Trial Outcomes & Findings for Impact of a Peer Support Program Amongst COPD Patients and Their Caregivers (NCT NCT02891200)

NCT ID: NCT02891200

Last Updated: 2020-02-27

Results Overview

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 weights for all items, times 100. Total scores range from 0 to 100. Higher score reflect worse quality of life and a decrease in score indicates improvement HRQoL . Change in score was calculated as the total score at 6 month post-enrollment minus total score at baseline ( i.e at enrollment ). Minimum clinically important difference (MCID) for SGRQ is a 4-point improvement (i.e decrease in score).

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 292 participants
• Primary outcome timeframe: enrollment to 6 months
• Results posted on: 2020-02-27

Participant Flow

Participant milestones

Measure	Healthcare Professional (HCP) Arm Healthcare professional (HCP) Arm includes a trained respiratory therapist who will provide Chronic Obstructive Pulmonary Disease (COPD) self-management education and support via an in-person session and written materials . HCP support: Healthcare professional (HCP) support will be provided by a trained respiratory therapist who will provide COPD self-management education and support via an in-person session and written materials .	HCP Plus Peer Arm HCP plus Peer arm involves delivering of HCP support as in HCP Arm , along with adding Peer Support Program services. This program is offered to participants by especially trained 'peer mentors' with oversight from a social worker. Peer support program: The Peer Support Program offers education and support to participants by especially trained 'peer mentors' with oversight from a social worker. HCP support: Healthcare professional (HCP) support will be provided by a trained respiratory therapist who will provide COPD self-management education and support via an in-person session and written materials .
Overall Study STARTED	145	147
Overall Study COMPLETED	103	98
Overall Study NOT COMPLETED	42	49

Reasons for withdrawal

Measure	Healthcare Professional (HCP) Arm Healthcare professional (HCP) Arm includes a trained respiratory therapist who will provide Chronic Obstructive Pulmonary Disease (COPD) self-management education and support via an in-person session and written materials . HCP support: Healthcare professional (HCP) support will be provided by a trained respiratory therapist who will provide COPD self-management education and support via an in-person session and written materials .	HCP Plus Peer Arm HCP plus Peer arm involves delivering of HCP support as in HCP Arm , along with adding Peer Support Program services. This program is offered to participants by especially trained 'peer mentors' with oversight from a social worker. Peer support program: The Peer Support Program offers education and support to participants by especially trained 'peer mentors' with oversight from a social worker. HCP support: Healthcare professional (HCP) support will be provided by a trained respiratory therapist who will provide COPD self-management education and support via an in-person session and written materials .
Overall Study Lost to Follow-up	31	36
Overall Study Death	10	9
Overall Study Withdrawal by Subject	1	4

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Healthcare Professional (HCP) Arm n=145 Participants Healthcare professional (HCP) Arm includes a trained respiratory therapist who will provide COPD self-management education and support via an in-person session and written materials . HCP support: Healthcare professional (HCP) support will be provided by a trained respiratory therapist who will provide COPD self-management education and support via an in-person session and written materials .	HCP Plus Peer Arm n=147 Participants HCP plus Peer arm involves delivering of HCP support as in HCP Arm , along with adding Peer Support Program services. This program is offered to participants by especially trained 'peer mentors' with oversight from a social worker. Peer support program: The Peer Support Program offers education and support to participants by especially trained 'peer mentors' with oversight from a social worker. HCP support: Healthcare professional (HCP) support will be provided by a trained respiratory therapist who will provide COPD self-management education and support via an in-person session and written materials .	Total n=292 Participants Total of all reporting groups
Age, Continuous	67.0 years STANDARD_DEVIATION 9.5 • n=5 Participants	67.5 years STANDARD_DEVIATION 9.3 • n=7 Participants	67.3 years STANDARD_DEVIATION 9.4 • n=5 Participants
Sex: Female, Male Female	94 Participants n=5 Participants	85 Participants n=7 Participants	179 Participants n=5 Participants
Sex: Female, Male Male	51 Participants n=5 Participants	62 Participants n=7 Participants	113 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	4 Participants n=7 Participants	4 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	42 Participants n=5 Participants	34 Participants n=7 Participants	76 Participants n=5 Participants
Race (NIH/OMB) White	101 Participants n=5 Participants	106 Participants n=7 Participants	207 Participants n=5 Participants
Race (NIH/OMB) More than one race	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Total Score for St. George Respiratory Questionnaire	55.0 units on a scale STANDARD_DEVIATION 20.0 • n=5 Participants	56.3 units on a scale STANDARD_DEVIATION 18.0 • n=7 Participants	55.6 units on a scale STANDARD_DEVIATION 19.0 • n=5 Participants

PRIMARY outcome

Timeframe: 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 weights for all items, times 100. Total scores range from 0 to 100. Higher score reflect worse quality of life and a decrease in score indicates improvement HRQoL . Change in score was calculated as the total score at 6 month post-enrollment minus total score at baseline ( i.e at enrollment ). Minimum clinically important difference (MCID) for SGRQ is a 4-point improvement (i.e decrease in score).

Outcome measures

Measure	Healthcare Professional (HCP) Arm n=144 Participants Healthcare professional (HCP) Arm includes a trained respiratory therapist who will provide COPD self-management education and support via an in-person session and written materials . HCP support: Healthcare professional (HCP) support will be provided by a trained respiratory therapist who will provide COPD self-management education and support via an in-person session and written materials .	HCP Plus Peer Arm n=143 Participants HCP plus Peer arm involves delivering of HCP support as in HCP Arm , along with adding Peer Support Program services. This program is offered to participants by especially trained 'peer mentors' with oversight from a social worker. Peer support program: The Peer Support Program offers education and support to participants by especially trained 'peer mentors' with oversight from a social worker. HCP support: Healthcare professional (HCP) support will be provided by a trained respiratory therapist who will provide COPD self-management education and support via an in-person session and written materials .
Change in Health-related Quality of Life at 6 Months	-1.78 units on a scale Standard Deviation 19.7	-0.52 units on a scale Standard Deviation 18.3

SECONDARY outcome

Timeframe: Measured at 6 months post enrollment

Population: Patients who have passed away or withdrew before 6 months from enrollment are excluded from the analysis

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; J96.92; R06.03; R09.2 .

Outcome measures

Measure	Healthcare Professional (HCP) Arm n=135 Participants Healthcare professional (HCP) Arm includes a trained respiratory therapist who will provide COPD self-management education and support via an in-person session and written materials . HCP support: Healthcare professional (HCP) support will be provided by a trained respiratory therapist who will provide COPD self-management education and support via an in-person session and written materials .	HCP Plus Peer Arm n=137 Participants HCP plus Peer arm involves delivering of HCP support as in HCP Arm , along with adding Peer Support Program services. This program is offered to participants by especially trained 'peer mentors' with oversight from a social worker. Peer support program: The Peer Support Program offers education and support to participants by especially trained 'peer mentors' with oversight from a social worker. HCP support: Healthcare professional (HCP) support will be provided by a trained respiratory therapist who will provide COPD self-management education and support via an in-person session and written materials .
Combined Number of COPD-related Hospitalizations and ED Visits Per Participant at 6 Months	0.79 COPD-related visits per participant Interval 0.3 to 1.2	0.62 COPD-related visits per participant Interval 0.34 to 0.9

SECONDARY outcome

Timeframe: Measured at 9 months post enrollment

Population: Patients who have passed away or withdrew before 9 months from enrollment are excluded from the analysis

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; J96.92; R06.03; R09.2 .

Outcome measures

Measure	Healthcare Professional (HCP) Arm n=120 Participants Healthcare professional (HCP) Arm includes a trained respiratory therapist who will provide COPD self-management education and support via an in-person session and written materials . HCP support: Healthcare professional (HCP) support will be provided by a trained respiratory therapist who will provide COPD self-management education and support via an in-person session and written materials .	HCP Plus Peer Arm n=130 Participants HCP plus Peer arm involves delivering of HCP support as in HCP Arm , along with adding Peer Support Program services. This program is offered to participants by especially trained 'peer mentors' with oversight from a social worker. Peer support program: The Peer Support Program offers education and support to participants by especially trained 'peer mentors' with oversight from a social worker. HCP support: Healthcare professional (HCP) support will be provided by a trained respiratory therapist who will provide COPD self-management education and support via an in-person session and written materials .
Combined Number of COPD-related Hospitalizations and ED Visits Per Participant at 9 Months	1.06 COPD-related visits per participant Interval 0.22 to 1.9	1.02 COPD-related visits per participant Interval 0.45 to 1.6

SECONDARY outcome

Timeframe: Measured at 3 months post enrollment

Population: Patients who have passed away or withdrew before 3 months from enrollment are excluded from the analysis

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; J96.92; R06.03; R09.2 .

Outcome measures

Measure	Healthcare Professional (HCP) Arm n=140 Participants Healthcare professional (HCP) Arm includes a trained respiratory therapist who will provide COPD self-management education and support via an in-person session and written materials . HCP support: Healthcare professional (HCP) support will be provided by a trained respiratory therapist who will provide COPD self-management education and support via an in-person session and written materials .	HCP Plus Peer Arm n=142 Participants HCP plus Peer arm involves delivering of HCP support as in HCP Arm , along with adding Peer Support Program services. This program is offered to participants by especially trained 'peer mentors' with oversight from a social worker. Peer support program: The Peer Support Program offers education and support to participants by especially trained 'peer mentors' with oversight from a social worker. HCP support: Healthcare professional (HCP) support will be provided by a trained respiratory therapist who will provide COPD self-management education and support via an in-person session and written materials .
Combined Number of COPD-related Hospitalizations and ED Visits Per Participant at 3 Months	0.41 COPD-related visits per participant Interval 0.16 to 0.6	0.27 COPD-related visits per participant Interval 0.15 to 0.3

SECONDARY outcome

Timeframe: Measured at 6 months post enrollment

Population: Patients who have passed away or withdrew before 6 months from enrollment are excluded from the analysis

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

Outcome measures

Measure	Healthcare Professional (HCP) Arm n=135 Participants Healthcare professional (HCP) Arm includes a trained respiratory therapist who will provide COPD self-management education and support via an in-person session and written materials . HCP support: Healthcare professional (HCP) support will be provided by a trained respiratory therapist who will provide COPD self-management education and support via an in-person session and written materials .	HCP Plus Peer Arm n=137 Participants HCP plus Peer arm involves delivering of HCP support as in HCP Arm , along with adding Peer Support Program services. This program is offered to participants by especially trained 'peer mentors' with oversight from a social worker. Peer support program: The Peer Support Program offers education and support to participants by especially trained 'peer mentors' with oversight from a social worker. HCP support: Healthcare professional (HCP) support will be provided by a trained respiratory therapist who will provide COPD self-management education and support via an in-person session and written materials .
Combined Number of All-cause Hospitalizations and ED Visits Per Participant at 6 Months	1.32 visits per participant Interval 0.52 to 2.1	1.07 visits per participant Interval 0.58 to 1.5

SECONDARY outcome

Timeframe: Measured at 9 months post enrollment

Population: Patients who have passed away or withdrew before 9 months from enrollment are excluded from the analysis

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

Outcome measures

Measure	Healthcare Professional (HCP) Arm n=120 Participants Healthcare professional (HCP) Arm includes a trained respiratory therapist who will provide COPD self-management education and support via an in-person session and written materials . HCP support: Healthcare professional (HCP) support will be provided by a trained respiratory therapist who will provide COPD self-management education and support via an in-person session and written materials .	HCP Plus Peer Arm n=130 Participants HCP plus Peer arm involves delivering of HCP support as in HCP Arm , along with adding Peer Support Program services. This program is offered to participants by especially trained 'peer mentors' with oversight from a social worker. Peer support program: The Peer Support Program offers education and support to participants by especially trained 'peer mentors' with oversight from a social worker. HCP support: Healthcare professional (HCP) support will be provided by a trained respiratory therapist who will provide COPD self-management education and support via an in-person session and written materials .
Combined Number of All-cause Hospitalizations and ED Visits Per Participant at 9 Months	1.79 visits per participant Interval 0.47 to 3.1	1.65 visits per participant Interval 0.82 to 2.4

SECONDARY outcome

Timeframe: Measured at 3 months post enrollment

Population: Patients who have passed away or withdrew before 3 months from enrollment are excluded from the analysis

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

Outcome measures

Measure	Healthcare Professional (HCP) Arm n=140 Participants Healthcare professional (HCP) Arm includes a trained respiratory therapist who will provide COPD self-management education and support via an in-person session and written materials . HCP support: Healthcare professional (HCP) support will be provided by a trained respiratory therapist who will provide COPD self-management education and support via an in-person session and written materials .	HCP Plus Peer Arm n=142 Participants HCP plus Peer arm involves delivering of HCP support as in HCP Arm , along with adding Peer Support Program services. This program is offered to participants by especially trained 'peer mentors' with oversight from a social worker. Peer support program: The Peer Support Program offers education and support to participants by especially trained 'peer mentors' with oversight from a social worker. HCP support: Healthcare professional (HCP) support will be provided by a trained respiratory therapist who will provide COPD self-management education and support via an in-person session and written materials .
Combined Number of All-cause Hospitalizations and ED Visits Per Participant at 3 Months	0.71 visits per participant Interval 0.3 to 1.11	0.53 visits per participant Interval 0.3 to 0.76

SECONDARY outcome

Timeframe: enrollment to 9 months

Population: The Number of Participants Analyzed for change in quality of life at 9 months is different from that at 6 months because not all participants were candidates to receive the 9 months quality of life measurement due to end of project period.

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 weights for all items, times 100. Total scores range from 0 to 100. Higher score reflect worse quality of life and a decrease in score indicates improvement HRQoL . Change in score was calculated as the total score at 9 month post-enrollment minus total score at baseline ( i.e at enrollment ). Minimum clinically important difference (MCID) for SGRQ is a 4-point improvement (i.e decrease in score).

Outcome measures

Measure	Healthcare Professional (HCP) Arm n=144 Participants Healthcare professional (HCP) Arm includes a trained respiratory therapist who will provide COPD self-management education and support via an in-person session and written materials . HCP support: Healthcare professional (HCP) support will be provided by a trained respiratory therapist who will provide COPD self-management education and support via an in-person session and written materials .	HCP Plus Peer Arm n=143 Participants HCP plus Peer arm involves delivering of HCP support as in HCP Arm , along with adding Peer Support Program services. This program is offered to participants by especially trained 'peer mentors' with oversight from a social worker. Peer support program: The Peer Support Program offers education and support to participants by especially trained 'peer mentors' with oversight from a social worker. HCP support: Healthcare professional (HCP) support will be provided by a trained respiratory therapist who will provide COPD self-management education and support via an in-person session and written materials .
Change in Health-related Quality of Life at 9 Months	2.27 units on a scale Standard Deviation 23.29	4.61 units on a scale Standard Deviation 20.83

SECONDARY outcome

Timeframe: Measured at 6 months post enrollment

Population: Patients who withdrew from study are excluded from analysis.

Assessed at 6 months

Outcome measures

Measure	Healthcare Professional (HCP) Arm n=144 Participants Healthcare professional (HCP) Arm includes a trained respiratory therapist who will provide COPD self-management education and support via an in-person session and written materials . HCP support: Healthcare professional (HCP) support will be provided by a trained respiratory therapist who will provide COPD self-management education and support via an in-person session and written materials .	HCP Plus Peer Arm n=143 Participants HCP plus Peer arm involves delivering of HCP support as in HCP Arm , along with adding Peer Support Program services. This program is offered to participants by especially trained 'peer mentors' with oversight from a social worker. Peer support program: The Peer Support Program offers education and support to participants by especially trained 'peer mentors' with oversight from a social worker. HCP support: Healthcare professional (HCP) support will be provided by a trained respiratory therapist who will provide COPD self-management education and support via an in-person session and written materials .
Mortality Rate	10 Participants	9 Participants

SECONDARY outcome

Timeframe: Measured at 9 months post enrollment

Population: Patients who withdrew from study are excluded from analysis.

Assessed at 9 months

Outcome measures

Measure	Healthcare Professional (HCP) Arm n=144 Participants Healthcare professional (HCP) Arm includes a trained respiratory therapist who will provide COPD self-management education and support via an in-person session and written materials . HCP support: Healthcare professional (HCP) support will be provided by a trained respiratory therapist who will provide COPD self-management education and support via an in-person session and written materials .	HCP Plus Peer Arm n=143 Participants HCP plus Peer arm involves delivering of HCP support as in HCP Arm , along with adding Peer Support Program services. This program is offered to participants by especially trained 'peer mentors' with oversight from a social worker. Peer support program: The Peer Support Program offers education and support to participants by especially trained 'peer mentors' with oversight from a social worker. HCP support: Healthcare professional (HCP) support will be provided by a trained respiratory therapist who will provide COPD self-management education and support via an in-person session and written materials .
Mortality Rate	15 Participants	13 Participants

SECONDARY outcome

Timeframe: Measured at 3 months post enrollment

Population: Patients who withdrew from study are excluded from analysis.

Assessed at 3 months

Outcome measures

Measure	Healthcare Professional (HCP) Arm n=144 Participants Healthcare professional (HCP) Arm includes a trained respiratory therapist who will provide COPD self-management education and support via an in-person session and written materials . HCP support: Healthcare professional (HCP) support will be provided by a trained respiratory therapist who will provide COPD self-management education and support via an in-person session and written materials .	HCP Plus Peer Arm n=143 Participants HCP plus Peer arm involves delivering of HCP support as in HCP Arm , along with adding Peer Support Program services. This program is offered to participants by especially trained 'peer mentors' with oversight from a social worker. Peer support program: The Peer Support Program offers education and support to participants by especially trained 'peer mentors' with oversight from a social worker. HCP support: Healthcare professional (HCP) support will be provided by a trained respiratory therapist who will provide COPD self-management education and support via an in-person session and written materials .
Mortality Rate	5 Participants	5 Participants

Adverse Events

Healthcare Professional (HCP) Arm

Serious events: 57 serious events

Other events: 0 other events

Deaths: 15 deaths

HCP Plus Peer Arm

Serious events: 57 serious events

Other events: 0 other events

Deaths: 13 deaths

Serious adverse events

Measure	Healthcare Professional (HCP) Arm n=144 participants at risk Healthcare professional (HCP) Arm includes a trained respiratory therapist who will provide COPD self-management education and support via an in-person session and written materials . HCP support: Healthcare professional (HCP) support will be provided by a trained respiratory therapist who will provide COPD self-management education and support via an in-person session and written materials .	HCP Plus Peer Arm n=143 participants at risk HCP plus Peer arm involves delivering of HCP support as in HCP Arm , along with adding Peer Support Program services. This program is offered to participants by especially trained 'peer mentors' with oversight from a social worker. Peer support program: The Peer Support Program offers education and support to participants by especially trained 'peer mentors' with oversight from a social worker. HCP support: Healthcare professional (HCP) support will be provided by a trained respiratory therapist who will provide COPD self-management education and support via an in-person session and written materials .
General disorders Hospitalizations for any cause	39.6% 57/144 • 9 months post enrollment Deaths were systematically assessed. Serious adverse events were assessed systematically for all hospitalizations. Other serious adverse events were tracked based on reports by patient or study interventionists. Reported adverse events results are for all participants except those who withdrew from study (total of 5). Reasons for withdrawal included administrative dis-enrollment (n=2) and patient desire due to reported data collection burden (n=3).	39.9% 57/143 • 9 months post enrollment Deaths were systematically assessed. Serious adverse events were assessed systematically for all hospitalizations. Other serious adverse events were tracked based on reports by patient or study interventionists. Reported adverse events results are for all participants except those who withdrew from study (total of 5). Reasons for withdrawal included administrative dis-enrollment (n=2) and patient desire due to reported data collection burden (n=3).

Other adverse events

Adverse event data not reported

Additional Information

Principle Investigator

Johns Hopkins University

Phone: 410-637-7152

Email: habouma1@jhmi.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place