Telenursing System by Providing Health Education and Lifestyle Modification Among Diabetic Patients in Bangladesh

March 18, 2026 updated by: KATM Ehsanul Huq, Hiroshima University

Establish Telenursing System by Providing Health Education and Lifestyle Modification Among Diabetic Patients in Bangladesh

The global burden of chronic diseases is increasing and becoming a public health issue throughout the world. The use of telenursing is increasing significantly during and after the COVID-19 pandemic to treat and prevent chronic diseases. Study objectives: The objective of this study is to apply the self-management telenursing program and telenursing system developed by the researchers to Bangladesh and to evaluate its feasibility and efficacy (improved diabetes control in participants). Method: This is a pilot, quasi-experimental pre- and post-intervention study. Diabetes patients who will attend the Grameen Primary Health Care Centers (PHCs) in Bangladesh will be enrolled. Investigators include patients who have been diagnosed with type 2 diabetes, both sexes, age above 18-75 years old, all types of treatment, and willing to participate / give consent. Investigators exclude patients who have been diagnosed as gestational diabetes, diabetes as a secondary cause, complication of CKD stage 5, HbA1c is less than 7.0% for past 1 year with CKD stage 1 or 2, no complications or complications with good control, having enough knowledge (had education before) and implemented good practice regarding diabetes management assessed by the research nurses, and disabled persons who need other person's support for daily living. The sample size was calculated and found 70. Patients who meet the eligibility criteria will be introduced by physicians at the PHCs, and the nurses will contact the patients at the PHC. Written informed consent (ICFs) will be obtained from all the participants. Protocol including ICFs got approval from the Institutional Review Board of Bangladesh Medical Research Council (BMRC/NREC/2022-2025/336) on September 08, 2024. The outcome of this study is to evaluate the effects of telenursing intervention by controlling HbA1c. Investigators set various secondary endpoints including feasibility. By making self-supported decisions, the patients will be able to manage their diet, exercise and medication.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Bangladesh
      • Dhaka, Bangladesh
        • Grameen Caledonian College of Nursing (GCCN)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients who have been diagnosed as type 2 diabetes
  • Both sexes
  • Age18-75 years old
  • Who will have a smartphone or mobile phone
  • Who are willing to participate / give us the consent

Exclusion Criteria:

  • Patients who have been diagnosed as Type 1 and gestational diabetes
  • Patients whose diabetes is secondary causes
  • Patients who have complication of CKD stage 5
  • Patients whose HbA1c is less than 7.0% past 1 year with CKD stage 1 or 2, no complications or complications with good control, having enough knowledge (had education before) and implemented good practice regarding diabetes management assessed by the research nurses (hereafter "the nurses")
  • Disabled persons who need other person's support for daily living

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Pre- and post-intervention design
After enrollment patients receive 'Health Education'. Then patients receive weekly follow up monitoring over phone call for 1st month, then biweekly from 2nd month to 6th month follow up over phone call and at the end of 6 month, group evaluation for 1 hour and endline data will be collected by the nurses at the PHC.
Behavioral: Health Education

Provide 'Health Education' for acquisition of self-management skills, acquiring knowledge of both the disease and self-care. By making self-supported decisions, the patients are able to manage their diet, exercise and medication.

Patients will start implementing diabetes management right after the group education. Each patient will develop monthly goal settings (behavior change plan) related to their diabetes management, daily practice them, and record the results every day on the self-monitoring notebook. The nurses call each patient on the scheduled day, ask/evaluate his/her behavior changes and monitored data, then make "step-up goals" for the next month. In addition, based on his/her knowledge and practice level, the nurses provide education using the education booklet. Patients and the nurses repeat these activities during 6 months.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in HbA1c
Time Frame: From enrollment to 6 months
Change HbA1c level between baseline and endline.
From enrollment to 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Operational feasibility of the system (Qualitative)
Time Frame: From enrollment to 6 months
Interview to the nurses, PHC staff Any issues and obstacles
From enrollment to 6 months
Patient feasibility (qualitative and quantitative)
Time Frame: From enrollment to 6 months
Engagement rate, Follow-up rate, Satisfaction, Nurse education, Education booklet used, Self-monitoring booklet used, Material will be combined to report patient feasibility. Satisfaction scale has 6 items, 0-5 point, higher point indicates better outcome.
From enrollment to 6 months
Fasting blood sugar or random blood sugar
Time Frame: From enrollment to 6 months
Change the value of fasting blood sugar or random blood sugar from baseline to endline
From enrollment to 6 months
Hospitalized by complication
Time Frame: From enrollment to 6 months
Count the number of hospitalization
From enrollment to 6 months
Economical evaluation
Time Frame: At 6th month
Cost-effectiveness analysis by using questionnaire
At 6th month
Behavior modification (quantitative and qualitative)
Time Frame: From enrollment up to 6 months
Achievement of monthly set goals, Behavior change (Lifestyle behavior questionnaire), 0-5 score, higher is better
From enrollment up to 6 months
Blood pressure
Time Frame: From enrollment up to 6 months
Change the value of blood pressure from baseline to endline
From enrollment up to 6 months
Body mass index
Time Frame: From enrollment up to 6 months
Change the value of body mass index from baseline to endline
From enrollment up to 6 months
Non-high-density lipoprotein cholesterol
Time Frame: From enrollment up to 6 months
Change the value of non-high-density lipoprotein cholesterol from baseline to endline
From enrollment up to 6 months
Triglyceride
Time Frame: From enrollment up to 6 months
Change the value of triglyceride from baseline to endline
From enrollment up to 6 months
Estimated glomerular filtration (eGFR)
Time Frame: From enrollment up to 6 months
Change the value of estimated glomerular filtration (eGFR) from baseline to endline
From enrollment up to 6 months
Urine albumin
Time Frame: From enrollment up to 6 months
Change the value of urine albumin from baseline to endline
From enrollment up to 6 months
Newly diagnosed diseases (any)
Time Frame: From enrollment up to 6 months
Count the number of newly diagnosed diseases
From enrollment up to 6 months
Medication/treatment change
Time Frame: From enrollment up to 6 months
Count the times of medication/treatment change and describe the change (better or worse)
From enrollment up to 6 months
Death
Time Frame: From enrollment up to 6 months
Count the number of death participants
From enrollment up to 6 months
Adverse events
Time Frame: From enrollment up to 6 months
Count the number of all adverse events
From enrollment up to 6 months
Compliance of eye check (clinic visit), ECG (cardiovascular check) and Lab test
Time Frame: From enrollment up to 6 months
Count the number of participants who follow nurses' advice to visit eye check, ECG check and laboratory testing
From enrollment up to 6 months
Change the self-efficacy
Time Frame: From enrollment to 6 months
Self-efficacy is measured by the Diabetes Management Self-Efficacy Scale, 5 domain, 20 questions, scale 1-5, higher number indicates more self efficacy
From enrollment to 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hiroshima University

Collaborators

Grameen Caledonian College of Nursing

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 26, 2024

Primary Completion (Actual)

September 30, 2025

Study Completion (Actual)

September 30, 2025

Study Registration Dates

First Submitted

September 20, 2024

First Submitted That Met QC Criteria

October 7, 2024

First Posted (Actual)

October 9, 2024

Study Record Updates

Last Update Posted (Actual)

March 23, 2026

Last Update Submitted That Met QC Criteria

March 18, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BMRC/NREC/2022-2025/336

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

IPD not be shared to maintain the individual participants privacy.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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