Effectiveness of Integrated Care on Delaying Chronic Kidney Disease Progression in Rural Communities of Thailand
NCT ID: NCT01978951
Last Updated: 2014-04-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
443 participants
INTERVENTIONAL
2011-07-31
2013-12-31
Brief Summary
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Detailed Description
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Design This study is a community-based cluster randomized controlled trial to be conducted in 2 districts of Kamphaeng Phet Province, located about 400 kilometers north of Bangkok. About 300 stage 3-4 CKD patients will be enrolled to each of the 2 treatment groups. Patients in both groups will be treated according to The National Kidney Foundation Kidney Disease Outcomes Quality Initiative guidelines. The District 1 (control group) patients will be provided a conventional CKD care. For the District 2 (intervention group) patients, an integrated CKD care program will be provided by the multidisciplinary team of district hospital in conjunction with the community CKD care networks (i.e. primary-health care officers and VHVs). The key activities of integrated CKD care program are live demonstration about treatment and optimal diets for CKD patients which will be provided during each hospital visit and quarterly home visits. Clinical and laboratory parameters of all cases will be assessed every 3 months. Duration of the study is 24 months. The primary outcome of this study is the rate of eGFR decline. The secondary outcomes are time of initiation of dialysis, cardiovascular mortality, and all-cause mortality.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Integrated Chronic Kidney Disease care
standard guidelines of CKD treatment + Integrated CKD care consisting of multidisciplinary team care and home visit by community care network
Integrated Chronic Kidney Disease care
Activities of integrated CKD care program, which will be provided during each hospital visit and quarterly home visits, are live demonstration about treatment and optimal diets for CKD patients, monitor drug compliance.
Conventional CKD care
standard guidelines of CKD treatment
Conventional CKD care
group counselling about optimal diets for CKD patients
Interventions
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Integrated Chronic Kidney Disease care
Activities of integrated CKD care program, which will be provided during each hospital visit and quarterly home visits, are live demonstration about treatment and optimal diets for CKD patients, monitor drug compliance.
Conventional CKD care
group counselling about optimal diets for CKD patients
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* eGFR are in a range of 15 - 59 ml/min/1.73m2 estimated twice at 3 months.
Exclusion Criteria
* active glomerular disease, obstructive uropathy, end-stage renal disease, HIV infection, pregnancy, body mass index (BMI) less than 18 or more than 40 kg/m2, being under treatment for malignancy, urine protein-creatinine ratio more than 3.5 g/g creatinine and active urinary sediment (urine red blood cells \>3 cells/high power field or urine white blood cells \>10 cells/high power field).
18 Years
70 Years
ALL
No
Sponsors
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Ministry of Health, Thailand
OTHER_GOV
Bhumirajanagarindra Kidney Institute, Thailand
OTHER
Responsible Party
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Dr.Teerayut Jiamjariyaporn
Principal Investigator, Nephrologist
Principal Investigators
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Teerayuth Jiamjariyaporn, M.D.
Role: PRINCIPAL_INVESTIGATOR
Bhumirajanagarindra Kidney Institute
Locations
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Bhumirajanagarindra Kidney Institute
Bangkok, Bangkok, Thailand
Countries
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References
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Jiamjariyapon T, Ingsathit A, Pongpirul K, Vipattawat K, Kanchanakorn S, Saetie A, Kanistanon D, Wongprompitak P, Leesmidt V, Watcharasaksilp W, Wang W, Chandraker AK, Tungsanga K. Effectiveness of Integrated Care on Delaying Progression of stage 3-4 Chronic Kidney Disease in Rural Communities of Thailand (ESCORT study): a cluster randomized controlled trial. BMC Nephrol. 2017 Mar 2;18(1):83. doi: 10.1186/s12882-016-0414-4.
Jiamjariyaporn T, Ingsathit A, Tungsanga K, Banchuin C, Vipattawat K, Kanchanakorn S, Leesmidt V, Watcharasaksilp W, Saetie A, Pachotikarn C, Taechangam S, Teerapornlertratt T, Chantarojsiri T, Sitprija V. Effectiveness of integrated care on delaying chronic kidney disease progression in rural communities of Thailand (ESCORT study): rationale and design of the study [NCT01978951]. BMC Nephrol. 2014 Jun 25;15:99. doi: 10.1186/1471-2369-15-99.
Other Identifiers
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#07-004
Identifier Type: -
Identifier Source: org_study_id
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