NCT06148688

Brief Summary

The aim of this study is to evaluate the effect of digital storytelling intervention on diabetes self-management in women with gestational diabetes. It is a quasi-experimental study with a pretest-posttest control group. The main hypotheses of the study are: Digital storytelling has an impact on women with gestational diabetes' perception of diabetes self-management. Digital storytelling has an impact on the diabetes self-efficacy levels of women with gestational diabetes.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 27, 2023

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2023

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

November 20, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 28, 2023

Completed
3 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

November 29, 2023

Status Verified

November 1, 2023

Enrollment Period

7 months

First QC Date

November 20, 2023

Last Update Submit

November 28, 2023

Conditions

Outcome Measures

Primary Outcomes (3)

  • Perceived Diabetes Self-Management Scale

    The Turkish adaptation of the scale, which was adapted and validated by Wallston et al. (2007), was made by Bayındır Çevik (2010).The scale consists of 7 items and is of 5-point likert type.A high total score indicates that the individual's awareness of diabetes management is very good.

    before and end of the interventions (fourth weeks)

  • Diabetes Self-Efficacy Scale

    This scale was developed by Lorig et al. in 2009 to determine the self-efficacy of individuals with diabetes and was adapted into Turkish by Mankan et al. in 2017.The Likert type scale consists of 8 items. The items of the scale have a numbering system between 1 and 10 (1-I do not feel safe at all, 10-I am completely confident).The scale has no cut-off point. As individuals' total scale scores increase, their self-efficacy also increases.

    before and end of the interventions (fourth weeks)

  • International Physical Activity Questionnaire

    The International Physical Activity Questionnaire was designed to detect the physical activity and sedentary lifestyles of adults. Craig et al. (2003) and the Turkish validity and reliability of the questionnaire developed by Öztürk (2005). The questionnaire is recommended for adults aged 18-69. The short-form questionnaire consists of four separate sections and a total of seven questions. The questionnaire includes questions about physical activity performed for at least 10 minutes in the last seven days. Calculation of the total score of the short form includes the sum of the duration (minutes) and frequency (days) of walking, moderate activity and vigorous activity. From these calculations, a score in MET-minutes is obtained. One MET-minute; It is calculated by multiplying the minutes of activity performed by the MET score. Walk = 3.3 METs, Moderate physical activity = 4.0 METs, Vigorous physical activity = 8.0 METs

    before and end of the interventions (fourth weeks)

Secondary Outcomes (1)

  • Blood Sugar Monitoring Form

    first week, second week, third week and fourth week

Study Arms (2)

Intervention Group

EXPERIMENTAL

In addition to the standard training, digital story videos were watched in the intervention group. Digital story videos created in line with four main topics related to diabetes self-management were sent to women via online platforms. During the follow-up period, reminder videos were sent once a week regarding the topics. Pre-test and post-test were administered face to face.

Other: Digital Story

Control Group

NO INTERVENTION

The control group received only standard training.

Interventions

Digital storytelling; It is used in education and training, business marketing, non-profit organizations such as libraries, community centers and museums, and health sciences education. Digital storytelling in health sciences can be a tool for patients and health science professionals to share their experiences, cope with diseases, and add a human element to health problems. In the study, digital stories were created to increase the self-management of pregnant women with gestational diabetes. In creating a digital story; Qualitative studies involving the self-management experiences of women with gestational diabetes have been examined in the literature. Using the results of the studies, scenarios were created that included factors that facilitate and complicate diabetes self-management. The created scenarios were used in the digital storytelling initiative. A total of four long and four short digital story videos were prepared.

Intervention Group

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Being 18 years or older
  • Being diagnosed with Gestational Diabetes
  • being between weeks of pregnancy
  • Having a treatment plan made after gestational diabetes diagnosis
  • Volunteering to participate in the study
  • Knowing how to read and write Turkish
  • Not having any pregnancy complications other than Gestational Diabetes
  • Having a smart phone

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Izmir Katip Celebi University

Çiğli, İzmir, 35620, Turkey (Türkiye)

RECRUITING

Study Officials

  • Gülşen Işık

    Izmir Katip Celebi University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Gülşen Işık

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant

Study Record Dates

First Submitted

November 20, 2023

First Posted

November 28, 2023

Study Start

March 27, 2023

Primary Completion

November 1, 2023

Study Completion

December 1, 2023

Last Updated

November 29, 2023

Record last verified: 2023-11

Locations