Department of Psychiatry and Human Behavior, Alpert Medical School of Brown University, Providence, RI, United States.
Department of Psychiatry, Rhode Island Hospital, Providence, RI, United States.
JMIR Res Protoc. 2024 Oct 16;13:e60395. doi: 10.2196/60395.
A total of 12 modifiable risk factors account for 40% of dementia cases globally, yet population adherence to health behaviors associated with these factors is low. Midlife is a critical window for dementia prevention, as brain pathology often begins to accumulate years or decades before the onset of symptoms. Although multidomain behavioral interventions have been efficacious in reducing the risk of cognitive decline, adherence is low. Intrapersonal factors, such as health beliefs, are known mediators of the relationship between knowledge and health behavior.
In keeping with stage I of the National Institutes of Health (NIH) Stage Model for Behavioral Intervention Development, this study will use mixed methods to (1) develop an enhanced health education intervention, including an explanatory method for communicating information about dementia risk and personal health beliefs, and (2) conduct a pilot randomized controlled trial (n=20 per intervention arm) over 8 weeks to assess the feasibility of delivering the enhanced intervention versus basic health education alone.
Phase 1 will involve focus groups and individual qualitative interviews. Focus groups will be analyzed using (1) a descriptive framework matrix analysis and (2) interpretive data review by the research team. Individual qualitative interviews will be coded using applied thematic analysis using a phenomenographic approach. Phase 2 will involve a pilot randomized controlled trial. Proximal outcomes (measured at baseline, 4 weeks, and 8 weeks) include the perceived threat of Alzheimer disease, dementia awareness, and self-efficacy.
This project was funded in August 2022. Data collection began in 2023 and is projected to be completed in 2025.
Study findings will reveal the feasibility of delivering an 8-week multidomain health education intervention for primary prevention of dementia in midlife and will provide preliminary evidence of mechanisms of change.
ClinicalTrials.gov NCT05599425; https://clinicaltrials.gov/study/NCT05599425.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/60395.
全球共有 12 个可改变的风险因素,占痴呆症病例的 40%,但人口对与这些因素相关的健康行为的依从性很低。中年是预防痴呆症的关键时期,因为脑病理通常在症状出现前几年或几十年就开始积累。尽管多领域行为干预已被证明能有效降低认知能力下降的风险,但依从性较低。健康信念等个体内部因素是知识与健康行为之间关系的已知中介。
根据美国国立卫生研究院(NIH)行为干预发展阶段模型的第一阶段,本研究将使用混合方法:(1)制定一个增强的健康教育干预措施,包括一种解释性方法,用于传达痴呆症风险和个人健康信念信息;(2)在 8 周内进行一项试点随机对照试验(每组干预措施 20 人),以评估与单独提供基本健康教育相比,提供增强干预措施的可行性。
第 1 阶段将包括焦点小组和个人定性访谈。焦点小组将使用(1)描述性框架矩阵分析和(2)研究团队的解释性数据审查进行分析。个人定性访谈将使用现象学方法的应用主题分析进行编码。第 2 阶段将涉及一项试点随机对照试验。近端结果(在基线、4 周和 8 周时测量)包括阿尔茨海默病的感知威胁、痴呆症意识和自我效能感。
该项目于 2022 年 8 月获得资助。数据收集于 2023 年开始,预计于 2025 年完成。
研究结果将揭示在中年进行为期 8 周的多领域健康教育干预预防痴呆症的可行性,并提供机制变化的初步证据。
ClinicalTrials.gov NCT05599425;https://clinicaltrials.gov/study/NCT05599425。
国际注册报告标识符(IRRID):DERR1-10.2196/60395。