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Online Self-learning for Women With Gestational Diabetes Mellitus (iSelf-Learn)

Primary Purpose

Gestational Diabetes

Status
Completed
Phase
Not Applicable
Locations
Singapore
Study Type
Interventional
Intervention
Telesupport - Telehealth
Sponsored by
KK Women's and Children's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gestational Diabetes focused on measuring Gestational Diabetes Mellitus, GDM, Medical Nutrition Therapy, Telehealth

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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)

Sites / Locations

  • KK Women's and Children's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control arm

Intervention arm

Arm Description

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.

Outcomes

Primary Outcome Measures

Completion rate
The completion of online dietary education
Attendance rate
The attendance of each dietitian visit

Secondary Outcome Measures

Knowledge assessment using a quiz
The change in knowledge assessment, assessed as difference in score of quiz before and after dietary education
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
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)
Glycaemic control
Blood glucose profile ranges pre- and post-meals
Maternal outcome
Total gestational weight gain in kilograms
Foetal outcome 1
Birth weight in grams
Foetal outcome 2
Neonatal hypoglycaemia as defined by blood glucose level below 3.0mmol/L

Full Information

First Posted
November 26, 2021
Last Updated
December 27, 2021
Sponsor
KK Women's and Children's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05188625
Brief Title
Online Self-learning for Women With Gestational Diabetes Mellitus
Acronym
iSelf-Learn
Official Title
Comparison of Conventional Face-to-face Dietary Education With Online Self-learning for Women With GDM - a Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
January 13, 2021 (Actual)
Primary Completion Date
June 23, 2021 (Actual)
Study Completion Date
August 13, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
KK Women's and Children's Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gestational Diabetes
Keywords
Gestational Diabetes Mellitus, GDM, Medical Nutrition Therapy, Telehealth

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control arm
Arm Type
No Intervention
Arm Description
This group will receive the standard care of face-to-face dietitian counselling sessions.
Arm Title
Intervention arm
Arm Type
Experimental
Arm Description
This group will receive online self-paced dietary education, and followed up by telehealth video consultation with dietitian for dietary counselling.
Intervention Type
Other
Intervention Name(s)
Telesupport - Telehealth
Intervention Description
Online self-paced dietary education videos; Dietary counselling via video consultation; Blood glucose monitoring via a specially-designed health app
Primary Outcome Measure Information:
Title
Completion rate
Description
The completion of online dietary education
Time Frame
Completion of online dietary education at Day 3
Title
Attendance rate
Description
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.
Secondary Outcome Measure Information:
Title
Knowledge assessment using a quiz
Description
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)
Title
Patient experience
Description
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
Title
Telehealth usability
Description
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
Title
Glycaemic control
Description
Blood glucose profile ranges pre- and post-meals
Time Frame
Every 2-4 weeks throughout the study, up to 12 weeks
Title
Maternal outcome
Description
Total gestational weight gain in kilograms
Time Frame
At end of study, up to 12 weeks
Title
Foetal outcome 1
Description
Birth weight in grams
Time Frame
At end of study, up to 12 weeks
Title
Foetal outcome 2
Description
Neonatal hypoglycaemia as defined by blood glucose level below 3.0mmol/L
Time Frame
At end of study, up to 12 weeks

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wee Meng Han, PhD
Organizational Affiliation
KK Women's and Children's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
KK Women's and Children's Hospital
City
Singapore
ZIP/Postal Code
229899
Country
Singapore

12. IPD Sharing Statement

Plan to Share IPD
No

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Online Self-learning for Women With Gestational Diabetes Mellitus

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