Ignite Creation Date:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-03-31 @ 2:27 AM
Study NCT ID:
NCT07423351
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-02-20
First Post:
2026-02-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Telemedicine-Based Behavioral Intervention to Improve Outcomes Among Diabetic Patients
Sponsor:
Bahir Dar University
Organization:
Study Overview
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
Status:
NOT_YET_RECRUITING
Status Verified Date:
2026-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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)
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.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: