Usability Study of the Sensors and eMOM GDM Application (eMOMGDM)

February 26, 2024 updated by: Saila Koivusalo, Helsinki University Central Hospital

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

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.

Study Overview

Status

Active, not recruiting

Detailed 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.

Study Type

Observational

Enrollment (Estimated)

49

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Helsinki, Finland, 00029
        • HUS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

  • General population of pregnant women
  • Pregnant women without gestational diabetes in previous pregnancy
  • Pregnant women with or without gestational diabetes in previous pregnancies
  • Health care professionals (nurses/midwives)

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Women with gestational diabetes without a prior GDM
The investigators will evaluate the usability of the sensors and define what features the application should have and how the data should be presented to the users. Participants (n=up to 10) use the sensors for one week and fill out logbooks for physical activity, sleep and diet. Participants fill questionnaires before and after the usage period, and take part in semi-structured interview.
Women with gestational diabetes with or without a prior GDM
The investigators 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. GDM women (n=up to 12) will use the available version of the application for one week, and afterward the participants with GDM will take part in semi-structured interview.
General pregnant women
The investigators 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) will use the available version of the application for one week, and afterward the general pregnant women will fill out a web form of usability of the application after the application week.
Health care professionals
Nurses/midwifes (n=up to 15) will be interviewed for collecting user requirements for the professional eMOM GDM application in semi-structured interviews. Also the usability of the user interface prototypes will be evaluated using cognitive walkthrough.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Basic version of the eMOM GDM application has developed
Time Frame: 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.
1 week

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Acceptability of sensors assessed by UTAUT questionnaire
Time Frame: 1 week
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
Acceptability of sensors and eMOM GDM prototype application assessed by UTAUT questionnaire
Time Frame: 1 week
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
Usability of sensors and their current applications
Time Frame: 1 week

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
First impressions of a partially functional prototype of the eMOM GDM
Time Frame: 1 week

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
Usability of eMOM GDM prototype application
Time Frame: 1 week
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
Technical functionality of eMOM GDM application
Time Frame: 1 week
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
User requirements for professional eMOM GDM application
Time Frame: 2 hours
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
Usability of professional eMOM GDM application
Time Frame: 1 hours
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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Continuous glucose levels dataset
Time Frame: 1 week
Dataset from Medtronic Guardian Connect glucose meter
1 week
Physical activity dataset
Time Frame: 1 week
Dataset from Vivosmart 3, ExSed, Firstbeat Bodyguard 2, and physical activity logbook
1 week
Sleep dataset
Time Frame: 1 week
Dataset from Vivosmart 3, Firstbeat Bodyguard 2, and sleep logbook
1 week
Recovery dataset
Time Frame: 1 week
Dataset from Vivosmart 3 and Firstbeat Bodyguard 2
1 week
Stress dataset
Time Frame: 1 week
Dataset from Vivosmart 3 and Firstbeat Bodyguard 2
1 week
Heart beat dataset
Time Frame: 1 week
Dataset from Vivosmart 3 and Firstbeat Bodyguard 2
1 week
Nutrition dataset
Time Frame: 1 week
Dataset from nutrition logbook
1 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: Seppo T Heinonen, prof, Helsinki University Hospital, Women's Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 27, 2019

Primary Completion (Actual)

October 30, 2022

Study Completion (Estimated)

December 30, 2024

Study Registration Dates

First Submitted

April 25, 2019

First Submitted That Met QC Criteria

May 7, 2019

First Posted (Actual)

May 8, 2019

Study Record Updates

Last Update Posted (Actual)

February 28, 2024

Last Update Submitted That Met QC Criteria

February 26, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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