Clinical trial NCT06632652: Telenursing System by Providing Health Education and Lifestyle Modification Among Diabetic Patients in Bangladesh
Official title: Establish Telenursing System by Providing Health Education and Lifestyle Modification Among Diabetic Patients in Bangladesh
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Diabetes Mellitus
Keywords: telenursing
health education
lifestyle modification
diabetes
Lead sponsor: Hiroshima University
Sponsor class: OTHER
Collaborators: name: Grameen Caledonian College of Nursing
First posted: 2024-10-09
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention 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.
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in HbA1c
timeFrame: From enrollment to 6 months
Secondary outcomes:
measure: Change the self-efficacy
timeFrame: From enrollment to 6 months
measure: Operational feasibility of the system (Qualitative)
timeFrame: From enrollment to 6 months
measure: Patient feasibility (qualitative and quantitative)
timeFrame: From enrollment to 6 months
measure: Fasting blood sugar or random blood sugar
timeFrame: From enrollment to 6 months
measure: Hospitalized by complication
timeFrame: From enrollment to 6 months
measure: Economical evaluation
timeFrame: At 6th month
measure: Behavior modification (quantitative and qualitative)
timeFrame: From enrollment up to 6 months
measure: Blood pressure
timeFrame: From enrollment up to 6 months
measure: Body mass index
timeFrame: From enrollment up to 6 months
measure: Non-high-density lipoprotein cholesterol
timeFrame: From enrollment up to 6 months
measure: Triglyceride
timeFrame: From enrollment up to 6 months
measure: Estimated glomerular filtration (eGFR)
timeFrame: From enrollment up to 6 months
measure: Urine albumin
timeFrame: From enrollment up to 6 months
measure: Newly diagnosed diseases (any)
timeFrame: From enrollment up to 6 months
measure: Medication/treatment change
timeFrame: From enrollment up to 6 months
measure: Death
timeFrame: From enrollment up to 6 months
measure: Adverse events
timeFrame: From enrollment up to 6 months
measure: Compliance of eye check (clinic visit), ECG (cardiovascular check) and Lab test
timeFrame: From enrollment up to 6 months
Other outcomes:
Locations:
city: Dhaka
country: Bangladesh
facility: Grameen Caledonian College of Nursing (GCCN)
Study officials:
References: