An interventional study of Telesupport - Telehealth in Gestational Diabetes, sponsored by KK Women's and Children's Hospital. Completed at 1 site in Singapore. Open to female participants aged 21 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-01-12.
Sponsored by KK Women's and Children's Hospital · Not applicable, Interventional, and Treatment
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.
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.
842 studies on the registry are indexed under Diabetes, Gestational; 198 are open to participants now.
This study's enrollment of 50 is below the median of 110 across 550 interventional studies indexed under Diabetes, Gestational.
Browse Diabetes, Gestational studies →KK Women's and Children's Hospital is the lead sponsor of 136 studies on the registry; 33 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
This group will receive the standard care of face-to-face dietitian counselling sessions.
This group will receive online self-paced dietary education, and followed up by telehealth video consultation with dietitian for dietary counselling.
Other: Telesupport - Telehealth
Online self-paced dietary education videos; Dietary counselling via video consultation; Blood glucose monitoring via a specially-designed health app
Completion rate
The completion of online dietary education
Time frame: Completion of online dietary education at Day 3
Attendance rate
The attendance of each dietitian visit
Time frame: Mean attendance of each dietitian visit throughout study completion for an average of up to 12 weeks.
Knowledge assessment using a quiz
The change in knowledge assessment, assessed as difference in score of quiz before and after dietary education
Time frame: At baseline Day 0 and between Day 3 (for intervention group) and Day 14 (for control group)
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
Time frame: At end of study up to 12 weeks
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)
Time frame: At end of study up to 12 weeks
Glycaemic control
Blood glucose profile ranges pre- and post-meals
Time frame: Every 2-4 weeks throughout the study, up to 12 weeks
Maternal outcome
Total gestational weight gain in kilograms
Time frame: At end of study, up to 12 weeks
Foetal outcome 1
Birth weight in grams
Time frame: At end of study, up to 12 weeks
Foetal outcome 2
Neonatal hypoglycaemia as defined by blood glucose level below 3.0mmol/L
Time frame: At end of study, up to 12 weeks
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Plan to share: No
This study is completed, as verified in Dec 2021. You cannot join it, but the record below documents what was studied.
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KK Women's and Children's Hospital