Pelvic Organ ProlapseNCT03706716
Testing a Decision Aid for Women With Urogenital Prolapse
A study testing decision aid developed for pelvic organ prolapse in people with Pelvic Organ Prolapse, run by University of Southern Denmark at 3 sites in Denmark.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pelvic Organ Prolapse
- What is being tested?
- decision aid developed for pelvic organ prolapse
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 3 sitesDenmark
- Study dates
- 7 Jun 2018to 26 Apr 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- urogenital prolaps symptoms
- e boks
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
Denmark3 sites
Hospital of Southern Jutland
Aabenraa, 6200
Hospital of Lillebaelt, Kolding
Kolding, 6000
Odense University Hospital
Odense, 5000
About this study
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.
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.
Read the detailed 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)
- Conditions
- Pelvic Organ Prolapse
- Being tested
- decision aid developed for pelvic organ prolapse
- Keywords
- shared decision making
- Medical subject headings
- Pelvic Organ Prolapse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
decision aid developed for pelvic organ prolapseOther
Conversation based upon the inter face in the Electronic patient journal.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 hour immediately after the decision on treatment was taken
Secondary outcomes (1)
PROM of Satisfaction with decision
Measurement of satisfaction with the decision for treatment of pelvic organ prolapse symptoms measured by questionnaire SWD
Measured: 1 hour immediately after the decision on treatment was taken
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2018
- Study start7 Jun 2018
- Primary completion22 Mar 2019
- Study completion26 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pelvic Organ ProlapseStudies of the same condition, open and under way.
- More trials run by University of Southern DenmarkThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Arm A - intervention /consultation with use of decision aid Arm B - Controls / consultation without use of decision aid
- Masking
- None (open label)
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern Denmark
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mette Hulbaek, Ph.d. stud., Principal investigator, Gynecology dep, Southern hospital of Jutland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03706716
- Sponsor's protocol ID
- OP_613
- Status last verified
- Apr 2019
- First submitted
- 11 Oct 2018
- Last updated
- 3 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 34238835
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT03706716
- Acronym / sponsor ID
- OP_613
- Conditions
- Pelvic Organ Prolapse
- Keywords
- shared decision making
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- University of Southern DenmarkUniversity, hospital or other
- Study start
- 7 Jun 2018 (actual)
- Primary completion
- 22 Mar 2019 (actual)
- Study completion
- 26 Apr 2019 (actual)
- First posted
- 16 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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)
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Arm A - intervention /consultation with use of decision aid Arm B - Controls / consultation without use of decision aid
| Arm | Type | Receives |
|---|---|---|
| Intervention with use of decision aid in the consultation | Other | Other: decision aid developed for pelvic organ prolapseWith 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- urogenital prolaps symptoms
- e boks
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| decision aid developed for pelvic organ prolapseConversation based upon the inter face in the Electronic patient journal. | Other | Intervention with use of decision aid in the consultation |
Primary outcome
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
1 secondary outcome
PROM of Satisfaction with decision
Time frame: 1 hour immediately after the decision on treatment was taken
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2019.
- Derived from this study: PubMed 34238835Hulbaek 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mette Hulbaek, Ph.d. stud. principal investigator
Gynecology dep, Southern hospital of Jutland
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing decision aid developed for pelvic organ prolapse in people with Pelvic Organ Prolapse, run by University of Southern Denmark at 3 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PROM of the shared decision making process (time frame: 1 hour immediately after the decision on treatment was taken). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03706716, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2019.