COPD
Conditions
Brief 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.
Detailed description
Chronic Obstructive Pulmonary Disease (COPD) is a prevalent global condition that results in high mortality, morbidity, symptom burden, and functional limitations that impact the quality of life. COPD is the third leading cause of death in the US and a leading cause of hospitalizations. COPD patients report unmet needs in regards to information about their disease and how to manage and cope with it at an intellectual, emotional, and social level. Many COPD patients lack the information and skills that they need to correctly use their inhaled medications, manage 'breathlessness episodes', and detect early signs of a COPD exacerbation. Pulmonary rehabilitation programs are established to help COPD patients increase their exercise capacity and reduce fatigue and dyspnea with daily activity. While clinical trials testing these programs have demonstrated significant improvements in health-related quality of life and reduced dyspnea and fatigue amongst participants, it remains unclear how best to engage and motivate patients to participate in them. Self-management support interventions which involve collaboratively helping patients acquire and practice the skills needed to carry out disease-specific medical regimens, change their health behavior to adjust their roles for optimal function, improve day-to-day control of their disease, and improve their well-being, have been demonstrated in several trials to improve health-related quality of life, and reduce symptom burden, hospitalizations, and ED visits amongst COPD patients. However, it is still unclear which self-management support strategies employed in 'real world' settings are most effective in engaging, motivating, and enabling patients to successfully follow recommended treatments, adopt desired health behaviors, and thus achieve the desired improvements in their health outcomes. The planned study design is a single- blinded randomized controlled trial to compare the effectiveness of two strategies for engaging and supporting COPD patients and their family caregivers in self-management of COPD. The two strategies/study arms are: 1) the 'HCP arm' where the healthcare professional (HCP) is the primary communicator about COPD self-management with the patient participants; and 2) the 'HCP plus Peer arm', where both healthcare professionals and peer mentors engage with study participants in conversations about COPD self-management using multiple channels including one- to- one and group conversations. Participants will be randomized in a 1:1 ratio into the two study arms. The trial will be conducted amongst COPD patients coming to the hospital or clinic at two study sites within Johns Hopkins Healthcare System. Recruitment from both sites and multiple settings allows for a more representative COPD patient population to be enrolled in the study, thus increasing the external validity of study findings. The research study will answer the research question: Amongst COPD patients and their caregivers, would a dual strategy that combines healthcare professional and peer mentor delivery of COPD self- management education and support result in greater improvements in health status and quality of life, and reductions in acute healthcare services' utilization, compared to relying on healthcare professionals alone in these communications? Would such dual strategy result in reduced caregiver stress and improved coping and satisfaction? The study hypothesis is that the dual strategy of using 'HCP plus peer support' to engage and support COPD patients and caregivers will have superior outcomes to the 'HCP only' strategy in the following areas : a) Improved health- related quality of life and reduced numbers of COPD-related hospital and ED visits; b) improved patient activation, self-efficacy, and self-care behaviors; c) improved family caregivers' satisfaction and self- efficacy. These improvements will be noted at 3, 6, and 9 months compared to baseline.
Interventions
OTHERPeer support program
The Peer Support Program offers education and support to participants by especially trained 'peer mentors' with oversight from a social worker.
OTHERHCP 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 .
Sponsors
Patient-Centered Outcomes Research Institute
Johns Hopkins University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Health-related Quality of Life at 6 Months | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Combined Number of COPD-related Hospitalizations and ED Visits Per Participant at 9 Months | 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; J96.92; R06.03; R09.2 . |
| Combined Number of COPD-related Hospitalizations and ED Visits Per Participant at 3 Months | 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; J96.92; R06.03; R09.2 . |
| Combined Number of All-cause Hospitalizations and ED Visits Per Participant at 6 Months | 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. |
| Combined Number of COPD-related Hospitalizations and ED Visits Per Participant at 6 Months | 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; J96.92; R06.03; R09.2 . |
| Combined Number of All-cause Hospitalizations and ED Visits Per Participant at 3 Months | 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. |
| Change in Health-related Quality of Life at 9 Months | 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 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). |
| Mortality Rate | Measured at 6 months post enrollment | Assessed at 6 months |
| Combined Number of All-cause Hospitalizations and ED Visits Per Participant at 9 Months | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Healthcare Professional (HCP) Arm 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 . | 145 |
| 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 . | 147 |
| Total | 292 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 10 | 9 |
| Overall Study | Lost to Follow-up | 31 | 36 |
| Overall Study | Withdrawal by Subject | 1 | 4 |
Baseline characteristics
| Characteristic | Healthcare Professional (HCP) Arm | Total | HCP Plus Peer Arm |
|---|---|---|---|
| Age, Continuous | 67.0 years STANDARD_DEVIATION 9.5 | 67.3 years STANDARD_DEVIATION 9.4 | 67.5 years STANDARD_DEVIATION 9.3 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 4 Participants | 4 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 42 Participants | 76 Participants | 34 Participants |
| Race (NIH/OMB) More than one race | 2 Participants | 3 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 101 Participants | 207 Participants | 106 Participants |
| Sex: Female, Male Female | 94 Participants | 179 Participants | 85 Participants |
| Sex: Female, Male Male | 51 Participants | 113 Participants | 62 Participants |
| Total Score for St. George Respiratory Questionnaire | 55.0 units on a scale STANDARD_DEVIATION 20 | 55.6 units on a scale STANDARD_DEVIATION 19 | 56.3 units on a scale STANDARD_DEVIATION 18 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 15 / 144 | 13 / 143 |
| other Total, other adverse events | 0 / 144 | 0 / 143 |
| serious Total, serious adverse events | 57 / 144 | 57 / 143 |
Outcome results
Primary
Change in Health-related Quality of Life at 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).
Time frame: enrollment to 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Healthcare Professional (HCP) Arm | Change in Health-related Quality of Life at 6 Months | -1.78 units on a scale | Standard Deviation 19.7 |
| HCP Plus Peer Arm | Change in Health-related Quality of Life at 6 Months | -0.52 units on a scale | Standard Deviation 18.3 |
p-value: 0.46795% CI: [-2.47, 5.38]Mixed Models Analysis
Secondary
Change in Health-related Quality of Life at 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 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).
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Healthcare Professional (HCP) Arm | Change in Health-related Quality of Life at 9 Months | 2.27 units on a scale | Standard Deviation 23.29 |
| HCP Plus Peer Arm | Change in Health-related Quality of Life at 9 Months | 4.61 units on a scale | Standard Deviation 20.83 |
Secondary
Combined Number of All-cause Hospitalizations and ED Visits Per Participant at 3 Months
All hospitalizations and ED visits will be counted from time of participant enrollment into study till 3 months afterwards.
Time frame: Measured at 3 months post enrollment
Population: Patients who have passed away or withdrew before 3 months from enrollment are excluded from the analysis
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Healthcare Professional (HCP) Arm | Combined Number of All-cause Hospitalizations and ED Visits Per Participant at 3 Months | 0.71 visits per participant |
| HCP Plus Peer Arm | Combined Number of All-cause Hospitalizations and ED Visits Per Participant at 3 Months | 0.53 visits per participant |
Secondary
Combined Number of All-cause Hospitalizations and ED Visits Per Participant at 6 Months
All hospitalizations and ED visits will be counted from time of participant enrollment into study till 6 months afterwards.
Time frame: Measured at 6 months post enrollment
Population: Patients who have passed away or withdrew before 6 months from enrollment are excluded from the analysis
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Healthcare Professional (HCP) Arm | Combined Number of All-cause Hospitalizations and ED Visits Per Participant at 6 Months | 1.32 visits per participant |
| HCP Plus Peer Arm | Combined Number of All-cause Hospitalizations and ED Visits Per Participant at 6 Months | 1.07 visits per participant |
Secondary
Combined Number of All-cause Hospitalizations and ED Visits Per Participant at 9 Months
All hospitalizations and ED visits will be counted from time of participant enrollment into study till 9 months afterwards.
Time frame: Measured at 9 months post enrollment
Population: Patients who have passed away or withdrew before 9 months from enrollment are excluded from the analysis
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Healthcare Professional (HCP) Arm | Combined Number of All-cause Hospitalizations and ED Visits Per Participant at 9 Months | 1.79 visits per participant |
| HCP Plus Peer Arm | Combined Number of All-cause Hospitalizations and ED Visits Per Participant at 9 Months | 1.65 visits per participant |
Secondary
Combined Number of COPD-related Hospitalizations and ED Visits Per Participant at 3 Months
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 .
Time frame: Measured at 3 months post enrollment
Population: Patients who have passed away or withdrew before 3 months from enrollment are excluded from the analysis
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Healthcare Professional (HCP) Arm | Combined Number of COPD-related Hospitalizations and ED Visits Per Participant at 3 Months | 0.41 COPD-related visits per participant |
| HCP Plus Peer Arm | Combined Number of COPD-related Hospitalizations and ED Visits Per Participant at 3 Months | 0.27 COPD-related visits per participant |
Secondary
Combined Number of COPD-related Hospitalizations and ED Visits Per Participant at 6 Months
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 .
Time frame: Measured at 6 months post enrollment
Population: Patients who have passed away or withdrew before 6 months from enrollment are excluded from the analysis
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Healthcare Professional (HCP) Arm | Combined Number of COPD-related Hospitalizations and ED Visits Per Participant at 6 Months | 0.79 COPD-related visits per participant |
| HCP Plus Peer Arm | Combined Number of COPD-related Hospitalizations and ED Visits Per Participant at 6 Months | 0.62 COPD-related visits per participant |
Secondary
Combined Number of COPD-related Hospitalizations and ED Visits Per Participant at 9 Months
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 .
Time frame: Measured at 9 months post enrollment
Population: Patients who have passed away or withdrew before 9 months from enrollment are excluded from the analysis
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Healthcare Professional (HCP) Arm | Combined Number of COPD-related Hospitalizations and ED Visits Per Participant at 9 Months | 1.06 COPD-related visits per participant |
| HCP Plus Peer Arm | Combined Number of COPD-related Hospitalizations and ED Visits Per Participant at 9 Months | 1.02 COPD-related visits per participant |
Secondary
Mortality Rate
Assessed at 6 months
Time frame: Measured at 6 months post enrollment
Population: Patients who withdrew from study are excluded from analysis.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Healthcare Professional (HCP) Arm | Mortality Rate | 10 Participants |
| HCP Plus Peer Arm | Mortality Rate | 9 Participants |
Secondary
Mortality Rate
Assessed at 9 months
Time frame: Measured at 9 months post enrollment
Population: Patients who withdrew from study are excluded from analysis.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Healthcare Professional (HCP) Arm | Mortality Rate | 15 Participants |
| HCP Plus Peer Arm | Mortality Rate | 13 Participants |
Secondary
Mortality Rate
Assessed at 3 months
Time frame: Measured at 3 months post enrollment
Population: Patients who withdrew from study are excluded from analysis.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Healthcare Professional (HCP) Arm | Mortality Rate | 5 Participants |
| HCP Plus Peer Arm | Mortality Rate | 5 Participants |