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Идёт набор NCT05951660

Sex, Psychopharmacology, and Diabetes

Без фазы С лечением Schizophrenia Schizophrenia Spectrum and Other Psychotic Disorders Diabetes Mellitus PreDiabetes

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Educational intervention.
Кому может быть актуально
Состояния в реестре: Schizophrenia, Schizophrenia Spectrum and Other Psychotic Disorders, Diabetes Mellitus, PreDiabetes. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Дания
Следующий шаг
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Официальное название

The Effect of Targeted Education on Number, Severity, and Perception of Sexual Side Effects of Patients Suffering From Schizophrenia and Diabetes or Prediabetes.

Обзор

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.

Вмешательства

  • Поведенческое Educational intervention
    Different teaching sessions are used for patients and healthcare professionals, respectively. The teaching sessions are held at the Assertive Community Treatment (ACT) Centers from which the patients are recruited. The duration is 3x30 minutes with breaks for patients and 60 minutes for healthcare professionals. Teaching sessions are held by two doctors a specialist in clinical pharmacology and a specialist in psychiatry and clinical sexology providing the participants with knowledge and tools

Первичные конечные точки

  • Changes from baseline to follow up in the total score of Changes in Sexual Function Questionnaire-14 (CSFQ-14) [Срок оценки: At inclusion and at follow-up, i.e. 6 months after the educational intervention is finished.]
Вторичные конечные точки (4)
  • Changes in psycho-pharmacological treatment [Срок оценки: 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.]
  • The frequency in which sexual issues are discussed in the clinical consultation [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: At inclusion and at follow-up, i.e. 6 months after the educational intervention is finished.]

Критерии участия

Критерии включения

  • 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)

Критерии исключения

  • Incapacitated or subject to mental health probation
  • Unable to speak danish

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Простое слепое
Основная цель
Поддерживающая терапия

Центры проведения

Дания · 1 центр
  • Assertive Community Centres — Slagelse

Идентификаторы

NCT: NCT05951660 · EMN-2022-08015, SJ-1005

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗