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Trial record 6 of 114 for:    centurion

Promoting Activity After COPD Exacerbations, Aim 2 (PACE2)

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ClinicalTrials.gov Identifier: NCT03793192
Recruitment Status : Enrolling by invitation
First Posted : January 4, 2019
Last Update Posted : September 24, 2019
Sponsor:
Information provided by (Responsible Party):
Valentin Prieto Centurion, University of Illinois at Chicago

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.

Condition or disease Intervention/treatment Phase
Chronic Obstructive Pulmonary Disease Other: PACE2 Intervention Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Intervention versus Enhanced Usual Care
Masking: Single (Outcomes Assessor)
Masking Description: Allocation sequence will be concealed
Primary Purpose: Other
Official Title: Promoting Activity After COPD Exacerbations, Aim 2 (PACE2)
Actual Study Start Date : March 18, 2019
Estimated Primary Completion Date : January 2022
Estimated Study Completion Date : May 2022

Arm Intervention/treatment
Experimental: PACE2 Intervention
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
Written educational materials regarding physical activity, telephone-based coaching to integrate physical activity in daily life activities and address barriers to attending pulmonary rehabilitation.

No Intervention: Enhanced Usual Care
All participants will receive usual healthcare as per their treating medical team and carry a pedometer for recording of physical activity.



Primary Outcome Measures :
  1. Change in mean daily step counts [ Time Frame: 12 weeks ]
    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 :
  1. Patient-Reported Outcomes Measurement Information System (PROMIS) Emotional Distress - Depression [ Time Frame: 12 weeks ]
    Change in T-score from baseline to week 12 (A negative change in score indicates less emotional distress - depression).

  2. PROMIS Emotional Distress - Anxiety [ Time Frame: 12 weeks ]
    Change in T-score from baseline to week 12 (A negative change in score indicates less emotional distress - anxiety).

  3. PROMIS Fatigue [ Time Frame: 12 weeks ]
    Change in T-score from baseline to week 12 (A negative change in score indicates less fatigue).

  4. PROMIS Physical function [ Time Frame: 12 weeks ]
    Change in T-score from baseline to week 12 (A negative change in score indicates lower physical function).



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03793192


Locations
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United States, Illinois
University of Illinois at Chicago
Chicago, Illinois, United States, 60612
Sponsors and Collaborators
University of Illinois at Chicago
Investigators
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Principal Investigator: Valentin Prieto-Centurion, MD University of Illinois at Chicago

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Responsible Party: Valentin Prieto Centurion, Assistant Professor of Medicine, University of Illinois at Chicago
ClinicalTrials.gov Identifier: NCT03793192     History of Changes
Other Study ID Numbers: 2018-1526
5K23HL130524-03 ( U.S. NIH Grant/Contract )
First Posted: January 4, 2019    Key Record Dates
Last Update Posted: September 24, 2019
Last Verified: September 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Lung Diseases
Respiratory Tract Diseases