Usability Study of the Sensors and the eMOM GDM Application eHealth in Treatment of Gestational Diabetes - eMOM GDM -Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- Basic version of the eMOM GDM application has developed
研究概览
简要总结
The principal aim of the eMOM GDM-project is to evaluate the effect of the eMOM GDM -application and the integrated service concept model on maternal and neonatal outcomes.
In the first phase of the project the investigators evaluate the usability, functionality and acceptability of developed eMOM GDM application and used sensors (continuous glucose meter, accelerometer, speech-enabled food record, optical pulse, beat-to-beat heart rate). Two different user interfaces (one for the women with GDM and one for the health care professionals) of the eMOM GDM application will we be developed and evaluated.
详细描述
The first phase of the eMOM GDM -project consists of two parts.
Phase 1.1. the usability of the sensors will be evaluated by asking participants with GDM diagnosis (n = up to 10) to use the sensors (Garmin Vivosmart 3, Medtronic Guardian Connect, Firstbeat Bodyguard 2, and Exced) and by collecting participants' blood glucose values from glucose meter (Contour Next ONE) for one week. Participants fill out a logbook for physical activity and sleeping for seven days, and a logbook for diet for three days during the study period. For ensuring the quality of food record a researcher will phone interview the participant based on her diet recordings.
Before starting using the sensors, the participants will fill Background questionnaire and Technology acceptance questionnaire (UTAUT). After the usage period, the participants will fill the same Technology acceptance questionnaire (UTAUT) and take part in semi-structured interview. The interview has to parts. In the first part, participants will be interviewed about the acceptability of sensors. In the second part, researcher will show a non-functional prototype of eMoM GDM application to the participant and will ask predetermined questions. Interview will be recorded and data obtained from the interviews will be transcribed for analysis.
Phase 1.2. will define major usability issues with different versions of functional prototypes of eMOM GDM application developed in the project before moving to phase 2 of the study. General pregnant women (n = up to 30 in total) and GDM women (n=up to 10) will use the available version of the application for one week, and afterward the participants with GDM will take part in semi-structured interview. Interview will be recorded and data will be transcribed for analysis. General pregnant women will fill out a web form of usability of the application after application week. Based on the responses of the form, the participants may be contacted for further inquiries about the usability issues they have reported. For ensuring the quality of food record a researcher will phone interview all participants based on her diet recordings.
In Phase 1.3 user requirements for the professional eMOM GDM application will be collected. The first aim of this evaluation is to define what features the application should have. These user requirements are collected with a semi-structured interview. Before the interview, background of the 15-20 nurses/midwifes is asked with background questionnaire on profession. In the interviews, the questions are predetermined, but some flexibility is allowed. Interviews will be recorded and data obtained from the interviews will be transcribed for analysis.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 68 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •General pregnant women at gestational week >=24
- •GDM women without a prior GDM at gestational week >=24
- •GDM women with or without a prior GDM at gestational week >=24
排除标准
- •Type 1 Diabetes Mellitus
- •Type 2 Diabetes Mellitus
- •Use of medication that influences glucose metabolism in the beginning of the study (e.g. oral corticosteroids, metformin,insulin)
- •Multiple Pregnancy
- •Current substance abuse
- •Severe psychiatric disorder
- •Significant difficulty in cooperating (e.g. inadequate Finnish language skills)
- •Significant physical disabilities
- •For health care professionals
- •Inclusion Criteria:
- •Consult and treat women with GDM regularly
- •Exclusion Criteria:
- •Inadequate Finnish language skills
结局指标
主要结局
Basic version of the eMOM GDM application has developed
时间窗: 1 week
Goal of the eMOM GDM -project is develop an application for gestational diabetes. The basic version of eMOM GDM application is ready to use in Phase 2 when in all sectors of Software Usability Measurement Inventory (SUMI) scale have mean of 50 or higher during the same development period (sprint). SUMI is a rigorously tested and proven method of measuring software quality from the end user's point of view. Sectors which SUMI measures are efficiency, affect, helpfulness, control, learnability, and global usability of software.
次要结局
- Acceptability of sensors assessed by UTAUT questionnaire(1 week)
- Acceptability of sensors and eMOM GDM prototype application assessed by UTAUT questionnaire(1 week)
- Usability of sensors and their current applications(1 week)
- First impressions of a partially functional prototype of the eMOM GDM(1 week)
- Usability of eMOM GDM prototype application(1 week)
- Technical functionality of eMOM GDM application(1 week)
- User requirements for professional eMOM GDM application(2 hours)
研究者
Saila Koivusalo
Adjunct prof, Obstetrician, Development Manager
Helsinki University Central Hospital