Usability Study of the Sensors and eMOM GDM Application

Gestational Diabetes Clinical Trial

— eMOMGDM  

Official title:

Usability Study of the Sensors and the eMOM GDM Application eHealth in Treatment of Gestational Diabetes - eMOM GDM -Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03941652
• Other study ID #: HUS/2165/2018
• Status: Active, not recruiting
• Start date: May 27, 2019
• Est. completion date: December 30, 2024

Study information

• Verified date: February 2024
• Source: Helsinki University Central Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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 10-15 nurses/midwifes is asked with background questionnaire on profession. Usability of the prototype of the professional eMOM GDM application will be evaluated using a cognitive walkthrough. This is implemented by asking participants to use the prototype of the application and asking questions about the use. In these 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 49
• Est. completion date: December 30, 2024
• Est. primary completion date: October 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Diabetes, Gestational
• Gestational Diabetes

Locations

Country	Name	City	State
Finland	HUS	Helsinki

Sponsors (7)

Lead Sponsor	Collaborator
Helsinki University Central Hospital	Aalto University, Business Finland, CleverHealth Network, Elisa Oyj, Fujitsu Finland Oy, University of Helsinki

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Continuous glucose levels dataset	Dataset from Medtronic Guardian Connect glucose meter	1 week
Other	Physical activity dataset	Dataset from Vivosmart 3, ExSed, Firstbeat Bodyguard 2, and physical activity logbook	1 week
Other	Sleep dataset	Dataset from Vivosmart 3, Firstbeat Bodyguard 2, and sleep logbook	1 week
Other	Recovery dataset	Dataset from Vivosmart 3 and Firstbeat Bodyguard 2	1 week
Other	Stress dataset	Dataset from Vivosmart 3 and Firstbeat Bodyguard 2	1 week
Other	Heart beat dataset	Dataset from Vivosmart 3 and Firstbeat Bodyguard 2	1 week
Other	Nutrition dataset	Dataset from nutrition logbook	1 week
Primary	Basic version of the eMOM GDM application has developed	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.	1 week
Secondary	Acceptability of sensors assessed by UTAUT questionnaire	The acceptability of the sensors (Medtronic Guardian Connect, Garmin Vivosmart 3, Firsbeat Bodyguard 2, UKK Exsed, Ascensia Contour Next One) will be assessed by UTAUT (Unified Theory of Acceptance and Use of Technology)-questionnaire. UTAUT-questionnaire will be common for each sensor, so UTAUT will not be conducted for each sensor separately. The answers applied quantitative way so investigators are able analyzed change of acceptability of sensors caused by the intervention. Results applied to development of the eMOM GDM application.	1 week
Secondary	Acceptability of sensors and eMOM GDM prototype application assessed by UTAUT questionnaire	The acceptability of the sensors (Garmin Vivosmart 3, Medtronic Guardian Connect, Ascensia Contour Next One, Speechgrinder Snackchat) and the eMOM GDM prototype application will be assessed by UTAUT (Unified Theory of Acceptance and Use of Technology) questionnaire. UTAUT questionnaire will be common for each sensor and the application, so UTAUT will not be conducted for each sensor separately. The answers applied quantitative way so investigators are able analyzed change of acceptability of sensors and application caused by the intervention. Results applied to development of the eMOM GDM application.	1 week
Secondary	Usability of sensors and their current applications	Semi-structured interview of usability of chosen sensors and their current applications (Medtronic Guardian Connect, Garmin Vivosmart 3, Firsbeat Bodyguard 2, UKK Exsed, Ascensia Contour Next One).; General questions related to the usability issues of sensors and their current applications.; Sensors specific questions relate to usage of specific sensor and features of its application.; The answers of participants give for investigators the guideline for development of eMOM GDM application. The answers itself won't be scaled, there isn't wrong or correct answers. Answers which repeat the most commonly in the interviews are the most common issues and they will have a higher priority in the guideline than answers which arises only in one interview.	1 week
Secondary	First impressions of a partially functional prototype of the eMOM GDM	First impressions of eMOM GDM application questions relate to usability and acceptability of the eMOM GDM application which is under the development.; The answers of participants give for investigators the guideline for development of eMOM GDM application. The answers itself won't be scaled, there isn't wrong or correct answers. Answers which repeat the most commonly in the interviews are the most common issues and they will have a higher priority in the guideline than answers which arises only in one interview.	1 week
Secondary	Usability of eMOM GDM prototype application	Usability of the eMOM GDM prototype application will be assessed with a semi-structured interview. The interview has general questions about the usability issues of sensors (Garmin Vivosmart 3, Medtronic Guardian Connect, Ascensia Contour Next One, Speechgrinder Snackchat) and the eMOM GDM prototype application, and tasks which the participants try to solve using the eMOM GDM prototype application. The answers used as the guideline for development of eMOM GDM application.	1 week
Secondary	Technical functionality of eMOM GDM application	Technical functionality of eMOM GDM application will be assessed by a web-based survey. The web-survey asks feedback from the eMOM GDM prototype application, and Garmin Vivosmart 3 bracelet, and there are 20 questions from Software Usability Measurement Inventory (SUMI) which the participant answers agree, disagree or not sure. This survey used as a guideline for development of eMOM GDM application. The answers tell how much major problems investigators still have in the eMOM GDM prototype application.	1 week
Secondary	User requirements for professional eMOM GDM application	User requirements will be collected through a semi-structured interviews. The interviews will be transcribed and a a framework analysis will be conducted to find the most important features. The answers used as the guideline for development of professional eMOM GDM application.	2 hours
Secondary	Usability of professional eMOM GDM application	The usability will be evaluated with cognitive walkthrough technique, which provides infomation about how easily users can find correct elements and paths to conduct tasks with the user interface. Based on this we obtain information about the user interface, for example what labels to use and how to position user interface elements.	1 hours