AzTrials
AzTrials

Diabetes MellitusNCT06632652

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

A study testing Health Education in people with Diabetes Mellitus, run by Hiroshima University at 1 site in Bangladesh.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Diabetes Mellitus
What is being tested?
Health Education
Could I receive a placebo?
No, everyone receives an active treatment
How many people
70 participants
Where
1 siteBangladesh
Study dates
26 Oct 2024to 30 Sep 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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 locations and contacts

1 site in 1 country.

Bangladesh1 site

  • Grameen Caledonian College of Nursing (GCCN)

    Dhaka

Other trials in Bangladesh

About this study

Official title: 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.

Being tested
Health Education
Keywords
telenursing, health education, lifestyle modification, diabetes
Medical subject headings
Diabetes Mellitus, Health Education

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Health EducationBehavioural

    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.

Study groups in NCT06632652
Study groupRoleWhat they receive
Pre- and post-intervention designExperimentalAfter 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.
Receives: Behavioral: Health Education

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in HbA1c

    Change HbA1c level between baseline and endline.

    Measured: From enrollment to 6 months

Secondary outcomes (18)

  1. Change the self-efficacy

    Self-efficacy is measured by the Diabetes Management Self-Efficacy Scale, 5 domain, 20 questions, scale 1-5, higher number indicates more self efficacy

    Measured: From enrollment to 6 months

  2. Operational feasibility of the system (Qualitative)

    Interview to the nurses, PHC staff Any issues and obstacles

    Measured: From enrollment to 6 months

  3. Patient feasibility (qualitative and quantitative)

    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.

    Measured: From enrollment to 6 months

  4. Fasting blood sugar or random blood sugar

    Change the value of fasting blood sugar or random blood sugar from baseline to endline

    Measured: From enrollment to 6 months

  5. Hospitalized by complication

    Count the number of hospitalization

    Measured: From enrollment to 6 months

  6. Economical evaluation

    Cost-effectiveness analysis by using questionnaire

    Measured: At 6th month

  7. Behavior modification (quantitative and qualitative)

    Achievement of monthly set goals, Behavior change (Lifestyle behavior questionnaire), 0-5 score, higher is better

    Measured: From enrollment up to 6 months

  8. Blood pressure

    Change the value of blood pressure from baseline to endline

    Measured: From enrollment up to 6 months

  9. Body mass index

    Change the value of body mass index from baseline to endline

    Measured: From enrollment up to 6 months

  10. Non-high-density lipoprotein cholesterol

    Change the value of non-high-density lipoprotein cholesterol from baseline to endline

    Measured: From enrollment up to 6 months

  11. Triglyceride

    Change the value of triglyceride from baseline to endline

    Measured: From enrollment up to 6 months

  12. Estimated glomerular filtration (eGFR)

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

    Measured: From enrollment up to 6 months

  13. Urine albumin

    Change the value of urine albumin from baseline to endline

    Measured: From enrollment up to 6 months

  14. Newly diagnosed diseases (any)

    Count the number of newly diagnosed diseases

    Measured: From enrollment up to 6 months

  15. Medication/treatment change

    Count the times of medication/treatment change and describe the change (better or worse)

    Measured: From enrollment up to 6 months

  16. Death

    Count the number of death participants

    Measured: From enrollment up to 6 months

  17. Adverse events

    Count the number of all adverse events

    Measured: From enrollment up to 6 months

  18. Compliance of eye check (clinic visit), ECG (cardiovascular check) and Lab test

    Count the number of participants who follow nurses' advice to visit eye check, ECG check and laboratory testing

    Measured: From enrollment up to 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Oct 2024
  2. Study start26 Oct 2024
  3. Primary completion30 Sep 2025
  4. Study completion30 Sep 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Not applicable
Intervention model
Single group
Model description
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.
Masking
None (open label)
Enrolment
70 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06632652
Sponsor's protocol ID
BMRC/NREC/2022-2025/336
Status last verified
Mar 2026
First submitted
20 Sep 2024
Last updated
23 Mar 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: IPD not be shared to maintain the individual participants privacy.

Publications

  • 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.

    PubMed 40343747

Questions about this trial

What is this clinical trial studying?

A study testing Health Education in people with Diabetes Mellitus, run by Hiroshima University at 1 site in Bangladesh.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Bangladesh. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in HbA1c (time frame: From enrollment to 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06632652, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2026.

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