Online Self-learning for Women With Gestational Diabetes Mellitus

Gestational Diabetes Clinical Trial

— iSelf-Learn  

Official title:

Comparison of Conventional Face-to-face Dietary Education With Online Self-learning for Women With GDM - a Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05188625
• Other study ID #: 2019-2927 CIRB
• Status: Completed
• Phase: N/A
• Start date: January 13, 2021
• Est. completion date: August 13, 2021

Study information

• Verified date: December 2021
• Source: KK Women's and Children's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study aims to determine the feasibility and acceptability of using telehealth in the care of women with Gestational Diabetes Mellitus (GDM) by providing a self-learning alternative via an online portal compared to a one-to-one dietary education, conducted face-to-face in a dietitian clinic. The investigators hypothesize that the use of technology would enable a higher percentage of women to receive the necessary dietary education, thereby empowering behaviour change and resulting in positive maternal blood glucose control and pregnancy outcomes.

The primary hypothesis is that the new care model will reach out to a higher proportion compared to the conventional model (Service utilization), as determined by the completion of the online self-learning, comparing it to attendance rates with the conventional model.

The secondary hypothesis is that the new care model will be able to provide care that would be comparable to those in the traditional outpatient clinic setting, as measured by the blood glucose and pregnancy outcomes, as well as patient satisfaction and patient experience.

Description:

GDM is a significant health issue amongst women. Medical nutrition therapy is established as the first-line treatment for GDM. The goal is to support maternal and foetal nutrition in order to ensure adequate pregnancy weight gain and foetal growth, whilst at the same time, maintain optimal glycemic control. Health education continues to play an important role in managing GDM. However, not all women with GDM receive dietary education as recommended, due to a multitude of personal and circumstantial factors. Failure to attend diabetes-related appointment has been associated with poorer glycaemic control by 36 weeks' gestation, which leads to a higher risk of macrosomia and an unfavourable set-up for neonatal outcomes. Therefore, this pilot study aims to determine the feasibility and acceptability of using telehealth in the dietary management of GDM compared with the current standard care, i.e. traditional face-to-face dietary education.

A total of 50 women diagnosed with GDM will be randomized to the standard care or telehealth, where self-education will be done via an online portal and subsequently followed up by teleconsult. Both groups will be followed up by the dietitian every 2-4 weeks until delivery either face-to-face (control group) or telehealth video consultation (intervention group). Each participant will be provided with a set of glucometer and the required consumables for home blood glucose monitoring.

Outcomes to determine the success of the study will be the percentage of women who completed dietary education. Other outcomes will include birth outcome data - birth weight to assess for large-for-gestational age baby, type of delivery, incidence of neonatal hypoglycaemia and total maternal weight gain, to establish the efficacy of this model of care. The effectiveness of self-learning will be assessed using pre- and post-test assessment quizzes. The experience and satisfaction of this model will also be surveyed.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: August 13, 2021
• Est. primary completion date: June 23, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 21 Years and older

Eligibility

Inclusion Criteria:

• Singleton pregnancy

• Women diagnosed with GDM before 32 weeks

• Women willing and have provided written consent to participate

• Women with ability to use telemedicine services after briefed

• Women who have sufficient communication abilities (written, listening and spoken) to be fully involved

• Women who have access to phone and internet

• Women willing to download and send blood glucose readings to research team.

Exclusion Criteria:

• Multiple pregnancies

• Gestational age 35 weeks and above

• Women with existing Type 1 or Type 2 Diabetes

• Women receiving oral steroid therapy

• Women with evidence of fetal complications (such as fetal anomalies, intrauterine growth retardation) and known history of pregnancy complications (e.g. pre-eclampsia)

Related Conditions & MeSH terms

• Diabetes, Gestational
• Gestational Diabetes

Intervention

Other:
• Telesupport - Telehealth
Online self-paced dietary education videos; Dietary counselling via video consultation; Blood glucose monitoring via a specially-designed health app

Locations

Country	Name	City	State
Singapore	KK Women's and Children's Hospital	Singapore

Sponsors (1)

Lead Sponsor	Collaborator
KK Women's and Children's Hospital

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Completion rate	The completion of online dietary education	Completion of online dietary education at Day 3
Primary	Attendance rate	The attendance of each dietitian visit	Mean attendance of each dietitian visit throughout study completion for an average of up to 12 weeks.
Secondary	Knowledge assessment using a quiz	The change in knowledge assessment, assessed as difference in score of quiz before and after dietary education	At baseline Day 0 and between Day 3 (for intervention group) and Day 14 (for control group)
Secondary	Patient experience	The Hospital Consumer Assessment of Healthcare Providers and Systems Survey (HCAHPS) is used to collect information on how satisfied patients are with their healthcare providers; includes questions on level of care & concern, treated with kindness & compassion, courtesy & respect, being listened to	At end of study up to 12 weeks
Secondary	Telehealth usability	Usefulness, ease of use, reliability, interface and interaction quality of the telesupport-telehealth service using a specific questionnaire (International Journal of Telerehabilitation 2016; 8(1): 3-10)	At end of study up to 12 weeks
Secondary	Glycaemic control	Blood glucose profile ranges pre- and post-meals	Every 2-4 weeks throughout the study, up to 12 weeks
Secondary	Maternal outcome	Total gestational weight gain in kilograms	At end of study, up to 12 weeks
Secondary	Foetal outcome 1	Birth weight in grams	At end of study, up to 12 weeks
Secondary	Foetal outcome 2	Neonatal hypoglycaemia as defined by blood glucose level below 3.0mmol/L	At end of study, up to 12 weeks