Can Early Counseling and Support for Alzheimer's Disease Caregivers Improve Burden? A Multi-centre Active Randomized Clinical Trial in Local Health Services
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 230
- 试验地点
- 2
- 主要终点
- Care-giver burden measured with Zarit Burden Inventory (ZBI)
研究概览
简要总结
This randomized trial evaluates the efficacy of counselling for reducing anxiety and depression in caregivers of patients with dementia. Half of the participants will receive six hours providing counselling and psycho-social support to caregivers along with a specific telephone support service - Ad Hoc Telephone Counselling whereas the remaining participants will receive six hours providing general information about Alzheimer Disease.
详细描述
This study will be a multicentre Umbrian PROBE design (treatment regimens are blinded to both caregivers and evaluators) with investigating the effectiveness comparing two active treatment "counseling and support" versus "educational group focusing on AD" in 230 primary caregivers of AD patients.
If all inclusion criteria are met, the caregiver will be asked to sign a written informed consent form. Failure to do so, will result in exclusion from the study. The treatment will not be disclosed to the caregivers, although the caregivers will be told that they will participate in a study with two different active treatments which will require a total of six-hour sessions.
Care providers and Study settings
Caregiver will be recruited in secondary outpatient clinic located in Umbrian health maintenance organizations (HMO). Outpatient clinic in Umbria are disseminated in the territory and each small city has its own clinic (Città di Castello, Foligno, Gualdo Tadino, Gubbio, Perugia, Marsciano, Passignano, San Giustino, Spoleto, Terni, Todi, Umbertide with population ranging from 11,000 to 166,000 inhabitants, of them around 70% living in the country/small village). Care providers were neurologist and geriatrician with twelve to 30 year experience in dementia practice, working in high volume outpatient clinic.
INTERVENTION
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
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Caregiver actively caring the patient for at least 4 hours a day over the last 6 months.
- •Their patients must have scored lower than 24 on the Mini-Mental State Examination score, at screening.
- •Their patients must have at least one limitation according to the Activities of Daily Living (ADL) test, or two limitations based on the Instrumental Activities of Daily Living (IADL) test.
排除标准
- •Self-reported current psychiatric history, not related to patient's disease
- •caregiver of non-AD dementias
- •their patients could not undergo clinical and neuropsychological evaluation
- •caregiver with insufficient Italian language knowledge
- •can not be contacted by telephone regularly (eg. Do not have telephone/mobile, severe auditory deficits).
结局指标
主要结局
Care-giver burden measured with Zarit Burden Inventory (ZBI)
时间窗: ZBI evaluated at 6 months
Change from baseline of care-giver burden at 6 months
Care-giver burden measured with ZBI
时间窗: ZBI evaluated at 24 months
Change from baseline of care-giver burden at 24 months
次要结局
- BPSD using the Revised Memory and Behaviour Checklist (RMBC)(At baseline, and after 6 months, 12 and 24 months from baseline)
- Patient quality-of-life measure with Logdson's Quality of Life AD(At baseline, and after 6 months, 12 and 24 months from baseline)
- Behavioural and psychological symptoms of dementia (BPSD) using the Neuropsychiatric Inventory (NPI)(At baseline, and after 6 months, 12 and 24 months from baseline)
- Caregiver depression measured using the Hospital Anxiety and Depression Scale (HADS)(At baseline, and after 6 months, 12 and 24 months from baseline)
- Care-giver quality-of-life measure with Euro-Quality of Life(At baseline, and after 6 months, 12 and 24 months from baseline)
研究者
Serena Amici
MD
Azienda Sanitaria Locale N.1 dell'Umbria