跳至主要内容
临床试验/NCT05999929
NCT05999929招募中不适用

Implementation of the Memory Support System: A Feasibility Study

Bruyère Health Research Institute.1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2023年12月17日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
40
试验地点
1
主要终点
Interest in completion of MSS training

研究概览

简要总结

The purpose of this study is to determining the feasibility of providing the Memory Support System (MSS) to individuals with mild cognitive impairment (MCI) and their partners at a clinic in Ontario, Canada. This will involve a) collecting information from patients referred to the a memory clinic and geriatric day hospital about the patient's interest in and the patient's preferred method to administer the MSS; and b) a cost analysis related to implementation of the MSS. The study will also measure efficacy outcomes of the MSS regarding program adherence as well as to self-reported IADLs, self-efficacy for memory, quality of life, mood, anxiety, and caregiver burden among a sample of individuals with MCI and their care partners

详细描述

A survey will be created and sent out to participants with MCI who have expressed interest in participating in research and have been seen at a memory clinic or geriatric day hospital after the initiation of the study. The survey will consist of a Likert scale and open questions related to patient interest in and preferred length of MSS administration and preference for in-person versus virtual administration.

During and after collection of the survey data, a sample of 20 individuals with MCI (ages ≥50) and their care partners will undergo MSS training.

At enrollment in the MSS training, participants with MCI and their care partners will complete measures of cognitive and functional status. Participants and partners will also complete measures of treatment adherence, IADLs, self-efficacy for memory, quality of life, mood, anxiety, and caregiver burden at baseline, treatment end, and 8-week follow-up. Participants will complete the MSS training consisting of ten 1-hour sessions delivered over two or six weeks, starting 7-10 days after initial assessment. Training will be offered in English or French. After the intervention, participants and their partners will complete a semi-structured interview, seeking suggestions for improving the MSS, teaching curriculum, and intervention logistics.

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
50 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •diagnosis of single or multi-domain MCI
  • •Clinical Dementia Rating global (CDR) score of ≤ 0.5
  • •Montreal Cognitive Assessment score of ≥18
  • •available contact with a care partner ≥ 2 times weekly
  • •absence or stable intake of nootropic(s) for ≥ 3 months

排除标准

  • •visual/hearing impairment and/or history of reading or written inability/disability sufficient to interfere with MSS training
  • •concurrent participation in another related clinical trial

研究组 & 干预措施

Memory Support System participants

Experimental

干预措施: Memory Support System (Behavioral)

结局指标

主要结局

Interest in completion of MSS training

时间窗: From study start date up to 19 months.

Percentage of participants that complete the feasibility survey and agree or strongly agree with the statement that they are interested in completing MSS training.

次要结局

  • Center for Epidemiologic Studies Depression Scale(Baseline, at completion of the treatment - on average 6 weeks, and at 8 week follow-up after treatment end.)
  • Everyday Cognition questionnaire.(Baseline, at completion of the treatment - on average 6 weeks, and at 8 week follow-up after treatment end.)
  • Quality of Life in Alzheimer Disease(Baseline, at completion of the treatment - on average 6 weeks, and at 8 week follow-up after treatment end.)
  • Functional Assessment Questionnaire(Baseline, at completion of the treatment - on average 6 weeks, and at 8 week follow-up after treatment end.)
  • Adherence to French Memory Support System Intervention(One week after starting the treatment (MSS intervention), at completion of the treatment - on average 6 weeks, and at 8 week follow-up after treatment end.)
  • Chronic Disease Self-efficacy Scale(Baseline, at completion of the treatment - on average 6 weeks, and at 8 week follow-up after treatment end.)
  • State-Trait Anxiety Inventory by the Resources for Enhancing Alzheimer's Caregiver Health project(Baseline, at completion of the treatment - on average 6 weeks, and at 8 week follow-up after treatment end.)
  • Caregiver Burden Inventory Short-Form(Baseline, at completion of the treatment - on average 6 weeks, and at 8 week follow-up after treatment end.)

研究者

发起方
Bruyère Health Research Institute.
申办方类型
Other
责任方
Sponsor

研究点 (1)

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