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临床试验/NCT05501119
NCT05501119已完成不适用

Palliative Care Telehealth Delivered Program of SUPPORT-D Intervention for Persons With Alzheimer's Disease and Caregivers Phase 2

Medical University of South Carolina2 个研究点 分布在 1 个国家目标入组 58 人开始时间: 2023年1月27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
58
试验地点
2
主要终点
Change in Alzheimer's Disease Knowledge Scale (ADKS) Score

研究概览

简要总结

The purpose of this research is pilot test a nurse led intervention previously used in patients with pulmonary fibrosis and their caregivers in a new population (persons living with Mild Cognitive Impairment or Alzheimer's disease and their caregivers. The researchers hypothesize improving advanced care planning in this population will result in enhanced quality of life over illness trajectory and improve safety for community dwelling PWD/CG dyads. Findings from this study will inform additional necessary adaptations required prior to conducting larger scale powered randomized control trial.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Supportive Care
盲法
None

入排标准

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

入选标准

  • The participants in this study include persons with Alzheimer's disease (PWD) and their caregivers (CG.
  • Persons with Alzheimer's Disease (investigators anticipate cognitive impairment within this group)
  • 18 years old or older
  • Diagnosis of Alzheimer's Disease or suspected Alzheimer's disease (FAST score < 4)
  • Able to read and speak English (intervention in English)
  • Caregivers (CG)
  • > 18 years old
  • Non-paid (eliminates professional caregivers)
  • Provides care to someone living with Alzheimer's Disease or suspected Alzheimer's disease (self-report)
  • Able to read and speak English (written materials in English)
  • No diagnosis of cognitive impairment

排除标准

  • Inability or unwillingness to provide informed consent

结局指标

主要结局

Change in Alzheimer's Disease Knowledge Scale (ADKS) Score

时间窗: baseline, at study completion, an average of 8 weeks

30 items (T/F) summed total of correct items higher score indicates higher knowledge (scores range from 0-30)

Acceptability of Intervention Measure (AIM) Score

时间窗: at study completion, an average of 8 weeks

4 items (5 point Likert scale) average score across items higher score indicates more acceptability of intervention (raw score ranges from 4-20)

Feasibility Score

时间窗: at study completion, an average of 8 weeks

4 items (5 point Likert scale) average score across items higher score indicates greater feasibility of intervention (raw scores range from 4-20)

Change Zarit Caregiver Burden Score

时间窗: baseline, at study completion, an average of 8 weeks

12 items (5 point Likert scale (0-4)) summed score with higher scores indicating greater caregiver distress (raw scores range from 0-48)

Change in Perceived Stress Scale Score

时间窗: baseline and at study completion, an average of 8 weeks

10 items (4 point Likert scale ranging from 0-4) summed score across items with higher scores indicate greater levels of stress (scores range from 0-40)

Change in Quality of Life-Alzheimer's Disease (QoL-AD) Score

时间窗: baseline and at study completion, an average of 8 weeks

13 items (4 point Likert scale ranging from 1-4) summed score across items with higher scores indicating better quality of life (scores range from 13-52)

Change in Self-efficacy for Caregiving Score

时间窗: baseline and at study completion, an average of 8 weeks

8 items rated from 1-10 mean score across items with higher scores indicating higher self-efficacy (raw scores range from 8-80)

Change in Safety Assessment Scale Score

时间窗: baseline and at study completion, an average of 8 weeks

16 items with response options ranging from 0 to 4. The minimum score is 0, indicating no safety concerns, while the maximum score is 64, indicating significant safety risks.

Appropriateness of Intervention Score

时间窗: at study completion, an average of 8 weeks

4 items (5 point Likert scale) average score across items higher score indicates greater appropriateness of intervention (scores range from 4-20)

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Diana Layne

Assistant Professor

Medical University of South Carolina

研究点 (2)

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