Pilot Study to Investigate the Influence of an App on the Quality of Life and Symptoms of Patients With Polycystic Ovary Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 220
- 试验地点
- 1
- 主要终点
- Polycystic Ovary Syndrome Questionnaire (PCOSQ-G)
研究概览
简要总结
This study investigates the influence of a PCOS app on the quality of life and symptoms of individuals with polycystic ovary syndrome (PCOS). The intervention group can use the app over the study period of twelve weeks in addition to care-as-usual (CAU). In the control group, this is compared with no use of the PCOS-App for a twelve-week period, that is, care-as-usual only/ continuation of the current treatment (waitlist design). The aim is to evaluate the effectiveness of the app and to gain insights for the design of future studies. The study is expected to last seven months and include 220 participants.
详细描述
The study aims to investigate the effect of a PCOS app on quality of life and symptoms of individuals with polycystic ovary syndrome (PCOS). PCOS is a widespread and distressing health problem that can significantly affect quality of life and well-being of affected individuals. Research into digital health applications has shown the potential to provide innovative solutions to improve care and self-management of chronic conditions.
The present study is designed as a single-blind, two-arm, randomised controlled trial in which participants will either receive the PCOS app over a 12-week period in addition to care-as-usual (intervention group) or only care-as-usual as typically available (control group). The study will be conducted online. The aim is to evaluate the effectiveness of the app by analysing various questionnaires as endpoints. The primary endpoint is the Polycystic Ovary Syndrome Questionnaire (PCOSQ-G). The questionnaires/endpoints will be completed at T0 (baseline) and after 12 weeks. Statistical analyses will be conducted using R and SPSS. Exploratory evaluations of change scores in the relevant questionnaires will be performed.
Overall, this study aims to provide important insights into whether and to what extent a PCOS app can have a positive impact on the quality of life and symptoms of women with PCOS.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Triple (Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Legal capacity
- •Resident in Germany
- •Female gender
- •Age ≥18 years up to 65 years
- •Diagnosed and medically confirmed Polycystic Ovary Syndrome (E28.2)
- •Ownership of a smartphone with a compatible iOS or Android version and the ability to operate it
- •Internet access and an email address for registration, app usage, and completing questionnaires
- •Willingness to complete questionnaires online
- •Motivation to use the app regularly
- •Sufficient knowledge of the German language
排除标准
- •Changes in hormone therapy within eight weeks prior to the start of the study and/or planned within the next 12 weeks
- •Changes in treatment with metformin within eight weeks prior to the start of the study and/or planned within the next 12 weeks
- •Current treatment with medications for obesity (e.g., liraglutide, orlistat)
- •Changes in treatment with anti-androgens (e.g., spironolactone, cyproterone acetate, flutamide) within eight weeks prior to the start of the study and/or planned within the next 12 weeks
- •Pregnancy or breastfeeding
- •Current hormonal fertility treatment
- •Changes in treatment with psychotropic medications within eight weeks prior to the start of the study and/or planned within the next 12 weeks
- •Current psychotherapeutic treatment
- •Previous or current access to the Endo-App or other digital health applications (DiGAs)
- •Current participation in other clinical studies
- •Current nutritional counseling according to §20 SGB V or nutritional therapy according to §43 SGB V, or participation in weight reduction programs
研究组 & 干预措施
Control Group
Control group has access to care-as-usual only.
Intervention Group
The intervention group has access to the PCOS app and its functions in in addition to care-as-usual
干预措施: PCOS-App (Device)
结局指标
主要结局
Polycystic Ovary Syndrome Questionnaire (PCOSQ-G)
时间窗: From enrollment to the end of treatment at 12 weeks
次要结局
- Depression Anxiety Stress Scale 21 Items (DASS-21)(From enrollment to the end of treatment at 12 weeks)
- Body Appreciation Scale - 2 (BAS-2)(From enrollment to the end of treatment at 12 weeks)
- Patient Activation Measure 13 (PAM-13)(From enrollment to the end of treatment at 12 weeks)