Self management and psychosocial wellbeing in adults with polycystic ovary syndrome (PCOS) Nutritional, Metabolic, Endocrine
Conditions
Interventions
The Hope PCOS intervention will be hosted on a digital platform owned by Hope for The Community (H4C) Community Interest Company, a research social enterprise spinout company from Coventry University
Sponsors
Coventry University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age 18+ years 2. UK based 3. Self report that diagnosis of PCOS has been confirmed by participant's general practitioner and/or a hospital specialist. 4. Capacity to give informed consent 5. Ability to communicate in English, to participate in the intervention and complete outcome measures 6. Internet connection and internet-enabled device.
Exclusion criteria
Exclusion criteria: 1. Age less than 18 years 2. Non-UK based 3. No diagnosis of PCOS, or diagnosis has not been confirmed by participant's general practitioner and/or a hospital specialist.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Recruitment; Retention; Follow-up; and Completion Rates, and adverse and serious adverse events 1. Recruitment rates will be calculated from the following: (1) providing consent and (2) completing baseline questionnaires. Direct email from participants indicating refusal or declining to participate in the study indicating a refusal. These participants will still be offered access to the Hope PCOS intervention but will not be contacted further. 2. Retention rates will be calculated as the percentage of participants attending all 6 programme sessions. 3. Follow-up rates will be calculated as the percentage of participants who complete all web-based study questionnaires. Participants lost to follow-up will be identified as those who do not complete the T1 or T2 questionnaires. 4. Completion rates will be calculated as the percentage of participants who attended at least half of the intervention (3 sessions) and completed the study questionnaires. 5. Participants will be requested to report any adverse events such as psychological distress to the study researchers. Adherence and Engagement Measures The intervention platform collects user engagement data, such as the number of pages viewed in each session and the number of goals set that assists the moderators with participant engagement and experience. We measure the mean percentage of pages viewed per session, and the number of posts or comments a participant made for key activities (e.g. setting goals, comments posted). | — |
Secondary
| Measure | Time frame |
|---|---|
| The following outcomes will be measured at baseline, after the intervention (6 weeks after baseline), and at follow up (3 months after baseline): 1. Health-related quality of life questionnaire for polycystic ovary syndrome (PCOSQ-50) assesses of quality of life of 50 items in six domains; psychosocial and emotional; fertility; sexual function; obesity and menstrual disorders; hirsutism, and coping. 2. The Warwick Edinburgh Mental Well-being Scale (WEMWBS) assesses mental well-being. The scale includes measures of positive affect, satisfying interpersonal relationships and positive functioning. 3. The 9-item Patient Health Questionnaire (PHQ-9) assesses the frequency of experience of the symptoms of depression. 4. The 7-item Generalized Anxiety Disorder scale (GAD-7) measures symptoms of generalized anxiety disorder. 5. The 6-item Self-Efficacy for Managing Chronic Disease scale (SEMCD6) provides a robust measure of participants’ confidence to self-manage their symptoms of LC. The questions relate to participants’ confidence that they can keep issues relating to their condition from interfering with daily life. 6. System Usability Scale (SUS). The System Usability Scale (SUS) is reliable tool for measuring website an app usability. Qualitative outcomes A subset of participants will be randomly selected from the Intervention Group and Control Group to take part in post-course interviews with the research team to explore issues relating to acceptability of the Hope PCOS course. We will aim to interview participants who completed all or most of the intervention (N=10), as well as those who completed fewer than half of the sessions (N=10), to gain a balanced evaluation to inform future co-design of the intervention. | — |
Countries
England, United Kingdom
Contacts
Public ContactCarol Percy
Outcome results
None listed