NCT05151276

Brief Summary

This study aimed to examine the effect of mobile phone-based distance video education given to individuals with type 2 diabetes on metabolic variables and cognitive-social factors. This study is a randomized controlled trial.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
93

participants targeted

Target at P50-P75 for not_applicable diabetes-mellitus-type-2

Timeline
Completed

Started Jul 2018

Shorter than P25 for not_applicable diabetes-mellitus-type-2

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2018

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2019

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2019

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

October 23, 2021

Completed
2 months until next milestone

First Posted

Study publicly available on registry

December 9, 2021

Completed
Last Updated

December 9, 2021

Status Verified

November 1, 2021

Enrollment Period

7 months

First QC Date

October 23, 2021

Last Update Submit

November 28, 2021

Conditions

Keywords

Type 2 diabetesdiabetes educationmobile phone-baseddistance video educationrandomized controlled trial

Outcome Measures

Primary Outcomes (1)

  • The Turkish Multidimensional Diabetes Questionnaire

    Change from baseline diabetes-related cognitive and social factors at 3 months. Responses were on a Likert-type scale (0-not at all significant). not, 100-very important) is marked. High school scores perceived self-efficacy and outcome indicates high expectations.

    pre-test (baseline), post-test (3 months follow-up)

Secondary Outcomes (6)

  • HbA1C

    pre-test (baseline), post-test (3 months follow-up)

  • glucose

    pre-test (baseline), post-test (3 months follow-up)

  • total cholesterol

    pre-test (baseline), post-test (3 months follow-up)

  • HDL

    pre-test (baseline), post-test (3 months follow-up)

  • LDL

    pre-test (baseline), post-test (3 months follow-up)

  • +1 more secondary outcomes

Study Arms (2)

Intervention Group

EXPERIMENTAL

individuals with odd sequence numbers were assigned to the intervention group (n=46)

Behavioral: mobile phone-based distance video education group

Control Group

NO INTERVENTION

those with even numbers to the control group (n=47).

Interventions

Following the first interview, diabetes education videos created previously were sent to the mobile phones of the individuals in two episodes a week fashion. Video submission was completed in a total of four weeks. In the second interview, three months after the video submission had been completed, data collection forms were re-administered to the individuals, and blood analysis results were recorded.

Intervention Group

Eligibility Criteria

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

You may qualify if:

  • Having a diagnosis of Type 2 diabetes mellitus for at least 6 months.
  • Being between the ages of 18-65.
  • Being on oral antidiabetic and/or insulin therapy.
  • Having a mobile phone capable of receiving and playing video messages.
  • Volunteering to participate in the study.
  • Sensory losses such as hearing and speech that will prevent communication

You may not qualify if:

  • Being under 18 years of age
  • Not having a mobile phone capable of receiving and playing video messages
  • Not willing to participate in the study
  • Having sensory loss such as hearing and speaking that prevents communication

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Balıkesir University

Balıkesir, Altıeylül, 10100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Ali Kamil Bayraktar

    Balikesir University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assist.Prof.Dr.

Study Record Dates

First Submitted

October 23, 2021

First Posted

December 9, 2021

Study Start

July 1, 2018

Primary Completion

January 31, 2019

Study Completion

July 1, 2019

Last Updated

December 9, 2021

Record last verified: 2021-11

Data Sharing

IPD Sharing
Will not share

Locations