Establish Telenursing System by Providing Health Education and Lifestyle Modification Among Diabetic Patients in Bangladesh
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Change in HbA1c
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Change in HbA1c
时间窗: From enrollment to 6 months
Change HbA1c level between baseline and endline.
次要结局
- Blood pressure(From enrollment up to 6 months)
- Death(From enrollment up to 6 months)
- Hospitalized by complication(From enrollment to 6 months)
- Economical evaluation(At 6th month)
- Behavior modification (quantitative and qualitative)(From enrollment up to 6 months)
- Adverse events(From enrollment up to 6 months)
- Operational feasibility of the system (Qualitative)(From enrollment to 6 months)
- Patient feasibility (qualitative and quantitative)(From enrollment to 6 months)
- Fasting blood sugar or random blood sugar(From enrollment to 6 months)
- Body mass index(From enrollment up to 6 months)
- Non-high-density lipoprotein cholesterol(From enrollment up to 6 months)
- Triglyceride(From enrollment up to 6 months)
- Estimated glomerular filtration (eGFR)(From enrollment up to 6 months)
- Urine albumin(From enrollment up to 6 months)
- Newly diagnosed diseases (any)(From enrollment up to 6 months)
- Medication/treatment change(From enrollment up to 6 months)
- Compliance of eye check (clinic visit), ECG (cardiovascular check) and Lab test(From enrollment up to 6 months)
- Change the self-efficacy(From enrollment to 6 months)
研究者
KATM Ehsanul Huq
Principal Investigator
Hiroshima University