Testing a Decision Aid for Women With Urogenital Prolapse

Pelvic Organ Prolapse Clinical Trial

Official title:

Support Women's Decision Making - the Effect of Using an Online App in the Clinical Consultations of Patients With Urogenital Prolapse. A Protocol for a Randomized Controlled Non Blinded Multicenter Study. Assessing Feasibility.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03706716
• Other study ID #: OP_613
• Status: Completed
• Phase: N/A
• Start date: June 7, 2018
• Est. completion date: April 26, 2019

Study information

• Verified date: April 2019
• Source: University of Southern Denmark
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Development of a decision aid for women with urogenital prolapse followed by an intervention with use of the decision aid to investigate the effect on the perceived shared decision making in the clinical consultations.

A protocol for a randomized controlled non blinded multicenter trial. A feasibility trial for the protocol.

Description:

Objective :

The objective is to develop a decision aid to increase successful patient involvement and increased health care professionals integration of preferences in the clinical consultations with women with urogenital prolapse.

Method:

in the context of consultations an online app solution using a multicriterial analytic approach is developed and tested in order to support shared decision making (SDM). The decision aid is developed involving four national gynecological departments through participatory design. The decision aid is tested in a randomized, controlled multicenter trial in three hospital departments in the Region of Southern Denmark. A feasibility trial for the protocol of a randomized controlled trial will decide for further approach in relations to testing the online app. in a larger scale In the randomized trial patients will either receive consultations as usual (controls) or consultations using the interface (IF) in an app. The IF is generated upon data from a patient survey regarding their preferences for treatment beforehand.

Effect measures are the perceived shared decision making within the consultation (SDM-Q-9 ) and the patientperceived satisfaction with the decision (SWD)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 82
• Est. completion date: April 26, 2019
• Est. primary completion date: March 22, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• urogenital prolaps symptoms

• e boks

Exclusion Criteria:

• complicated pelvic organ prolapse which requires treatment other than dialogue, pessary, cystocele or rectocele surgery, physiotherapy or local hormones

• physical status classification system (ASA) score 3 or above

• not able to understand Danish without interpreter

• recurrent pelvic organ prolapse

Related Conditions & MeSH terms

• Pelvic Organ Prolapse
• Prolapse

Intervention

Other:
• decision aid developed for pelvic organ prolapse
Conversation based upon the inter face in the Electronic patient journal.

Locations

Country	Name	City	State
Denmark	Hospital of Southern Jutland	Aabenraa
Denmark	Hospital of Lillebaelt, Kolding	Kolding
Denmark	Odense University Hospital	Odense

Sponsors (1)

Lead Sponsor	Collaborator
University of Southern Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PROM of the shared decision making process	Measurement of shared decision making for treatment of pelvic organ prolapse symptoms measured by questionnaire SDM-Q-9	1 hour immediately after the decision on treatment was taken
Secondary	PROM of Satisfaction with decision	Measurement of satisfaction with the decision for treatment of pelvic organ prolapse symptoms measured by questionnaire SWD	1 hour immediately after the decision on treatment was taken