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NCT Number: NCT07423351

Telemedicine-Based Behavioral Intervention to Improve Outcomes Among Diabetic Patients

The goal of this quasi-experimental clinical study is to learn whether a telemedicine-based behavioral intervention can improve health outcomes among adult patients with diabetes receiving care at tertiary hospitals in Northwest Amhara, Ethiopia.

The main questions it aims to answer are:

* Does a telemedicine-based behavioral intervention improve glycemic control (HbA1c) among diabetic patients? * Does the intervention improve medication adherence among diabetic patients? * Does the intervention improve diabetes self-care practices? * Does the intervention increase patients' knowledge about diabetes? * Does the intervention reduce hospital admissions among diabetic patients?

We will compare patients who receive telemedicine-based counseling with patients who receive usual care to see if the intervention improves glycemic control, medication adherence, self-care practices, diabetes knowledge, and reduces hospital admissions.

Participants will:

* Receive structured telephone-based education every two weeks for three months (intervention group only) * Participate in 30-50-minute counseling sessions during the first call and 15-30 Minutes sessions during subsequent calls (intervention group only) * Receive education on diabetes basics, nutrition and meal planning, physical activity, medication management, blood glucose monitoring, complication prevention, and psychosocial support (intervention group only) * Engage in interactive discussions and receive individualized guidance from trained nurses (intervention group only) * Continue routine diabetes care at the hospital (both groups)

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

Diabetes mellitus (DM) is one of the fastest-growing non-communicable diseases in Ethiopia, contributing significantly to premature morbidity, mortality, and healthcare costs. Despite national efforts to improve chronic disease management, diabetic patients in Ethiopia continue to experience suboptimal glycemic control, high rates of complications, inconsistent follow-up, and limited access to specialist care. Traditional face-to-face service delivery in tertiary hospitals is often constrained by long travel distances, overcrowded clinics, inadequate consultation time, and shortages of trained providers. All of these challenges hinder effective self-management support and timely monitoring.

Telemedicine has emerged globally as a promising strategy to bridge gaps in chronic disease management by enhancing continuity of care, enabling remote monitoring, improving patient engagement, and reducing unnecessary hospital visits. Evidence from various low- and middle-income countries shows that telemedicine-based diabetes care can improve glycemic outcomes, diabetes self-management behaviors (medication adherence, dietary adherence, and physical activity adherence), and patient satisfaction. However, in Ethiopia, the integration of telemedicine into routine chronic care is still in its infancy, and there is limited evidence on feasibility, fidelity, and effectiveness in resource-constrained tertiary hospital settings.

Tertiary hospitals in the Northwest Amhara region serve large catchment populations, where physical access is uneven and many patients face geographic, financial, and time-related barriers that hinder regular follow-up. At the same time, mobile phone ownership and digital literacy are rapidly improving, creating a favorable environment for telemedicine-supported diabetes care. There is a need for locally tailored, evidence-based telemedicine intervention guidelines that can standardize remote consultations, patient education, medication review, monitoring of clinical indicators, and follow-up protocols.

This intervention guideline tool was developed to support the implementation and fidelity monitoring of a structured telemedicine-based diabetes care model within the context of a quasi-experimental study. The guideline outlines standardized procedures for virtual consultations, patient assessment, documentation, and follow-up, ensuring consistent delivery of the intervention across participating tertiary hospitals. The guideline also provides a structured framework for evaluating fidelity, quality, and patient outcomes, enabling the investigators to determine whether the telemedicine intervention leads to measurable improvements in clinical, behavioral, and service-related outcomes.

Overall, the rationale for developing this guideline tool is to ensure high-quality, consistent, and replicable telemedicine implementation, strengthen evidence on digital health interventions for chronic care in Ethiopia, and generate context-specific insights that can inform national policy, scale-up decisions, and future digital health strategies.

A two-arm quasi-experimental study design with parallel groups and a 1:1 allocation ratio will be employed to evaluate the effect of telemedicine-based education on outcomes among patients with diabetes mellitus. The study setting will include two teaching hospitals in Northwest Amhara: the University of Gondar Comprehensive Specialized Hospital and Tibebe Ghion Comprehensive Specialized Hospital. The intervention group will receive telemedicine-based diabetes care in addition to standard care, while the control group will receive standard routine hospital follow-up only. The follow-up duration will be three months, and data will be collected at baseline and at three months.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adult patients ≥18 with diabetes mellitus who have follow-up for ≥6 months at the study settings
  • Have access to mobile or fixed telephones
  • Will stay for the study follow-up period

Exclusion criteria

  • Participants who have coexisting severe mental health illnesses
  • Severe hearing impairments
  • Pregnant will be excluded
  • Currently enrolled in another diabetes intervention study

Treatment and study plan

Telemedicine-Based Diabetes Self-Management Counseling

Behavioral

Participants in the intervention group will receive telephone-based behavioral counseling focused on diabetes self-management. Counseling sessions will be conducted every two weeks for three months by trained healthcare providers.

The intervention will emphasize glycemic control, adherence to prescribed medications, healthy dietary practices, regular physical activity, self-monitoring of blood glucose, recognition of warning signs, and stress management. The program aims to empower patients to actively participate in managing their condition and improving clinical outcomes.

Primary outcomes

  1. Diabetic management outcome

    Time frame: The intervention will be delivered over a period of three months, with participants in the intervention group receiving 15-30 minute telephone counseling sessions every two weeks. Assessments will be done at baseline and end of intervention.

    Glycemic control will be assessed using glycated hemoglobin (HbA1c), which reflects average blood glucose levels over the preceding 2-3 months. HbA1c will be measured through standardized laboratory testing using venous blood samples collected at baseline and at the end of the three-month intervention period.

    Samples will be analyzed in accredited hospital laboratories using standardized assay methods. Glycemic control will be evaluated by comparing HbA1c levels before and after the intervention. A reduction in HbA1c indicates improved glycemic control. Participants achieving an HbA1c level of <7% will be classified as having good glycemic control, in accordance with standard clinical guidelines.

Secondary outcomes

  1. Medication Adherence

    Time frame: The intervention will be delivered over a period of three months, with participants in the intervention group receiving 15-30 minute telephone counseling sessions every two weeks. Assessments will be done at baseline and end of intervention.

    Medication adherence will be measured using the Hill-Bone Medication Adherence Scale adapted for diabetes management, which assesses behaviors related to taking prescribed antidiabetic medications. The scale evaluates the frequency of missed doses, timing adherence, and correct dosing over the past seven days.

    Scores will be calculated according to standardized Hill-Bone criteria, with higher scores indicating better adherence. Medication adherence will be classified as good if all prescribed doses are taken on all seven days, and poor if any dose is missed.

  2. Hospital Admission

    Time frame: baseline and three months

    Hospital admission due to diabetes-related complications will be assessed using a self-report question: "Have you been admitted to a hospital in the past one month due to diabetes or its complications?" Responses will be coded as 1 = Yes and 2 = No. This outcome will be analyzed as a binary variable, with "Yes" indicating an admission and "No" indicating no admission.

    The measure will be collected at baseline and at the end of the intervention period to evaluate recent hospitalization related to diabetes.

  3. Diabetes Self-Care Practice

    Time frame: The intervention will be delivered over a period of three months, with participants in the intervention group receiving 15-30 minute telephone counseling sessions every two weeks. Assessments will be done at baseline and end of intervention.

    Diabetes self-care practice will be measured using the Summary of Diabetes Self-Care Activities (SDSCA) questionnaire, a validated instrument that assesses adherence to key diabetes self-management behaviors. The SDSCA evaluates the frequency of self-care activities performed over the past seven days across multiple domains, including general diet, specific diet, physical activity, blood glucose testing, foot care, and medication adherence.

    Each item is scored based on the number of days (0-7) the activity was performed during the previous week. Domain scores will be calculated according to standardized SDSCA guidelines, and higher scores indicate better self-care practice. Overall self-care practice will be classified as good if participants achieve at least 70% of the recommended behaviors across domains, and poor if they score below this threshold.

  4. Diabetes Knowledge Score

    Time frame: The intervention will be delivered over a period of three months, with participants in the intervention group receiving 15-30 minute telephone counseling sessions every two weeks. Assessments will be done at baseline and end of intervention.

    Diabetes knowledge will be measured using the Diabetes Knowledge Questionnaire (DKQ-24), a validated instrument designed to assess patients' understanding of diabetes and its management. The questionnaire consists of 24 items covering key areas, including disease etiology, symptoms, treatment, medication use, diet, physical activity, blood glucose monitoring, and prevention of complications.

    Each item is scored as correct or incorrect according to standardized DKQ-24 scoring guidelines. The total knowledge score ranges from 0 to 24, with higher scores indicating better diabetes-related knowledge. Participants scoring ≥70% of correct responses will be classified as having good diabetes knowledge, while those scoring below this threshold will be classified as having poor knowledge.

Study contacts

Contact information is provided by the study sponsor or research team.

Asnake G Belayneh, Master in Emergency Nursing

CONTACT

[email protected]

0918793885

Eyob K Bogale, Master of Public Health

CONTACT

[email protected]

+251961640637

Sponsors and collaborators

Lead sponsor

Bahir Dar University

Other

Registry information

Official study title

The Effects of the Telemedicine-Based Behavioral Intervention on Improving the Outcomes of Diabetic Patients in Northwest Amhara Tertiary Hospitals, Ethiopia, 2025/26: A Quasi-Experimental Study Intervention Protocol

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Feb 20, 2026
Registry last updated
Feb 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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