Telemedicine-Based Behavioral Intervention to Improve Outcomes Among Diabetic Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Telemedicine-Based Diabetes Self-Management Counseling.
- Who it may be relevant to
- Registry conditions: Diabete Mellitus, Diabetes Knowledge Score. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official 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
Overview
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)
Detailed description
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.
Interventions
- Behavioral Telemedicine-Based Diabetes Self-Management Counseling
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
Primary outcome measures
- 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.]
Secondary outcome measures (4)
- 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.]
- Hospital Admission [Time frame: baseline and three months]
- 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 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.]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Supportive care
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07423351 · 6007/2026