Polycystic Ovary SyndromeLW-PCOSNCT04777461
Living With Polycystic Ovary Syndrome
A study testing Survey on patient's perspectives on the development of an structured education programme for PCOS, Pre-pilot questionnaire and Piloting the structured education programme for PCOS in people with Polycystic Ovary Syndrome, run by University of Hull at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Polycystic Ovary Syndrome
- What is being tested?
- Survey on patient's perspectives on the development of an structured education programme for PCOS, Pre-pilot questionnaire and Piloting the structured education programme for PCOS
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Sep 2021to 31 Oct 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Hull University Teaching Hospitals NHS Trust, Academic diabetes, Endocrinology and metabolism
Hull, HU32RW
About this study
Official title: Living With Polycystic Ovary Syndrome- Structured Education Programme
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.
Read the 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 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.
- Conditions
- Polycystic Ovary Syndrome
- Being tested
- Survey on patient's perspectives on the development of an structured education programme for PCOS, Pre-pilot questionnaire, Piloting the structured education programme for PCOS, Post-pilot questionnaire, cognitive outcomes outcome evaluation form
- Medical subject headings
- Polycystic Ovary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
Pre-pilot questionnaireOther
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 PCOSOther
Piloting the education program through 2 educational group sessions
Post-pilot questionnaireOther
The questionnaire aimed to capture participant's satisfactions and knowledge gained by taking part in the pilot study
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.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | Pilot the structured education in women with PCOS Receives: Other: Survey on patient's perspectives on the development of an structured education programme for PCOS; Other: Pre-pilot questionnaire; Other: Piloting the structured education programme for PCOS; Other: Post-pilot questionnaire; Other: cognitive outcomes outcome evaluation form |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
- Do you think you have enough knowledge about PCOS? Please circle the answer in the scale below
1 2 3 4 5
Measured: 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
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2021
- Study start1 Sep 2021
- Primary completion31 Oct 2021
- Study completion31 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Polycystic Ovary SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Hull
- Sponsor type
- University, hospital or other
- Collaborators
- British Dietetic Association
- Responsible party
- Principal investigator, Thozhukat Sathyapalan, University of Hull
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04777461
- Sponsor's protocol ID
- LW-PCOS V1.2020
- Acronym
- LW-PCOS
- Status last verified
- Nov 2021
- First submitted
- 26 Sep 2020
- Last updated
- 23 Nov 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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
Study at a glance
From the registry record, last updated by the sponsor on 23 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Living With Polycystic Ovary Syndrome- Structured Education Programme
- ClinicalTrials.gov ID
- NCT04777461
- Acronym / sponsor ID
- LW-PCOS / LW-PCOS V1.2020
- Conditions
- Polycystic Ovary Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of HullUniversity, hospital or other
- Collaborators
- British Dietetic Association
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 31 Oct 2021 (actual)
- Study completion
- 31 Oct 2021 (actual)
- First posted
- 2 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Other: Survey on patient's perspectives on the development of an structured education programme for PCOS, Other: Pre-pilot questionnaire, Other: Piloting the structured education programme for PCOS, Other: Post-pilot questionnaire, Other: cognitive outcomes outcome evaluation formPilot the structured education in women with PCOS |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Survey on patient's perspectives on the development of an structured education programme for PCOSThe outcome of this survey will help with developing curriculum for the structured education programme. | Other | Group 1 |
| Pre-pilot questionnaireThe questionnaire is aimed to capture the knowledge and expectations of the participants from taking part in the educational sessions. | Other | Group 1 |
| Piloting the structured education programme for PCOSPiloting the education program through 2 educational group sessions | Other | Group 1 |
| Post-pilot questionnaireThe questionnaire aimed to capture participant's satisfactions and knowledge gained by taking part in the pilot study | Other | Group 1 |
| cognitive outcomes outcome evaluation formThis aimed to capture skills developed, knowledge gained and changes in participants behaviour and perceptions by taking part in the pilot study. | Other | Group 1 |
Primary outcome
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 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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Nov 2021.
- Individual participant dataSharing planned: No. 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Survey on patient's perspectives on the development of an structured education programme for PCOS, Pre-pilot questionnaire and Piloting the structured education programme for PCOS in people with Polycystic Ovary Syndrome, run by University of Hull at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
develop an evidence-based structured education programme for women with PCOS (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Nov 2021.