|- candidate number||8137|
|- NTR Number||NTR2367|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||11-jun-2010|
|- Secondary IDs||2009.13.014 / 2010/99 ; Diabetes Fonds / METC VUmc|
|- Public Title||Diabetes and sexuality: An evaluation of the need for care among diabetes type 2 patients.
Diabetes en seksualiteit: Een inventarisatie van de zorgbehoefte bij type 2 diabetespatienten.
|- Scientific Title||Diabetes and sexuality: An evaluation of the need for care among diabetes type 2 patients.|
|- ACRONYM||Diabetes and sexuality|
|- hypothesis||Diabetes patients have an elevated risk to develop sexual dysfunctions. These sexual problems can have a negative impact on the quality of life of these patients. Despite this negative influence, little attention seems to be paid to these sexual problems in the regular diabetes care. Caregivers as well as patients seem to be ashamed to mention this aspect of health. Therefore many patients with diabetes and sexual problems do not receive the required care. We would like to evaluate the need for care among diabetic patients on sexual problems. The results of this study might give insight into what the current barriers are and which actions are needed to improve the diabetes care.|
|- Healt Condition(s) or Problem(s) studied||Diabetes Mellitus Type 2 (DM type II), Sexual dysfunction|
|- Inclusion criteria||1. Patients with type 2 diabetes;|
2. Age between 40 and 75 years;
3. Good understanding of the Dutch language;
4. Capable of answering questions of a questionnaire.
|- Exclusion criteria||N/A|
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||Single arm|
|- planned startdate ||1-aug-2010|
|- planned closingdate||1-feb-2011|
|- Target number of participants||200|
|- Interventions||Diabetic patients are asked to fill in a questionnaire.|
In the second part of the study we will organise semi-structured interviews with approximately 20 men and 20 women.
|- Primary outcome||Our primary study parameter is the need for care among diabetes type 2 patients.|
|- Secondary outcome||1. Prevalence of sexual dysfunctions;|
2. Sexual satisfaction;
3. Presence of depressive symptoms.
|- Timepoints||1. Need for care will be measured by the self-made questionnaire and we will ask for it during the interviews;|
2. Prevalence of sexual dysfunctions among men will be measured by the International Index of Erectile Function (IIEF). We will look at the percentage of men who have a score of 25 or lower on the erectile function domain of the IIEF;
3. Prevalence of sexual dysfunctions among women will be measured by the Female Sexual Function Index (FSFI). We will look at the percentage of women who have a total score of 26.55 or lower on the FSFI;
4. Sexual satisfaction will be measured by the Female Sexual Distress Scale (FSDS). We will look at the pecentage of women who have a score of 15 or higher on the FSDS;
5. Presence of depressive symptoms will be measured by the CES-D. We will look at the percentage of people who have a score of 16 or higher on the CES-D.
|- Trial web site||N/A|
|- CONTACT FOR PUBLIC QUERIES|| M.M.I. Splunter, van|
|- CONTACT for SCIENTIFIC QUERIES|| M.M.I. Splunter, van|
|- Sponsor/Initiator ||VU University Medical Center, EMGO Institute|
(Source(s) of Monetary or Material Support)
|Diabetes Research Fund |
|- Brief summary||This study will take place in the Netherlands and will evaluate the need for care among diabetic type 2 patients on sexual problems. Patients are asked to fill in a questionnaire and semi-structured interviews will be held.|
|- Main changes (audit trail)|
|- RECORD||11-jun-2010 - 20-jun-2010|