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Developing a Nonpharmacological Pain Intervention for Community-dwelling Older Adults With Dementia

StatusNot Yet Recruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Minor Start date: Jun 1, 2025 to Jun 2, 2025v6
  2. Notable Start date: Jan 1, 2025 to Jun 1, 2025v5
  3. Notable Start date: Oct 9, 2024 to Jan 1, 2025
    • Primary completion date: May 1, 2027 to Mar 31, 2027
    v4
  4. Notable Enrollment target: 85 to 40
    • Start date: Oct 9, 2023 to Oct 9, 2024
    • Trial status: Recruiting to Not Yet Recruiting
    • Site details revised
    v3
  5. Notable Enrollment target: 35 to 85v2
  6. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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The purpose of this study is to develop an exercise treatment program for knee osteoarthritis that works well for people with memory problems. This study will include two parts. Participants can choose to participate in either or both parts. In Part 1 (not a clinical trial) - The investigators are inviting the following people to participate in an interview: 1. Individuals aged 60 years or older who do not live in a nursing home and have both memory issues and knee pain. 2. Care partners of people with knee pain and memory issues. A care partner can be a family member or friend who helps regularly. 3. Clinicians (exercise physiologists or rehabilitation therapists like physical and occupational therapists) who have worked with older adults with memory issues and knee pain. The goal of these interviews is to learn from the experiences of people with memory issues and knee pain and those who care for them. From these interviews, the investigators hope to design a non-drug, tailored physical activity program that will be interesting and helpful in managing knee pain for older adults with memory problems. For people with memory problems and knee pain and their care partners: The investigators will ask some questions to determine eligibility to participate in the study. Those who qualify for the study will be invited to participate in an interview that could be completed online or in person (Philadelphia, PA). The interview could last up to 90 minutes (1 and a half hours) and can be completed as one or multiple sessions. For clinicians: Participants will engage in a 90-minute focus group with other clinicians where lunch will be served if in person. Those participating in an online focus group will receive a gift card equal to the value of lunch. In Part 2 (a clinical trial) - The program developed in Part 1 will be tested. The program will be physical activity-based. Specific program details for part 2 will be provided as they emerge. Participants can choose to sign up for either or both parts. Signing up for Part 1 does not mean participants have to sign up for Part 2. Please contact us for any questions.
Trial Details
NCT Number NCT06264362
Lead Sponsor Drexel University
Collaborators: National Institute on Aging (NIA)
Conditions
(from sponsor)
Pain, Chronic, Dementia, Mild, Mobility Limitation, Physical Disability, Osteo Arthritis Knee, Mild Cognitive Impairment
Related terms Chronic Pain, Cognitive Dysfunction, Dementia, Lymphoma, Follicular, Mobility Limitation, Osteoarthritis, Pain
Enrollment 40 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov