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

Not Applicable

Not yet recruiting

• Conditions: Osteo Arthritis Knee; Pain, Chronic; Dementia, Mild; Mobility Limitation; Physical Disability; Mild Cognitive Impairment
• Interventions: Behavioral: Tailored Physical Activity Program

• Registration Number: NCT06264362
• Lead Sponsor: Drexel University

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2023-12-14
• Study First Submitted QC: 2024-02-15
• Study First Posted: 2024-02-20
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-20
• Last Update Posted: 2024-11-22
• Study Start: 2025-01-01
• Primary Completion: 2027-03-31
• Study Completion: 2027-05-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Tailored Physical Activity Program for Pain	Tailored Physical Activity Program	Specific characteristics of the intervention delivered in Phase 2 will be based on the information gathered from stakeholders in Phase 1.

Primary Outcome Measures

Name	Time	Method
Feasibility of Intervention Measure	At study completion, an average of 8 weeks	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.
Program parameters	Day 1	Focus groups of clinicians to determine preferred program parameters.
Perception of program	At study completion, an average of 8 weeks	Qualitative Interview of all who participated in the program to determine components of the intervention prototype that needs revising

Secondary Outcome Measures

Name	Time	Method
Numeric Pain Score	Through study completion, an average of 8 weeks.	A self-reported pain measurement ranging from 0 (no pain) to 10 (worst pain). A high score indicates more pain.
Zarit Burden Interview-Short Form	At study completion, an average of 8 weeks	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.

Trial Locations

Locations (1)

Drexel University; 🇺🇸 Philadelphia, Pennsylvania, United States