COPDNCT06350799
Chronic Obstructive Pulmonary Disease and Community Health Worker Home-visits
An observational study of COPD, run by VA Puget Sound Health Care System at 1 site in United States.
Trial summary
We examined a Community Health Worker (CHW) program for Chronic Obstructive Pulmonary Disease (COPD) in Veteran Participants. The goal of this study was to assess participants' perceived acceptability, appropriateness, and feasibility of the intervention, explore participants' COPD health outcomes, and gather insights… Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- COPD
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Mar 2019to 28 Apr 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
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 45 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients recruited for this study will be Veterans with COPD.
Who may be able to join
- Clinical diagnosis of COPD
- Enrolled in VA primary care
- English speaking
- Access to a telephone
- Clinically stable breathing for at least 1 month prior to enrollment
- If available, post-bronchodilator spirometry with FEV1/FVC < 0.70 in the last 5 years
- ≥ 1 exacerbation in the past year treated with prednisone and/or antibiotics or treated in the ED or stay in the hospital
- Ability to connect to CVT-to-Home
Who cannot join
- Nursing home resident or institutionalized
- Pregnancy
- Pulmonary rehabilitation program in the last year
- Uncontrolled hypertension, angina, or heart failure
- Life expectancy < 1 year or terminal illness.
- Dementia or uncontrolled psychiatric illness
- Other safety concerns with participating in physical activity
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Puget Sound Health Care System
Seattle, Washington, 98108
About this study
Official title: COPD Home-Visits: Community Health Worker Home-visit Support to Enhance Self-Management and Improve Quality of Life Among Rural Veterans With Chronic Obstructive Pulmonary Disease
We examined a Community Health Worker (CHW) program for Chronic Obstructive Pulmonary Disease (COPD) in Veteran Participants. The goal of this study was to assess participants' perceived acceptability, appropriateness, and feasibility of the intervention, explore participants' COPD health outcomes, and gather insights from participants and CHWs to inform potential improvements.
Veteran participants enrolled in the 12-week intervention and received a series of 9 CHW home, phone, or video visits. These visits provided education and chronic disease self-management practices to improve COPD health.
Researchers examined the participant and CHW perception of the intervention through qualitative interviews and surveys.
Read the detailed description
Background: One-third of Veterans live in rural areas, and rural patients are more likely to have chronic obstructive pulmonary disease (COPD) and rural Veterans with COPD have lower health status than urban Veterans. COPD patients often have exacerbations that can lead to emergency room visits and hospitalizations. Since COPD exacerbations and hospitalizations can be prevented by interventions such as appropriate use of inhaled COPD medications, focusing efforts to improve COPD management for these high-risk rural Veterans with COPD is essential.
Objectives: The proposed project will test the feasibility and potential effectiveness of a Community Health Worker (CHW) intervention to help reduce risk of COPD exacerbations among Veterans. The overall goal of this pilot study is to determine the feasibility and acceptability of a community health worker intervention to promote health behavior change among Veterans with COPD. To target a high risk population, we will focus on Veterans with moderate-severe exacerbations in the past year.
Methods: Participants at VA Puget Sound will be enrolled in the study. We will develop a program to serve rural Veterans, though we will also serve all Veterans meeting the criteria particularly in these initial stages at the VA Puget Sound in Seattle. Participants will be scheduled for 9 education visits over 12 weeks that will be delivered either in-person, though a Clinical Video Telehealth into the home (CVT-to-Home), or by phone. Participants will be offered to have additional phone calls in between visits to check-in on their COPD self-management goals and confirm their upcoming appointments. Participants will be followed for a total of 3 months in this pilot study. Data on proportion of eligible patients who enroll in the study, number of intervention visits completed, and completion of study questionnaires will be collected. Data analysis will examine whether any changes in outcomes such as quality of life or physical activity between baseline and follow-up are associated with the intervention. Semi-structured exit interviews will be conducted at the end of the study to assess the design of intervention components, use of technology, appropriateness, and feasibility.
- Conditions
- COPD
- Keywords
- Community Health Workers
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceptability, Appropriateness, Feasibility
Patient perception through interviews
Measured: one month post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2024
- Study start14 Mar 2019
- Primary completion27 May 2021
- Study completion28 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPDStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Puget Sound Health Care System
- Sponsor type
- US federal agency
- Collaborators
- Public Health - Seattle and King County, University of Washington
- Responsible party
- Principal investigator, Vincent S. Fan, VA Puget Sound Health Care System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06350799
- Sponsor's protocol ID
- 01741
- Status last verified
- Apr 2024
- First submitted
- 1 Apr 2024
- Last updated
- 5 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COPD Home-Visits: Community Health Worker Home-visit Support to Enhance Self-Management and Improve Quality of Life Among Rural Veterans With Chronic Obstructive Pulmonary Disease
- ClinicalTrials.gov ID
- NCT06350799
- Acronym / sponsor ID
- 01741
- Conditions
- COPD
- Keywords
- Community Health Workers
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- VA Puget Sound Health Care SystemUS federal agency
- Collaborators
- Public Health - Seattle and King County, University of Washington
- Study start
- 14 Mar 2019 (actual)
- Primary completion
- 27 May 2021 (actual)
- Study completion
- 28 Apr 2023 (actual)
- First posted
- 5 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
We examined a Community Health Worker (CHW) program for Chronic Obstructive Pulmonary Disease (COPD) in Veteran Participants. The goal of this study was to assess participants' perceived acceptability, appropriateness, and feasibility of the intervention, explore participants' COPD health outcomes, and gather insights from participants and CHWs to inform potential improvements.
Veteran participants enrolled in the 12-week intervention and received a series of 9 CHW home, phone, or video visits. These visits provided education and chronic disease self-management practices to improve COPD health.
Researchers examined the participant and CHW perception of the intervention through qualitative interviews and surveys.
Detailed description
Background: One-third of Veterans live in rural areas, and rural patients are more likely to have chronic obstructive pulmonary disease (COPD) and rural Veterans with COPD have lower health status than urban Veterans. COPD patients often have exacerbations that can lead to emergency room visits and hospitalizations. Since COPD exacerbations and hospitalizations can be prevented by interventions such as appropriate use of inhaled COPD medications, focusing efforts to improve COPD management for these high-risk rural Veterans with COPD is essential.
Objectives: The proposed project will test the feasibility and potential effectiveness of a Community Health Worker (CHW) intervention to help reduce risk of COPD exacerbations among Veterans. The overall goal of this pilot study is to determine the feasibility and acceptability of a community health worker intervention to promote health behavior change among Veterans with COPD. To target a high risk population, we will focus on Veterans with moderate-severe exacerbations in the past year.
Methods: Participants at VA Puget Sound will be enrolled in the study. We will develop a program to serve rural Veterans, though we will also serve all Veterans meeting the criteria particularly in these initial stages at the VA Puget Sound in Seattle. Participants will be scheduled for 9 education visits over 12 weeks that will be delivered either in-person, though a Clinical Video Telehealth into the home (CVT-to-Home), or by phone. Participants will be offered to have additional phone calls in between visits to check-in on their COPD self-management goals and confirm their upcoming appointments. Participants will be followed for a total of 3 months in this pilot study. Data on proportion of eligible patients who enroll in the study, number of intervention visits completed, and completion of study questionnaires will be collected. Data analysis will examine whether any changes in outcomes such as quality of life or physical activity between baseline and follow-up are associated with the intervention. Semi-structured exit interviews will be conducted at the end of the study to assess the design of intervention components, use of technology, appropriateness, and feasibility.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients recruited for this study will be Veterans with COPD.
Key inclusion criteria (8 listed)
- Clinical diagnosis of COPD
- Enrolled in VA primary care
- English speaking
- Access to a telephone
- Clinically stable breathing for at least 1 month prior to enrollment
Key exclusion criteria (7 listed)
- Nursing home resident or institutionalized
- Pregnancy
- Pulmonary rehabilitation program in the last year
- Uncontrolled hypertension, angina, or heart failure
- Life expectancy < 1 year or terminal illness.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Acceptability, Appropriateness, Feasibility
Time frame: one month post-intervention
Patient perception through interviews
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2024.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COPD, run by VA Puget Sound Health Care System at 1 site 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 8 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 5 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Acceptability, Appropriateness, Feasibility (time frame: one month post-intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Apr 2024.