NCT05266742

Brief Summary

This is a quasi-experimental study that was carried out to examine the effect of the web-based education given to female individuals using insulin with Type 2 diabetes on self-care management and family support. Methods A randomized controlled trial using a sample (N=66) of women with type 2 diabetes who admitted to the hospital's outpatient clinic in 2020. The intervention group received web-based education for six months. Socio-demographic data, metabolic values, "Diabetes Self-Care Scale" and "Family Support and Conflict Scale in Type 2 Diabetes" were used.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
66

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2019

Shorter than P25 for not_applicable

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 15, 2019

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 15, 2020

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 15, 2020

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

January 20, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 4, 2022

Completed
Last Updated

March 4, 2022

Status Verified

February 1, 2022

Enrollment Period

5 months

First QC Date

January 20, 2022

Last Update Submit

February 23, 2022

Conditions

Keywords

Diabetes Mellitusnurseself careweb based educationfamily

Outcome Measures

Primary Outcomes (4)

  • Diabetes Self-Care Scale

    Diabetes Self-Care Scale Diabetes Self-Care Scale is a survey. It has been stated that patients who score points more than 66% of the scale total points are assumed at a level to meet their self-care. Based on the 4-point Likert type, the maximum score of the scale was 140 points. As the score increases, the self-care activities of the patients increase positively. It contains 35 items. These items aim to get information about eating on time, exercising, measuring and recording blood sugar, using oral antidiabetics and insulin as recommended, visiting a doctor for checking blood sugar, foot care, personal hygiene practices, diabetes, and its complications.

    a day before the education

  • Family Support and Conflict Scale in Type 2 Diabetes

    The Family Support and Conflict Scale in Type 2 Diabetes is a survey. DFSC has two sub-dimensions being 'Family Support' and 'Family Conflict'. The highest score obtained from the sub-dimensions was 50 and the lowest score was 10. As the subscale scores increase, the level of support increases. As the family conflict sub-dimension score decreases, the family conflict increase. The answers in the scale are 5-point Likert type and are classified as strongly agree, agree, undecided, disagree, strongly disagree. The scale contains 10 items in total. The items aim to get information to measure the family's attitude towards the diet, exercise, medications, and mental state of the diabetic.

    a day before the education

  • Metabolic Control Variables Form

    Metabolic Control Variables Form is created for this study by scanning the literature. It has questions regarding the disease of the individuals. The questions are about fasting blood glucose, HbA1c, LDL, HDL, total cholesterol, triglycerides, weight, height, and body mass index.

    a day before the education

  • Patient Identification Form

    Patient Identification Form is created for this study by scanning the literature. In this form, there are 12 questions in total. The questions included the first letters of the name and surname for coding purposes. There are questions about the age, marital status, employment status, educational status, smoking, alcohol and snacking habits, regular insulin use, blood glucose measurement, physical activity, dietary compliance, and previous educations about diabetes.

    a day before the education

Study Arms (2)

END

EXPERIMENTAL

Use of web based education

Other: web based education

END free

NO INTERVENTION

patient witout of web based education

Interventions

An educative website was created for our study. The content of the website was accessible from "www.diyabet.mumcu.net" and the content of the website was brought together by scanning the literature. The content text was quoted from publicly available information and guides as ADA and IDF.

END

Eligibility Criteria

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

You may qualify if:

  • diagnosed with Type 2 diabetes at least a year ago
  • using insulin
  • able to use computers and smartphones

You may not qualify if:

  • Not having been diagnosed with diabetes

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ankara Yıldırım Beyazıt University

Ankara, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator, PhD student, RN

Study Record Dates

First Submitted

January 20, 2022

First Posted

March 4, 2022

Study Start

December 15, 2019

Primary Completion

May 15, 2020

Study Completion

August 15, 2020

Last Updated

March 4, 2022

Record last verified: 2022-02

Data Sharing

IPD Sharing
Will not share

Locations