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临床试验/NCT04777461
NCT04777461已完成不适用

Living With Polycystic Ovary Syndrome- Structured Education Programme

University of Hull2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2021年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
30
试验地点
2
主要终点
develop an evidence-based structured education programme for women with PCOS

研究概览

简要总结

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.

详细描述

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).

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
盲法
None

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • 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

排除标准

  • 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.

结局指标

主要结局

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

时间窗: 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 1. Do you think you have enough knowledge about PCOS? Please circle the answer in the scale below 1 2 3 4 5

Pilot the structured education programme

时间窗: 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

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Thozhukat Sathyapalan

Professor/ Honorary consultant Endocrinologist

University of Hull

研究点 (2)

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