The Effect of Targeted Education on Number, Severity, and Perception of Sexual Side Effects of Patients Suffering From Schizophrenia and Diabetes or Prediabetes.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 256
- 试验地点
- 1
- 主要终点
- Changes from baseline to follow up in the total score of Changes in Sexual Function Questionnaire-14 (CSFQ-14)
研究概览
简要总结
The term sexual (SD) dysfunction covers conditions that prevent people from having a satisfactory sex life. SD is a frequent and sometimes debilitating complication of mental illness and a known adverse reaction to psycho-pharmacological treatment. SD is also associated with diabetes, a common somatic comorbidity in psychiatric patients. SD is associated with both reduced quality-of-life and reduced treatment adherence, yet SD is far too rarely addressed between the patient and the healthcare professional in clinical consultations.
The purpose of the study is to investigate whether targeted education of patients with schizophrenia and diabetes/prediabetes and/or their healthcare professionals in causes and management of SD:
- Increases the number of systematic examinations of sexual side effects,
- Causes changes in the psycho-pharmacological treatment, and
- Reduces the severity or perception of sexual side effects.
The study is a multicenter Randomized Controlled Trial (RCT) with four arms, in which the educational intervention is provided to patients, healthcare professionals, or both groups. The effect of the educational intervention is compared to a non-educated control group. The study is expected to include 192 patients recruited from 16 assertive community treatment centers evenly distributed in four Danish regions.
The study is part of an interdisciplinary project named SECRET. The educational intervention was developed in an ethnographic pre-study incorporating stakeholder engagement. Parallel to the present RCT, an ethnographic field study will be carried out to broaden the perspective on the effects of the intervention.
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
- •Age ≥ 18 years
- •A diagnosis in the schizophrenic spectrum (ICD10 F2x)
- •One of the following:
- •A diagnosis of diabetes (ICD10 E10x, E11x, E12x, E13x, 14x)
- •A current or previous prediabetes defined as an HbA1c between 39-47 mmol/mol (both included) measured in at least two blood samples collected with ≥3 months intervals as part of the patient's routine clinical monitoring
- •Obesity defined as a Body-Mass Index (BMI) ≥30 kg/m2
- •Ongoing treatment with at least one antipsychotic agent
- •A SD that can be rated using Changes in Sexual Function Questionnaire-14 (CSFQ-14)
排除标准
- •Incapacitated or subject to mental health probation
- •Unable to speak danish
结局指标
主要结局
Changes from baseline to follow up in the total score of Changes in Sexual Function Questionnaire-14 (CSFQ-14)
时间窗: At inclusion and at follow-up, i.e. 6 months after the educational intervention is finished.
Measured by Changes in Sexual Function Questionnaire-14 (CSFQ-14)
次要结局
- Changes in psycho-pharmacological treatment(Recorded continuously throughout the entire study period, i.e. from the day of the educational intervention to 6 months after the end of the educational intervention.)
- Changes from baseline to follow up in compliance / Adherence to the Pharmacological Treatment(At inclusion and at follow-up, i.e. 6 months after the educational intervention is finished.)
- Changes from baseline to follow up in shared decision making(At inclusion and at follow-up, i.e. 6 months after the educational intervention is finished.)
- The frequency in which sexual issues are discussed in the clinical consultation(Recorded continuously throughout the entire study period, i.e. from the day of the educational intervention to 6 months after the end of the educational intervention.)