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Completed

NCT Number: NCT06632652

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Grameen Caledonian College of Nursing (GCCN)

Dhaka, Bangladesh

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Change in HbA1c

    Time frame: From enrollment to 6 months

    Change HbA1c level between baseline and endline.

Secondary outcomes

  1. 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

  2. Operational feasibility of the system (Qualitative)

    Time frame: From enrollment to 6 months

    Interview to the nurses, PHC staff Any issues and obstacles

  3. 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.

  4. 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

  5. Hospitalized by complication

    Time frame: From enrollment to 6 months

    Count the number of hospitalization

  6. Economical evaluation

    Time frame: At 6th month

    Cost-effectiveness analysis by using questionnaire

  7. 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

  8. Blood pressure

    Time frame: From enrollment up to 6 months

    Change the value of blood pressure from baseline to endline

  9. Body mass index

    Time frame: From enrollment up to 6 months

    Change the value of body mass index from baseline to endline

  10. 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

  11. Triglyceride

    Time frame: From enrollment up to 6 months

    Change the value of triglyceride from baseline to endline

  12. Estimated glomerular filtration (eGFR)

    Time frame: From enrollment up to 6 months

    Change the value of estimated glomerular filtration (eGFR) from baseline to endline

  13. Urine albumin

    Time frame: From enrollment up to 6 months

    Change the value of urine albumin from baseline to endline

  14. Newly diagnosed diseases (any)

    Time frame: From enrollment up to 6 months

    Count the number of newly diagnosed diseases

  15. 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)

  16. Death

    Time frame: From enrollment up to 6 months

    Count the number of death participants

  17. Adverse events

    Time frame: From enrollment up to 6 months

    Count the number of all adverse events

  18. 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

Sponsors and collaborators

Lead sponsor

Hiroshima University

Other

Collaborators

  • Grameen Caledonian College of Nursing

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Oct 9, 2024
Registry last updated
Mar 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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