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

N/ANot Yet RecruitingNCT06632652

Hiroshima University70 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Interventions

Health EducationBEHAVIORAL

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Change in HbA1c

Change HbA1c level between baseline and endline.

Time frame: From enrollment to 6 months

Secondary Outcomes

Change the self-efficacy

Self-efficacy is measured by the Diabetes Management Self-Efficacy Scale, 5 domain, 20 questions, scale 1-10, higher number indicates more self efficacy

Time frame: From enrollment to 6 months

Operational feasibility of the system (Qualitative)

Interview to the nurses, PHC staff Any issues and obstacles

Time frame: From enrollment to 6 months

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.

Time frame: From enrollment to 6 months

Fasting blood sugar or random blood sugar

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

Time frame: From enrollment to 6 months

Hospitalized by complication

Count the number of hospitalization

Time frame: From enrollment to 6 months

Economical evaluation

Cost-effectiveness analysis by using questionnaire

Time frame: At 6th month

Behavior modification (quantitative and qualitative)

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