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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 60 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria for people living with dementia:

  • - 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.
Exclusion Criteria for people living with dementia:
  • - 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT06264362
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 Drexel University
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Annalisa Na, PT, PhD
Principal Investigator Affiliation Drexel University
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Other, NIH
Overall Status Not yet recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Pain, Chronic, Dementia, Mild, Mobility Limitation, Physical Disability, Osteo Arthritis Knee, Mild Cognitive Impairment
Additional Details

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.

Arms & Interventions

Arms

Experimental: 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.

Interventions

Behavioral: - 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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Drexel University, Philadelphia, Pennsylvania

Status

Address

Drexel University

Philadelphia, Pennsylvania, 19104

Site Contact

Annalisa Na, PT, PhD

[email protected]

267-359-5889

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