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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06436443
Other study ID # MAKU GO 2020/193
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date August 15, 2021
Est. completion date April 24, 2022

Study information

Verified date May 2024
Source Mehmet Akif Ersoy University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The use of technology-based education and counseling services in the self-management of gestational diabetes contributes to better control of blood sugar levels, motivation and increased self-efficacy in women. Therefore, this study was planned as interventional research to determine the effect of SMS counseling given to individuals with gestational diabetes on self-efficacy and knowledge levels. This study was conducted descriptively with 95 patients with gestational diabetes who were treated in the endocrine service of a university hospital between August 15, 2021 and April 24, 2022. Personal information form created by the researchers, The Self-Efficacy Scale in Gestational Diabetes, and Diabetes Knowledge Scale were used to collect data.


Recruitment information / eligibility

Status Completed
Enrollment 95
Est. completion date April 24, 2022
Est. primary completion date March 15, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: - diagnosed with gestational diabetes, - being in the 30th week of pregnancy, - having a smartphone, - volunteering to participate in the study, - having no communication problems, - having no psychiatric problems Exclusion Criteria: - being non-literate, - having communication problems (hearing or sight), - not volunteering to participate in the research

Study Design


Intervention

Other:
SMS Counseling
In addition to routine physician check-ups, an SMS group was created for the individuals in the intervention group, and basic information messages for diabetes control were sent to this group at regular intervals. In addition, individuals asked questions via this group. At the end of the eight-week follow-up, the data collection forms were filled out again and the study was terminated.

Locations

Country Name City State
Turkey Burdur Mehmet Akif Ersoy University Burdur

Sponsors (1)

Lead Sponsor Collaborator
Mehmet Akif Ersoy University

Country where clinical trial is conducted

Turkey, 

References & Publications (3)

Guo Y, Zhou L, Sun B, Wang C, Zhang J. Application of online-offline integrated medical care management in patients with gestational diabetes. Ginekol Pol. 2021;92(10):720-725. doi: 10.5603/GP.a2021.0054. Epub 2021 Apr 29. — View Citation

Hemmati Maslakpak M, Razmara S, Niazkhani Z. Effects of Face-to-Face and Telephone-Based Family-Oriented Education on Self-Care Behavior and Patient Outcomes in Type 2 Diabetes: A Randomized Controlled Trial. J Diabetes Res. 2017;2017:8404328. doi: 10.115 — View Citation

Miremberg H, Ben-Ari T, Betzer T, Raphaeli H, Gasnier R, Barda G, Bar J, Weiner E. The impact of a daily smartphone-based feedback system among women with gestational diabetes on compliance, glycemic control, satisfaction, and pregnancy outcome: a randomi — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Diabetes Knowledge Scale This scale was first developed by Dunn et al.13 to measure diabetes knowledge. Afterward, it was developed by Carolan et al. to examine three effect domains: pregnant women's GDM knowledge, nutritional values, and GDM self-management principles. The scale consists of 18 questions. Cronbach's alpha value of the total scale was determined as 0.654. 5 Minute
Primary The Self-Efficacy Scale in Gestational Diabetes This is a five-point Likert-type scale consisting of 23 items developed by Polat and Avdal in 2019 to evaluate the self-efficacy levels of individuals with gestational diabetes. It consists of four sub-dimensions: "diet-weight management"; "complication measures"; "compliance with nutrition education"; "medical therapy practices". As the total score on the scale increases, the level of self-efficacy increases, as well. Cronbach's alpha value of the total scale was determined as 0.654. 5 minute
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