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Pain Management for Dementia

Phase 2
Recruiting
Research Sponsored by University of Maryland, Baltimore
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights
No Placebo-Only Group

Summary

This trial will test an approach to improve assessment, diagnosis and management of pain in nursing home residents living with dementia, and also evaluate differences in measurement, treatment and response to treatment between male/female and Black/White.

Who is the study for?
This trial is for nursing home residents aged 65 or older with dementia and pain. They must show signs of dementia through various tests like BIMS, AD8, CDR, or FAQ and have experienced pain recently as per staff reports or assessments.
What is being tested?
The study is testing a Pain Management Clinical Practice Guideline (Pain-CPG) using the Evidence Integration Triangle (EIT). It involves education, mentoring by nurses, stakeholder teamwork, and ongoing evaluation to improve pain management in people with dementia.
What are the potential side effects?
Since this trial focuses on implementing a guideline rather than a drug intervention, side effects are not typical as seen with medications. However, there may be indirect effects related to changes in care practices.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Appropriate use of opioids
Pain management in careplan
pain assessment completed
Secondary study objectives
Pain in Alzheimer's Disease (PAIN-AD)

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Pain-CPG-EITExperimental Treatment1 Intervention
The four components of the PAIN-CPG-EIT are provided by a research nurse facilitator working with the champion(s) and stakeholder team. Following the first stakeholder team meeting, the research nurse facilitator works 8 hours weekly during months one and two and then for four hours weekly months three to 12 to implement: Component I: Stakeholder team meeting and goal setting; Component II: Education of the staff; Component III: Mentoring and motivating the staff to address pain using the Pain Management CPG ; and Component IV: Ongoing monitoring of pain management in the community based on the Pain Management CPG.
Group II: Pain-CPG-Education OnlyActive Control1 Intervention
Communities randomized to education only will be provided with staff education using our developed Powerpoint for Component II of the PAIN-CPG-EIT intervention in 30 minute sessions as is currently done in usual practice. They will also be given access to an online copy of the Pain Management CPG. The education will be provided in the preferred format (e.g., face-to-face; webinar).

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Who is running the clinical trial?

University of Maryland, BaltimoreLead Sponsor
713 Previous Clinical Trials
379,192 Total Patients Enrolled
8 Trials studying Dementia
3,842 Patients Enrolled for Dementia
~200 spots leftby Dec 2028
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