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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: COPD (Chronic Obstructive Pulmonary Disease)
• Intervention / Treatment: Behavioral: Tiered whole health support for people living with COPD

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 Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Rachel Johnson, PhD, LCSW; Phone Number: 303-842-0270; Email: rachel.a.johnson@cuanschutz.edu

Study Locations

• United States
  • Colorado
    • Aurora, Colorado, United States, 80232
      • University of Colorado Anschutz Medical Campus
      • Contact: Rachel Johnson, PhD, LCSW; Phone Number: 303-842-0270; Email: rachel.a.johnson@cuanschutz.edu
      • Sub-Investigator: Matthew Griffith, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Participant led tiered intervention; 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; 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: Psychotherapy; Reflective writing prompts; Healthcare navigation and coaching

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Generalized Anxiety Disorder-7 items (GAD7)	The GAD7 is an established, validated measurement of anxiety in clinical and research settings.	0 months, 3 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
St George Respiratory Questionnaire (SGRQ)	The SGRQ is an established and validated respiratory distress measurement for people with COPD in both clinical and research settings.	0 months, 3 months

Collaborators and Investigators

• Sponsor: University of Colorado, Denver

Study record dates

Study Major Dates

• Study Start (Estimated): December 1, 2025
• Primary Completion (Estimated): August 1, 2028
• Study Completion (Estimated): November 1, 2028

Study Registration Dates

• First Submitted: December 30, 2024
• First Submitted That Met QC Criteria: January 7, 2025
• First Posted (Actual): January 13, 2025

Study Record Updates

• Last Update Posted (Actual): May 8, 2025
• Last Update Submitted That Met QC Criteria: May 5, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: implementation; asynchronous; whole health support; website based intervention; access to whole health care
• Additional Relevant MeSH Terms: Pathologic Processes; Chronic Disease; Disease Attributes; Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: 24-2639

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No