Developing a Nonpharmacological Pain Intervention for Community-dwelling Older Adults With Dementia
NCT ID: NCT06264362
Last Updated: 2025-03-11
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
NOT_YET_RECRUITING
Clinical Phase
NA
Total Enrollment
40 participants
Study Classification
INTERVENTIONAL
Study Start Date
2025-06-02
Study Completion Date
2027-05-01
Brief Summary
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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.
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.
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Detailed Description
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Chronic musculoskeletal pain, specifically osteoarthritis (OA) of the knee, is common among community-dwelling people living with memory issues and associated with cascading negative consequences on physical function limitations, quality of life decline, and caregiver burden; however, few beneficial and appropriate treatment options exist. This study seeks to use evidence, theory, and stakeholder input to design an exercise-based intervention for knee OA pain management tailored to the interests, preserved abilities, and biopsychosocial-environmental needs of community-dwelling older adults with mild to very mild dementia. Findings from K23 research will yield a nonpharmacological intervention prototype and delivery parameters that will inform a future efficacy study and have a strong potential for preserving or improving the quality of life of community-dwelling older adults with dementia and OA.
Conditions
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Pain, Chronic
Dementia, Mild
Mobility Limitation
Physical Disability
Osteo Arthritis Knee
Mild Cognitive Impairment
Study Design
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Allocation Method
NA
Intervention Model
SINGLE_GROUP
In Phase 1 (not a clinical trial), 15 dyads and 15 clinicians will be interviewed (a dyad equals one person living with mild to very mild dementia and their care partner) to inform design of the intervention. In Phase 2 (a clinical trial), 20 people living with mild to very mild dementia will be treated with the new intervention. Their care partners may be involved in treatment.
Primary Study Purpose
TREATMENT
Blinding Strategy
NONE
Study Groups
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Tailored Physical Activity Program for Pain
Specific characteristics of the intervention delivered in Phase 2 will be based on the information gathered from stakeholders in Phase 1.
Group Type
EXPERIMENTAL
Tailored Physical Activity Program
Intervention Type
BEHAVIORAL
Adaptation of physical activity as an intervention for pain management using the 3-Step Tailored Approach: assessing in Step 1 the Person Living with Dementia (PLWD), in Step 2 the Environment, and in Step 3 the Caregiver. With this approach, traditional exercises can be adapted to 1) functional activities (e.g., stair climbing) that are tailored to the interests (e.g., dancing, boxing) and preserved abilities of PLWD; 2) preferred and well-tolerated environments (e.g., home); and 3) account for extent and type of interventionist and caregiver involvement.
Interventions
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Tailored Physical Activity Program
Adaptation of physical activity as an intervention for pain management using the 3-Step Tailored Approach: assessing in Step 1 the Person Living with Dementia (PLWD), in Step 2 the Environment, and in Step 3 the Caregiver. With this approach, traditional exercises can be adapted to 1) functional activities (e.g., stair climbing) that are tailored to the interests (e.g., dancing, boxing) and preserved abilities of PLWD; 2) preferred and well-tolerated environments (e.g., home); and 3) account for extent and type of interventionist and caregiver involvement.
Intervention Type
BEHAVIORAL
Eligibility Criteria
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Inclusion Criteria
* 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.
* 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.
Exclusion Criteria
* Reside in long term care facility
* Unable or unwilling to consent
* Has a condition with a life expectancy of less than 1-year
* No care partner who is also willing to participate
* Recent changes to pain or psychotropic medications in the last 60 days
* Recent knee surgery in the last 1-year
* Has a condition that contraindicates exercise (Phase 2 only)
* Currently receiving rehab services (Phase 2 only)
For care partners:
* No sex, gender, or age criteria
* Has known person living with dementia ≥ 1 year
* Speaks English
* Able and willing to consent, including being recorded
For clinicians:
* No sex, gender, or age criteria
* Speaks English
* Has ≥ 2 years of experience working with community-dwelling people with dementia and pain
* Able and willing to consent, including being recorded
* Unable or unwilling to consent
* Has a condition with a life expectancy of less than 1-year
* No care partner who is also willing to participate
* Recent changes to pain or psychotropic medications in the last 60 days
* Recent knee surgery in the last 1-year
* Has a condition that contraindicates exercise (Phase 2 only)
* Currently receiving rehab services (Phase 2 only)
For care partners:
* No sex, gender, or age criteria
* Has known person living with dementia ≥ 1 year
* Speaks English
* Able and willing to consent, including being recorded
For clinicians:
* No sex, gender, or age criteria
* Speaks English
* Has ≥ 2 years of experience working with community-dwelling people with dementia and pain
* Able and willing to consent, including being recorded
Minimum Eligible Age
60 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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National Institute on Aging (NIA)
NIH
Sponsor Role
collaborator
Drexel University
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Annalisa Na, PT, PhD
Role: PRINCIPAL_INVESTIGATOR
Drexel University
Locations
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Drexel University
Philadelphia, Pennsylvania, United States
Site Status
Countries
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United States
Central Contacts
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Facility Contacts
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References
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