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

NCT06770777 | Not Yet Recruiting

• 1 other identifier: 24-2639
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

COPD (Chronic Obstructive Pulmonary Disease)

Keywords

asynchronous; whole health support; website based intervention; implementation; access to whole health care

Outcome Measures

Primary Outcomes (1)

• Personal Health Questionnaire- 9 item (PHQ9)

  The PHQ9 is a standardized, validated measurement used to track depression in both clinical and research settings.

  0 months, 3 months

Secondary Outcomes (1)

• Generalized Anxiety Disorder-7 items (GAD7)

  0 months, 3 months

Other Outcomes (1)

• St George Respiratory Questionnaire (SGRQ)

  0 months, 3 months

Study Arms (1)

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.

Behavioral: Tiered whole health support for people living with COPD

Interventions

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.

Also known as: Reflective writing prompts, Psychotherapy, Healthcare navigation and coaching

Participant led tiered intervention

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Not in a conflicting research study

Sponsors & Collaborators

• University of Colorado, Denver: lead

Study Sites (1)

University of Colorado Anschutz Medical Campus

Aurora, Colorado, 80232, United States

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Psychotherapy

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Behavioral Disciplines and Activities

Central Study Contacts

Rachel Johnson, PhD, LCSW

CONTACT

303-842-0270; rachel.a.johnson@cuanschutz.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Participants will choose which tier of the intervention that they are interested in accessing. Care providers will be notified about which services are accessed.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 30, 2024
• First Posted: January 13, 2025
• Study Start: December 1, 2025
• Primary Completion (Estimated): August 1, 2028
• Study Completion (Estimated): November 1, 2028
• Last Updated: May 8, 2025

Record last verified: 2025-01

Locations

US (1)