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NCT05858996 · ClinicalTrials.gov registry record · Phase 2
Testing the Pain Clinical Practice Guideline
A Phase 2 study of Pain and Dementia, sponsored by University of Maryland, Baltimore.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 300
- Enrollment target
- 7
- Study locations
NCT05858996 is a Phase 2 study of Pain and Dementia that is actively recruiting participants, run by University of Maryland, Baltimore. The registered enrollment target is 300 participants, roughly in line with the 303-participant average among 374 other Pain trials with a reported enrollment target. The trial reports 7 study locations across 1 state.
The verdict
NCT05858996, a Phase 2 study of Pain and Dementia, is actively recruiting participants, sponsored by University of Maryland, Baltimore.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 300 participants
- Enrollment target
- 7
- Study locations
Study Summary
There are evidence based processes for assessment and management of pain using pharmacologic and nonpharmacological approaches. These were reviewed and included within the Pain Management Clinical Practice Guideline (Pain Management CPG) recently developed by AMDA: The Society for Post-Acute and Long-Term Care Medicine. There are, however, many challenges to translating the use of Clinical Practice Guidelines into clinical settings. To overcome these challenges we developed and previously tested a theoretically based approach and merged this approach with the Pain Management CPG, which is referred to as the PAIN-CLINICAL PRACTICE GUIDELINE-USING THE EVIDENCE INTEGRATION TRIANGLE (PAIN-CPG-EIT). The PAIN-CPG-EIT involves a research nurse facilitator working with an identified community champion(s) and stakeholder team for 12 months to provide the following four components: Component I: Establishing and meeting monthly with a Stakeholder Team; Component II: Education of the staff; Component III: Mentoring and motivating the staff to address pain; Component IV: Ongoing evaluation of resident pain outcomes. Twelve communities will be included with 25 residents living with dementia and pain recruited from each community. Six communities will be randomized to treatment (PAIN-CPG-EIT) and six randomized to education only (EO) which involves providing the same education to staff as is done in Component II of PAIN-CPG-EIT. The primary aim of this study is to test the effectiveness of use of the PAIN-CPG-EIT to improve the assessment, diagnosis and management of pain and decrease pain intensity among nursing home residents living with dementia between baseline, 4 and 12 months and evaluate treatment fidelity. A secondary aim of the study is to consider differences in measurement, treatment and response to treatment between male and female and Black versus White residents living with dementia. Findings from this study will help build on the currently limited information about
Interventions
- BEHAVIORAL Pain-CPG-EIT
- OTHER Pain-CPG-Education Only
Study Locations (7)
Maryland
- Future Care Coldspring - Baltimore
- Future Care Courtland - Baltimore
- Futurecare Northpoint - Baltimore
- Futurecare Irvington - Baltimore
- Communicare Ellicott City - Ellicott City
- communicare Marley Station - Glen Burnie
- Charles E Smilth Life Community - Rockville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 300 participants |
| Start Date | 2023-12-01 |
| Est. Completion | 2028-12-31 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05858996
The ClinicalTrials.gov registry entry for NCT05858996 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 300 participants, a figure that helps gauge the scale of data the investigators plan to collect, roughly in line with the 303-participant average among 374 other Pain trials with a reported enrollment target. The listed sponsor is University of Maryland, Baltimore, which has 560 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Pain appearing as the primary indexed condition, and to 2 interventions - of which Pain-CPG-EIT is the first listed.
NCT05858996 reports 7 study locations spanning 1 distinct geographic area - top geographies include Maryland.
Frequently Asked Questions
What is clinical trial NCT05858996 about?
NCT05858996 is a clinical study titled "Testing the Pain Clinical Practice Guideline". There are evidence based processes for assessment and management of pain using pharmacologic and nonpharmacological approaches. These were reviewed and included within the Pain Management Clinical Practice Guideline (Pain Management CPG) recently developed by AMDA: The Society for Post-Acute and Lon...
What is the current status of trial NCT05858996?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 300 participants. The study started on 2023-12-01. Estimated completion is 2028-12-31.
What conditions does trial NCT05858996 study?
This clinical trial studies the following conditions: Pain, Dementia.
What interventions are being tested in trial NCT05858996?
The interventions under investigation include: Pain-CPG-EIT (BEHAVIORAL), Pain-CPG-Education Only (OTHER).
Who is sponsoring clinical trial NCT05858996?
This trial is sponsored by University of Maryland, Baltimore, which has 560 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05858996 being conducted?
This trial has 7 study locations across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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