Testing a Decision Aid for Women With Urogenital Prolapse

NCT03706716 | Completed

• 1 other identifier: OP_613
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Pelvic Organ Prolapse

Keywords

shared decision making

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• PROM of Satisfaction with decision

  1 hour immediately after the decision on treatment was taken

Study Arms (2)

Intervention with use of decision aid in the consultation

OTHER

With use of developed decision aid for pelvic organ prolapse / At the beginning of the consultation the IF will be opened within the patients electronic journal. The conversation will take its starting point from the generated IF which should define the area of interest rather for the patient.

Other: decision aid developed for pelvic organ prolapse

Control with no use of decision aid in the consultation

NO INTERVENTION

Without decision aid / The conversation during the consultation will follow the general standard for consultation conversations in the department.

Interventions

decision aid developed for pelvic organ prolapse OTHER

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

Intervention with use of decision aid in the consultation

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• urogenital prolaps symptoms
• e boks

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Southern Denmark: lead

Study Sites (3)

Hospital of Southern Jutland

Aabenraa, 6200, Denmark

Location

Hospital of Lillebaelt, Kolding

Kolding, 6000, Denmark

Location

Odense University Hospital

Odense, 5000, Denmark

Location

Related Publications (1)

• Hulbaek M, Primdahl J, Birkelund R, Al-Kozai SAH, Barawi S, Ebbesen NT, Nielsen JB. A Preference-Sensitive Online Instrument to Support Shared Decision Making for Patients With Pelvic Organ Prolapse: A Pilot Multicenter Randomized Controlled Trial. Comput Inform Nurs. 2021 Jul 12;39(11):714-724. doi: 10.1097/CIN.0000000000000789.

  PMID: 34238835 DERIVED

MeSH Terms

Conditions

Pelvic Organ Prolapse

Condition Hierarchy (Ancestors)

Prolapse; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Mette Hulbaek, Ph.d. stud.

  Gynecology dep, Southern hospital of Jutland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Arm A - intervention /consultation with use of decision aid Arm B - Controls / consultation without use of decision aid

Study Record Dates

• First Submitted: October 11, 2018
• First Posted: October 16, 2018
• Study Start: June 7, 2018
• Primary Completion: March 22, 2019
• Study Completion: April 26, 2019
• Last Updated: May 3, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

DK (3)