Clinical trial NCT03793192: Promoting Activity After COPD Exacerbations, Aim 2
Official title: Promoting Activity After COPD Exacerbations, Aim 2 (PACE2)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease
Lead sponsor: University of Illinois at Chicago
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2019-01-04
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Intervention versus Enhanced Usual Care
Primary purpose: OTHER

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

1. Age 18 years or older;
2. Physician diagnosis of COPD;
3. Hospitalized as an inpatient, 23-hour observation, or clinical decision unit
4. Admitting respiratory conditions sensitive to the Centers for Medicare and Medicaid Services Hospital Readmission Reduction Program as listed below:

   * COPD exacerbation
   * Asthma/COPD overlap
   * Decompensated heart failure
   * Pneumonia
   * Chronic Airway Disease

Exclusion Criteria:

1. Physical inability to participate in a walking program;
2. Oxygen saturation \<90% by pulse oximetry refractory to supplemental oxygen, or in a patient unable or unwilling to use supplemental oxygen;
3. Fall in the previous 6 months;
4. Resting electrocardiogram (ECG) with new ST changes or tachyarrhythmia;
5. Planned discharge home to hospice or to long term care facility/skilled nursing facility;
6. Life expectancy \<3 months;
7. Medical contraindication to participating in a physical activity promotion program as determined by the inpatient treating clinician;
8. Unable to communicate in English;
9. Unable or declines to provide informed consent.

Primary outcomes:
measure: Change in mean daily step counts
timeFrame: 12 weeks
Secondary outcomes:
measure: Patient-Reported Outcomes Measurement Information System (PROMIS) Emotional Distress - Depression
timeFrame: 12 weeks
measure: PROMIS Emotional Distress - Anxiety
timeFrame: 12 weeks
measure: PROMIS Fatigue
timeFrame: 12 weeks
measure: PROMIS Physical function
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Illinois at Chicago
state: Illinois
Study officials:
affiliation: University of Illinois at Chicago
name: Jerry Krishnan, MD
role: PRINCIPAL_INVESTIGATOR
References: