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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age60+
SponsorDrexel University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age 60 or older

Speaks English

Mild/Very Mild dementia

Knee pain lasting ≥ 3 months, potentially related to arthritis

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • Tailored Physical Activity Program

    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.

Treatment groups

40 Participants
are divided into 1 treatment group
Group A: Tailored Physical Activity Program for PainExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Program parameters

Qualitative interviews to determine preferred program parameters.

Time frame
Day 1
2

Program parameters

Focus groups of clinicians to determine preferred program parameters.

Time frame
Day 1
3

Feasibility of Intervention Measure

The Feasibility of Intervention Measure is a standardized 4-question self-reported outcome measure to assess feasibility. Each item is scored on a 5-point scale, where 1 = completely disagree, 2 = disagree, 3 = neither agree or disagree, 4 = agree, 5 = completely agree. The responses are summed and range between 5 to 20, with higher scores indicating greater feasibility. A score of 16 or greater suggests the program is feasible, 15 to 9 indicates the program may be feasible, and a score of 8 or less suggests the program is not feasible.

Time frame
At study completion, an average of 8 weeks
4

Perception of program

Qualitative Interview of all who participated in the program to determine components of the intervention prototype that needs revising

Time frame
At study completion, an average of 8 weeks

Secondary outcomes

1

Numeric Pain Score

A self-reported pain measurement ranging from 0 (no pain) to 10 (worst pain). A high score indicates more pain.

Time frame
Through study completion, an average of 8 weeks.
2

Zarit Burden Interview-Short Form

Zarit Burden Interview-Short Form is a12-item questionnaire to assess the burden of caregiving using a 5-point scale where 0 (never) to 4 (almost always). Scores are summed, ranging from 0-48, where a higher score indicates a greater caregiver burden.

Time frame
At study completion, an average of 8 weeks

Other outcomes

Sponsors and contacts

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Drexel University

Lead sponsor

National Institute on Aging (NIA)

Collaborator

This trial is not recruiting at the moment. You can still explore other options: