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临床试验/NCT04920006
NCT04920006已完成不适用

Developing and Testing the Enhancing Active Caregiver Training (EnACT) Intervention for Dementia Family Caregivers

University of Utah2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2023年7月13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
30
试验地点
2
主要终点
Change from Baseline Imagined Interactions at 14 weeks

研究概览

简要总结

Persons with Alzheimer's disease and related dementias (ADRD) experience behavioral symptoms such as agitation, combativeness, depression, and apathy. These behaviors increase caregiver stress, which leads to negative outcomes, such as poor health, depression, and increased caregiver burden. This project seeks to develop and test an intervention to enhance active caregiver skill training to prepare caregivers to better manage behavioral symptoms in order to improve ADRD caregiver wellbeing. This intervention is called Enhancing Active Caregiver Training (EnACT).

The study team will develop and conduct initial testing of EnACT techniques in a small group intervention with family caregivers of persons living with dementia. This intervention will first develop and refine EnACT through small group meetings with ADRD caregivers. Next, EnACT will be tested by two groups of ADRD caregivers in order to assess how achievable and useful caregivers find it to be. In addition, EnACT will be evaluated for its impact on caregiver preparation, stress process, and well-being.

详细描述

Specific Aim 1: Develop and iteratively refine the EnACT intervention for ADRD caregivers.

A series of three sequential focus groups will be used to gather ADRD caregiver feedback about EnACT-intervention techniques, including frequency, duration, delivery, feasibility, acceptability, and relevance of the intervention. Between focus groups, the investigators will refine and edit the EnACT intervention in an iterative process. Intervention scenarios and activities will be chosen and refined as part of Aim 1 in preparation for testing feasibility and acceptability during Aim 2 and mechanisms of action in Aim 3.

Setting and Participants: The investigators will partner with community-based services through the Utah Caregiver Support Program and the Utah Alzheimer's Association to recruit 10 ADRD caregivers to participate in a series of three focus groups. Formal caregivers, persons under the age of 18, and individuals who have English fluency ratings of none or poor will be excluded.

Data Source: During Focus Group 1, participants will view previously developed video segments in order to identify those that caregivers prefer for intervention practice. Participants will also explore intervention activities to assess which are most useful and acceptable. Revisions to the process will be made based on reactions and feedback. During Focus Group 2, participants will work through a revision of the steps based on Focus Group 1 feedback using a second video segment focused on behavioral symptoms in ADRD. A prototype intervention manual will be developed based on feedback from the first two focus groups. Focus Group 3 will involve reviewing developed prototype materials (i.e., manuals, videos) and a discussion on acceptability, the logistics for incorporating this intervention into caregiver training, challenges, and benefits of activities. Feedback from this focus group will be incorporated into the EnACT intervention in preparation for Aims 2 and 3.

Measures: Each focus group will be audio-recorded and transcribed. The PI will also document observations and thoughts using field notes and journaling in order to account for bias. Focus group questions will focus on participant reactions to intervention steps (view, practice, reflect) to identify which activities are meaningful, facilitate or impede participation, and are of most help in ADRD caregiving. Participants will complete a demographic questionnaire to document age, caregiving experience, gender identity/sexual orientation, race/ethnicity, and education. All materials developed during the process of intervention development, including edits and revisions, will be retained as an audit trail.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
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

  • providing primary, informal, support to family members with Alzheimer's disease or related dementia (ADRD).
  • 18 and older
  • ability to read and speak English.

排除标准

  • Formal caregivers
  • Persons under the age of 18
  • individuals who have English fluency ratings of none or poor

结局指标

主要结局

Change from Baseline Imagined Interactions at 14 weeks

时间窗: Assessed at six timepoints over 14 weeks.

The Survey of Imagined Interactions is a 7-point Likert scale, with higher scores representing more of a quality of imagined interactions. Four subscales will be used to assess specific characteristics and functions of imagined interactions. These subscales include: the rehearsal function with a minimum value (worse outcome) of 4 and a maximum value (better outcome) of 28, the characteristic of Specificity with a minimum value (worse outcome) of 4 and a maximum value (better outcome) of 28, Proactivity with a minimum value (worse outcome) of 4 and a maximum value (better outcome) of 28, and Discrepancy with a minimum value (better outcome) of 6 and a maximum value (worse outcome) of 42.

Change from Baseline Capacity to Adapt at 14 weeks

时间窗: Assessed at six timepoints over 14 weeks.

Capacity to Adapt will be measured using the Resilience Scale. This is a 7-point Likert scale, with a minimum value 25 (worse outcome) and a maximum value of 175 (better outcome). This scale measures one's ability to adapt, specific to constructs of meaning, self-confidence, perseverance, serenity, and loneliness.

Change from Baseline Caregiver Capacity to Appraise Demands at 14 weeks

时间窗: Assessed at six timepoints over 14 weeks.

This outcome will be measured using the Revised Caregiving Appraisal Scale (5-point Likert scale) which asks ADRD caregivers to assess the following five subscales: Burden with a minimum value (better outcome) of 9 and a maximum value (worse outcome) of 45 , Satisfaction with a minimum value (worse outcome) of 6 and a maximum value (better outcome) of 30, Mastery with a minimum value (worse outcome) of 6 and a maximum value (better outcome) of 30, Demand with a minimum value (better outcome) of 3 and a maximum value (worse outcome) of 15, and Impact with a minimum value (better outcome) of 3 and a maximum value (worse outcome) of 15.

次要结局

  • Caregiver Well-being(Assessed at six timepoints over 14 weeks.)
  • Perceived Stress(Assessed at six timepoints over 14 weeks.)

研究者

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

Jacqueline Eaton

Assistant Professor

University of Utah

研究点 (2)

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