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

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. 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. 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.

Participants will go through the following processes in the study:

Participants in the Intervention Group:

For three months, they will attend monthly in-person (or video-based, upon request) follow-up sessions with their family physicians. The first session lasts approximately 45 minutes, the second 20 minutes, and the third 15 minutes.

Together with their doctors, they will complete a "Diabetes (DM) ID Card" and receive education on diabetes care and monitoring for complications.

At home, they will monitor their own blood sugar levels, perform foot checks, and record this data in the "DM Diary" developed by the researchers.

At the clinic, they will undergo screenings for complications such as neuropathy, including foot examinations and the monofilament test, performed by their family physicians.

They will review changes in diet and physical activity with their physicians. At the start of the study and at the end of the third month, they will complete self-management and health literacy assessment scales.

Participants in the Control Group:

For three months, they will receive monthly phone calls from their family physicians lasting approximately 10 minutes, which will include general information about diabetes and reminders about complication screenings (eye, foot, and kidney examinations).

Participants will complete the diabetes self-management assessment scale at the start of the study and again at the end of the third month.

Conditions

• Diabetes Mellitus Type 2

Interventions

BEHAVIORAL

A structured shared follow-up plan combined with patient education

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.

Sponsors & Collaborators

• Aysenur Aktemur

  lead OTHER

Principal Investigators

• Serap S Ciftcili, Prof. Dr. · Marmara University Faculty of Medicine, Department of Family Medicine

Study Design

Allocation

NON_RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-05-01

Primary Completion

2022-01-30

Completion

2022-01-30

Countries

• Turkey (Türkiye)

Study Locations