Adapting Evidence-based Behavioral Interventions to Address Non-communicable Diseases and Common Mental Health Conditions Among People With Dementia or Mild Cognitive Impairment
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Adaptation of BECOME intervention for people with dementia or mild cognitive impairments
研究概览
简要总结
This pilot study aims to adapt the BEhavioral Community-based COmbined Intervention for MEntal Health and Noncommunicable Diseases (BECOME) to address the unique needs of individuals with dementia or mild cognitive impairment (PwD/MCIs) and their caregivers. Coexisting NCDs and CMDs in individuals with dementia can worsen cognitive functions, intensify neuropsychiatric symptoms, increase caregiver burden, and decrease overall quality of life. While Alzheimer's Disease and Related Dementias cannot be cured, managing these co-occurring conditions can slow disease progression and reduce caregiver stress. Our study will be focused on helping people with dementia or mild cognitive impairment (PwD/MCI) manage non-communicable diseases (NCDs) like diabetes and hypertension, and common mental disorders (CMDs) such as depression and anxiety by delivering skills-based behavioral interventions, adapted to the cognitive capacities of people with dementia and mild cognitive impairment (PwD/MCI) and the needs of their caregivers. The parent BECOME trial (NCT06449521) integrates behavioral activation, evidence-based stress reduction, and motivational interviewing to target depression, anxiety, and behavioral changes, respectively, delivered by community health workers (CHWs). This supplement seeks to tailor the BECOME manual into a dyadic intervention for people with dementia or mild cognitive impairment and their caregivers and conduct a pilot study to examine the acceptability and feasibility of the adapted intervention.
详细描述
General Objective: To adapt evidence-based behavioral interventions for people with cognitive impairment and dementia to address non-communicable diseases and common mental health conditions.
Specific Objectives:
- To adapt BECOME intervention into dyadic format based on iterative feedback from a multidisciplinary dementia advisory board.
- To assess the preliminary acceptability and feasibility of the adapted intervention among 5 dyads of PwD/MCIs and their caregivers, and CHW.
Research method: Mixed
Study site: The parent study, BECOME (NCT06449521), is being conducted in two municipalities of Nepal, Chandragiri and Bardibas. For this pilot study, the investigators will recruit from Chandragiri municipality only.
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
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •For Patient participant :
- •Adult men and women age: ≥60 year with cognitive impairment as indicated at a score of 22 or lower on RUDAS
- •living in the target wards with no intention of leaving in the next 2.5 yrs
- •anxiety (HSCL-25 anxiety subscale ≥1.75) and/or depression (HSCL-25 depression subscale ≥1.75) AND
- •at least one non-communicable disease (NCD) based on WHO PEN criteria: Hypertension (HTN) (SBP ≥130 and/or DBP ≥80) and/or Diabetes Mellitus (DM) (fasting plasma glucose (FPG) ≥126mg/dl or random plasma glucose ≥200mg/dl).
- •For Caregiver:
- •A family member identified as the primary caregiver of the PwD/MCI
- •18 years and older
- •provide their consent to participate in the study.
- •For Community Health Worker (CHW):
- •CHW working in the community health program in the identified study cluster.
- •18 years and above
- •provide their consent to participate in the study
排除标准
- •For Patient Participants:
- •Participants who cannot provide consent
- •Participants who will score 3 or less on the 3-item questionnaire that assesses potential participants' ability to provide consent to participate in research.
- •For Caregiver:
- •- The primary caregivers who do not provide consent to participate in our study.
- •For Community Health Worker (CHW):
- •- CHWs who do not provide consent to participate in our study.
研究组 & 干预措施
Single-arm intervention study
干预措施: BECOME-D Intervention (Behavioral)
结局指标
主要结局
Adaptation of BECOME intervention for people with dementia or mild cognitive impairments
时间窗: The advisory board will meet at least monthly during the first 4 months to provide direct input and feedback to adapt the intervention. The advisory board will meet again during month 12 to discuss lessons learned.
For this pilot study, the investigators will create a dementia advisory board with 8-10 individuals including clinicians with expertise in dementia care (1-2), NCDs (1), and CMDs (1), at least two members who are PwD/MCI, their caregivers, and local community leaders who are involved in awareness-raining and advocacy work for PwD/MCI and their caregivers. The advisory board will meet at least monthly during the first 4 months to provide direct input and feedback to adapt the intervention. The advisory board will meet again during month 12 to discuss lessons learned from this formative study and provide suggestions to make any changes prior to future studies. The overarching goal is to adapt the BECOME interventional manual (developed under the parent R01) to meet the unique needs of people with dementia and their caregivers: making it accessible and relevant to people with cognitive challenges; and transforming the target of the intervention from a singular patient to the dyad.
次要结局
- Acceptability and feasibility of the adapted intervention (BECOME-D)(First in baseline assessment followed by immediate post intervention assessment and then 2 months post intervention.)