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NCT Number: NCT04777461

Living With Polycystic Ovary Syndrome

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.

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Key information

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

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

Hull, HU32RW, United Kingdom

About this study

The first aim of this project is to develop an evidence-based structured education programme for women with PCOS. According to the Medical Research Council framework for complex interventions, robust patient-education programmes should have an evidence-based structured written curriculum, which is delivered by trained educators and is regularly assessed and audited. To meet these standards, the investigators first aim to develop a written curriculum for the structured education programme, written presentation material for the educational sessions and participants' handouts, but also material for training for the educators who will deliver the programme.

The philosophy of the programme is based on patient empowerment. The structured group education programme will be based on psychological theories of learning including the Leventhal's common-sense theory, the dual-process theory, and the social learning theory. Similar to previous successful programmes in diabetes education and based on the experience gained by conducting the education programme "Living with type 2 diabetes" in our centre, the programme will be designed as a six-hour of education programme with a formal and informed curriculum. It will be offered in two three-hour sessions of teaching for 8-12 PCOS women at a time. Attendees will be encouraged to be accompanied by a person of their choice.

Initial thoughts on the curriculum and the format of the written material have been already discussed within our clinical and research team (Dr Papageorgiou, Professor Sathyapalan, Mrs Baldwin consultant endocrinologists, general practitioners and dietitian specialists/educators delivering the "Living with Diabetes" education programme for patients with type 2 diabetes) based on their experience and views expressed to them by women with PCOS. As such, the areas that will be covered in the structured education programme include:

  • Thoughts and feelings of the participants around PCOS
  • Understanding PCOS pathophysiology: what happens in the body
  • Understanding the risk factors (e.g., obesity) and health risks associated with PCOS
  • Emotional wellbeing and PCOS
  • Management of PCOS symptoms -how to take control:
  • Pharmacological options (i.e., hormonal contraceptives, anti-androgens, and insulin sensitisers)
  • Lifestyle changes (i.e., basics of energy balance, healthy eating based on Eat well Plate, mindful eating, physical activity recommendations, practical advice).
  • Planning for the future (e.g., family planning, screening for long-term conditions).

Importantly, the investigators are also going to conduct a patients' survey to find out what women with PCOS expect to gain from an educational programme addressing several aspects of PCOS. The investigators will use the collected data to further refine the aspects of PCOS that will be included in the final curriculum of the programme.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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

Exclusion criteria

  • 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.

Treatment and study plan

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

Other

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

Pre-pilot questionnaire

Other

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

Piloting the structured education programme for PCOS

Other

Piloting the education program through 2 educational group sessions

Post-pilot questionnaire

Other

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

cognitive outcomes outcome evaluation form

Other

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

Primary outcomes

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

    Time frame: 12 months

    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

    • Do you think you have enough knowledge about PCOS? Please circle the answer in the scale below

    1 2 3 4 5

  2. Pilot the structured education programme

    Time frame: 12 months

    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

Sponsors and collaborators

Lead sponsor

University of Hull

Other

Collaborators

  • British Dietetic Association

Registry information

Official study title

Living With Polycystic Ovary Syndrome- Structured Education Programme

Acronym: LW-PCOS

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Mar 2, 2021
Registry last updated
Nov 23, 2021

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.

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