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临床试验/NCT04956874
NCT04956874已完成不适用

The Florida REACH Translation Project

University of Central Florida4 个研究点 分布在 1 个国家目标入组 39 人开始时间: 2019年10月4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
39
试验地点
4
主要终点
Caregiver Burden

研究概览

简要总结

The primary aim of this study is to test feasibility of a modified REACH II intervention in an outpatient clinic.

详细描述

Primary Aim The primary aim of this study is to test feasibility of a modified REACH II intervention in an outpatient clinic.

Hypothesis:

  1. The FL REACH intervention can be implemented reliably in this setting, with fidelity to the model and minimal burden on existing clinic structure.

Secondary Aims Aim 2: Examine the effectiveness of a REACH II translation in an outpatient setting.

Hypotheses: 2. CG disease knowledge will increase from pre-assessment to post-assessment. 3. Caregiver preparedness for caregiving will increase from pre-assessment to post-assessment. 4. Perceived risk by CG (CR access to dangerous objects + smoking + supervision + wandering + driving + screaming + desire to hit) will be reduced from pre-assessment to post-assessment. 5. Caregivers will demonstrate mastery of skill acquisition related to behavior change strategies. 6. Caregiver burden will decrease from pre-assessment to post-assessment. 7. Caregiver self-rated health will improve from pre-assessment to post-assessment. 8. Caregivers will have initiated the process of advanced care planning by the end of the intervention. 9. All measures will maintain gain in the anticipated direction from baseline measures at 6 months post-assessment.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 89 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Identified caregiver or care partner of an individual who has been diagnosed with Alzheimer's disease or another dementia by the memory disorders clinic, and/or who has sought ongoing treatment through the memory disorders clinic
  • Able to provide informed consent
  • Able to engage in the intervention weekly by attending sessions in person at the clinic
  • Able to participate in the intervention in English or in Spanish
  • No previous experience with a caregiver training program in the past (this applies to theory based, structured interventions delivered by professionals, and does not include peer-led support groups that the family may have engaged with)

排除标准

  • Under age of 18 or over the age of 89
  • Unable to provide informed consent or subject to a conflict of interest for this study
  • Unable to return regularly to the clinic for sessions
  • Engaged in another caregiver training program concurrently or have completed a multi-week caregiver training program in the past (this exclusion applies to theory based, structured interventions delivered by professionals, and does not include peer-led support groups that the family may have engaged with)

结局指标

主要结局

Caregiver Burden

时间窗: Baseline; 6 weeks (therapy termination); 6 month follow-up

Zarit Burden Inventory

Preparedness for Caregiving Measure

时间窗: Baseline, session 2, 4, 6 (therapy termination); 6 month follow-up

Preparedness for dementia caregiving

Alzheimer's disease Knowledge Scale

时间窗: Baseline, 6 (therapy termination); 6 month follow-up

Knowledge of Alzheimers Disease and Related Dementias

次要结局

  • FL-REACH Satisfaction Survey(Baseline, 6 (therapy termination); 6 month follow-up)
  • Risk Assessment(Baseline, 6 (therapy termination); 6 month follow-up)
  • Health Self-Report(Baseline, 6 (therapy termination); 6 month follow-up)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (4)

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