|- candidate number||19535|
|- NTR Number||NTR4807|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||23-sep-2014|
|- Secondary IDs||2012.00.1554 Dutch Diabetes Research Foundation|
|- Public Title||Improving care for sexual problems in persons with type 2 diabetes|
|- Scientific Title||Improving care for sexual problems in persons with type 2 diabetes mellitus|
|- hypothesis||The overall aim of this study is to study the effectiveness of a PLISSIT-model intervention in men and women with type 2 diabetes in primary care. |
Primary outcomes include sexual functioning, sexual satisfaction, and quality of life. Secondary outcomes concern depressive symptoms, sexual distress, emotional well-being, and treatment satisfaction.
|- Healt Condition(s) or Problem(s) studied||Diabetes Mellitus Type 2 (DM type II), Quality of life, Sexual function|
|- Inclusion criteria||1. Men and women with diagnosed type 2 diabetes mellitus|
2. Patients aged between 40 and 75 years
3. Patients who indicate to be dissatisfied about their sexual function
4. Patients who indicate they want to talk about their sexual problem with their general practitioner.
5. Patients have to be able to read, write and understand the Dutch language.
|- Exclusion criteria||1. Participation in scientific research that aims to improve one or more of our outcome measures.|
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-dec-2014|
|- planned closingdate||1-dec-2015|
|- Target number of participants||200|
|- Interventions||Patients in the intervention group will receive sexual counselling from their general practitioner based on the PLISSIT model. General practitioners in the intervention group will be trained by a sexologist to execute the PLISSIT model.
Patients in the control group will receive an information leaflet on Diabetes and Sexuality from their general practitioner, in addition to usual care.
|- Primary outcome||Primary outcomes include sexual functioning, sexual satisfaction, and quality of life.|
|- Secondary outcome||Secondary outcomes concern depressive symptoms, sexual distress, emotional well-being, and treatment satisfaction.|
|- Timepoints||All outcomes will be measured by means of self-report questionnaires at baseline, and after 3 and 12 months post-baseline. Treatment satisfaction will be assessed in telephone interviews.
|- Trial web site||none|
|- CONTACT FOR PUBLIC QUERIES||MSc. A. Rutte|
|- CONTACT for SCIENTIFIC QUERIES|| P.J.M. Elders|
|- Sponsor/Initiator ||VU University Medical Center, EMGO+ Institute|
(Source(s) of Monetary or Material Support)
|Dutch Diabetes Research Foundation|
|- Brief summary|
|- Main changes (audit trail)|
|- RECORD||23-sep-2014 - 18-okt-2014|