Promoting Activity After COPD Exacerbations, Aim 2

NCT03793192 | Terminated DMC

• 2 other identifiers: 2018-15265K23HL130524-03
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Obstructive Pulmonary Disease

Outcome Measures

Primary Outcomes (1)

• 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.

  12 weeks

Secondary Outcomes (4)

• Patient-Reported Outcomes Measurement Information System (PROMIS) Emotional Distress - Depression

  12 weeks

• PROMIS Emotional Distress - Anxiety

  12 weeks

• PROMIS Fatigue

  12 weeks

• PROMIS Physical function

  12 weeks

Study Arms (2)

PACE2 Intervention

EXPERIMENTAL

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

Enhanced Usual Care

NO INTERVENTION

All participants will receive usual healthcare as per their treating medical team and carry a pedometer for recording of physical activity.

Interventions

PACE2 Intervention OTHER

Written educational materials regarding physical activity, telephone-based coaching to integrate physical activity in daily life activities and address barriers to attending pulmonary rehabilitation.

PACE2 Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 years or older;
• Physician diagnosis of COPD;
• Hospitalized as an inpatient, 23-hour observation, or clinical decision unit
• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Illinois at Chicago: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

University of Illinois at Chicago

Chicago, Illinois, 60612, United States

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Jerry Krishnan, MD

  University of Illinois at Chicago

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Allocation sequence will be concealed
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Intervention versus Enhanced Usual Care

Study Record Dates

• First Submitted: January 2, 2019
• First Posted: January 4, 2019
• Study Start: March 18, 2019
• Primary Completion: April 8, 2022
• Study Completion: April 8, 2022
• Last Updated: January 20, 2025

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)