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

NCT06632652 | Completed

• 1 other identifier: BMRC/NREC/2022-2025/336
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Diabetes Mellitus

Keywords

telenursing; health education; lifestyle modification; diabetes

Outcome Measures

Primary Outcomes (1)

• Change in HbA1c

  Change HbA1c level between baseline and endline.

  From enrollment to 6 months

Secondary Outcomes (18)

• Change the self-efficacy

  From enrollment to 6 months

• Operational feasibility of the system (Qualitative)

  From enrollment to 6 months

• Patient feasibility (qualitative and quantitative)

  From enrollment to 6 months

• Fasting blood sugar or random blood sugar

  From enrollment to 6 months

• Hospitalized by complication

  From enrollment to 6 months

Study Arms (1)

Pre- and post-intervention design

EXPERIMENTAL

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

Interventions

Health Education BEHAVIORAL

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.

Pre- and post-intervention design

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hiroshima University: lead
• Grameen Caledonian College of Nursing: collaborator

Study Sites (1)

Grameen Caledonian College of Nursing (GCCN)

Dhaka, Bangladesh

Location

Related Publications (1)

• Moriyama M, Huq KATME, Mondol L, Mita AR, Nahar NS. Telenursing Health Education and Lifestyle Modification Among Patients With Diabetes in Bangladesh: Protocol for a Pilot Study With a Quasi-experimental Pre- and Postintervention Design. JMIR Res Protoc. 2025 May 9;14:e71849. doi: 10.2196/71849.

  PMID: 40343747 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus; Health Education

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Adherence Interventions; Medication Adherence; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: A quasi-experimental pre- and post-intervention design will be implemented. Investigators will enroll the participants and collect baseline data and then investigators will educate participants, and after 6 months investigators will evaluate participants and compare the baseline (pretest) and endline (posttest) data of individual participants.

Study Record Dates

• First Submitted: September 20, 2024
• First Posted: October 9, 2024
• Study Start: October 26, 2024
• Primary Completion: September 30, 2025
• Study Completion: September 30, 2025
• Last Updated: March 23, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

BA (1)