An interventional study of PACE2 Intervention in Chronic Obstructive Pulmonary Disease, sponsored by University of Illinois at Chicago. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-01-20.
Sponsored by University of Illinois at Chicago · Not applicable, Interventional, and Other
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.
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.
2,592 studies on the registry are indexed under Lung Diseases, Obstructive; 198 are open to participants now.
This study's enrollment of 7 is below the median of 66 across 1,837 interventional studies indexed under Lung Diseases, Obstructive.
Browse Lung Diseases, Obstructive studies →University of Illinois at Chicago is the lead sponsor of 515 studies on the registry; 133 are open to participants now.
Of its 31 completed or terminated interventional studies of FDA-regulated products, 18 (58%) have results posted.
Counted across the registry records on this site, refreshed daily.
Admitting respiratory conditions sensitive to the Centers for Medicare and Medicaid Services Hospital Readmission Reduction Program as listed below:
Exclusion Criteria:
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.
Other: PACE2 Intervention
All participants will receive usual healthcare as per their treating medical team and carry a pedometer for recording of physical activity.
Written educational materials regarding physical activity, telephone-based coaching to integrate physical activity in daily life activities and address barriers to attending pulmonary rehabilitation.
Change in mean daily step counts
change in mean daily step counts (averaged over 1 week) over time using repeated measures over the 12 weeks of the study.
Time frame: 12 weeks
Patient-Reported Outcomes Measurement Information System (PROMIS) Emotional Distress - Depression
Change in T-score from baseline to week 12 (A negative change in score indicates less emotional distress - depression).
Time frame: 12 weeks
PROMIS Emotional Distress - Anxiety
Change in T-score from baseline to week 12 (A negative change in score indicates less emotional distress - anxiety).
Time frame: 12 weeks
PROMIS Fatigue
Change in T-score from baseline to week 12 (A negative change in score indicates less fatigue).
Time frame: 12 weeks
PROMIS Physical function
Change in T-score from baseline to week 12 (A negative change in score indicates lower physical function).
Time frame: 12 weeks
Plan to share: No
No publications or documents are linked to this record.
This study is terminated, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.
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University of Illinois at Chicago