Ignite Creation Date:
2024-05-06 @ 3:50 PM
Last Modification Date:
2024-10-26 @ 1:58 PM
Study NCT ID:
NCT04777461
Status:
COMPLETED
Last Update Posted:
2021-11-23
First Post:
2020-09-26
Brief Title:
Living With Polycystic Ovary Syndrome
Sponsor:
University of Hull
Organization:
University of Hull
Study Overview
Official Title:
Living With Polycystic Ovary Syndrome- Structured Education Programme
Status:
COMPLETED
Status Verified Date:
2021-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
LW-PCOS
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
Detailed Description:
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 Leventhals 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 specialistseducators 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 eg obesity and health risks associated with PCOS
Emotional wellbeing and PCOS
Management of PCOS symptoms -how to take control
Pharmacological options ie hormonal contraceptives anti-androgens and insulin sensitisers
Lifestyle changes ie basics of energy balance healthy eating based on Eat well Plate mindful eating physical activity recommendations practical advice
Planning for the future eg 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
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 Leventhals 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 specialistseducators 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 eg obesity and health risks associated with PCOS
Emotional wellbeing and PCOS
Management of PCOS symptoms -how to take control
Pharmacological options ie hormonal contraceptives anti-androgens and insulin sensitisers
Lifestyle changes ie basics of energy balance healthy eating based on Eat well Plate mindful eating physical activity recommendations practical advice
Planning for the future eg 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None