COPDNCT02891200
Impact of a Peer Support Program Amongst COPD Patients and Their Caregivers
A study testing Peer support program and HCP support in people with COPD, run by Johns Hopkins University at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- COPD
- What is being tested?
- Peer support program and HCP support
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 292 participants
- Where
- 2 sitesUnited States
- Study dates
- 17 Apr 2017to 4 Nov 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Johns Hopkins Bayview Medical Center
Baltimore, Maryland, 21224
Howard County General Hospital
Columbia, Maryland, 21044
About this study
Official title: Comparing Effectiveness of Self-management and Peer Support Communication Programs Amongst Chronic Obstructive Pulmonary Disease (COPD) Patients and Their Family Caregivers
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.
Read the 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.
- Conditions
- COPD
- Being tested
- Peer support program, HCP support
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peer support programOther
The Peer Support Program offers education and support to participants by especially trained 'peer mentors' with oversight from a social worker.
HCP supportOther
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 .
| Study group | Role | What they receive |
|---|---|---|
| Healthcare professional (HCP) Arm | Experimental | 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 . Receives: Other: HCP support |
| HCP plus Peer arm | Experimental | 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. Receives: Other: Peer support program; Other: HCP support |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: enrollment to 6 months
Secondary outcomes (10)
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:
- 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
- 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 .
Measured: Measured at 6 months post enrollment
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:
- 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
- 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 .
Measured: Measured at 9 months post enrollment
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:
- 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
- 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 .
Measured: Measured at 3 months post enrollment
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.
Measured: Measured at 6 months post enrollment
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.
Measured: Measured at 9 months post enrollment
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.
Measured: Measured at 3 months post enrollment
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).
Measured: enrollment to 9 months
Mortality Rate
Assessed at 6 months
Measured: Measured at 6 months post enrollment
Mortality Rate
Assessed at 9 months
Measured: Measured at 9 months post enrollment
Mortality Rate
Assessed at 3 months
Measured: Measured at 3 months post enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2016 (estimated)
- Study start17 Apr 2017
- Primary completion29 Jun 2019
- Study completion4 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for COPDStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 292 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Responsible party
- Sponsor
- Investigators
- Hanan Aboumatar, MD, MPH, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02891200
- Sponsor's protocol ID
- IRB00114571
- Status last verified
- Feb 2020
- First submitted
- 31 Aug 2016
- Last updated
- 27 Feb 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Aboumatar H, Garcia Morales EE, Jager LR, Naqibuddin M, Kim S, Saunders J, Bone L, Linnell J, McBurney M, Neiman J, Riley M, Robinson N, Rand C, Wise R. Comparing Self-Management Programs with and without Peer Support among Patients with Chronic Obstructive Pulmonary Disease: A Clinical Trial. Ann Am Thorac Soc. 2022 Oct;19(10):1687-1696. doi: 10.1513/AnnalsATS.202108-932OC.
PubMed 35442179
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Effectiveness of Self-management and Peer Support Communication Programs Amongst Chronic Obstructive Pulmonary Disease (COPD) Patients and Their Family Caregivers
- ClinicalTrials.gov ID
- NCT02891200
- Acronym / sponsor ID
- IRB00114571
- Conditions
- COPD
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 292 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Study start
- 17 Apr 2017 (actual)
- Primary completion
- 29 Jun 2019 (actual)
- Study completion
- 4 Nov 2019 (actual)
- First posted
- 7 Sep 2016 (estimated)
- Results
- Posted 27 Feb 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthcare professional (HCP) Arm | Experimental | Other: HCP supportHealthcare 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 plus Peer arm | Experimental | Other: Peer support program, Other: HCP supportHCP 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. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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)
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Peer support programThe Peer Support Program offers education and support to participants by especially trained 'peer mentors' with oversight from a social worker. | Other | HCP plus Peer arm |
| HCP supportHealthcare 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 . | Other | HCP plus Peer arm, Healthcare professional (HCP) Arm |
Primary outcome
Change in Health-related Quality of Life at 6 Months
Time frame: 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).
10 secondary outcomes
Combined Number of COPD-related Hospitalizations and ED Visits Per Participant at 6 Months
Time frame: Measured at 6 months post enrollment
Combined Number of COPD-related Hospitalizations and ED Visits Per Participant at 9 Months
Time frame: Measured at 9 months post enrollment
Combined Number of COPD-related Hospitalizations and ED Visits Per Participant at 3 Months
Time frame: Measured at 3 months post enrollment
Combined Number of All-cause Hospitalizations and ED Visits Per Participant at 6 Months
Time frame: Measured at 6 months post enrollment
Combined Number of All-cause Hospitalizations and ED Visits Per Participant at 9 Months
Time frame: Measured at 9 months post enrollment
Combined Number of All-cause Hospitalizations and ED Visits Per Participant at 3 Months
Time frame: Measured at 3 months post enrollment
Change in Health-related Quality of Life at 9 Months
Time frame: enrollment to 9 months
Mortality Rate
Time frame: Measured at 6 months post enrollment
Mortality Rate
Time frame: Measured at 9 months post enrollment
Mortality Rate
Time frame: Measured at 3 months post enrollment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 35442179Aboumatar H, Garcia Morales EE, Jager LR, Naqibuddin M, Kim S, Saunders J, Bone L, Linnell J, McBurney M, Neiman J, Riley M, Robinson N, Rand C, Wise R. Comparing Self-Management Programs with and without Peer Support among Patients with Chronic Obstructive Pulmonary Disease: A Clinical Trial. Ann Am Thorac Soc. 2022 Oct;19(10):1687-1696. doi: 10.1513/AnnalsATS.202108-932OC.
- Individual participant dataSharing planned: No
Related trials for COPD
RecruitingPhase 2
A Study of Brenipatide (LY3537031) in Adult Participants With Moderate-to-Severe Chronic Obstructive Pulmonary Disease (COPD)
Pulmonary Disease, Chronic Obstructive
RecruitingPhase 2
Oral Sildenafil for Exercise Capacity, Dyspnea and Cardiopulmonary Function in COPD
Chronic Obstructive Pulmonary Disease
Recruiting
Evaluating the Safety and Efficacy of dNerva Lung Denervation System in Patients With COPD
COPD, Chronic Obstructive Pulmonary Disease
Recruiting
WIN Ratio Analysis to Determine a Strategy of Non- Invasive SUpport for Respiratory Failure in the EmeRgency Department
Acute Hypoxic Respiratory Failure, Acute Respiratory Distress Syndrome (ARDS)
Recruiting
Comparison of Several Oxygenation Targets With Different Oxygen Interfaces - Impact on Oxygen Flow Rates
Oxygen Toxicity, COPD Bronchitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hanan Aboumatar, MD, MPH principal investigator
Johns Hopkins University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Peer support program and HCP support in people with COPD, run by Johns Hopkins University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Feb 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Health-related Quality of Life at 6 Months (time frame: enrollment to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02891200, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2020.