Ignite Creation Date:
2025-12-24 @ 3:38 PM
Ignite Modification Date:
2026-01-29 @ 9:02 AM
Study NCT ID:
NCT03793192
Status:
TERMINATED
Last Update Posted:
2025-01-20
First Post:
2019-01-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Promoting Activity After COPD Exacerbations, Aim 2
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D029424', 'term': 'Pulmonary Disease, Chronic Obstructive'}], 'ancestors': [{'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'Allocation sequence will be concealed'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Intervention versus Enhanced Usual Care'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 7}}, 'statusModule': {'whyStopped': 'PI leaving institution, data collected is insufficient for analysis', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2019-03-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2022-04-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-01-16', 'studyFirstSubmitDate': '2019-01-02', 'studyFirstSubmitQcDate': '2019-01-02', 'lastUpdatePostDateStruct': {'date': '2025-01-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-01-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-04-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in mean daily step counts', 'timeFrame': '12 weeks', 'description': 'change in mean daily step counts (averaged over 1 week) over time using repeated measures over the 12 weeks of the study.'}], 'secondaryOutcomes': [{'measure': 'Patient-Reported Outcomes Measurement Information System (PROMIS) Emotional Distress - Depression', 'timeFrame': '12 weeks', 'description': 'Change in T-score from baseline to week 12 (A negative change in score indicates less emotional distress - depression).'}, {'measure': 'PROMIS Emotional Distress - Anxiety', 'timeFrame': '12 weeks', 'description': 'Change in T-score from baseline to week 12 (A negative change in score indicates less emotional distress - anxiety).'}, {'measure': 'PROMIS Fatigue', 'timeFrame': '12 weeks', 'description': 'Change in T-score from baseline to week 12 (A negative change in score indicates less fatigue).'}, {'measure': 'PROMIS Physical function', 'timeFrame': '12 weeks', 'description': 'Change in T-score from baseline to week 12 (A negative change in score indicates lower physical function).'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Chronic Obstructive Pulmonary Disease']}, 'descriptionModule': {'briefSummary': 'This randomized controlled pilot study involving patients with chronic obstructive pulmonary disease (COPD) recently discharged from the hospital will evaluate the feasibility and efficacy of a home-based mobile-health supported physical activity promotion program.', 'detailedDescription': 'Deconditioning is common in patients with chronic obstructive pulmonary disease (COPD) and has been associated with poor outcomes (e.g. difficulty breathing). Pulmonary rehabilitation (PR) initiated shortly after hospital discharge following a COPD exacerbation has been shown to improve some of these outcomes. However, for many patients, access to PR programs is limited due to environmental, physical, and psycho-social reasons. Home-based physical activity promotion, combined with education and social support, could help to overcome some barriers to access and have been shown to be effective in populations with mild to moderate COPD. However, home-based interventions have not been tested in patients recovering from COPD exacerbations, a group for whom solutions to safely promote physical activity are urgently needed. In PACE2 up to 64 adult participants with a physician diagnosis of COPD will be enrolled and randomized to one of two groups: physical activity promotion intervention or enhanced usual care. Participants will be enrolled while hospitalized and randomization will occur approximately 7 days after hospital discharge. All participants will be provided self-management educational materials and community resources both prior to hospital discharge and during a home visit shortly after hospital discharge. For the participants randomized to the intervention group, physical activity promotion will start following randomization and continue for 12 weeks. These participants will also receive a personalized plan to attend pulmonary rehabilitation, a guideline-recommended program for patients with COPD recovering from exacerbations. The primary endpoint will be the change in physical activity (mean daily step counts over 1 week) over time using repeated measures over the 12 weeks of the study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age 18 years or older;\n2. Physician diagnosis of COPD;\n3. Hospitalized as an inpatient, 23-hour observation, or clinical decision unit\n4. Admitting respiratory conditions sensitive to the Centers for Medicare and Medicaid Services Hospital Readmission Reduction Program as listed below:\n\n * COPD exacerbation\n * Asthma/COPD overlap\n * Decompensated heart failure\n * Pneumonia\n * Chronic Airway Disease\n\nExclusion Criteria:\n\n1. Physical inability to participate in a walking program;\n2. Oxygen saturation \\<90% by pulse oximetry refractory to supplemental oxygen, or in a patient unable or unwilling to use supplemental oxygen;\n3. Fall in the previous 6 months;\n4. Resting electrocardiogram (ECG) with new ST changes or tachyarrhythmia;\n5. Planned discharge home to hospice or to long term care facility/skilled nursing facility;\n6. Life expectancy \\<3 months;\n7. Medical contraindication to participating in a physical activity promotion program as determined by the inpatient treating clinician;\n8. Unable to communicate in English;\n9. Unable or declines to provide informed consent.'}, 'identificationModule': {'nctId': 'NCT03793192', 'acronym': 'PACE2', 'briefTitle': 'Promoting Activity After COPD Exacerbations, Aim 2', 'organization': {'class': 'OTHER', 'fullName': 'University of Illinois at Chicago'}, 'officialTitle': 'Promoting Activity After COPD Exacerbations, Aim 2 (PACE2)', 'orgStudyIdInfo': {'id': '2018-1526'}, 'secondaryIdInfos': [{'id': '5K23HL130524-03', 'link': 'https://reporter.nih.gov/quickSearch/5K23HL130524-03', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'PACE2 Intervention', 'description': 'All participants will receive usual healthcare as per their treating medical team and carry a pedometer for recording of physical activity. In addition, participants randomized to the PACE2 intervention will receive written educational materials regarding physical activity, telephone-based coaching to integrate physical activity in daily life activities and address barriers to attending pulmonary rehabilitation.', 'interventionNames': ['Other: PACE2 Intervention']}, {'type': 'NO_INTERVENTION', 'label': 'Enhanced Usual Care', 'description': 'All participants will receive usual healthcare as per their treating medical team and carry a pedometer for recording of physical activity.'}], 'interventions': [{'name': 'PACE2 Intervention', 'type': 'OTHER', 'description': 'Written educational materials regarding physical activity, telephone-based coaching to integrate physical activity in daily life activities and address barriers to attending pulmonary rehabilitation.', 'armGroupLabels': ['PACE2 Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60612', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'University of Illinois at Chicago', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}], 'overallOfficials': [{'name': 'Jerry Krishnan, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Illinois at Chicago'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Illinois at Chicago', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Heart, Lung, and Blood Institute (NHLBI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Jerry Krishnan', 'investigatorAffiliation': 'University of Illinois at Chicago'}}}}