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임상 레이더 AI
임상시험 NCT06264362은(는) 만성 통증, 경도 치매, 이동성 제한, 신체 장애, 무릎 골관절염, 경도 인지 장애에 대해 대상자모집전 상태입니다. 모든 세부 정보를 보려면 임상시험 레이더 카드 뷰와 AI 발견 도구를 확인하거나 여기에서 무엇이든 물어보세요.
하나의 임상시험이 필터 기준과 일치합니다.
카드 뷰

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

대상자모집전
임상시험 세부 정보는 주로 영어로 제공됩니다. 하지만 임상 레이더 AI가 도와드릴 수 있습니다! '시험 설명하기'를 클릭하여 선택한 언어로 임상시험 정보를 확인하고, 이에 대해 AI와 논의해 보세요.
임상시험 NCT06264362은(는) 만성 통증, 경도 치매, 이동성 제한, 신체 장애, 무릎 골관절염, 경도 인지 장애에 대해 알아보는 중재연구입니다. 현재 상태는 대상자모집전이며, 2025년 6월 2일부터 참여 신청이 가능합니다. 40명의 참여자를 모집할 예정입니다. 드렉셀 대학교이(가) 진행하는 이 연구는 2027년 5월 1일까지 진행될 예정입니다. ClinicalTrials.gov의 가장 최근 정보는 2025년 3월 11일에 갱신되었습니다.
간단한 개요
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.

상세한 설명
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.
공식 제목

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

질환/상태
만성 통증경도 치매이동성 제한신체 장애무릎 골관절염경도 인지 장애
출판물
이 임상 시험에 대해 발표된 과학 논문 및 연구 자료.
더 보기
기타 연구 식별자
NCT 번호
실제 연구 시작일
2025-06-02
최신 업데이트 게시
2025-03-11
예상 연구 완료일
2027-05-01
계획된 등록 인원
40
연구종류
중재연구
단계/상
해당 없음
상태
대상자모집전
키워드
pain
dementia
cognitive impairment
osteoarthritis
knee pain
memory
주요 목적
치료
설계 할당
해당 없음
중재 모델
단일군설계
맹검 (마스킹)
없음 (공개라벨)
시험군 / 개입
참가자 그룹/시험군개입/치료
실험적Tailored 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.
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.
주요결과변수
결과변수측정값 설명시간 범위
Program parameters
Qualitative interviews to determine preferred program parameters.
Day 1
Program parameters
Focus groups of clinicians to determine preferred program parameters.
Day 1
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
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
이차결과변수
결과변수측정값 설명시간 범위
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.
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
적격성 기준

연령대
성인, 노인
최소 연령
60 Years
참여 가능한 성별
전체
  • 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.

  • 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
National Institute on Aging (NIA) logoNational Institute on Aging (NIA)
연구 대표 연락처
연락처: Annalisa Na, PT, PhD, 2673595889, [email protected]
연락처: Ben Senderling, 2673595655, [email protected]
1 1개국에 임상시험 장소

Pennsylvania

Drexel University, Philadelphia, Pennsylvania, 19104, United States
Annalisa Na, PT, PhD, 연락처, 267-359-5889, [email protected]
Ben Senderling, MS, 연락처, 2673595655, [email protected]