Grameen Caledonian College of Nursing (GCCN)
Dhaka, Bangladesh
NCT Number: NCT06632652
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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Notify Me18 year–75 year
All sexes
Interventional
Not applicable
Dhaka, Bangladesh
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: From enrollment to 6 months
Change HbA1c level between baseline and endline.
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
Time frame: From enrollment to 6 months
Interview to the nurses, PHC staff Any issues and obstacles
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.
Time frame: From enrollment to 6 months
Change the value of fasting blood sugar or random blood sugar from baseline to endline
Time frame: From enrollment to 6 months
Count the number of hospitalization
Time frame: At 6th month
Cost-effectiveness analysis by using questionnaire
Time frame: From enrollment up to 6 months
Achievement of monthly set goals, Behavior change (Lifestyle behavior questionnaire), 0-5 score, higher is better
Time frame: From enrollment up to 6 months
Change the value of blood pressure from baseline to endline
Time frame: From enrollment up to 6 months
Change the value of body mass index from baseline to endline
Time frame: From enrollment up to 6 months
Change the value of non-high-density lipoprotein cholesterol from baseline to endline
Time frame: From enrollment up to 6 months
Change the value of triglyceride from baseline to endline
Time frame: From enrollment up to 6 months
Change the value of estimated glomerular filtration (eGFR) from baseline to endline
Time frame: From enrollment up to 6 months
Change the value of urine albumin from baseline to endline
Time frame: From enrollment up to 6 months
Count the number of newly diagnosed diseases
Time frame: From enrollment up to 6 months
Count the times of medication/treatment change and describe the change (better or worse)
Time frame: From enrollment up to 6 months
Count the number of death participants
Time frame: From enrollment up to 6 months
Count the number of all adverse events
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
Hiroshima University
Other
Establish Telenursing System by Providing Health Education and Lifestyle Modification Among Diabetic Patients in Bangladesh
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