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临床试验/NCT03622814
NCT03622814已完成不适用

Mealtime Partnerships for People With Dementia in Respite Centers and at Home

Medical University of South Carolina2 个研究点 分布在 1 个国家目标入组 106 人开始时间: 2017年8月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
106
试验地点
2
主要终点
Monthly Weight in Pounds on a Scale for Person With Dementia

研究概览

简要总结

The goal of this study was to test the efficacy of a mealtime intervention in respite care centers for people with dementia and their caregivers. Mealtimes become more challenging as dementia progresses causing nutritional and behavioral issues in the affected individuals. Using a train-the-trainer program built on the Partners at Meals model, volunteers in respite centers partner worked with caregivers and developed a mealtime plan that builds on the strengths of the person with dementia (PWD), and developed a supportive environment for change. A tele-health component was involved in the communication between the respite center volunteers/staff and families. Recruitment was limited to people attending the particular respite centers. Two large RCCs with a total of 5 sites of care in suburban and rural areas of SC were the sites of this project.

详细描述

The goal of this study was to test the efficacy of a mealtime intervention (Partners at Meals) in respite care centers (RCCs) that provided a social model of care for people with dementia living in the community and support for their caregivers. Largely staffed by long-time volunteers, these centers support caregivers' ability to maintain their loved one in the home. Traditionally, support for social activities and mealtime offered by the RCCs cannot be extended to home. In this project, we used a telehealth interface to provide consultation to family caregivers in the context of home where problems arise.

The primary unit of analysis was PWD and their caregiver (CG) outcomes which included: a) PWD weight; b) dysfunctional behaviors at meals; c) quality of life (QOL) of both persons with dementia and their caregivers; and, d) CG self efficacy of managing meals at home.

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 (Participant)

盲法说明

Participants did not know if they are in a site that is receiving the treatment or in the usual condition site. Randomization is by site, not by individuals.

入排标准

年龄范围
60 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Persons with Dementia (PWD): aged ≥ 60 years; attending a participating respite care center (RCC) at least once/week; living with or within the same property as caregiver (CG); diagnosis of Alzheimer's disease or related dementia with mild to moderate stage as demonstrated by the Functional Assessment Staging Scale (FAST) of 5 or greater and a MMSE of 12 or above; absence of wasting disorders (e.g., HIV/AIDS, heart or renal failure or COPD, end-stage cancer); some supervision required or dysfunctional behavior present (e.g., redirection)
  • Caregiver (CG): lives with or on same property as the PWD; provides 4 hours or more of care/day; assists with ADLs including meals
  • Volunteer: present at the RCC at least weekly (at least 4 hours/week); identify as comfortable in the teacher/coach role, and demonstrate ability to use televideo and photograph.

排除标准

  • Persons with Dementia (PWD): not receiving enteral feeding or active treatment by a speech pathologist/therapist; not diagnosed with dysphagia as identified by caregiver or on RCC Intake Sheet. Those enrolled in or qualifying for hospice will not be included.
  • Caregiver (CG): paid for services as caregiver; unable to speak or read English
  • Volunteer: unable to read and speak English

结局指标

主要结局

Monthly Weight in Pounds on a Scale for Person With Dementia

时间窗: This was a 6-month study. We are reporting the change from baseline to the 6-month end of study time period.

Assessed by unit of measure in pounds; reported as mean difference in pounds from baseline to follow-up at 6 months

Person With Dementia: Dysfunctional Behavior at Meals Measured With the Edinburgh Feeding in Dementia Scale (EdFED)

时间窗: This was a 6-month study. We are reporting the change from baseline to the 6-month end of study time period.

The Edinburgh Feeding in Dementia Scale (EdFED) is an observational instrument used across settings to evaluate feeding problem behavior. Using Guttmann Scaling, the EdFED Q has 4 items that measure level of assistance and 6 behavioral descriptors of specific mealtime behaviors; all are each rated 'never, sometimes, often' and cannot be rated 0, 1, 2, respectively, producing a range of 0-20 with higher scores indicating more problem behaviors. The instrument was used to also assess specific behaviors seen in moderate stage dementia such as wandering, distracted, perseverating, unable to use utensils, premature oral closure.

Person With Dementia: Quality of Life

时间窗: This was a 6-month study. We are reporting the change from baseline to the 6-month end of study time period.

The QOL scale in Alzheimer's disease (QOL--AD) is a 13--item rating of domains of physical condition, mood, memory, functional abilities, interpersonal relationships, ability to participate in meaningful activities, financial situation, and global assessments of self as a whole and QOL as a whole. Scoring instructions for QOL-AD: Points are assigned to each item as follows: poor = 1, fair = 2, good = 3, excellent = 4. The total score is the sum of all 13 items (scoring ranging from 13 to 52. Higher scores indicated better quality of life.

Caregiver: Quality of Life Measured With European Quality of Life (Euro-QOL)

时间窗: This was a 6-month study. We are reporting the change from baseline to the 6-month end of study time period.

European Quality of Life (Euro--QL) measures 5 domains: mobility, self--care, usualactivities, pain/discomfort, and depression and have three levels of functioning each (no problems, some problems, and unable to/extreme problems). The VAS is a scale from 0 (worst imaginable health state) to 100 (best imaginable health state).

Caregiver: Self Efficacy

时间窗: This was a 6-month study. We are reporting the change from baseline to the 6-month end of study time period.

The self-efficacy score was a 8--item likert scale with each item rated from 1--5 (unable to most able). A total score for the instrument is provided by summing the scores of each item and dividing by the number of items producing a score in the range of 1-5. Higher overall mean scores indicate greater self efficacy.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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