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

Hiroshima University

Status: Not yet enrolling

Conditions: Diabetes Mellitus

Treatments: Behavioral: Health Education

Study type: Interventional

Funder types: Other

Identifiers

NCT06632652

BMRC/NREC/2022-2025/336

Details and patient eligibility

About

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.

Enrollment: 70 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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70 participants in 1 patient group

Pre- and post-intervention design

Experimental group

Description:

After enrollment patients receive 'Health Education'. Then patients receive weekly follow up monitoring over phone call for 3 months. After 3 months, patients are requested to visit the Primary Health Care Center (PHC) for follow-up by physician and lab test. From 4-6 months, they receive bi-weekly 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.

Treatment:

Behavioral: Health Education