Ignite Creation Date:
2025-12-25 @ 2:22 AM
Ignite Modification Date:
2026-01-03 @ 3:42 AM
Study NCT ID:
NCT05130034
Status:
COMPLETED
Last Update Posted:
2025-05-06
First Post:
2021-11-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Home-based Pulmonary Rehabilitation and Health Coaching in Fibrotic Interstitial Lung Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 81}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-12-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2025-04-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-05-05', 'studyFirstSubmitDate': '2021-11-10', 'studyFirstSubmitQcDate': '2021-11-10', 'lastUpdatePostDateStruct': {'date': '2025-05-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-11-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-04-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Change in self-management ability', 'timeFrame': 'Baseline, 12 weeks', '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.'}, {'measure': 'Change in mood or affect', 'timeFrame': 'Baseline, 12 weeks', '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.'}, {'measure': 'Change in self-reported dyspnea', 'timeFrame': 'Baseline, 12 weeks', '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.'}], 'primaryOutcomes': [{'measure': 'Change in patient-reported respiratory-related quality of life CRQ Physical Summary score', 'timeFrame': 'Baseline, 12 weeks', '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.'}, {'measure': 'Change in patient-reported respiratory-related quality of life CRQ Emotional score', 'timeFrame': 'Baseline, 12 weeks', '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.'}, {'measure': 'Physical activity', 'timeFrame': 'Baseline, 12 weeks', 'description': 'Measured by mean number of steps per 24-hour period as assessed by Actigraphy, pre- and post-intervention'}], 'secondaryOutcomes': [{'measure': 'Qualitative assessment of patient-reported efficacy', 'timeFrame': '12 weeks', '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.'}, {'measure': 'Self-reported tolerance of directed medical management', 'timeFrame': 'Baseline, 12 weeks', 'description': 'Pre and post-intervention assessment of patient-reported side-effect severity from medical management'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Fibrotic Interstitial Lung Disease']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.mayo.edu/research/clinical-trials', 'label': 'Mayo Clinic Clinical Trials'}]}, 'descriptionModule': {'briefSummary': '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).', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '95 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of idiopathic pulmonary fibrosis (IPF) or other fibrotic interstitial lung disease, with a minimum of \\> 10% fibrosis on computed tomography imaging.\n* Clinically meaningful breathlessness: modified Medical Research Council (mMRC) dyspnea score \\>1.\n\nExclusion Criteria:\n\n* Inability to walk (orthopedic/neurologic/cardiac limitation causing immobility).\n* Cognitive impairment or inability to understand and follow instructions.\n* Traditional PR completed within 3 months of study recruitment.\n* Hospice or end-of-life care at the time of screening.\n* Acute exacerbation at the time of screening.'}, 'identificationModule': {'nctId': 'NCT05130034', 'briefTitle': 'Home-based Pulmonary Rehabilitation and Health Coaching in Fibrotic Interstitial Lung Disease', 'organization': {'class': 'OTHER', 'fullName': 'Mayo Clinic'}, 'officialTitle': 'Home-based Pulmonary Rehabilitation and Health Coaching to Improve Respiratory-related Quality of Life and Physical Activity in Fibrotic Interstitial Lung Disease', 'orgStudyIdInfo': {'id': '21-006804'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Home-based pulmonary rehab for fibrotic interstitial lung disease', 'description': 'Subjects diagnosed with fibrotic interstitial lung disease will participate in a home-rehab program that promotes more physical activity in daily life.', 'interventionNames': ['Behavioral: Home-based pulmonary rehabilitation']}], 'interventions': [{'name': 'Home-based pulmonary rehabilitation', 'type': 'BEHAVIORAL', 'description': 'Home-based tablet-assisted pulmonary rehabilitation with monitoring technology and telephonic health coach calls using motivational interviewing techniques', 'armGroupLabels': ['Home-based pulmonary rehab for fibrotic interstitial lung disease']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic in Rochester', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}], 'overallOfficials': [{'name': 'Teng Moua, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mayo Clinic'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mayo Clinic', 'class': 'OTHER'}, 'collaborators': [{'name': 'Boehringer Ingelheim', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Teng Moua', 'investigatorAffiliation': 'Mayo Clinic'}}}}