Community-based Screening of Chronic Kidney Disease (CKD) and Measure the Impact of Health Education

NCT04094831 | Unknown

• 1 other identifier: PR-19081
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Chronic Kidney Disease (CKD)

Outcome Measures

Primary Outcomes (1)

• Chronic Kidney Disease Knowledge Questionnaire

  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.

  6 months after the intervention

Secondary Outcomes (1)

• EURO- Quality of Life questionnaire (5 EURO-QOL questionnaire)

  at 3 months and 6 months of intervention

Study Arms (2)

Intervention arm

ACTIVE COMPARATOR

Intervention group (Health education through CKD campaign and mHealth) technology

Other: Health education

Control

ACTIVE COMPARATOR

No intervention

Other: Health education

Interventions

Health education OTHER

The intervention group will receive health education through CKD campaign and mHealth technology. During the half day CKD campaign, health education materials (leaflet and short textbook and recording notebook) will be provided to the study participants. A nephrologist will facilitate the campaign and contents (Annex-3) of the text book and leaflet (Annex-4) will be discussed. Important message from the text book (such as stage, risk factor, preventive measures) will be used to develop the leaflet. In addition,Basic health education information about CKD is included in the contents to help patients gain knowledge, awareness, and improve their behaviors. Discussion on basic kidney diseases, risk factors, and preventive measures of CKD is performing by CHWs over a mobile phone call to the study patients. The patients have the liberty to discuss their health-related issues with the CHWs over a period of 10 minutes

Control; Intervention arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• CKD participants with stage 4-5.
• Not willing to participate in the study

Sponsors & Collaborators

• International Centre for Diarrhoeal Disease Research, Bangladesh: lead
• Hiroshima University: collaborator
• Child Health Research Foundation, Bangladesh: collaborator

Study Sites (1)

icddr,b Mirzapur Field site

Tāngāil, 1212, Bangladesh

Location

Related Publications (2)

• Sarker MHR, Moriyama M, Rashid HU, Rahman MM, Chisti MJ, Das SK, Saha SK, Arifeen SE, Ahmed T, Faruque ASG. Chronic Kidney Disease Awareness Campaign and Mobile Health Education to Improve Knowledge, Quality of Life, and Motivation for a Healthy Lifestyle Among Patients With Chronic Kidney Disease in Bangladesh: Randomized Controlled Trial. J Med Internet Res. 2022 Aug 11;24(8):e37314. doi: 10.2196/37314.

  PMID: 35969429 DERIVED

• Sarker MHR, Moriyama M, Rashid HU, Rahman MM, Chisti MJ, Das SK, Jahan Y, Saha SK, Arifeen SE, Ahmed T, Faruque ASG. Health Education Through a Campaign and mHealth to Enhance Knowledge and Quality of Life Among Patients With Chronic Kidney Disease in Bangladesh: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2021 Nov 19;10(11):e30191. doi: 10.2196/30191.

  PMID: 34806998 DERIVED

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 17, 2019
• First Posted: September 19, 2019
• Study Start: July 1, 2020
• Primary Completion: December 30, 2021
• Study Completion: December 30, 2021
• Last Updated: October 1, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

BA (1)