NCT06192121

Brief Summary

Type and Aim of Research This research will be conducted as a randomised controlled experimental study design to test the effect of web-based diabetes education on the quality of life and self-care activities of individuals with Type 2 Diabetes. Place and Time of the Study This research will be conducted between September 2023 and March 2024 with individuals registered to the Cyprus Turkish Diabetes Association. Population and Sample of the Study The population of the study consisted of individuals with Type-2 diabetes who applied to the Cyprus Turkish Diabetes Centre. The sample of the study included individuals with type-2 diabetes who met the inclusion criteria at the Turkish Cypriot Diabetes Centre. Sample size was calculated using G Power statistical programme (n=74). In order to evaluate the effectiveness in the experimental and control groups, simple randomisation was performed to ensure the similarity of the two groups. Randomisation was applied after the pre-tests. The data of the study will be collected by Sociodemographic Data Form, Diabetes Specific Quality of Life Scale, Diabetes Self-Care Activities Questionnaire, Website Analysis and Measurement Inventory. The forms will be applied to the participants face to face. People in the experimental group, whose information was sent to the researcher, will receive reminder messages twice a week (Wednesday-Friday) during the 3-month follow-up period via the website. No intervention will be applied to the control group. The post-test will be applied.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
80

participants targeted

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

Timeline
Completed

Started Sep 2023

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

September 1, 2023

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

December 20, 2023

Completed
16 days until next milestone

First Posted

Study publicly available on registry

January 5, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2024

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 19, 2024

Completed
Last Updated

July 24, 2024

Status Verified

July 1, 2024

Enrollment Period

6 months

First QC Date

December 20, 2023

Last Update Submit

July 22, 2024

Conditions

Keywords

Diabetes MellitusInternet-Based InterventionModels, NursingRandomised Control Trial

Outcome Measures

Primary Outcomes (2)

  • Diabetes-Specific Quality of Life

    It consists of four subscales, including diabetes-related anxiety and social/occupational anxiety, and 46 items. Each item in the scale is scored between 1-5 points. In the dimension of psychological satisfaction with the treatment (questions 22-24), the answer "very satisfied" is calculated as 1 point, the answer "very dissatisfied" is calculated as 5 points, while in other dimensions the answer "never" is calculated as 1 point, and the answer "always" is calculated as 5 points. The total score of the scale varies between 46-230. The total scale score and each subscale score are divided by the number of items, and the scores of 1 are converted into 5 points to obtain the total scale score. According to the scale total scores, high scores indicate good quality of life. The Turkish validity and reliability study of the scale was conducted by Yıldırım.

    3 months

  • Diabetes Self-Care Activities

    The Diabetes Self-Care Activities Questionnaire was developed by Toobert. In the survey, individuals; It is asked how many days (days/week) in the last seven days the patient performed self-care activities under the headings of diet, exercise, blood sugar test, foot care and smoking. The answers are marked as days (0-7) on a number line, and the 11th item, which only questions smoking, is stated as 0 - I do not smoke, 1 - I smoke (amount/piece of cigarettes smoked). Each subscale of the scale is scored separately and can be used independently. The Turkish validity and reliability study of the scale was conducted by Coşansu.

    3 months

Study Arms (2)

Control

NO INTERVENTION

Standart Health Care which is provided regular from ministry of health for 3 months

Experiment

EXPERIMENTAL

Standart Health Care which is provided regular from ministry of health for 3 months Web Based Education for 3 months 3 reminder messages (SMS) per week

Other: Web Based Education

Interventions

In this research, a reminder message will be sent 3 times a week along with web-based training.

Experiment

Eligibility Criteria

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

You may qualify if:

  • Having access to the Internet,
  • Diagnosed with Type II Diabetes,
  • Mentally competent,
  • Individuals who volunteered to participate in the study were recruited.

You may not qualify if:

  • Cannot use a computer or smartphone,
  • Under 18 years of age,
  • Those with Type 1 Diabetes
  • Working in the field of health and receiving health education in any field,
  • Individuals who participated in the preliminary application were not included in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Near East University

Mersin, Lefkoşa, 1010, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Kemal KE Elyeli, PhD(c).

    Near East University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Simple Randomization and single blinding will be done.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Randomised Control Trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Asistant, PhD (c)

Study Record Dates

First Submitted

December 20, 2023

First Posted

January 5, 2024

Study Start

September 1, 2023

Primary Completion

March 1, 2024

Study Completion

July 19, 2024

Last Updated

July 24, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Locations