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

Primary Purpose

Chronic Kidney Disease (CKD)

Status
Unknown status
Phase
Not Applicable
Locations
Bangladesh
Study Type
Interventional
Intervention
Health education
Sponsored by
International Centre for Diarrhoeal Disease Research, Bangladesh
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Chronic Kidney Disease (CKD)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

  • icddr,b Mirzapur Field site

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Intervention arm

Control

Arm Description

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

No intervention

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

EURO- Quality of Life questionnaire (5 EURO-QOL questionnaire)
This questionnaire based on 5 Dimensions, five-level version questionnaire. This scale is numbered from 0 to 100. 100 mean the best health you can imagine.

Full Information

First Posted
September 17, 2019
Last Updated
September 30, 2021
Sponsor
International Centre for Diarrhoeal Disease Research, Bangladesh
Collaborators
Hiroshima University, Child Health Research Foundation, Bangladesh
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1. Study Identification

Unique Protocol Identification Number
NCT04094831
Brief Title
Community-based Screening of Chronic Kidney Disease (CKD) and Measure the Impact of Health Education
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Unknown status
Study Start Date
July 1, 2020 (Actual)
Primary Completion Date
December 30, 2021 (Anticipated)
Study Completion Date
December 30, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
International Centre for Diarrhoeal Disease Research, Bangladesh
Collaborators
Hiroshima University, Child Health Research Foundation, Bangladesh

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
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). Blood sample (at hospital) Serum creatinine (estimate eGFR), serum albumin, Hb%, FBS, HbA1C, lipid profile (TP, HDL-c, LDL-c, triglyceride, and ratio: estimate non-HDL), serum uric acid, Urea (BUN). Urine specimens (at hospital) Albumin to creatinine ratio (ACR), urine RME, urine Na (calculate sodium intake) Questionnaires/Interviewing : Chronic Kidney Disease Knowledge Questionnaire (24 questions) Awareness question (1 question) QOL (5 EURO-QOL questionnaire) Randomisation: A simple randomization (1:1) either intervention group or control group will be undertaken following a computer-generated random number sequence. An experienced statistician, who will not be involved in the study in any way, will prepare the randomization table and list of study participants' numbers with corresponding intervention allocations for CKD individual in serially numbered sealed envelopes according to randomization schedule to correspond to the serial number of the CKD individuals. These envelopes will be kept in an office locker. Allocation will be concealed in identical sealed envelopes that will only be opened when the study participant is ready for enrolment. This will take place after a CKD individual has been enrolled in the study following obtaining voluntarily informed written consent and assigning a study number. Necessary attempts will be made to keep CHWs unaware about case/control status of the participants. Similar approach will also be followed at the time of data analysis. Study contents: 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, education through mHealth will be provided by Short Message Service (SMS) during the study period. The contents of the SMS are: 1). Reduce salt intake; 2) Do exercise and take medicine regularly; 3). Control blood pressure (if hypertensive) and blood sugar (if diabetic); and 4) Avoid painkiller and smoking will be sent to the participants using mobile phone once a week for first 2.5 months and once a 2-week for next 3 months. The CKD knowledge questionnaire consisted a total of 24 questions with the multiple-choice options 'true', 'false' and 'I don't know'. The validated questionnaire will be adapted according to Bangldesh context and will be pre-tested before starting the study. The quality of life will be assessed using an adapted and validated Bangla version of the 5 EURO-QOL questionnaire. It has five domains: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Sample size calculation: Assuming that proportion of knowledge and awareness among CKD patients at baseline as 30%; and at the end of six months it will increase to 70% (intervention group) and 40% (control group). Therefore, considering 90% power and 20% loss to follow-up the total sample size will be 136 (68 in each group). Data analysis: The descriptive statistics will be expressed as frequency, mean, median, cross tabulation, and standard deviation. Chi-square test, t-test or Mann-Whitney U-test will be performed to see the differences between intervention group and control group at baseline, 3 and 6 months. Multiple comparisons will be performed by ANOVA test for evaluation of the outcome variables such as CKD knowledge and awareness questionnaire and QOL at baseline, 3 and 6 months. Data will be analyzed using SPSS ver. 22.0 (IBM Co., Armonk, NY) and the significance level will be set at the level of p < 5%.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Disease (CKD)

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
126 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention arm
Arm Type
Active Comparator
Arm Description
Intervention group (Health education through CKD campaign and mHealth) technology
Arm Title
Control
Arm Type
Active Comparator
Arm Description
No intervention
Intervention Type
Other
Intervention Name(s)
Health education
Intervention Description
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
Primary Outcome Measure Information:
Title
Chronic Kidney Disease Knowledge Questionnaire
Description
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.
Time Frame
6 months after the intervention
Secondary Outcome Measure Information:
Title
EURO- Quality of Life questionnaire (5 EURO-QOL questionnaire)
Description
This questionnaire based on 5 Dimensions, five-level version questionnaire. This scale is numbered from 0 to 100. 100 mean the best health you can imagine.
Time Frame
at 3 months and 6 months of intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: CKD participants with stage 4-5. Not willing to participate in the study
Facility Information:
Facility Name
icddr,b Mirzapur Field site
City
Tangail
ZIP/Postal Code
1212
Country
Bangladesh

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35969429
Citation
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.
Results Reference
derived
PubMed Identifier
34806998
Citation
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.
Results Reference
derived

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

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