Developing Resource Interventions for Healthcare Professionals and Patients to Improve Knowledge About Fertility in Primary Ciliary Dyskinesia (REPRoDUCE)

April 8, 2026 updated by: University of Southampton

REproductive Health in PRimary Ciliary Dyskinesia: Developing User-informed Clinical and Educational Resources (REPRoDUCE)

This project will involve working with people with PCD and medical professionals to develop resources that will help patients and the people providing their care to better understand fertility and pregnancy safety in people with this condition.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

The study investigators will co-develop an online educational animation and text resource for patients and the public about PCD and fertility and pregnancy.

Development of patient resource:

The study investigators will conduct workshops with a group of approximately ten people including additional PPI representatives (adults with lived experience of PCD), representatives from PCD Support UK and medical professionals specialising in PCD. In stage 1 of the resource development, the study investigators will conduct an online workshop to identify priorities for information for inclusion in the resource. In stage 2 the study investigators will create a resource prototype based on the information gained in stage 1. In stage 3 the study investigators will conduct and record 1:1 online think aloud interviews to capture real-time reactions and gain evaluation of the resource prototype to identify areas for improvement. In stage 4, the study investigators will make further resource modifications. In stage 5 the intervention will be tested in a sample of men and women with PCD (n=10). The study investigators will then conduct an online quiz to measure pre- and post- resource use knowledge about PCD, fertility and pregnancy, and collect suggestions for improvement via a survey form. Feedback from stage 5 will be incorporated into the final resource prior to dissemination.

The resource will be translated into non-English languages spoken in the UK to aid inclusion of a wider audience.

Co-development of toolkit for medical professionals:

The study investigators will co-develop an online educational toolkit for medical professionals about fertility and pregnancy in patients with PCD. The study investigators will utilise the same group of approximately ten people including PPI representatives, representatives from PCD Support UK and medical professionals specialising in PCD as above. The study investigators will follow the above stages 1-4 for development of the toolkit. In stage 5, the study investigators will test the intervention in a sample of non-PCD specialists (n=10). During this stage an online quiz will be conducted to measure pre- and post- toolkit use knowledge about PCD, fertility and pregnancy, and collect suggestions for improvement via a survey form. Feedback from stage 5 will be incorporated into the final resource prior to dissemination.

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Aged 18 years or older
  2. 'Highly likely' or confirmed diagnosis of Primary Ciliary dyskinesia, or being a healthcare professional, or representative from a stakeholder group e.g. patient led charity
  3. Able to understand and willing to sign the informed participant consent prior to participation

Exclusion Criteria:

  1. Unwilling to participate in the study
  2. Not meeting inclusion criteria
  3. Unable to understand or unwilling to sign the informed participant consent prior to participation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Use of educational resource for patients
Online resource use by adults with PCD
Other: Online educational resource
Co-developed educational resource for patients
Experimental: Use of educational resource for healthcare professionals
Use of online toolkit by healthcare professionals
Other: Toolkit for healthcare professionals
co-developed online educational toolkit for healthcare professionals

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
A resource for patients and a toolkit for medical professionals
Time Frame: Duration of study (up to 3 years)
  1. Development of a resource for patients and toolkit for healthcare professionals
  2. Qualitative and quantitive participant data on the acceptability and usefulness of above resources.
Duration of study (up to 3 years)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Southampton

Collaborators

University Hospital Southampton NHS Foundation Trust
University of Cardiff

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2026

Primary Completion (Estimated)

March 31, 2029

Study Completion (Estimated)

March 31, 2029

Study Registration Dates

First Submitted

March 24, 2026

First Submitted That Met QC Criteria

April 8, 2026

First Posted (Actual)

April 15, 2026

Study Record Updates

Last Update Posted (Actual)

April 15, 2026

Last Update Submitted That Met QC Criteria

April 8, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 107544

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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