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NCT04330365 · ClinicalTrials.gov registry record · NA
Pragmatic Trial of WHT vs. PC-GE to Promote Non-Pharmacological Strategies to Treat Chronic Pain in Veterans
A NA study, sponsored by San Francisco Veterans Affairs Medical Center.
- Completed
- Registry status
- NA
- Development phase
- 793
- Enrollment target
NCT04330365 is a NA study that has completed, run by San Francisco Veterans Affairs Medical Center. The registered enrollment target is 793 participants.
The verdict
NCT04330365, a NA study, has completed, sponsored by San Francisco Veterans Affairs Medical Center.
- COMPLETED
- Registry status
- NA
- Development phase
- 793 participants
- Enrollment target
Study Summary
The overarching goal of this Pain Management Collaboratory Demonstration project is to test a new Whole Health paradigm for chronic pain care, emphasizing non-pharmacological pain self-management that is hypothesized to reduce pain symptoms and improve overall functioning and quality of life in Veterans. In UH3 Aim 1, the investigators will conduct a 12-month pragmatic effectiveness trial at 6 VA sites across the country to test whether veterans with moderate to severe chronic pain randomized to receive the Whole Health Team (WHT) intervention are more likely than those receiving Primary Care Group Education (PC-GE) to: Hypothesis 1: Experience improved pain interference (primary outcome), pain intensity, functioning and quality of life (secondary outcomes); Hypothesis 2: Decrease use of higher-risk pain medications, including opioids, or high-risk combinations; Hypothesis 3: Engage in a greater number of non-pharmacological pain management activities; and Hypothesis 4: Experience improved mental health-related symptoms, including sleep problems and suicidality. In addition, both the WHT and PC-GE arms will be compared to a third group of veterans randomized to Usual Primary Care (UPC, Control) on the same primary and secondary outcomes above. After the baseline assessment, masked telephone assessments will be administered to participants at 3, 6, 9, and 12 months. UH3 Aim 2 is to conduct a process evaluation of the two active interventions (WHT and PC-GE) and a budget impact analysis that includes costs to implement and execute the two active interventions as well as the control condition (UPC) to inform the development of an implementation toolkit for scaling and dissemination. Eligible participants are veterans reporting moderate to severe chronic pain present every day or nearly every day for ≥ 6 months. The total sample size for the population is based on our main study aim/hypothesis and is N=764. This breaks down to n=343 in the WHT intervention, n=339 in the
Interventions
- BEHAVIORAL Whole Health Team (WHT) Intervention Arm, Primary Care Group Education (PC-GE) Intervention Arm, Usual Primary Care (UPC) Arm
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 793 participants |
| Start Date | 2020-09-15 |
| Est. Completion | 2025-01-23 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04330365
The ClinicalTrials.gov registry entry for NCT04330365 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 793 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is San Francisco Veterans Affairs Medical Center, which has 15 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Whole Health Team (WHT) Intervention Arm, Primary Care Group Education (PC-GE) Intervention Arm, Usual Primary Care (UPC) Arm is the first listed.
NCT04330365 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04330365 about?
NCT04330365 is a clinical study titled "Pragmatic Trial of WHT vs. PC-GE to Promote Non-Pharmacological Strategies to Treat Chronic Pain in Veterans". The overarching goal of this Pain Management Collaboratory Demonstration project is to test a new Whole Health paradigm for chronic pain care, emphasizing non-pharmacological pain self-management that is hypothesized to reduce pain symptoms and improve overall functioning and quality of life in Vete...
What is the current status of trial NCT04330365?
This trial is currently completed. It is a NA study. The enrollment target is 793 participants. The study started on 2020-09-15. Estimated completion is 2025-01-23.
What interventions are being tested in trial NCT04330365?
The interventions under investigation include: Whole Health Team (WHT) Intervention Arm, Primary Care Group Education (PC-GE) Intervention Arm, Usual Primary Care (UPC) Arm (BEHAVIORAL).
Who is sponsoring clinical trial NCT04330365?
This trial is sponsored by San Francisco Veterans Affairs Medical Center, which has 15 total clinical trials registered on ClinicalTrials.gov.
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