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临床试验/NCT04094831
NCT04094831Unknown不适用

Community-based Screening to Determine the Prevalence, Current Health and Nutritional Status of Individuals With Chronic Kidney Disease (CKD) and Measure the Outcome of Health Education to Enhance Knowledge, Awareness and Risk Reduction Strategies in Mirzapur Sub-district, Bangladesh

International Centre for Diarrhoeal Disease Research, Bangladesh2 个研究点 分布在 1 个国家目标入组 126 人开始时间: 2020年7月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
126
试验地点
2
主要终点
Chronic Kidney Disease Knowledge Questionnaire

研究概览

简要总结

Background: Chronic kidney disease (CKD) is a global public health concern. Currently 10-16% adults are affected with CKD. Adult individuals from low- and middle-income countries are at higher risk of developing CKD and End stage renal disease (ESRD). Preventive and risk reduction measures have potentials to reduce the disease progression; however, population in general from developing countries are yet to be properly aware about all these strategies that may help reduction in progression of CKD.

Knowledge gap: Specific studies are grossly lacking about CKD prevalence, its associated factors, and the knowledge and awareness about preventive and risk reduction strategies among adults with CKD in rural and peri-urban Bangladesh. Moreover, knowledge gaps still exist about the role of Protein Energy Wasting (PEW), physical activities, medication adherence, dietary practice, salt restriction behaviours, etc. in influencing progression of CKD.

Relevance: It has become essential to know more about the burden of CKD, its associated factors, current knowledge and awareness about healthy practices related to CKD and formulation of appropriate preventive and risk reduction strategies that will have potentials in reducing the progression of CKD in rural and peri-urban Bangladesh. The health education program for population in general and CKD individuals in particular will help in achieving meaningful results.

Hypothesis:Health education about CKD and its preventive and risk reduction strategies will enhance the knowledge, awareness, and motivation for healthy practices among the residents of demographic surveillance system (DSS) area with CKD.

Objectives:

To implement and evaluate impact of a health education program in order to enhance knowledge, awareness, and motivation about healthy practices among rural adults suffering from CKD.

Methods:

A community based randomized controlled effectiveness trial (RCT) Study site: DSS area of Mirzapur sub-district under Tangail, Bangladesh.

Outcome measures:

Primary outcomes: Changes of scores of Australian CKD knowledge questionnaire Secondary outcomes: Awareness, Quality of life (QOL), and healthy practices leading to maintenance of blood pressure, blood sugar and body weight within normal ranges by the adult CKD individuals.

详细描述

This would be a community-based randomized controlled trial (RCT) among the individuals diagnosed as having CKD with stage 1-3 who agreed to participate.

Registration/Enrolment of participants:

Community health workers (CHWs) will perform home -visits to obtain written informed consent, perform physical examination, and interview the respondents administering field tested questionnaires.

Interviewing by administering a structured questionnaire: if changed from Study 1: Age, gender, marital status, occupation, educational background, income/month, participant's current medical history including medication use, past medical history, sleeping hours, and family history (3rd generation) including current and immediate past medical history.

Physical examinations will be performed to measure: Blood pressure, pulse, height, weight, waist circumference, hip circumference, triceps skin fold (TSF), mid-upper arm circumference (MUAC), body mass index (BMI) and mid-arm muscle circumference (MAMC).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Double (Participant, Care Provider)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • All diagnosed CKD patients with stage 1-3 from Study 1
  • Who gave written informed consent to participate in the study.
  • At least 1-5 years of schooling
  • Using mobile phone at house

排除标准

  • CKD participants with stage 4-
  • Not willing to participate in the study

结局指标

主要结局

Chronic Kidney Disease Knowledge Questionnaire

时间窗: 6 months after the intervention

The questionnaire consisted a total of 24 questions with the multiple-choice options 'True', 'False' and 'I don't know'. Correct responses were given a score of 1 and incorrect responses were given a score of 0. The option 'I don't know' was considered as lack of knowledge and given a score of 0. Score \<50% considered as poor. The questionnaire consisted a total of 24 questions with the multiple-choice options 'True', 'False' and 'I don't know'. Correct responses were given a score of 1 and incorrect responses were given a score of 0. The option 'I don't know' was considered as lack of knowledge and given a score of 0. Score \<50% considered as poor.

次要结局

  • EURO- Quality of Life questionnaire (5 EURO-QOL questionnaire)(at 3 months and 6 months of intervention)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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