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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.



- candidate number8137
- NTR NumberNTR2367
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR11-jun-2010
- Secondary IDs2009.13.014 / 2010/99 ; Diabetes Fonds / METC VUmc
- Public TitleDiabetes 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 TitleDiabetes and sexuality: An evaluation of the need for care among diabetes type 2 patients.
- ACRONYMDiabetes and sexuality
- hypothesisDiabetes 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) studiedDiabetes Mellitus Type 2 (DM type II), Sexual dysfunction
- Inclusion criteria1. 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 criteriaN/A
- mec approval receivedyes
- multicenter trialno
- randomisedno
- groupParallel
- TypeSingle arm
- Studytypeobservational
- planned startdate 1-aug-2010
- planned closingdate1-feb-2011
- Target number of participants200
- InterventionsDiabetic 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 outcomeOur primary study parameter is the need for care among diabetes type 2 patients.
- Secondary outcome1. Prevalence of sexual dysfunctions;
2. Sexual satisfaction;
3. Presence of depressive symptoms.
- Timepoints1. 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 siteN/A
- statusplanned
- 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
- Funding
(Source(s) of Monetary or Material Support)
Diabetes Research Fund
- PublicationsN/A
- Brief summaryThis 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)
- RECORD11-jun-2010 - 20-jun-2010


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