임상 레이더 AI | ||
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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. | ||
Developing a Nonpharmacological Pain Intervention for Community-dwelling Older Adults With Dementia
In Part 1 (not a clinical trial) - The investigators are inviting the following people to participate in an interview:
- Individuals aged 60 years or older who do not live in a nursing home and have both memory issues and knee pain.
- Care partners of people with knee pain and memory issues. A care partner can be a family member or friend who helps regularly.
- 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.
Developing a Nonpharmacological Pain Intervention for Community-dwelling Older Adults With Dementia
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- Monroe TB, Misra SK, Habermann RC, Dietrich MS, Cowan RL, Simmons SF. Pain reports and pain medication treatment in nursing home residents with and without dementia. Geriatr Gerontol Int. 2014 Jul;14(3):541-8. doi: 10.1111/ggi.12130. Epub 2013 Sep 11.
- Rundell SD, Phelan EA, Patel KV, Jones BL, Marcum ZA. Longitudinal Patterns of Pain Reporting Among Community-dwelling Older Adults. Clin J Pain. 2020 Dec;36(12):912-922. doi: 10.1097/AJP.0000000000000874.
- 2020 Alzheimer's disease facts and figures. Alzheimers Dement. 2020 Mar 10. doi: 10.1002/alz.12068. Online ahead of print.
- AGS clinical practice guidelines: the management of chronic pain in older persons. Geriatrics. 1998 Oct;53 Suppl 3:S6-7. No abstract available.
- Bullock L, Bedson J, Jordan JL, Bartlam B, Chew-Graham CA, Campbell P. Pain assessment and pain treatment for community-dwelling people with dementia: A systematic review and narrative synthesis. Int J Geriatr Psychiatry. 2019 Jun;34(6):807-821. doi: 10.1002/gps.5078. Epub 2019 Apr 8.
- Bullock L, Chew-Graham CA, Bedson J, Bartlam B, Campbell P. The challenge of pain identification, assessment, and management in people with dementia: a qualitative study. BJGP Open. 2020 Jun 23;4(2):bjgpopen20X101040. doi: 10.3399/bjgpopen20X101040. Print 2020.
- Corbett A, Nunez KM, Smeaton E, Testad I, Thomas AJ, Closs SJ, Briggs M, Clifton L, Gjestsen MT, Lawrence V. The landscape of pain management in people with dementia living in care homes: a mixed methods study. Int J Geriatr Psychiatry. 2016 Dec;31(12):1354-1370. doi: 10.1002/gps.4445. Epub 2016 Feb 21.
- Gagliese L, Gauthier LR, Narain N, Freedman T. Pain, aging and dementia: Towards a biopsychosocial model. Prog Neuropsychopharmacol Biol Psychiatry. 2018 Dec 20;87(Pt B):207-215. doi: 10.1016/j.pnpbp.2017.09.022. Epub 2017 Sep 22.
- American Geriatrics Society Panel on Exercise and Osteoarthritis. Exercise prescription for older adults with osteoarthritis pain: consensus practice recommendations. A supplement to the AGS Clinical Practice Guidelines on the management of chronic pain in older adults. J Am Geriatr Soc. 2001 Jun;49(6):808-23. doi: 10.1046/j.1532-5415.2001.00496.x. No abstract available.
- Brown GA. AAOS clinical practice guideline: treatment of osteoarthritis of the knee: evidence-based guideline, 2nd edition. J Am Acad Orthop Surg. 2013 Sep;21(9):577-9. doi: 10.5435/JAAOS-21-09-577. No abstract available.
- Kolasinski SL, Neogi T, Hochberg MC, Oatis C, Guyatt G, Block J, Callahan L, Copenhaver C, Dodge C, Felson D, Gellar K, Harvey WF, Hawker G, Herzig E, Kwoh CK, Nelson AE, Samuels J, Scanzello C, White D, Wise B, Altman RD, DiRenzo D, Fontanarosa J, Giradi G, Ishimori M, Misra D, Shah AA, Shmagel AK, Thoma LM, Turgunbaev M, Turner AS, Reston J. 2019 American College of Rheumatology/Arthritis Foundation Guideline for the Management of Osteoarthritis of the Hand, Hip, and Knee. Arthritis Rheumatol. 2020 Feb;72(2):220-233. doi: 10.1002/art.41142. Epub 2020 Jan 6.
- Gitlin LN, Hodgson NA. Better Living with Dementia: Implications for Individuals, Families, Communities, and Societies. Elsevier Academic Press; 2018.
dementia
cognitive impairment
osteoarthritis
knee pain
memory
| 참가자 그룹/시험군 | 개입/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. |
| 결과변수 | 측정값 설명 | 시간 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 |
| 결과변수 | 측정값 설명 | 시간 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 |
- 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
Pennsylvania