Effectiveness of Combining Patient Follow-Up With an Educational Intervention on Self-Management Skills of Type 2 Diabetes Mellitus Patients: A Controlled Intervention Study in Primary Care

NCT07783451 | Completed

• 1 other identifier: 09.2021.601
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this clinical study is to evaluate whether patient education provided in conjunction with a structured, shared follow-up plan in primary care strengthens the self-management skills of patients with Type 2 Diabetes (T2DM). The study also aims to determine whether the effect of this intervention is associated with patients' baseline levels of health literacy. The key questions this study aims to address are as follows:

1. 1.Do the structured follow-up model and educational intervention improve diabetes self-management skills (healthy lifestyle behaviors, blood glucose management, and use of health services) among patients with T2DM?
2. 2.Can this improvement in diabetes self-management skills occur regardless of patients' baseline levels of health literacy? To measure the effectiveness of structured follow-up in improving diabetes self-management, researchers will compare the intervention group-which receives in-person sessions supported by visual aids-with the control group, which is followed up via standard phone calls.

Conditions

Diabetes Mellitus Type 2

Keywords

Self-Management; Patient-Empowerment; Primary Care

Outcome Measures

Primary Outcomes (1)

• Change in Type 2 Diabetes Self-Management Scale (DSMS) Total Score

  The DSMS is a validated 19-item scale designed to assess diabetes self-management skills in patients with type 2 diabetes. It uses a 5-point Likert-type scoring system. The total score ranges from 19 to 95, with higher scores indicating a higher level of diabetes self-management skills. This outcome measure evaluates the change in total self-management skills from baseline to the end of the 3-month follow-up period.

  Baseline and 3 months

Study Arms (2)

Intervention Group

EXPERIMENTAL

Behavioral: A structured shared follow-up plan combined with patient education

Control Group

NO INTERVENTION

Interventions

A structured shared follow-up plan combined with patient education BEHAVIORAL

This intervention consists of a structured, patient-centered diabetes self-management program integrated into routine primary care, specifically designed to address low health literacy. Delivered face-to-face (or via video call) by family physicians over three monthly sessions of decreasing duration (approximately 45, 20, and 15 minutes, respectively). It utilizes low-literacy communication strategies, including plain language, action-focused messaging, visual aids, and the 'teach-back' method to confirm and reinforce understanding.

Intervention Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Must have a documented clinical diagnosis of Type 2 Diabetes Mellitus (T2DM).
• Must be literate (able to read and write).
• Must be able to monitor/measure blood glucose at home.

You may not qualify if:

• Inability to complete/apply the health literacy scale independently.
• Currently receiving specialized diabetes care or treatment from a tertiary/specialized diabetes center.
• Hospitalization due to diabetes-related complications during the course of the study.

Sponsors & Collaborators

• Aysenur Aktemur: lead

Study Sites (1)

Marmara University Pendik Training and Research Hospital Tuzla Primary Health Center

Istanbul, 34953, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Patient Participation

Interventions

Patient Education as Topic

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Health Education; Preventive Health Services; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Serap S Ciftcili, Prof. Dr.

  Marmara University Faculty of Medicine, Department of Family Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Medicinae Doctor-Family Medicine Specialist

Model Details: Patients who were registered to Intervention Group were interviewed face-to-face or by video call once a month by the family physician (FP) according to the participant's request. A shared follow-up plan was created. For this purpose, a DM identity card was given to the patients and filled out together with the patient. Patients were also asked to complete a Blood Glucose Measurement and Foot Check Diary and were instructed on how to complete it. In Control Group FP informed the patients in the CG about basic DM care by phone calls once a month lasting 10 minutes

Study Record Dates

• First Submitted: August 20, 2026
• First Posted: August 24, 2026
• Study Start: May 1, 2021
• Primary Completion: January 30, 2022
• Study Completion: January 30, 2022
• Last Updated: August 27, 2026

Record last verified: 2026-08

Locations

TU (1)