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
- 否
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
研究点 (18)
Loading locations...
相似试验
已完成
不适用
Self-monitoring and Reflection's Impact on Psychotherapy Outcomes: A Trial Protocol.PsychotherapyTherapeutic AlliancePsychologicalNCT06038747University of North Carolina, Chapel Hill520
招募中
不适用
Efficacy of the Use of Diaries in Intensive Care UnitsDiary (Blank Journal)Intensive Care UnitPatientFamilyPICSStressQuality of LifeAnxietyDepressionNCT05288140University of Barcelona240
已完成
不适用
Evaluation of a Habit-based Work-up to Support Medication AdherenceMedication AdherenceHabitsNCT06230978University of Iowa33
已完成
不适用
Implantable Loop Recorder Versus Conventional Ambulatory Monitoring in Detecting Atrial Fibrillation After Pulmonary Vein IsolationAtrial FibrillationNCT00697359Odense University Hospital57
已完成
不适用
Evaluation of the Accuracy and Usability of the Minuteful - Kidney Urine Analysis Test System in the Lay User HandsAlbuminuriaChronic Kidney DiseasesDiabetesHypertensionNCT05838872Healthy.io Ltd.216
