NCT07383532

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2023

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

May 1, 2023

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 15, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 15, 2024

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

January 25, 2026

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 3, 2026

Completed
Last Updated

February 3, 2026

Status Verified

January 1, 2026

Enrollment Period

12 months

First QC Date

January 25, 2026

Last Update Submit

January 31, 2026

Conditions

Type 2 Diabetes Mellitus (T2DM)

Outcome Measures

Primary Outcomes (1)

  • Diabetes Self-Management Scale

    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 Outcomes (7)

  • Patient Adherence Scale for Type 2 Diabetes Mellitus Treatment

    Baseline and end of the third month after discharge

  • Diabetes Medication Use Self-efficacy Scale

    Baseline and end of the third month after discharge

  • Glycated hemoglobin

    Baseline and end of the third month after discharge

  • High-density lipoprotein

    Baseline and end of the third month after discharge

  • Low-density lipoprotein

    Baseline and end of the third month after discharge

  • +2 more secondary outcomes

Study Arms (2)

Diabetes Self-Management Education and Telephone Support

EXPERIMENTAL

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

Behavioral: Diabetes Self-Management Education and Telephone Support

Usual Care Control Group

NO INTERVENTION

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.

Interventions

Diabetes Self-Management Education and Telephone SupportBEHAVIORAL

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.

Diabetes Self-Management Education and Telephone Support

Eligibility Criteria

Age18 Years - 64 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Konya City Hospital

Konya, Karatay, 42020, Turkey (Türkiye)

Location

Related Publications (1)

  • Eroglu N, Sabuncu N. The effect of education given to type 2 diabetic individuals on diabetes self-management and self-efficacy: Randomized controlled trial. Prim Care Diabetes. 2021 Jun;15(3):451-458. doi: 10.1016/j.pcd.2021.02.011. Epub 2021 Mar 3.

    PMID: 33674221BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Alime Selçuk Tosun, Assoc. Prof.

    Selcuk University, Faculty of Nursing

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants were randomly assigned to either the intervention group or the usual care control group and followed in parallel throughout the study period.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

January 25, 2026

First Posted

February 3, 2026

Study Start

May 1, 2023

Primary Completion

April 15, 2024

Study Completion

April 15, 2024

Last Updated

February 3, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

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.

Locations

TU(1)