Effects of Education and Telephone Support on Type 2 Diabetes Management
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
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Study Type
Study Type
Enrollment (Actual)
Enrollment
Phase
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Karatay
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Konya, Karatay, Turkey (Türkiye), 42020
- Konya City Hospital
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-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
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
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / 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
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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.
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What is the study measuring?
Primary Outcome Measures
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
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.
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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.
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Baseline and end of the third month after discharge
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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.
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Baseline and end of the third month after discharge
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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.
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Baseline and end of the third month after discharge
|
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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
Sponsor
Sponsor
Investigators
Investigators
- Principal Investigator: Alime Selçuk Tosun, Assoc. Prof., Selcuk University, Faculty of Nursing
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Actual)
Primary Completion
Study Completion (Actual)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
Other Study ID Numbers
- 2023/08
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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