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NCT06264362Not yet recruiting

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

Source: ClinicalTrials.gov · Last updated 11 Mar 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Not yet recruiting
Study type
Interventional
Enrollment
40 (estimated)
First submitted
14 Dec 2023
Start date
2 Jun 2025
Primary completion date
31 Mar 2027
Lead sponsor
Drexel University
NCT number
NCT06264362

What you commit to

  • Study type: Interventional
  • Planned participants: 40
  • From 2 Jun 2025 to the primary completion date, 31 Mar 2027
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Recent changes to pain or psychotropic medications in the last 60 days
  • Recent knee surgery in the last 1-year
  • Currently receiving rehab services (Phase 2 only)
    • For care partners:

Other illness

  • Has a condition with a life expectancy of less than 1-year
  • Has a condition that contraindicates exercise (Phase 2 only)
  • Has known person living with dementia ≥ 1 year

Age

  • No sex, gender, or age criteria
  • No sex, gender, or age criteria
  • Has ≥ 2 years of experience working with community-dwelling people with dementia and pain

Other

  • Reside in long term care facility
  • Unable or unwilling to consent
  • No care partner who is also willing to participate
  • Speaks English
  • Able and willing to consent, including being recorded
    • For clinicians:
  • Speaks English
  • Able and willing to consent, including being recorded

Who the study is looking for

  • Age 60 or older
  • Speaks English
  • Mild/Very Mild dementia
  • Knee pain lasting ≥ 3 months, potentially related to arthritis
  • Knee pain is at least 2 out of 10 on average.

Age in the registry: 60 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Drexel University
Coordinator of this site? Confirm its status
PhiladelphiaUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.