Under-Resourced Adults With Chronic Pain eHealth Study
Flourish
Delivery of an eHealth Intervention for Under-resourced Adults With Chronic Pain (Flourish Study)
1 other identifier
interventional
300
1 country
1
Brief Summary
The purpose of this study is to examine the feasibility of the dissemination of a cognitive-behavioral eHealth application (app) for pain self-management with Black and LGBTQ+ adults with high-impact chronic pain lasting at least 3 months and disrupting daily functioning (Implementation aim).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable chronic-pain
Started Jul 2024
Typical duration for not_applicable chronic-pain
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 25, 2024
CompletedFirst Submitted
Initial submission to the registry
November 13, 2024
CompletedFirst Posted
Study publicly available on registry
November 14, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2026
February 13, 2026
February 1, 2026
2.4 years
November 13, 2024
February 11, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Change in West Haven Yale Multiphasic Pain Inventory (WHYMPI) score
The West Haven Yale Multiphasic Pain Inventory (WHYMPI) is a 52-item measure of various domains of the experience of pain, including pain interference (primary intervention outcome) and pain severity with daily functioning.
Baseline, 6 weeks
Secondary Outcomes (9)
Change in Concerns About Pain-Short Form (CAP)
Baseline, 6 weeks
Change in Pain Self-Efficacy Questionnaire (PSEQ) score
Baseline, 6 weeks
Change in Chronic Pain Acceptance Questionnaire-Revised (CPAQ-R) score
Baseline, 6 weeks
Change in Hospital Anxiety and Depression Scale (HADS) score
Baseline, 6 weeks
Change in Short Form-36 score
Baseline, 6 weeks
- +4 more secondary outcomes
Study Arms (2)
Black adults with chronic pain
EXPERIMENTALLGBTQIA+ adults with chronic pain
EXPERIMENTALInterventions
Participants will receive access to the app-based cognitive-behavioral pain self-management intervention program (EPIO) for 3 months.
Eligibility Criteria
You may qualify if:
- Identify as Black and/or LGBTQ+
- Reside in USA
- Chronic pain diagnosis for at least 3 months.
- Experience chronic pain that makes it harder to do their day-to-day activities
- Have daily access to a smart mobile device (smartphone or table) and are willing to use the EPIO app.
You may not qualify if:
- Unable or unwilling to use the digital app for the study
- Do not have daily access to a smart mobile device (smartphone or tablet)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Mayo Cliniclead
Study Sites (1)
Mayo Clinic in Rochester
Rochester, Minnesota, 55905, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Eleshia J. Morrison, Ph.D.
Mayo Clinic
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
November 13, 2024
First Posted
November 14, 2024
Study Start
July 25, 2024
Primary Completion (Estimated)
December 31, 2026
Study Completion (Estimated)
December 31, 2026
Last Updated
February 13, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will not share