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van CCT (UK)

van CCT (UK)

Study on shared decision making in choosing a treatment for pelvic organ prolapse

- candidate number25481
- NTR NumberNTR6070
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR30-okt-2016
- Secondary IDsNL55737.028.15 
- Public TitleStudy on shared decision making in choosing a treatment for pelvic organ prolapse
- Scientific TitleSHAred Decision making in Pelvic Organ Prolapse - A cluster Randomized Controlled Trial on use of the Decision Aid
- hypothesisThe use of an interactive web-based Decision Aid reduces decisional conflict and increases patient satisfaction with information and care.
- Healt Condition(s) or Problem(s) studiedProlapse
- Inclusion criteria1. Woman with a symptomatic prolapse
2. Woman for whom a (new) treatment must be chosen. Patients are eligible for at least two treatment options
3. Patients have to be able to make use of a computer with internet access in order to make use of the web-based decision aid and to complete the online questionnaires
4. Written informed consent
- Exclusion criteria1. Patients with a history of gynaecological cancer
2. Patients and clinicians who do not have any access to the internet
3. Patients and clinicians who do not have sufficient knowledge of the Dutch language
4. More than 1 POP-surgery in the past or POP-surgery < 2 years. Anti-incontinence surgery is not considered POP surgery here.
5. In case of a second opinion, the patient will not be included if the first opinion was obtained in one the hospitals involved in the study
6. Patients participating in the PEOPLE study
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-dec-2016
- planned closingdate
- Target number of participants415
- InterventionsIn the intervention group, patients will be presented with the decision aid after diagnosis. After completing the web-based decision aid program, patientsí preferences will be discussed with the clinician during the next consultation. In the control group patients will receive information regarding treatment options as usual.
- Primary outcomeThe main study endpoints are: satisfaction with treatment decision (making), and satisfaction with information.
- Secondary outcomeSecondary endpoints are satisfaction with care and treatment, decisional conflict and decisional regret, quality of life, healthcare providersí evaluation of the (implementation of the) decision aid, and recurring symptomatic POP.
- TimepointsT1: max. 2 weeks after treatment decision, before start treatment
T2: 6 months after T1
T3: 12 months after T1
T4: 24 months after T1
- Trial web site
- statusopen: patient inclusion
- Sponsor/Initiator Elisabeth-Twee Steden ziekenhuis , University of Tilburg , Zorgkeuzelab
- Funding
(Source(s) of Monetary or Material Support)
Elisabeth TweeSteden Ziekenhuis Tilburg, University of Tilburg, Zorgkeuzelab
- Publications
- Brief summaryFemale pelvic organ prolapse (POP) is a common problem among women worldwide. The prevalence in The Netherlands ranges from 8.4 to 11% in women aged 45-85 years. Pessary or surgical treatment are the two commonly applied treatments. The lack of randomized controlled treatment studies in this field makes recommendations on the best treatment option for individual patients speculative. Choice of treatment depends on both patient and doctor preference. Information on POP provided to patients is not always accurate. This can result in incorrect or incomplete ideas and expectations about the disease and its treatment. Shared decision making (SDM) and the use of a decision aid (DA) are ways to provide patients with sufficient information and improve their knowledge. Furthermore it helps clarify their preferences regarding treatment and improves comfort and participation in the process of decision making, it reduces decisional conflict and makes patients feel more comfortable with their choices. To this end a web-based DA for the treatment of POP was developed. The aim of this study is to investigate the effects of the DA on SDM regarding treatment choice and patient-reported outcomes.
- Main changes (audit trail)
- RECORD30-okt-2016 - 7-okt-2017

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