mGlide-Care: A Partnership With Caregivers to Improve HTN Management in Patients With Cognitive Impairment
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- HTN control
研究概览
简要总结
Hypertension (HTN) is the most significant stroke, cardiovascular disease and dementia risk factor and is substantially under-treated especially in older persons. In this study the investigators will develop mGlide-Care to address uncontrolled HTN in people with mild cognitive impairment (MCI) and early stage Alzheimer's Disease and Alzheimer's Disease Related Dementia (AD/ADRD). mGlide-Care is adapted from mGlide which is a mHealth (mobile health technology) mediated care model for HTN care. Aim 1 will engage stakeholders to study the acceptability of mHealth mediated HTN care and will use their input to develop mGlide-Care. Stakeholders are persons with early stage AD/ADRD and MCI, unpaid family caregivers, primary care providers, geriatricians and clinical pharmacists. Aim 2 is a feasibility pilot to test mGlide-Care vs. usual care in 75 participants with uncontrolled HTN and early stage AD/ADRD or MCI. Caregivers will assist participants. Outcomes will include HTN control and participant and caregiver reported measures.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 60 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Must meet all criteria
- •Diagnosed with early stage AD/ADRD or MCI
- •Have uncontrolled hypertension (HTN)
- •Have an unpaid, family caregiver
- •Have established medical diagnosis of hypertension (HTN)
- •English speaking
- •Participant or caregiver must have a smartphone or mobile device (e.g. iPad) that can transmit blood pressure (BP) from the BP monitor
- •Participant and caregiver capable and willing to comply with the entire study protocol
- •Able to give voluntary written informed consent.
排除标准
- •Any of the following will be an exclusion.
- •Severe comorbid illness including end-stage kidney disease, end-stage liver disease, and life expectancy <1 year, or if medical complexity of the patient precludes clinical trial participation
- •Active illicit drug use (e.g. cocaine, methamphetamines, opioids, phencyclidine) since this will interfere with HTN management
- •Participant and caregiver unable to complete study tasks, including are homeless, will leave the country, or will relocate in the next 12 months
- •Serious psychiatric illness that could interfere with treatment, assessment, or compliance including significant delusional disorders such as schizophrenia and bipolar illness
- •Unable or unwilling to give consent.
研究组 & 干预措施
mGlide-Care
mHealth mediated HTN care model with self-monitoring and medication adjustment
干预措施: mGlide-Care (Other)
Usual Care Plus
Usual Care including self-monitoring support
干预措施: Usual Care + (Other)
结局指标
主要结局
HTN control
时间窗: 6 months and 12 months
HTN control rates in intervention vs. control arm participants. HTN control for each participant will be defined based on personalized threshold for participant as determined by primary care.
次要结局
未报告次要终点