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临床试验/NCT05977855
NCT05977855招募中不适用

Use of a Diary to Assess and Monitor Behavioral and Psychological Symptoms of Dementia

Fondazione IRCCS San Gerardo dei Tintori18 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2023年7月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
300
试验地点
18
主要终点
Zarit Burden Interview

研究概览

简要总结

The goal of this randomized clinical trial is to compare the efficacy of the use of a diary to record behavioral and psychological symptoms of dementia (BPSD) in persons with dementia. The main questions it aims to answer are:

  • Does the use of a diary lead to a reduction of the caregiver's burden at 3 months, compared with standard care?
  • Does the use of a diary lead to a reduction of the neuropsychiatric inventory (NPI) score at 3 months, compared with standard care?
  • Does the use of a diary result in less psychotropic drugs prescribed to the patient at 3 months compared with standard care?
  • Are physicians and caregivers satisfied with managing patients with the use of a diary?
  • Does the use of a diary reduce the caregiver's stress related to BPSD at 3 months, compared with standard care? Participants will be randomly assigned to either the use of a diary or a control group. Caregivers in the diary arm will be asked to fill in a diary with BPSD including triggers, severity, day and hour, to be analyzed by physicians to prescribe appropriate pharmacological or non-pharmacological interventions. The control group will receive usual care (i.e., appropriate interventions will be applied after interviewing the caregiver and/or visiting the patient).

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
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Diagnosis of cognitive impairment (neurodegenerative or vascular)
  • Caregiver and patient willing to participate in the study
  • Caregiver living with the patient or able to cover all 24 hours
  • Presence of BPSD pertaining to the hyperactivity-irritability-impulsivity-disinhibition cluster (HIDA)
  • Signed informed consent before the beginning of the study

排除标准

  • Refusal to consent to participate in the study

结局指标

主要结局

Zarit Burden Interview

时间窗: 3 months

Zarit Burden Interview difference between intervention arm and controls

次要结局

  • Olanzapine equivalents(3 months)
  • Neuropsychiatric Inventory(3 months)
  • Neuropsychiatric Inventory - Caregiver Distress Scale(3 months)
  • Satisfaction questionnaire(3 months)

研究者

发起方
Fondazione IRCCS San Gerardo dei Tintori
申办方类型
Other
责任方
Sponsor

研究点 (18)

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