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

Mild Cognitive Impairment Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06264362
• Other study ID #: K23AG081547
• Secondary ID: 1K23AG081547-01
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 9, 2024
• Est. completion date: May 1, 2027

Study information

• Verified date: June 2024
• Source: Drexel University
• Contact: Annalisa Na, PT, PhD
• Phone: 2673595889
• Email: an838[@]drexel.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: May 1, 2027
• Est. primary completion date: May 1, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Pain
• Cognitive Dysfunction
• Dementia
• Dementia, Mild
• Mild Cognitive Impairment
• Mobility Limitation
• Osteo Arthritis Knee
• Osteoarthritis
• Osteoarthritis, Knee
• Pain, Chronic
• Physical Disability

Intervention

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.

Locations

Country	Name	City	State
United States	Drexel University	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Drexel University	National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

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Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Program parameters	Qualitative interviews to determine preferred program parameters.	Day 1
Primary	Program parameters	Focus groups of clinicians to determine preferred program parameters.	Day 1
Primary	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.	At study completion, an average of 8 weeks
Primary	Perception of program	Qualitative Interview of all who participated in the program to determine components of the intervention prototype that needs revising	At study completion, an average of 8 weeks
Secondary	Numeric Pain Score	A self-reported pain measurement ranging from 0 (no pain) to 10 (worst pain). A high score indicates more pain.	Through study completion, an average of 8 weeks.
Secondary	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.	At study completion, an average of 8 weeks