Progression of chronic kidney disease in patients with hypertension or type 2 diabetes mellitus, can it be delayed?

A quantitative approach with quasi-experimental, one group pretest- posttest design was used in this study. The aim of this study was to find the effect of a Disease Management Program (DMP) on delaying progression of Chronic Kidney Disease in patients with hypertension or type 2 diabetes mellitus. The participants were the people diagnosed with hypertension and/or diabetes for five or more year's duration and treatment. People visiting rural health centers of Udupi District, Karnataka State, India, aged 30 years and above were the sampled population selected through enumerative sampling technique. Sample size calculated to reach statistical significance with a power of 0.8, a standard deviation of eight, decline in eGFR in one year of five, and significance level 0.05, the total sample required was 22 each in stages 1, 2, and 3 of CKD. Keeping a 5% nonresponse rate total sample estimated was 70. The Chronic Kidney Disease stage was known after the serum creatinine test and formula application; hence the total sample taken was 103. Out of 103, for one year, 15 participants failed to follow up and hence 88 samples were analyzed. Study instruments The data were collected using demographic proforma which includes, age, gender, height, weight, serum creatinine, blood pressure, and RBS, hypertension, and diabetes mellitus status, and duration of illness. A calibrated weighing scale was used to measure the weight. New measuring tape, sphygmomanometer, and glucometer were used to assess the height, blood pressure, and blood sugar, respectively. The intervention, DMP, refers to educating the participants about the management of hypertension or diabetes mellitus on a one-to-one basis (explaining and giving leaflets) and follows up on every fourth month, till one year, with teaching reinforcement along with random blood sugar and blood pressure assessment, as well. Development of the education module and leaflet about hypertension and diabetes mellitus was prepared by the researcher by reviewing the published and unpublished literature and validated by experts. The education module contains the meaning, causes and risk factors, signs and symptoms, diagnosis, and management. Management included nutrition, exercise, monitoring of blood sugar and blood pressure, pharmacologic therapy. An explanation about the disease is given in a simple, understandable way, and doubts raised by patients were cleared. Complications were explained to improve the compliance level. The importance of exercise, nutrition, and compliance with medication in controlling blood sugar and blood pressure were also explained. The researcher filled the demographic proforma by collecting information from the participants and assessed height, weight, blood pressure, and Random Blood Sugar (RBS). Blood for serum creatinine was collected using serum vacutainer and assessed using the standard Jaffe method calibrated to Isotope Dilution Mass Spectrometry (IDMS). CKD-EPI formula was used to estimate GFR. Teaching was given about managing hypertension and diabetes mellitus, and a leaflet about the same was distributed during the baseline data collection. Fourth and eighth-month blood pressure and RBS were reassessed, and teaching was reinforced. At one-year blood pressure, RBS, and serum creatinine were tested. Study variables Demographic variables were age, gender, serum creatinine height, and weight. Teaching regarding management of Hypertension and Diabetes Mellitus is the independent variable. Blood pressure and RBS were the dependent variables that affect kidney function and eGFR is the key variable. Other variables are disease conditions (Diabetes Mellitus or Hypertension or both) and duration of illness..

本研究采用类实验性单组前测-后测设计的定量研究方法，旨在探究疾病管理计划(Disease Management Program, DMP)对高血压或2型糖尿病患者慢性肾脏病(Chronic Kidney Disease, CKD)进展的延缓效果。

本研究纳入确诊高血压和/或糖尿病且病程及治疗时长≥5年的人群；抽样人群为印度卡纳塔克邦乌杜皮县农村卫生中心就诊的30岁及以上居民，采用枚举抽样法选取研究样本。

基于检验效能0.8、标准差8、1年估算肾小球滤过率(estimated glomerular filtration rate, eGFR)下降值5、显著性水平0.05，计算得出达到统计学显著性所需的样本量：慢性肾脏病1、2、3期每组各需22例样本。考虑5%的无应答率，预计总样本量为70例。最终通过血清肌酐检测结合公式计算明确慢性肾脏病分期后，实际纳入总样本量为103例。1年随访期间共有15例受试者失访，最终纳入分析的有效样本为88例。

本研究采用人口学问卷收集数据，问卷内容涵盖年龄、性别、身高、体重、血清肌酐、血压、随机血糖(Random Blood Sugar, RBS)、高血压及糖尿病患病状态与病程。体重测量使用经校准的体重秤；身高、血压、血糖分别采用全新卷尺、血压计及血糖仪进行测量。

本研究的干预措施为疾病管理计划(DMP)，具体为通过一对一方式对受试者开展高血压或糖尿病管理教育，包括现场讲解及发放宣教手册，并每4个月进行1次随访，全程持续1年；随访期间将强化健康教育内容，同时检测受试者的随机血糖与血压。本研究的健康教育模块与宣教手册由研究者通过查阅已发表及未发表文献开发，并经专家论证。模块内容包含疾病定义、病因与危险因素、临床表现、诊断方法及管理方案，其中管理方案涵盖营养指导、运动锻炼、血糖与血压监测及药物治疗。教育过程采用通俗易懂的语言讲解疾病知识，解答受试者提出的疑问，并通过讲解并发症相关知识提升受试者的治疗依从性，同时强调运动、营养及遵医嘱用药对控制血糖与血压的重要性。

研究者通过采集受试者信息填写人口学问卷，并测量其身高、体重、血压及随机血糖。血清肌酐标本采用真空采血管采集，经校准至同位素稀释质谱法(Isotope Dilution Mass Spectrometry, IDMS)的标准Jaffe法进行检测。采用CKD-EPI公式估算肾小球滤过率。在基线数据收集阶段，研究者向受试者讲解高血压与糖尿病的管理知识并发放对应宣教手册。分别于随访第4、8个月复测血压与随机血糖，并强化健康教育内容。随访满1年时，再次检测受试者的血压、随机血糖及血清肌酐。

本研究的人口学变量包括年龄、性别、血清肌酐、身高与体重。高血压与糖尿病管理健康教育为自变量；血压与随机血糖为影响肾功能的因变量，估算肾小球滤过率为核心研究变量。其余研究变量包括疾病类型，即糖尿病、高血压或二者兼具，及病程。