Clinical trial NCT06264362: Developing a Nonpharmacological Pain Intervention for Community-dwelling Older Adults With Dementia
Official title: Developing a Nonpharmacological Pain Intervention for Community-dwelling Older Adults With Dementia
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Pain, Chronic
Dementia, Mild
Mobility Limitation
Physical Disability
Osteo Arthritis Knee
Mild Cognitive Impairment
Keywords: pain
dementia
cognitive impairment
osteoarthritis
knee pain
memory
Lead sponsor: Drexel University
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2024-02-20
Enrollment: 40
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 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 purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Program parameters
timeFrame: Day 1
measure: Program parameters
timeFrame: Day 1
measure: Feasibility of Intervention Measure
timeFrame: At study completion, an average of 8 weeks
measure: Perception of program
timeFrame: At study completion, an average of 8 weeks
Secondary outcomes:
measure: Numeric Pain Score
timeFrame: Through study completion, an average of 8 weeks.
measure: Zarit Burden Interview-Short Form
timeFrame: At study completion, an average of 8 weeks
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Drexel University
state: Pennsylvania
Study officials:
affiliation: Drexel University
name: Annalisa Na, PT, PhD
role: PRINCIPAL_INVESTIGATOR
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