Skip to main content
OpenTrials
Completed

NCT Number: NCT03706716

Testing a Decision Aid for Women With Urogenital Prolapse

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Pelvic Organ Prolapse Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Prolapse

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Hospital of Southern Jutland, Aabenraa, Denmark

Loading trial locations.

About this study

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)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

decision aid developed for pelvic organ prolapse

Other

Conversation based upon the inter face in the Electronic patient journal.

Primary outcomes

  1. PROM of the shared decision making process

    Time frame: 1 hour immediately after the decision on treatment was taken

    Measurement of shared decision making for treatment of pelvic organ prolapse symptoms measured by questionnaire SDM-Q-9

Secondary outcomes

  1. PROM of Satisfaction with decision

    Time frame: 1 hour immediately after the decision on treatment was taken

    Measurement of satisfaction with the decision for treatment of pelvic organ prolapse symptoms measured by questionnaire SWD

Sponsors and collaborators

Lead sponsor

University of Southern Denmark

Other

Registry information

Official study 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.

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Oct 16, 2018
Registry last updated
May 3, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.