Telemedicine-Based Behavioral Intervention to Improve Outcomes Among Diabetic Patients

NCT07423351 | Not Yet Recruiting DMC

• 1 other identifier: 6007/2026
• Study Type: interventional
• Target: 320
• Locations: 0 countries
• Sites: N/A

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)

Conditions

Diabete Mellitus; Diabetes Knowledge Score

Keywords

Behavioral intervention; Diabetes Mellitus; Telemedicine; Quasi-experimental study

Outcome Measures

Primary Outcomes (1)

• Diabetic management outcome

  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.

  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 Outcomes (4)

• Medication Adherence

  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

  baseline and three months

• Diabetes Self-Care Practice

  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

  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.

Study Arms (2)

Telemedicine-Based Behavioral Intervention Arm

EXPERIMENTAL

The intervention arm will receive a telemedicine-based behavioral intervention, including structured telephone counseling sessions every two weeks for three months. The first session will last 30-50 minutes, followed by 10-15-minute sessions for subsequent calls. Trained nurses will provide education on diabetes basics, blood glucose monitoring, medication adherence, nutrition and meal planning, physical activity, prevention and management of complications, and psychosocial support. Interactive discussions and individualized guidance will be incorporated into each session. The intervention package is designed based on existing literature and culturally appropriate practices. Participants in this arm will receive regular follow-up and tailored self-care support in addition to routine hospital care.

Behavioral: Telemedicine-Based Diabetes Self-Management Counseling

Usual Care Control Arm

NO INTERVENTION

The control arm will receive standard diabetes care provided at the tertiary hospitals. This may include routine outpatient follow-up visits, prescribed medications, laboratory monitoring, and general health education as part of routine clinical practice. Participants in this arm will not receive the telemedicine-based counseling, structured follow-up, or individualized self-care support provided to the intervention group.

Interventions

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.

Telemedicine-Based Behavioral Intervention Arm

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Bahir Dar University: lead

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Central Study Contacts

Eyob K Bogale, Master of Public Health

CONTACT

+251961640637; ketema.eyob@gmail.com

Asnake G Belayneh, Master in Emergency Nursing

CONTACT

0918793885; asnakegashaw27@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 12, 2026
• First Posted: February 20, 2026
• Study Start: February 20, 2026
• Primary Completion: March 20, 2026
• Study Completion (Estimated): July 10, 2026
• Last Updated: February 20, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share