Evaluation of a Psychoeducation Program for Families Caregivers of Schizophrenic Patients : Randomized Study in Two Arms
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Relapse
研究概览
简要总结
The involvement of family members is crucial and improves the prognosis of psychiatric patients and reinforces therapeutic adherence and reduces the frequency of relapses. For schizophrenia, the scientific literature clearly shows that it's in the interest of the patient to offer to his family a psychoeducational program.
Therapeutic education programs are now part of the recommendations of good clinical practice and in the French health through the law n ° 2009-879 of July 21, 2009 on the reform of the hospital and relating to patients, health and territories.
详细描述
Objectives We conducted a randomized study in two groups to evaluate the impact of a psychoeducational program for caregivers.
Methods 60 patients with a DSM-V diagnosis of schizophrenia and their families' caregivers are recruited. Families' caregivers are randomly assigned to receive either a 6 session psychoeducation program, or no psychoeducation.
Baseline evaluations:
Patients: symptomatology (PANSS), medication adherence (MARS); Families' Caregivers: Quality of Life (S-CGQoL), Burden (Zarit), knowledge of disease (KAST), therapeutic alliance (4PAS caregivers), depression (CES-D), medication adherence (CRS).
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
- Single (Outcomes Assessor)
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 schizophrenia, based on ICD-10 (F20 to F29)
- •Receive in-patient treatment at hospital (or medical center linked to Charles Perrens Hospital)
- •Be the caregiver or parent of the patient
- •Patient informed of the diagnosis of his disease
排除标准
- •Mental retardation or other diagnoses that could affect the ability to answer questionnaires, after the acute schizophrenia psychosis is controlled
- •Suicidal ideation
- •Non-comprehension of the French language
结局指标
主要结局
Relapse
时间窗: baseline (pre-treatment) to six months post-baseline
Reduction in the rate of relapse (hospitalization) in patients whose family participated in the psychoeducation group compared to patients without psychoeducation.
Medication adherence (caregiver perception)
时间窗: baseline (pre-treatment) to six months post-baseline.
Change from baseline (pre-treatment) to 6 months post-baseline in caregiver-report of medication adherence using respectively the Compliance Rating Scale.
次要结局
- Quality of Life(baseline (pre-treatment) to six months post-baseline)
- Burden(baseline (pre-treatment) to six months post-baseline)