COPD (Chronic Obstructive Pulmonary Disease)NCT06770777
Development And Evaluation of An Adaptive Web-Based Intervention for COPD
A study testing Tiered whole health support for people living with COPD in people with COPD (Chronic Obstructive Pulmonary Disease), run by University of Colorado, Denver at 1 site in United States.
Trial summary
Narrative-based tiered asynchronous psychosocial and behavioral whole health support for people adjusting to living with COPD. The intervention is administered by experienced LCSWs under the PI's supervision. Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- COPD (Chronic Obstructive Pulmonary Disease)
- What is being tested?
- Tiered whole health support for people living with COPD
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2025to Nov 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Has access to the internet once per week
- Has been diagnosed with COPD and is being seen at the ECHCS VA Medical Center or the University of Colorado Pulmonology clinics
Who cannot join
- Not in a conflicting research study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
University of Colorado Anschutz Medical Campus
Aurora, Colorado, 80232
Rachel Johnson, PhD, LCSW, 303-842-0270, rachel.a.johnson@cuanschutz.edu
Matthew Griffith, MD
About this study
Official title: Development And Evaluation of An Adaptive Web-Based Intervention for Whole Health Support For Patients With Chronic Pulmonology Obstructive Disease (COPD)
Narrative-based tiered asynchronous psychosocial and behavioral whole health support for people adjusting to living with COPD. The intervention is administered by experienced LCSWs under the PI's supervision.
Read the detailed description
This study will advance health access equity for people with Chronic Obstructive Pulmonary Disease (COPD) by providing an asynchronous, patient-led, web-based, adaptive, flexible, and tiered intervention that easily integrates into the daily lives of both providers and patients living with COPD. This intervention includes health navigation education, health and behavior coaching, and narrative, strengths-based mental and behavioral health support. COPD is a complex chronic illness with multiple domains to study whole person support. Not only because of the significant impact of a lack of whole person support for people living with COPD but also because COPD shares many of the same symptomology and impact on daily living as other significant chronic illnesses such as heart failure, some neurological disorders, and some types of cancer (5-7). The lessons learned from studying COPD whole person support can be applied to other similar symptomatic burdensome chronic illnesses that also suffer from fragmented care.
- Being tested
- Tiered whole health support for people living with COPD
- Keywords
- asynchronous, whole health support, website based intervention, implementation, access to whole health care
- 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.
Tiered whole health support for people living with COPDBehavioural
Also called Reflective writing prompts, Psychotherapy, Healthcare navigation and coaching
The website design allows study participants to choose the intervention tier(s) that meets their needs. There are three tiers from Tier 1: Information only, Tier 2 Reflective Writing, and Tier 3 LCSW Psychotherapeutic Intervention. Participants will also be able to choose multiple tiers if they are interested in continuing their participation. First Tier: The website offers standardized information about COPD care, healthcare navigation, and whole-person care. Information includes symptom management, disease progression and trajectory, healthcare navigation concepts, and directs people to the VA website with information about whole-person care. Second Tier: If participants choose, they can also select writing prompts with opportunities to reflect on their whole-person care and adjustment to illness. Third Tier: People living with COPD can also select to have asynchronous interaction with a licensed clinical social worker providing the narrative-based psychotherapeutic intervention.
| Study group | Role | What they receive |
|---|---|---|
| Participant led tiered intervention | Experimental | Participants living with COPD will navigate to the website and choose the tiered intervention that fits their needs. The first tier is information about COPD only. Second tier is reflective writing prompts for illness narrative generation and the third tier is asynchronous mental health support from a licensed clinical social worker. Receives: Behavioral: Tiered whole health support for people living with COPD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Personal Health Questionnaire- 9 item (PHQ9)
The PHQ9 is a standardized, validated measurement used to track depression in both clinical and research settings.
Measured: 0 months, 3 months
Secondary outcomes (1)
Generalized Anxiety Disorder-7 items (GAD7)
The GAD7 is an established, validated measurement of anxiety in clinical and research settings.
Measured: 0 months, 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2025
- Study startDec 2025 (estimated)
- Primary completionAug 2028 (estimated)
- Study completionNov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPD (Chronic Obstructive Pulmonary Disease)Studies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe 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
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06770777
- Sponsor's protocol ID
- 24-2639
- Status last verified
- Jan 2025
- First submitted
- 30 Dec 2024
- Last updated
- 8 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development And Evaluation of An Adaptive Web-Based Intervention for Whole Health Support For Patients With Chronic Pulmonology Obstructive Disease (COPD)
- ClinicalTrials.gov ID
- NCT06770777
- Acronym / sponsor ID
- 24-2639
- Keywords
- asynchronous, whole health support, website based intervention, implementation, access to whole health care
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Study start
- Dec 2025 (estimated)
- Primary completion
- Aug 2028 (estimated)
- Study completion
- Nov 2028 (estimated)
- First posted
- 13 Jan 2025 (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.
Narrative-based tiered asynchronous psychosocial and behavioral whole health support for people adjusting to living with COPD. The intervention is administered by experienced LCSWs under the PI's supervision.
Detailed description
This study will advance health access equity for people with Chronic Obstructive Pulmonary Disease (COPD) by providing an asynchronous, patient-led, web-based, adaptive, flexible, and tiered intervention that easily integrates into the daily lives of both providers and patients living with COPD. This intervention includes health navigation education, health and behavior coaching, and narrative, strengths-based mental and behavioral health support. COPD is a complex chronic illness with multiple domains to study whole person support. Not only because of the significant impact of a lack of whole person support for people living with COPD but also because COPD shares many of the same symptomology and impact on daily living as other significant chronic illnesses such as heart failure, some neurological disorders, and some types of cancer (5-7). The lessons learned from studying COPD whole person support can be applied to other similar symptomatic burdensome chronic illnesses that also suffer from fragmented care.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participant led tiered intervention | Experimental | Behavioral: Tiered whole health support for people living with COPDParticipants living with COPD will navigate to the website and choose the tiered intervention that fits their needs. The first tier is information about COPD only. Second tier is reflective writing prompts for illness narrative generation and the third tier is asynchronous mental health support from a licensed clinical social worker. |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Has access to the internet once per week
- Has been diagnosed with COPD and is being seen at the ECHCS VA Medical Center or the University of Colorado Pulmonology clinics
Key exclusion criteria (1 listed)
- Not in a conflicting research study
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 |
|---|---|---|
| Tiered whole health support for people living with COPDAlso: Reflective writing prompts, Psychotherapy, Healthcare navigation and coachingThe website design allows study participants to choose the intervention tier(s) that meets their needs. There are three tiers from Tier 1: Information only, Tier 2 Reflective Writing, and Tier 3 LCSW Psychotherapeutic Intervention. Participants will also be able to choose multiple tiers if they are interested in continuing their participation. First Tier: The website offers standardized information about COPD care, healthcare navigation, and whole-person care. Information includes symptom management, disease progression and trajectory, healthcare navigation concepts, and directs people to the VA website with information about whole-person care. Second Tier: If participants choose, they can also select writing prompts with opportunities to reflect on their whole-person care and adjustment to illness. Third Tier: People living with COPD can also select to have asynchronous interaction with a licensed clinical social worker providing the narrative-based psychotherapeutic intervention. | Behavioural | Participant led tiered intervention |
Primary outcome
Personal Health Questionnaire- 9 item (PHQ9)
Time frame: 0 months, 3 months
The PHQ9 is a standardized, validated measurement used to track depression in both clinical and research settings.
1 secondary outcome
Generalized Anxiety Disorder-7 items (GAD7)
Time frame: 0 months, 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2025.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tiered whole health support for people living with COPD in people with COPD (Chronic Obstructive Pulmonary Disease), run by University of Colorado, Denver 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 2 inclusion and 1 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: opening soon, as of the sponsor's last update on 8 May 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rachel Johnson, PhD, LCSW (303-842-0270, rachel.a.johnson@cuanschutz.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Personal Health Questionnaire- 9 item (PHQ9) (time frame: 0 months, 3 months). 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 8 May 2025.