Telemedicine-Based Behavioral Intervention to Improve Outcomes Among Diabetic Patients

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorBahir Dar University

About this trial

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)

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Participants who have coexisting severe mental health illnesses

Severe hearing impairments

Pregnant will be excluded

Currently enrolled in another diabetes intervention study

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

320 Participants
are divided into 2 treatment groups
Group A: Telemedicine-Based Behavioral Intervention ArmExperimental treatment 1 intervention
Group B: Usual Care Control ArmNo intervention 0 interventions

Trial outcomes

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.

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 outcomes

1

Medication Adherence

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.

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.
2

Hospital Admission

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.

Time frame
baseline and three months
3

Diabetes Self-Care Practice

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.

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.
4

Diabetes Knowledge Score

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.

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.

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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