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O estudo clínico NCT06264362 para Dor crônica, Demência, leve, Limitação de mobilidade, Deficiência física, Osteoartrite do joelho, Comprometimento cognitivo leve está ainda não recrutando. Consulte a visualização em cartões do Radar de Estudos Clínicos e as ferramentas de descoberta de IA para ver todos os detalhes. Ou pergunte qualquer coisa aqui.
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Developing a Nonpharmacological Pain Intervention for Community-dwelling Older Adults With Dementia

Ainda não recrutando
Os detalhes do estudo clínico estão disponíveis principalmente em inglês. No entanto, a IA Trial Radar pode ajudar! Basta clicar em 'Explicar o estudo' para visualizar e discutir as informações do estudo no idioma selecionado.
O estudo clínico NCT06264362 é um ensaio intervencionista para Dor crônica, Demência, leve, Limitação de mobilidade, Deficiência física, Osteoartrite do joelho, Comprometimento cognitivo leve. Seu status atual é: ainda não recrutando. O recrutamento está programado para iniciar em 2 de junho de 2025, com o objetivo de incluir 40 participantes. Coordenado por a Universidade Drexel e deve ser concluído em 1 de maio de 2027. Essas informações foram atualizadas no ClinicalTrials.gov em 11 de março de 2025.
Resumo
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.

Descrição detalhada
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.
Título oficial

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

Condições
Dor crônicaDemência, leveLimitação de mobilidadeDeficiência físicaOsteoartrite do joelhoComprometimento cognitivo leve
Publicações
Artigos científicos e trabalhos de pesquisa publicados sobre este estudo clínico:
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Outros IDs do estudo
Número NCT
Data de início (real)
2025-06-02
Última atualização postada
2025-03-11
Data de conclusão (estimada)
2027-05-01
Inscrição (estimada)
40
Tipo de estudo
Intervencionista
FASE
N/A
Status
Ainda não recrutando
Palavras-chave
pain
dementia
cognitive impairment
osteoarthritis
knee pain
memory
Propósito principal
Tratamento
Alocação do design
N/A
Modelo de intervenção
Grupo único
Cegamento (Mascaramento)
Nenhum (Estudo aberto)
Braços / Intervenções
Grupo de participantes/BraçoIntervenção/Tratamento
ExperimentalTailored 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.
Desfecho primário
Medida de desfechoDescrição da medidaPrazo
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
Desfecho secundário
Medida de desfechoDescrição da medidaPrazo
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
Critérios de elegibilidade

Idades elegíveis
Adulto, Adulto mais velho
Idade mínima
60 Years
Sexos elegíveis
Todos
  • 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)
Contato central do estudo
Contato: Annalisa Na, PT, PhD, 2673595889, [email protected]
Contato: Ben Senderling, 2673595655, [email protected]
1 Locais do estudo em 1 países

Pennsylvania

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