A Multidomain Intervention Program for Older People With Dementia: A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 4
- 主要终点
- Adherence
研究概览
简要总结
This is a pilot study to assess the feasibility of a multidomain intervention for older people with dementia in nursing homes. Participants will be randomized into two equal groups, to receive either an intensive multidomain intervention (intervention group) or regular health advice (control group). The intervention will include physical, cognitive, and social interventions and management of metabolic and vascular risk factors. We hypothesize that the multidomain intervention will be feasible in Vietnam, and participants who receive the intervention will show improvement in cognitive function, quality of life, behaviors, functional ability, sleep, and in reduction of falls, and death rate compared to those in the control group during the 6 months intervention period
详细描述
This is a two-armed, multicenter, randomized controlled pilot study, based in 3 nursing homes in Hanoi, Vietnam.
The study PI and/or researchers in the research team will contact adults aged 60 years and older in the nursing homes to introduce the study. If they are interested in participating, the study PI and/or researchers in the research team will screen them for their eligibility. If they meet the inclusion criteria and are interested in participating, written informed consent will be obtained.
Participants who agreed to participate in the study will be randomized into two equal groups, to receive either an intensive multidomain intervention (intervention group) or regular health advice (control group).
Participants in both the intervention and the control groups will be treated for dementia according to the recommendations of the Vietnam Alzheimer's Disease and Neurocognitive Disorders Association.
All participants will meet the study physician to have an examination at baseline, 3 months, and 6 months. At each examination, participants will undergo a physical examination, anthropometry (weight, hip and waist circumference), blood pressure determination, pulse rate and rhythm, risks of cardiovascular and metabolic diseases (smoking, drinking, hypertension, coronary artery disease, dyslipidemia, atherosclerosis, diabetes) and assess blood test results (lipid profile, HbA1C, and fasting glucose if patients have diabetes). Results will be provided to participants and their doctors.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Triple (Care Provider, Investigator, Outcomes Assessor)
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
- •We aim to enroll participants aged over 60 years old, living in nursing home, who have a diagnosis of dementia (according to DSM 5 criteria), stage mild to moderate (according to Clinical Dementia Rating scale - CDR). Participants receiving pharmacological treatment for dementia must be on a stable dose for at least 3 months prior to the study. Eligible participants must be able to mobilize independently with or without a mobility aid and without physical assistance.
排除标准
- •Acute and malignant diseases (e.g., advanced cancers, end-stage chronic diseases, acute myocardial infarction, stroke)
- •Symptomatic cardiovascular disease, coronary revascularization within 1 year
- •Clinical evidence of schizophrenia, severe depression, psychiatric or bipolar disorder (according to DSM-V TR criteria)
- •Alcoholism or substance dependence (according to DSM-5 criteria), currently, or within the past 2 years
- •Severe loss of vision, hearing, or communicative ability (according to the interRAI Community Health Assessment)
- •g. Participant or family unwilling to participate in the study
结局指标
主要结局
Adherence
时间窗: 6 months
Percentageof sessions attended out of the total planned
Retention
时间窗: 6 months
The retention rate was calculated as the number (percentage) of participants in each group who did not discontinue the study.
次要结局
- Behavioral and Psychological Symptoms of Dementia (BPSD)(Baseline, 6 months)
- Total Dependence of Participants Assessed Using the Barthel Index(Baseline, 6 months)
- Functional Ability Via the Handgrip Strength(Baseline, 6 months)
- Functional Ability Via 30 Seconds Sit To Stand Test(Baseline, 6 months)
- Fall(Baseline, 6 months)
- Quality of Sleep(Baseline, 6 months)
- Functional Ability Via the Instrumental Activities of Daily Living Scale(Baseline, 6 months)
- Global Cognition(Baseline, 6 months)
- Executive Function Via Clock Drawing Test(Baseline, 6 months)
- Attention Function Via Digit Span Forward(Baseline, 6 months)
- Atttention Function Will be Assessed Using Digit Span Backward.(Baseline, 6 months)
- Health-related Quality of Life(Baseline, 6 months)
- Death(6 months)
- Dependence of Participants Assessed Using the Instrumental Activities of Daily Living Scale(Baseline, 6 months)
研究者
Nguyen Xuan Thanh
Deputy Head of Palliative care department
National Geriatric Hospital