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NCT Number: NCT06770777

Development And Evaluation of An Adaptive Web-Based Intervention for 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.

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Key information

Age range

18 year–89 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Colorado Anschutz Medical Campus

Aurora, Colorado, 80232, United States

Location contact

Matthew Griffith, MD

SUB_INVESTIGATOR

Rachel Johnson, PhD, LCSW

CONTACT

[email protected]

303-842-0270

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • Not in a conflicting research study

Treatment and study plan

Tiered whole health support for people living with COPD

Behavioral

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.

Other names: Reflective writing prompts, Psychotherapy, Healthcare navigation and coaching

Primary outcomes

  1. 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.

Secondary outcomes

  1. Generalized Anxiety Disorder-7 items (GAD7)

    Time frame: 0 months, 3 months

    The GAD7 is an established, validated measurement of anxiety in clinical and research settings.

Other outcomes

  1. St George Respiratory Questionnaire (SGRQ)

    Time frame: 0 months, 3 months

    The SGRQ is an established and validated respiratory distress measurement for people with COPD in both clinical and research settings.

Study contacts

Contact information is provided by the study sponsor or research team.

Rachel Johnson, PhD, LCSW

CONTACT

[email protected]

303-842-0270

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Registry information

Official study title

Development And Evaluation of An Adaptive Web-Based Intervention for Whole Health Support For Patients With Chronic Pulmonology Obstructive Disease (COPD)

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Jan 13, 2025
Registry last updated
May 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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