Physical Activity in Fibrotic Interstitial Lung Disease
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 1, 2022 (Actual)
Primary Completion Date
August 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
Collaborators
Boehringer Ingelheim

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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).
Detailed Description
The home-based pulmonary rehabilitation program involves using a computer tablet paired with a pulse oximeter and activity tracker. Gentle upper body exercises, walking and a breathing practice are completed by following along on the computer tablet. Weekly check-in calls by telephone will be provided by a Health Coach to assess clinical status and monitor progress. The exercise portion of the program lasts 12 weeks. There are questionnaires and a research grade activity tracker measuring baseline and post-intervention findings at the end of 12-week period.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fibrotic Interstitial Lung Disease

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Home-based pulmonary rehab for fibrotic interstitial lung disease
Arm Type
Experimental
Arm Description
Subjects diagnosed with fibrotic interstitial lung disease will participate in a home-rehab program that promotes more physical activity in daily life.
Intervention Type
Behavioral
Intervention Name(s)
Home-based pulmonary rehabilitation
Intervention Description
Home-based tablet-assisted pulmonary rehabilitation with monitoring technology and telephonic health coach calls using motivational interviewing techniques
Primary Outcome Measure Information:
Title
Change in patient-reported respiratory-related quality of life CRQ Physical Summary score
Description
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.
Time Frame
Baseline, 12 weeks
Title
Change in patient-reported respiratory-related quality of life CRQ Emotional score
Description
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.
Time Frame
Baseline, 12 weeks
Title
Physical activity
Description
Measured by mean number of steps per 24-hour period as assessed by Actigraphy, pre- and post-intervention
Time Frame
Baseline, 12 weeks
Secondary Outcome Measure Information:
Title
Qualitative assessment of patient-reported efficacy
Description
Measured at the end of study through qualitative interviews using structured interview guide, combined with primary outcomes using mixed-methods analysis. Potential themes of relevance being sought include changes in patient perception of disease severity, overcoming emotional and physical burden of disease, and feasibility and long-term utility of the intervention.
Time Frame
12 weeks
Title
Self-reported tolerance of directed medical management
Description
Pre and post-intervention assessment of patient-reported side-effect severity from medical management
Time Frame
Baseline, 12 weeks
Other Pre-specified Outcome Measures:
Title
Change in self-management ability
Description
Assessed pre and post-intervention using SMAS-30, a validated questionnaire highlighting six core self-management abilities including taking initiative, investment behavior, variety, multi-functionality, self-efficacy, and positive frame of mind. Higher total or domain scores suggest higher relative self-management ability.
Time Frame
Baseline, 12 weeks
Title
Change in mood or affect
Description
Assessed pre and post-intervention using Positive and Negative Affect Scale (PANAS), a 20-item scale measures the positive and negative affective components of well-being. A ratio of 2.5 or higher for positive vs negative assessments suggests more positive mood.
Time Frame
Baseline, 12 weeks
Title
Change in self-reported dyspnea
Description
Assessed pre and post-intervention using Modified Medical Research Council (mMRC) scale; a change in 1 point is the minimal clinically important difference (MCID), with HIGHER scores suggesting greater dyspnea.
Time Frame
Baseline, 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
95 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Johanna Hoult
Phone
507-293-1989
Email
hoult.johanna@mayo.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Joshua Taylor
Phone
507-266-8957
Email
taylor.joshua@mayo.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Teng Moua, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic in Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials

Learn more about this trial

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

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