Improving Person-Environment Fit of Community-Residing Older Adults With Dementia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 84
- 试验地点
- 2
- 主要终点
- Caregiver satisfaction of patient performance [Feasibility]
研究概览
简要总结
This trial will assess feasibility of a non-pharmacological intervention for persons living with Alzheimer's disease and related dementias (ADRD) to improve behavioral and psychiatric symptoms of dementia and functional performance.
Using a two-arm, prospective randomized controlled trial, 38 dyads (person with ADRD and caregiver) will complete an 8-week telehealth occupational therapy intervention provided via Zoom with caregivers and persons with dementia or receive an active control with 8 telehealth sessions to discuss publicly available caregiver education with a non-clinical research assistant.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participants with Dementia
- •Men or women aged 60-99, inclusive.
- •Living at home in the community with one primary caregiver.
- •Diagnosis or probably diagnosis of dementia (confirmed by Clinical Dementia Rating Scale score of 1.0+)
- •If on psychotropic medication, they are at a point where dosage and treatment are stabilized for the duration of the study.
- •Functional sensory abilities with or without aids (hearing, vision, smell, touch, taste)
- •Caregiver report of challenges related to behaviors within 4 weeks of study enrollment.
- •Caregiver willing to participate throughout duration of study.
- •Contact with University of Kentucky Alzheimer's Disease Research Center or Kentucky Neuroscience Institute medical provider within 12 months of study recruitment.
- •Inclusion Criteria: Caregiver for Participants with Dementia
- •Men or women aged 21-99, inclusive.
- •Willingness to participate in study and implement recommended data collection tools.
- •English speaking, able to read and write.
- •Ability to retrieve and send mail.
排除标准
- •Participants with Dementia
- •Unstable medical conditions within one month prior to screening visit such as poorly controlled blood pressure, diabetes, current cancer diagnosis, or breathing problems, etc.
- •Wheelchair or bed bound.
- •Residence in skilled nursing facility or facility-based care.
- •Caregiver report of physically violent behaviors.
- •Initiation of antipsychotic medication within 4 weeks prior to screening or unpredictable use of such medications
- •Diagnosis of profound or total sensory altering disorders including macular degeneration, legal blindness, total deafness, severe peripheral neuropathy, anosmia.
- •Major depression in past 12 months (DSM-IV criteria), major mental illness such as schizophrenia, bipolar disorder, personality disorders, or recent (in past 12 months) alcohol or substance abuse.
- •Major infection within 4 weeks prior to the Baseline Visit.
- •Exclusion Criteria: Caregiver for Participant with Dementia:
- •Diagnosis of mild cognitive impairment or dementia.
结局指标
主要结局
Caregiver satisfaction of patient performance [Feasibility]
时间窗: 13 weeks (baseline, post intervention, follow up)
The primary outcome analysis is the feasibility of implementation as measured by caregiver satisfaction. The Canadian Occupational Performance Measure will measure caregiver satisfaction of patient performance, high scores indicate higher levels of satisfaction. Range 0-10.
Change in patient performance as measured by Canadian Occupational Performance Measure (COPM)
时间窗: 13weeks (baseline, post-intervention, follow up)
Criterion-referenced interview of patient performance with caregiver The COPM is a reliable and validated measure of performance in primary daily activities (self-care, leisure, productivity) with dyad-caregiver rated of performance and satisfaction. Scores are determined on a likert scale of 1-10 with 1 being lowest and 10 indicating highest of the topic of the question.
次要结局
- Zarit Caregiver Burden Scale(13 weeks (baseline, post intervention, follow up))
- Neuropsychiatric Inventory Questionnaire (NPI-Q)(13 weeks (baseline, post intervention, follow up))
- Functional Behavior Profile (FBP)(13 weeks (baseline, post intervention, follow up))
研究者
Elizabeth K Rhodus
Assistant Professor
University of Kentucky