NCT02891200

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

Completed NA Results posted Last updated 27 February 2020

What this trial tests

NA trial testing Peer support program in COPD in 292 participants. Completed in 4 November 2019.

Timeline

17 April 2017

Primary endpoint
29 June 2019

4 November 2019

Quick facts

Lead sponsor	Johns Hopkins University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	other
Enrollment	292
Start date	17 April 2017
Primary completion	29 June 2019
Estimated completion	4 November 2019
Sites	2 locations across United States

Drugs / interventions tested

• Peer support program
• HCP support

Conditions studied

• COPD — all drugs for COPD →

Sponsor

Johns Hopkins University

Who can join

40 and older, any sex, with COPD. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change in Health-related Quality of Life at 6 Months Primary · enrollment to 6 months

Change in health-related quality of life (HRQoL) at 6 months post-enrollment from baseline. The HRQoL is measured using the St. George Respiratory Questionnaire (SGRQ), a validated instrument that will be administered to participant by a trained research team member. SGRQ measures health-related quality of life among patients with respiratory diseases. It is a 40 items questionnaire grouped into three domains (Symptoms, Activity, and Impacts). The overall summary score is calculated by summing the weights of all items with positive response in the questionnaire and dividing that by sum of weig

Group	Value	95% CI
Healthcare Professional (HCP) Arm	-1.78	± 19.7
HCP Plus Peer Arm	-0.52	± 18.3

Combined Number of COPD-related Hospitalizations and ED Visits Per Participant at 6 Months Secondary · Measured at 6 months post enrollment

All hospitalizations and ED visits discharge diagnoses are reviewed and those that are COPD-related are counted from time of participant enrollment into study till 6 months afterwards. A visit is coded as COPD-related if: 1. The principle discharge diagnosis was any of the following : J41.0 ; J41.1; J41.8; J42; J43.0; J43.1; J43.2; J43.8; J43.9; J44.0; J44.1; J44.9. Or 2. The principle discharge diagnosis was respiratory failure AND the visit had a secondary diagnosis of J44.0 or J44.1 . The respiratory failure codes are J96.00; J96.01; J96.02; J96.20; J96.21; J96.22; J96.90; J96.91; J96.

Group	Value	95% CI
Healthcare Professional (HCP) Arm	0.79	0.30 – 1.2
HCP Plus Peer Arm	0.62	0.34 – 0.9

Combined Number of COPD-related Hospitalizations and ED Visits Per Participant at 9 Months Secondary · Measured at 9 months post enrollment

All hospitalizations and ED visits discharge diagnoses are reviewed and those that are COPD-related are counted from time of participant enrollment into study till 9 months afterwards. A visit is coded as COPD-related if: 1. The principle discharge diagnosis was any of the following : J41.0 ; J41.1; J41.8; J42; J43.0; J43.1; J43.2; J43.8; J43.9; J44.0; J44.1; J44.9. Or 2. The principle discharge diagnosis was respiratory failure AND the visit had a secondary diagnosis of J44.0 or J44.1 . The respiratory failure codes are J96.00; J96.01; J96.02; J96.20; J96.21; J96.22; J96.90; J96.91; J96.

Group	Value	95% CI
Healthcare Professional (HCP) Arm	1.06	0.22 – 1.9
HCP Plus Peer Arm	1.02	0.45 – 1.6

Combined Number of COPD-related Hospitalizations and ED Visits Per Participant at 3 Months Secondary · Measured at 3 months post enrollment

All hospitalizations and ED visits discharge diagnoses are reviewed and those that are COPD-related are counted from time of participant enrollment into study till 3 months afterwards. A visit is coded as COPD-related if: 1. The principle discharge diagnosis was any of the following : J41.0 ; J41.1; J41.8; J42; J43.0; J43.1; J43.2; J43.8; J43.9; J44.0; J44.1; J44.9. Or 2. The principle discharge diagnosis was respiratory failure AND the visit had a secondary diagnosis of J44.0 or J44.1 . The respiratory failure codes are J96.00; J96.01; J96.02; J96.20; J96.21; J96.22; J96.90; J96.91; J96.

Group	Value	95% CI
Healthcare Professional (HCP) Arm	0.41	0.16 – 0.6
HCP Plus Peer Arm	0.27	0.15 – 0.3

Combined Number of All-cause Hospitalizations and ED Visits Per Participant at 6 Months Secondary · Measured at 6 months post enrollment

All hospitalizations and ED visits will be counted from time of participant enrollment into study till 6 months afterwards.

Group	Value	95% CI
Healthcare Professional (HCP) Arm	1.32	0.52 – 2.1
HCP Plus Peer Arm	1.07	0.58 – 1.5

Combined Number of All-cause Hospitalizations and ED Visits Per Participant at 9 Months Secondary · Measured at 9 months post enrollment

All hospitalizations and ED visits will be counted from time of participant enrollment into study till 9 months afterwards.

Group	Value	95% CI
Healthcare Professional (HCP) Arm	1.79	0.47 – 3.1
HCP Plus Peer Arm	1.65	0.82 – 2.4

Combined Number of All-cause Hospitalizations and ED Visits Per Participant at 3 Months Secondary · Measured at 3 months post enrollment

All hospitalizations and ED visits will be counted from time of participant enrollment into study till 3 months afterwards.

Group	Value	95% CI
Healthcare Professional (HCP) Arm	0.71	0.3 – 1.11
HCP Plus Peer Arm	0.53	0.3 – 0.76

Change in Health-related Quality of Life at 9 Months Secondary · enrollment to 9 months

Change in health-related quality of life (HRQoL) at 9 months post-enrollment from baseline. The HRQoL is measured using the St. George Respiratory Questionnaire (SGRQ), a validated instrument that will be administered to participant by a trained research team member. SGRQ measures health-related quality of life among patients with respiratory diseases. It is a 40 items questionnaire grouped into three domains (Symptoms, Activity, and Impacts). The overall summary score is calculated by summing the weights of all items with positive response in the questionnaire and dividing that by sum of weig

Group	Value	95% CI
Healthcare Professional (HCP) Arm	2.27	± 23.29
HCP Plus Peer Arm	4.61	± 20.83

Mortality Rate Secondary · Measured at 6 months post enrollment

Assessed at 6 months

Group	Value	95% CI
Healthcare Professional (HCP) Arm	10
HCP Plus Peer Arm	9

Mortality Rate Secondary · Measured at 9 months post enrollment

Assessed at 9 months

Group	Value	95% CI
Healthcare Professional (HCP) Arm	15
HCP Plus Peer Arm	13

Mortality Rate Secondary · Measured at 3 months post enrollment

Assessed at 3 months

Group	Value	95% CI
Healthcare Professional (HCP) Arm	5
HCP Plus Peer Arm	5

Adverse events — posted to ClinicalTrials.gov

Time frame: 9 months post enrollment. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Healthcare Professional (HCP) Arm

Serious: 57/144 (40%)

Deaths: 15/144

HCP Plus Peer Arm

Serious: 57/143 (40%)

Deaths: 13/143

Serious adverse events (1 terms)

Reaction	System	Healthcare Professional (H…	HCP Plus Peer Arm
Hospitalizations for any cause	General disorders	—	—

Most-reported serious reactions: Hospitalizations for any cause.

Data from ClinicalTrials.gov NCT02891200 adverse events section.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Comparing Self-Management Programs with and without Peer Support among Patients with Chronic Obstructive Pulmonary Disease: A Clinical Trial.
   Aboumatar H, Garcia Morales EE, Jager LR, Naqibuddin M, et al · · 2022 · cited 5× · PMID 35442179 · DOI 10.1513/annalsats.202108-932oc