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Mobile Phone-based Video Education on Diabetes

Primary Purpose

Diabetes Mellitus, Type 2

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
mobile phone-based distance video education group
Sponsored by
Balikesir University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Diabetes Mellitus, Type 2 focused on measuring Type 2 diabetes, diabetes education, mobile phone-based, distance video education, randomized controlled trial

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Sites / Locations

  • Balıkesir University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention Group

Control Group

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

HbA1C
HbA1C-change from baseline HbA1C at 3 months
glucose
glucose -change from baseline glucose at 3 months
total cholesterol
total cholesterol -change from baseline total cholesterol at 3 months
HDL
HDL -change from baseline HDL at 3 months
LDL
LDL -change from baseline LDL at 3 months
triglyceride
triglyceride -change from baseline triglyceride at 3 months

Full Information

First Posted
October 23, 2021
Last Updated
November 28, 2021
Sponsor
Balikesir University
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1. Study Identification

Unique Protocol Identification Number
NCT05151276
Brief Title
Mobile Phone-based Video Education on Diabetes
Official Title
Effectiveness of Mobile Phone-based Distance Video Education in Individuals With Type 2 Diabetes: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
July 1, 2018 (Actual)
Primary Completion Date
January 31, 2019 (Actual)
Study Completion Date
July 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Balikesir University

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 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.
Detailed Description
MATERIALS AND METHODS: This study is a randomized controlled trial. Participants: The population of the study consisted of individuals with type 2 diabetes who presented to hospital diabetes outpatient clinic between July 2018 and January 2019, and the study sample, on the other hand, included a total of 100 individuals with type 2 diabetes who met the inclusion criteria and agreed to participate in the study. The study was completed with a total of 93 subjects, including 46 in the intervention group (n = 46) and 47 in the control group (n= 47). A Diagnosis and Follow-up Form for Individuals with Diabetes (socio-demographic characteristics, diabetes-related characteristics, metabolic values), which was prepared by the researcher in line with the literature, and the Turkish Multidimensional Diabetes Questionnaire (T-MDDQ) were used to collect the data. Preparation and content of the education material: The education material was based on four different guidelines, namely, educator's guidelines for adults with diabetes; the diagnosis, treatment, and follow-up guidelines for diabetes mellitus and its complications; diabetes diagnosis and treatment guidelines; and international education guidelines for diabetes health professionals. The diabetes education videos prepared and presented by the researcher in line with these resources were sent to the participants' smartphones in parts. The educational content consisted of 8 sections: what is diabetes? (basic concepts, symptoms, diagnostic criteria, importance), medical nutrition therapy in diabetes, exercise therapy in diabetes, medical treatment in diabetes, acute complications of diabetes, chronic complications of diabetes, foot problems in diabetes, life with diabetes, and diabetes management under special cases. Data collection process: The intervention group: In the first meeting, the individuals in the intervention group were informed about the video-based diabetes education and how they would get the videos, and data collection forms were administered. The blood analysis results (HbA1c, glucose, total cholesterol, HDL, LDL, triglyceride) taken on the same day during outpatient clinic follow-ups were recorded. After the administration of the forms, blood pressure, height, and weight measurements were made, and the first interview was completed. 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. The interview was completed after measuring their blood pressure and weight. During the period between the first and second interviews, the individuals continued to receive routine outpatient follow-ups. The control group: In the first interview, the individuals with diabetes in the control group were given information about the study, and then data collection forms were administered. The blood analysis results (HbA1c, glucose, total cholesterol, HDL, LDL, triglyceride) taken on the same day during outpatient clinic follow-ups were recorded. The first interview was completed after blood pressure, height, and weight measurements were made. Later, individuals continued to receive routine outpatient follow-ups without any other procedures. In the second interview held three months later, data collection forms were re-administered, and blood analysis results, blood pressure, and weight measurements were recorded. At the end of the second interview, diabetes education videos were sent to the individuals in the control group, too, and they were provided with the same education. Data analysis: The statistical package for social science (SPSS) version 25.0 (IBM Corp. Armonk, NY) was used to analyze the data. P<.05 was accepted statistically significant. In descriptive statistics, mean, ± standard deviation, median, minimum and maximum values, and percentages were used, and in nonparametric tests, Mann-Whitney U, Pearson's chi-square, Fisher's exact test, McNemar's test, Wilcoxon signed ranks test, and Spearman's rho measurements were employed.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2
Keywords
Type 2 diabetes, diabetes education, mobile phone-based, distance video education, randomized controlled trial

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
93 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention Group
Arm Type
Experimental
Arm Description
individuals with odd sequence numbers were assigned to the intervention group (n=46)
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
those with even numbers to the control group (n=47).
Intervention Type
Behavioral
Intervention Name(s)
mobile phone-based distance video education group
Intervention Description
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.
Primary Outcome Measure Information:
Title
The Turkish Multidimensional Diabetes Questionnaire
Description
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.
Time Frame
pre-test (baseline), post-test (3 months follow-up)
Secondary Outcome Measure Information:
Title
HbA1C
Description
HbA1C-change from baseline HbA1C at 3 months
Time Frame
pre-test (baseline), post-test (3 months follow-up)
Title
glucose
Description
glucose -change from baseline glucose at 3 months
Time Frame
pre-test (baseline), post-test (3 months follow-up)
Title
total cholesterol
Description
total cholesterol -change from baseline total cholesterol at 3 months
Time Frame
pre-test (baseline), post-test (3 months follow-up)
Title
HDL
Description
HDL -change from baseline HDL at 3 months
Time Frame
pre-test (baseline), post-test (3 months follow-up)
Title
LDL
Description
LDL -change from baseline LDL at 3 months
Time Frame
pre-test (baseline), post-test (3 months follow-up)
Title
triglyceride
Description
triglyceride -change from baseline triglyceride at 3 months
Time Frame
pre-test (baseline), post-test (3 months follow-up)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ali Kamil Bayraktar
Organizational Affiliation
Balikesir University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Balıkesir University
City
Balıkesir
State/Province
Altıeylül
ZIP/Postal Code
10100
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

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Mobile Phone-based Video Education on Diabetes

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