Integration of Health Information Technology and Promotion of Personhood in Family-Centered Dementia Care
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 42
- 试验地点
- 4
- 主要终点
- Change in Quality of Life In Alzheimer's disease- Care Recipient and Caregiver (proxy-interview)
研究概览
简要总结
Alzheimer's disease and related dementias (ADRD) are leading causes of disability and often result in communication deficits of the person with dementia (PWD) that can complicate ADRD caregiving and clinical care. The research team will work with stakeholders to develop and design a personalized Assistive and Alternative Communication (AAC) device that relies on information technology (IT) and touchscreens to promote communication and personhood for PWD about their care preferences and experiences. This study will integrate the AAC into an existing health IT intervention that already facilitates clinical communication between caregivers and providers of PWD. A clinical trial will be conducted to evaluate outcomes of 58 dyads (PWD/caregivers) and their health care provider utilizing the My PATI (My Person Assisted Touchscreen Interface)intervention as an adjunct to care and care giving for 6 months.
详细描述
The target enrollment for the clinical trial is 58 dyads of caregivers and people with dementia (PWD), where 58 unique dyads of caregivers/PWD will participate. The team plans to enroll a total of 58 dyads across two participating clinical sites. Participants will be randomly assigned to either the full intervention or a control condition for a period of 6 months, where they will be asked to communicate clinical and other relevant information with one another as part of regular caregiving and clinical care activities. Several psychosocial outcome variables for providers, caregivers, and PWD will be assessed. We will compare outcomes based on group assignment and different amounts and patterns of use of the MyPATI (e.g., minimal/non-users versus frequent users). The primary outcome variables are quality of life for caregivers and PWD. The research team will recruit an estimated 15 healthcare providers across both sites at the end of study to assess their experience with My PATI using open and closed ended queries.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
盲法说明
Outcome Assessors will not be involved with the intervention implementation and study participants will be asked not to reveal their group assignment.
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
- 否
入选标准
- •Caregivers:
- •Regular access to the internet (via computer or smartphone) and telephone
- •21 years-old or older
- •Providing caregiving activities (Activities of Daily Living and/or Instrumental Activities of Daily Living) for an average of 2 hours or more per day of direct assistance or supervision for a person with ADRD
- •Speak and understand English or Spanish.
- •Care Recipient:
- •60 years or older
- •Speak and understand English or Spanish
- •Have an established diagnosis of a Neurocognitive Disorder (Alzheimer's disease, vascular dementia, frontotemporal dementia, Lewy body dementia or Parkinson's disease dementia)
- •Receive a score on the Mini Mental Status Exam of less than 24
- •Be able to complete the eligibility vision screen.
- •Healthcare Providers:
- •* Provide ongoing healthcare and support services to PWD and their families.
排除标准
- •Caregivers:
- •Provide care to a PWD living in an assisted living facility or nursing home
- •Plan for the PWD to be placed in a long-term care facility during the study period
- •Plan to end their role as caregiver within 6 months of study enrollment
- •Have their own major medical conditions affecting independent functioning (e.g. illness or disability) or cognitive impairment
- •Do not speak and read English or Spanish
- •Have known active suicidal ideation
- •Care Recipients:
- •Significant visual or hearing impairment (with supports)
- •Known active suicidal ideation
- •Schizophrenia diagnosis
研究组 & 干预措施
Usual Care
Dyads (caregiver, PWD) randomly assigned to the usual care condition will receive usual care from the memory clinic.
Full Intervention
Dyads (caregiver, PWD) randomly assigned to the experimental arm will have access to the newly developed My PATI app. Providers' will receive information via the app.
干预措施: My PATI ( Person Assisted Touchscreen Interface) (Other)
结局指标
主要结局
Change in Quality of Life In Alzheimer's disease- Care Recipient and Caregiver (proxy-interview)
时间窗: Baseline, 3-months, 6- months
The 13-item QOL-AD scale uses a scale of 1-4 (poor, fair, good, or excellent) to rate a variety of life domains, including the care recipient's physical health, mood, relationships, activities, and ability to complete tasks. The Care Recipient (self-assesses) and caregiver (proxy-interview) complete the QOL-AD.
Change in Perceived Change Index- Caregiver QOL
时间窗: Baseline, 3-months, 6- months
A 13-item scale that measures caregiver appraisals of self-improvement or decline in distinct areas of well- being. Caregiver indicates whether each item has become worse, stayed the same, or improved in the past month: feeling rested, ability to have time for yourself, and feelings of being upset. The total and subscales (Affect, Somatic, and Ability to Manage)
次要结局
- Change in Oberved PHQ-9 Caregiver Interviewed about Care Recipient(Baseline, 6-months)
- Change in PATIENT HEALTH QUESTIONNAIRE (PHQ-9)- Caregiver(Baseline, 3-months, 6- months)
- Change in The Positive Aspects of Caregiving Scale- Caregiver(Baseline, 3-months, 6- months)
- Change in Zarit Caregiver Burden Inventory-22 items (ZBI-22)- Caregiver(Baseline, 3-months, 6-months)
- Change in 12 Item Short-Form Health Survey (SF-12) - Caregiver(Baseline,6-months)
- Change in The Revised Memory and Behavior Problems Checklist - Caregiver interviewed about Care Recipient(Baseline, 6-months)
- Change in Geriatric Depression Scale (GDS-15)- Care Recipient(Baseline, 6-months)
- Change in Partner-Patient Questionnaire for Shared Activities-Caregiver interviewed about relationship with Care Recipient(Baseline, 3 Months, 6 Months)
- Change in Functional Linguistic Communication Inventory (FLCI)- Care Recipient(Baseline)
- My PATI Usage - Links clicked on the app, resources accessed(6 months)
- Provider Interviews(6 months)
- My PATI Usage- Links clicked on the app, resources accessed(6 months)