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N/A N=292 Randomized Single-blind Other

Impact of a Peer Support Program Amongst COPD Patients and Their Caregivers

COPD

Enrolled (actual)
292
Serious AEs
39.7%
Results posted
Feb 2020
Primary outcome: Primary: Change in Health-related Quality of Life at 6 Months — -1.78; -0.52 units on a scale — p=0.467

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Peer support program (Other); HCP support (Other)
Age
Adult, Older Adult · 40+ yrs
Sex
All
Sponsor
Johns Hopkins University
Primary completion
Jun 2019

Outcome Measures

OutcomeResultp-value
PRIMARY
Change in Health-related Quality of Life at 6 Months
-1.78; -0.52 0.467
SECONDARY
Combined Number of COPD-related Hospitalizations and ED Visits Per Participant at 6 Months
0.79; 0.62
SECONDARY
Combined Number of COPD-related Hospitalizations and ED Visits Per Participant at 9 Months
1.06; 1.02
SECONDARY
Combined Number of COPD-related Hospitalizations and ED Visits Per Participant at 3 Months
0.41; 0.27
SECONDARY
Combined Number of All-cause Hospitalizations and ED Visits Per Participant at 6 Months
1.32; 1.07
SECONDARY
Combined Number of All-cause Hospitalizations and ED Visits Per Participant at 9 Months
1.79; 1.65
SECONDARY
Combined Number of All-cause Hospitalizations and ED Visits Per Participant at 3 Months
0.71; 0.53
SECONDARY
Change in Health-related Quality of Life at 9 Months
2.27; 4.61
SECONDARY
Mortality Rate
5; 5
SECONDARY
Mortality Rate
5; 5
SECONDARY
Mortality Rate
5; 5

Summary

The study is to compare the effectiveness of two health communication and dissemination strategies that are designed to engage patients and family caregivers in successfully managing COPD in 'real-world' settings. Both strategies aim to advance patient understanding of COPD, its treatment options, and self-care tasks; support them in coping with the disease; and enable them to adopt a variety of positive behaviors, including adherence to treatment plans, smoking cessation, joining pulmonary rehabilitation programs, and assuming an active, healthy lifestyle. One strategy relies on the healthcare professional (HCP) as the primary communicator about COPD self-management (HCP arm), whereas the other uses a dual approach that involves both healthcare professionals and peer mentors delivering such communication (HCP plus Peer arm). Peer mentors are COPD patients and caregivers who have successfully managed COPD and have received foundational training on peer mentoring. Specifically, the study aims are to : 1) Conduct a randomized controlled trial in which the 'HCP' and 'HCP plus Peer' strategies are tested in 'real-world' healthcare settings; 2) compare the impact of these strategies on patient satisfaction, experience, activation, self- efficacy, self-care behavior, health status, quality of life, use of Emergency Department (ED) and hospital services, and survival; and, 3) compare the impact of these strategies on caregiver satisfaction, experience, self-efficacy, stress, and coping skills.

Eligibility Criteria

Inclusion Criteria

  • Age 40 years or older
  • Has a physician diagnosis of COPD AND is on treatment for it ( defined as receiving treatment at hospital or clinic for COPD)

Exclusion Criteria

  • Cognitive dysfunction impairing ability to provide informed consent and follow instructions
  • Active substance abuse or unstable psychiatric condition
  • Terminal illness (i.e. less than 6 months life expectancy) that is non-COPD related
  • Planning to move from area
  • Living at a facility, such as Hospice or nursing home
  • Unable to provide contact information
  • Does not understand English
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02891200). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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