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Promoting Activity After COPD Exacerbations, Aim 2 (PACE2)

Primary Purpose

Chronic Obstructive Pulmonary Disease

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
PACE2 Intervention
Sponsored by
University of Illinois at Chicago
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Chronic Obstructive Pulmonary Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Illinois at Chicago

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

PACE2 Intervention

Enhanced Usual Care

Arm 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.

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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).
PROMIS Emotional Distress - Anxiety
Change in T-score from baseline to week 12 (A negative change in score indicates less emotional distress - anxiety).
PROMIS Fatigue
Change in T-score from baseline to week 12 (A negative change in score indicates less fatigue).
PROMIS Physical function
Change in T-score from baseline to week 12 (A negative change in score indicates lower physical function).

Full Information

First Posted
January 2, 2019
Last Updated
April 27, 2021
Sponsor
University of Illinois at Chicago
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
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1. Study Identification

Unique Protocol Identification Number
NCT03793192
Brief Title
Promoting Activity After COPD Exacerbations, Aim 2
Acronym
PACE2
Official Title
Promoting Activity After COPD Exacerbations, Aim 2 (PACE2)
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Unknown status
Study Start Date
March 18, 2019 (Actual)
Primary Completion Date
January 2022 (Anticipated)
Study Completion Date
May 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Illinois at Chicago
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Intervention versus Enhanced Usual Care
Masking
Outcomes Assessor
Masking Description
Allocation sequence will be concealed
Allocation
Randomized
Enrollment
64 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
PACE2 Intervention
Arm Type
Experimental
Arm 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.
Arm Title
Enhanced Usual Care
Arm Type
No Intervention
Arm Description
All participants will receive usual healthcare as per their treating medical team and carry a pedometer for recording of physical activity.
Intervention Type
Other
Intervention Name(s)
PACE2 Intervention
Intervention 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.
Primary Outcome Measure Information:
Title
Change in mean daily step counts
Description
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
Secondary Outcome Measure Information:
Title
Patient-Reported Outcomes Measurement Information System (PROMIS) Emotional Distress - Depression
Description
Change in T-score from baseline to week 12 (A negative change in score indicates less emotional distress - depression).
Time Frame
12 weeks
Title
PROMIS Emotional Distress - Anxiety
Description
Change in T-score from baseline to week 12 (A negative change in score indicates less emotional distress - anxiety).
Time Frame
12 weeks
Title
PROMIS Fatigue
Description
Change in T-score from baseline to week 12 (A negative change in score indicates less fatigue).
Time Frame
12 weeks
Title
PROMIS Physical function
Description
Change in T-score from baseline to week 12 (A negative change in score indicates lower physical function).
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jerry Krishnan, MD
Organizational Affiliation
University of Illinois at Chicago
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Illinois at Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Promoting Activity After COPD Exacerbations, Aim 2

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