- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07383532
Effects of Education and Telephone Support on Type 2 Diabetes Management
January 31, 2026 updated by: Alime Selçuk Tosun, Selcuk University
Effects of Self-Management Education and Follow-Up Telephone Support on Diabetes Self-Management, Treatment Compliance, and Medication Self-Efficacy in Adults With Type 2 Diabetes
This study examined the effects of self-management education combined with follow-up telephone support on diabetes self-management, treatment compliance, and medication self-efficacy in adults with Type 2 diabetes.
A total of 70 adults with type 2 diabetes were randomly assigned to an intervention group or a control group.
Participants in the intervention group received diabetes self-management education and follow-up telephone support while the control group received usual care.
Data were collected using the Personal Information Form, the Diabetes Self-Management Scale, the Patient Adherence Scale for Type 2 Diabetes Mellitus Treatment, and the Diabetes Medication Use Self-Efficacy Scale.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
70
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Karatay
-
Konya, Karatay, Turkey (Türkiye), 42020
- Konya City Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Individuals with a diagnosis of type 2 diabetes for at least 6 months
- Between the ages of 18-64
- Literate
- Planned hospitalisation for at least three days
- Using only insulin or insulin + oral antidiabetics as treatment
Exclusion Criteria:
- Individuals with Type 1
- Gestational diabetes,
- Communication disability
- Psychiatric illness
- Severe complications (retinopathy, neuropathy, nephropathy, diabetic foot, cardiovascular disease)
- Condition that prevents physical activity
- Individuals who could not attend at least two sessions of the diabetes education programme
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Diabetes Self-Management Education and Telephone Support
Participants in this arm received a structured diabetes self-management education program combined with follow-up telephone support.
The intervention consisted of three face-to-face education sessions covering diabetes self-management, treatment compliance, and medication use.
In addition, participants received two structured follow-up telephone support calls over a two-month period to reinforce education content, support adherence, and address participant questions.
Outcomes were assessed using pre-test and post-test measurements, including diabetes self-management, treatment compliance, medication self-efficacy, and biochemical parameters
|
The intervention consisted of a structured diabetes self-management education program and follow-up telephone support.
Participants received three face-to-face education sessions focusing on diabetes self-management, treatment compliance, and medication use.
Additionally, two structured follow-up telephone support calls were conducted over a two-month period to reinforce education, support adherence, and address participants' questions.
|
|
No Intervention: Usual Care Control Group
Participants in this arm received usual care for Type 2 diabetes without additional diabetes self-management education or follow-up telephone support.
They continued routine clinical follow-up and standard treatment as recommended by healthcare providers.
Pre-test and post-test assessments were conducted at the same time points as the intervention group, including measures of diabetes self-management, treatment compliance, medication self-efficacy, and biochemical parameters.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Diabetes Self-Management Scale
Time Frame: Baseline and end of the third month after discharge
|
The level of diabetes self-management was assessed using the Diabetes Self-Management Scale.
The scale evaluates participants' self-management behaviors across four sub-dimensions: glucose management, diet control, physical activity, and utilization of health services.
A minimum score of 0 and a maximum score of 10 is obtained from the total scale and sub-dimensions.
Higher scores indicating higher levels of diabetes self-management.
|
Baseline and end of the third month after discharge
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Patient Adherence Scale for Type 2 Diabetes Mellitus Treatment
Time Frame: Baseline and end of the third month after discharge
|
Treatment adherence was assessed using the Patient Adherence Scale for Type 2 Diabetes Mellitus Treatment, a validated self-report instrument developed to evaluate adherence behaviors in individuals with Type 2 diabetes.
The scale assesses multiple dimensions of attitude and emotional factors, knowledge and personal factors, lifestyle change, feelings of anger, feelings, and behaviours appropriate for adherence, diet bargaining and feelings of denial.
The highest score obtained from the scale is 150 and the lowest score is 30.
As the score obtained from the scale decreases, the individual's adherence to treatment increases.
|
Baseline and end of the third month after discharge
|
|
Diabetes Medication Use Self-efficacy Scale
Time Frame: Baseline and end of the third month after discharge
|
Medication use self-efficacy was assessed using the Diabetes Medication Use Self-Efficacy Scale, a validated instrument measuring individuals' confidence in their ability to use diabetes medications despite potential barriers.
The scale evaluates self-efficacy related to obligation, preoccupation, and anxiety associated with medication use.
The lowest score in the scale is 19 and the highest score is 57.
Higher scores indicate higher levels of medication use self-efficacy.
|
Baseline and end of the third month after discharge
|
|
Glycated hemoglobin
Time Frame: Baseline and end of the third month after discharge
|
Glycated hemoglobin (HbA1c) in mmol/mol.
This data was obtained from routine blood test results recorded in health records at baseline (during hospital admission) and at the physician follow-up visit three months after discharge.
|
Baseline and end of the third month after discharge
|
|
High-density lipoprotein
Time Frame: Baseline and end of the third month after discharge
|
High-density lipoprotein (HDL) in mg/dL.
This data was obtained from routine blood test results recorded in health records at baseline (during hospital admission) and at the physician follow-up visit three months after discharge.
|
Baseline and end of the third month after discharge
|
|
Low-density lipoprotein
Time Frame: Baseline and end of the third month after discharge
|
Low-density lipoprotein (LDL) in mg/dL.
This data was obtained from routine blood test results recorded in health records at baseline (during hospital admission) and at the physician follow-up visit three months after discharge.
|
Baseline and end of the third month after discharge
|
|
Total cholesterol
Time Frame: Baseline and end of the third month after discharge
|
Total cholesterol in mg/dL.
This data was obtained from routine blood test results recorded in health records at baseline (during hospital admission) and at the physician follow-up visit three months after discharge.
|
Baseline and end of the third month after discharge
|
|
Triglyceride
Time Frame: Baseline and end of the third month after discharge
|
Triglyceride in mg/dL.
This data was obtained from routine blood test results recorded in health records at baseline (during hospital admission) and at the physician follow-up visit three months after discharge.
|
Baseline and end of the third month after discharge
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Alime Selçuk Tosun, Assoc. Prof., Selcuk University, Faculty of Nursing
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 1, 2023
Primary Completion (Actual)
April 15, 2024
Study Completion (Actual)
April 15, 2024
Study Registration Dates
First Submitted
January 25, 2026
First Submitted That Met QC Criteria
January 31, 2026
First Posted (Actual)
February 3, 2026
Study Record Updates
Last Update Posted (Actual)
February 3, 2026
Last Update Submitted That Met QC Criteria
January 31, 2026
Last Verified
January 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2023/08
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
Individual participant data from this study will not be shared because the study was conducted solely for internal research purposes, and participant confidentiality and privacy are protected in accordance with institutional ethical approval.
Data sharing was not planned in the study protocol.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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