跳至主要内容
临床试验/NCT06965686
NCT06965686招募中不适用

Development of a Personalized, Psychosocial Intervention for Menopausal Individuals With Elevated Dementia Risk

University of Chicago1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年1月31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
入组人数
60
试验地点
1
主要终点
Number of participants who are enrolled and complete the study

研究概览

简要总结

By age 45, women's lifetime risk of dementia is estimated to be 1 in 5. Two-thirds of people currently living with a dementia diagnosis are women, and-women make up the majority of carers for people with dementia. Because women bear a larger burden of the dementia epidemic, they tend to be more fearful about dementia compared to men. Women may be especially fearful during the menopause transition, which can impact cognition. These fears can cause significant psychological distress, functional impairment, and avoidance of help seeking. Interventions that acknowledge women's fears and promote adaptive coping during the menopause transition are needed to combat dementia-related fear and its negative impacts.

This project aims to develop, and pilot test a brief personalized, psychosocial intervention for middle-aged perimenopausal individuals with elevated dementia risk. The investigators will assess the intervention's acceptability and feasibility for use in this population. The project will be completed in three stages. First, the investigators will conduct focus groups to better understand individual fears about dementia, informational and decisional needs, and strategies to promote adaptive coping as they transition through menopause (case-only, single time point). Second, the investigators will develop an intervention to meet the specific needs identified by the focus groups. Intervention components will address multiple areas of women's health in midlife, including aspects of physical and psychological health, as well as functional health outcomes that have important and long-lasting life implications. Finally, the investigators will conduct pilot testing to assess the acceptability and feasibility of the intervention (cohort, 3-week testing period).

This project will deliver a novel psychosocial intervention that can provide middle-aged perimenopausal women with the information and practical skills that can help them manage their dementia-related fears and encourage adaptive coping behaviors. Outputs from the project will serve as preliminary data for a fully powered randomized controlled 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
40 Years 至 58 Years(Adult)
性别
Female
接受健康志愿者
否

入选标准

  • •Female sex at birth
  • •Aged between 40-58 years
  • •Late perimenopause or early post-menopause
  • •Elevated dementia risk characterized by first degree relative with diagnosis of Alzheimer's disease or another dementia

排除标准

  • •Diagnosis of Mild Cognitive Impairment, Alzheimer's or another dementia
  • •Diagnosis of other chronic illness or condition that affects cognition (e.g., Axis I psychiatric disorders such as schizophrenia or mood disorders, neurological disorders such as stroke, cancer, traumatic brain injury)
  • •Inadequate vision or hearing to engage with intervention materials
  • •Unable or unwilling to provide informed consent
  • •Iatrogenic menopause (i.e., due to surgery)

研究组 & 干预措施

Perimenopausal individuals with a family history of dementia

Experimental

For the focus groups, the investigators will recruit a minimum of 20 participants. Participants will take part in a single 1-hour remote focus group session, where they will be asked about their fears about dementia, informational and decisional needs, and strategies to promote adaptive coping as they transition through menopause.

For pilot testing, we will recruit a minimum of 30 participants. Participants will be asked to evaluate the online intervention materials across 3-weeks. The evaluation will focus on feasibility and acceptability of the intervention.

干预措施: PERI-MIND (Behavioral)

结局指标

主要结局

Number of participants who are enrolled and complete the study

时间窗: From enrollment until pilot testing is completed

Feasibility outcomes will relate to the successful implementation and completion of the intervention, including the ease of recruitment and ability of participants to enroll and complete the study. Metrics will include the total number of participants identified and enrolled in the study and completion rate.

Acceptability of intervention content

时间窗: From enrollment until pilot testing is completed

Acceptability will be assessed using standard Likert-type scales, informed by the Theoretical Framework of Acceptability for healthcare interventions. Questions will focus on the content, presentation format and length.

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 (1)

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