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

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое 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

Первичные конечные точки

• Program parameters [Срок оценки: Day 1]
• Program parameters [Срок оценки: Day 1]
• Feasibility of Intervention Measure [Срок оценки: At study completion, an average of 8 weeks]
• Perception of program [Срок оценки: At study completion, an average of 8 weeks]

Вторичные конечные точки (2)

• Numeric Pain Score [Срок оценки: Through study completion, an average of 8 weeks.]
• Zarit Burden Interview-Short Form [Срок оценки: At study completion, an average of 8 weeks]

Критерии участия

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Drexel University — Philadelphia

Публикации

• Innes KE, Sambamoorthi U. The Association of Osteoarthritis and Related Pain Burden to Incident Alzheimer's Disease and Related Dementias: A Retrospective Cohort Study of U.S. Medicare Beneficiaries. J Alzheimers Dis. 2020;75(3):789-805. doi: 10.3233/JAD-191311. PMID 32333589
• Hunt LJ, Covinsky KE, Yaffe K, Stephens CE, Miao Y, Boscardin WJ, Smith AK. Pain in Community-Dwelling Older Adults with Dementia: Results from the National Health and Aging Trends Study. J Am Geriatr Soc. 2015 Aug;63(8):1503-11. doi: 10.1111/jgs.13536. Epub 2015 Jul 22. PMID 26200445
• Sverdrup K, Bergh S, Selbaek G, Benth JS, Roen IM, Husebo B, Tangen GG. Trajectories of physical performance in nursing home residents with dementia. Aging Clin Exp Res. 2020 Dec;32(12):2603-2610. doi: 10.1007/s40520-020-01499-y. Epub 2020 Feb 14. PMID 32060802
• Tanaka H, Nagata Y, Ishimaru D, Ogawa Y, Fukuhara K, Nishikawa T. Clinical factors associated with activities of daily living and their decline in patients with severe dementia. Psychogeriatrics. 2020 May;20(3):327-336. doi: 10.1111/psyg.12502. Epub 2019 Dec 28. PMID 31883310
• APTA Geriatrics Combined Sections Meeting 2022 Poster Abstracts. J Geriatr Phys Ther. 2022 Jan-Mar 01;45(1):E16-E77. doi: 10.1519/JPT.0000000000000336. No abstract available. PMID 34928240
• Gitlin LN, Arthur P, Piersol C, Hessels V, Wu SS, Dai Y, Mann WC. Targeting Behavioral Symptoms and Functional Decline in Dementia: A Randomized Clinical Trial. J Am Geriatr Soc. 2018 Feb;66(2):339-345. doi: 10.1111/jgs.15194. Epub 2017 Nov 28. PMID 29192967
• Whitlock EL, Diaz-Ramirez LG, Glymour MM, Boscardin WJ, Covinsky KE, Smith AK. Association Between Persistent Pain and Memory Decline and Dementia in a Longitudinal Cohort of Elders. JAMA Intern Med. 2017 Aug 1;177(8):1146-1153. doi: 10.1001/jamainternmed.2017.1622. PMID 28586818
• Hodgson N, Gitlin LN, Huang J. The influence of sleep disruption and pain perception on indicators of quality of life in individuals living with dementia at home. Geriatr Nurs. 2014 Sep-Oct;35(5):394-8. doi: 10.1016/j.gerinurse.2014.08.005. Epub 2014 Sep 2. PMID 25193739

Идентификаторы

NCT: NCT06264362 · K23AG081547 · 1K23AG081547-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗