NCT04777461

Brief Summary

This project aims to develop and pilot an evidence-based structured education program that can be run in groups to enable women with PCOS to make lifestyle changes, which will help them improve their PCOS and reduce the risk of future PCOS-related complications.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 26, 2020

Completed
5 months until next milestone

First Posted

Study publicly available on registry

March 2, 2021

Completed
6 months until next milestone

Study Start

First participant enrolled

September 1, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2021

Completed
Last Updated

November 23, 2021

Status Verified

November 1, 2021

Enrollment Period

2 months

First QC Date

September 26, 2020

Last Update Submit

November 21, 2021

Conditions

Polycystic Ovary Syndrome

Outcome Measures

Primary Outcomes (2)

  • develop an evidence-based structured education programme for women with PCOS

    Conducting a survey among women with PCOS to understand the service user's perspectives on the development of an educational programme for PCOS. The survey measures the need and knowledge about PCOS. The scales measures form 1 to 5. In which 1 is minimum or 5 is maximum. for example Information about PCOS 1\. Do you think you have enough knowledge about PCOS? Please circle the answer in the scale below 1 2 3 4 5

    12 months

  • Pilot the structured education programme

    cognitive outcomes related to PCOS, monitor and evaluate the education process the post-pilot survey measures the satisfaction about the education session, the knowledge gained and the skills developed from the education session, the cognitive outcome and illness perception on a scale of 1 to 5 where 1 is minimum and 5 is maximum. for example How often do you think about your illness? 1 2 3 4 5

    12 months

Study Arms (1)

Group 1

EXPERIMENTAL

Pilot the structured education in women with PCOS

Other: Survey on patient's perspectives on the development of an structured education programme for PCOSOther: Pre-pilot questionnaireOther: Piloting the structured education programme for PCOSOther: Post-pilot questionnaireOther: cognitive outcomes outcome evaluation form

Interventions

Survey on patient's perspectives on the development of an structured education programme for PCOSOTHER

The outcome of this survey will help with developing curriculum for the structured education programme.

Group 1
Pre-pilot questionnaireOTHER

The questionnaire is aimed to capture the knowledge and expectations of the participants from taking part in the educational sessions.

Group 1
Piloting the structured education programme for PCOSOTHER

Piloting the education program through 2 educational group sessions

Group 1
Post-pilot questionnaireOTHER

The questionnaire aimed to capture participant's satisfactions and knowledge gained by taking part in the pilot study

Group 1
cognitive outcomes outcome evaluation formOTHER

This aimed to capture skills developed, knowledge gained and changes in participants behaviour and perceptions by taking part in the pilot study.

Group 1

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsOnly female with PCOS aged between 18-50 years old will be involved
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Willingness and ability to provide signed informed consent before any study activity.
  • Women aged 18-50 years (inclusive), with a confirmed diagnosis of PCOS based on Rotterdam criteria.
  • Body mass index \> 25 kg/m²

You may not qualify if:

  • Participants under 18 years or over 50 years old.
  • Participants who cannot adequately understand verbal and written explanations given in English.
  • Lack of mental capacity to give written consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hull University Teaching Hospitals NHS Trust, Academic diabetes, Endocrinology and metabolism

Hull, HU32RW, United Kingdom

Location

MeSH Terms

Conditions

Polycystic Ovary Syndrome

Condition Hierarchy (Ancestors)

Ovarian CystsCystsNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesGonadal DisordersEndocrine System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor/ Honorary consultant Endocrinologist

Study Record Dates

First Submitted

September 26, 2020

First Posted

March 2, 2021

Study Start

September 1, 2021

Primary Completion

October 31, 2021

Study Completion

October 31, 2021

Last Updated

November 23, 2021

Record last verified: 2021-11

Data Sharing

IPD Sharing
Will not share

There is no plan to make any identifiable participants data available to anyone. the final results will be published in one of the medical journals

Locations

GB(1)