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| Name | Class |
|---|---|
| Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital | OTHER |
| Steno Diabetes Center Sjaelland | OTHER_GOV |
| University College Copenhagen | OTHER |
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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| INT1: Only patients are educated | Experimental |
| |
| INT2: Only Healthcare Professionals are educated | Experimental |
| |
| INT3: Both patients and Healthcare Professionals are educated | Experimental |
| |
| Control | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Educational intervention | Behavioral | 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 for the dialogue on SD and drug-related side effects. The topics of the teaching sessions are:
The topics will be addressed in a mixture of short informative talks using a PowerPoint presentation, group discussions, and exchanges of personal experiences. |
| Measure | Description | Time Frame |
|---|---|---|
| Changes from baseline to follow up in the total score of Changes in Sexual Function Questionnaire-14 (CSFQ-14) | Measured by Changes in Sexual Function Questionnaire-14 (CSFQ-14) | At inclusion and at follow-up, i.e. 6 months after the educational intervention is finished. |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in psycho-pharmacological treatment | Estimated by changes in prescribed medications | 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 |
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Inclusion Criteria:
Age ≥ 18 years
A diagnosis in the schizophrenic spectrum (ICD10 F2x)
One of the following:
Ongoing treatment with at least one antipsychotic agent
A SD that can be rated using Changes in Sexual Function Questionnaire-14 (CSFQ-14)
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Gesche Jürgens, Clinical Professor | Contact | +45-93566501 | gju@regionsjaelland.dk | |
| Rikke Meyer, MD | Contact | +45-20419810 | rikme@regionsjaelland.dk |
| Name | Affiliation | Role |
|---|---|---|
| Gesche Jürgens, Clinical Professor | Clinical Pharmacology Unit, Zealand University Hospital, Roskilde, Denmark | Study Chair |
| Annamaria Giraldi, Clinical Professor | Sexological Clinic, Psychiatric Centre Copenhagen, Denmark |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Assertive Community Centres | Recruiting | Slagelse | Denmark |
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| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D003920 | Diabetes Mellitus |
| D011236 | Prediabetic State |
| D012735 | Sexual Dysfunction, Physiological |
| D064420 | Drug-Related Side Effects and Adverse Reactions |
| D000074822 | Treatment Adherence and Compliance |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D018479 | Early Intervention, Educational |
| ID | Term |
|---|---|
| D002662 | Child Health Services |
| D003153 | Community Health Services |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
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The number of systematic examinations of sexual side effects estimated by the number of consultations where sexual side effects are addressed, and whether it is the patient or the healthcare professional, who addresses the subject. |
| 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 | Measured by Rating of Medication Influences (ROMI) Scale | 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 | Measured by Shared Decision Making-9 (SDM) measurement tool | At inclusion and at follow-up, i.e. 6 months after the educational intervention is finished. |
| Lise Tarnow, MD, DMSc | Steno Diabetes Center Sjaelland, Denmark | Principal Investigator |
| Charlotte Bredahl Jacobsen, Senior Researcher, PhD. | Institute of Social Work, University College Copenhagen, Copenhagen, Denmark | Principal Investigator |
| Rikke Meyer, MD | Clinical Pharmacology Unit, Zealand University Hospital, Roskilde, Denmark | Principal Investigator |
| D004700 | Endocrine System Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D064419 | Chemically-Induced Disorders |
| D015438 | Health Behavior |
| D001519 | Behavior |
| D011314 | Preventive Health Services |