Diabetes Mellitus
Conditions
Keywords
telenursing, health education, lifestyle modification, diabetes
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.
Interventions
BEHAVIORALHealth Education
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.
Sponsors
Hiroshima University
Grameen Caledonian College of Nursing
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in HbA1c | From enrollment to 6 months | Change HbA1c level between baseline and endline. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change the self-efficacy | 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 |
| Operational feasibility of the system (Qualitative) | From enrollment to 6 months | Interview to the nurses, PHC staff Any issues and obstacles |
| Patient feasibility (qualitative and quantitative) | 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. |
| Fasting blood sugar or random blood sugar | From enrollment to 6 months | Change the value of fasting blood sugar or random blood sugar from baseline to endline |
| Hospitalized by complication | From enrollment to 6 months | Count the number of hospitalization |
| Economical evaluation | At 6th month | Cost-effectiveness analysis by using questionnaire |
| Behavior modification (quantitative and qualitative) | From enrollment up to 6 months | Achievement of monthly set goals, Behavior change (Lifestyle behavior questionnaire), 0-5 score, higher is better |
| Blood pressure | From enrollment up to 6 months | Change the value of blood pressure from baseline to endline |
| Body mass index | From enrollment up to 6 months | Change the value of body mass index from baseline to endline |
| Non-high-density lipoprotein cholesterol | From enrollment up to 6 months | Change the value of non-high-density lipoprotein cholesterol from baseline to endline |
| Triglyceride | From enrollment up to 6 months | Change the value of triglyceride from baseline to endline |
| Estimated glomerular filtration (eGFR) | From enrollment up to 6 months | Change the value of estimated glomerular filtration (eGFR) from baseline to endline |
| Urine albumin | From enrollment up to 6 months | Change the value of urine albumin from baseline to endline |
| Newly diagnosed diseases (any) | From enrollment up to 6 months | Count the number of newly diagnosed diseases |
| Medication/treatment change | From enrollment up to 6 months | Count the times of medication/treatment change and describe the change (better or worse) |
| Death | From enrollment up to 6 months | Count the number of death participants |
| Adverse events | From enrollment up to 6 months | Count the number of all adverse events |
| Compliance of eye check (clinic visit), ECG (cardiovascular check) and Lab test | From enrollment up to 6 months | Count the number of participants who follow nurses' advice to visit eye check, ECG check and laboratory testing |
Countries
Bangladesh
Outcome results
None listed