Effectiveness of Integrated Care on Delaying Chronic Kidney Disease Progression in Rural Communities of Thailand (ESCORT)
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|ClinicalTrials.gov Identifier: NCT01978951|
Recruitment Status : Completed
First Posted : November 8, 2013
Last Update Posted : April 1, 2014
|Condition or disease||Intervention/treatment||Phase|
|Chronic Kidney Disease||Behavioral: Integrated Chronic Kidney Disease care Behavioral: Conventional CKD care||Not Applicable|
Background The unique characteristic of community-health care in Thailand is a system of primary- health care officers and Village Health Volunteers (VHVs) providing basic health care to more than 90% of Thai population. Should these allied personnel be trained on how to render proper chronic kidney disease (CKD) care, it would be interesting to study whether their role play care will result in better quality of CKD care.
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||443 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Effectiveness of Integrated Care on Delaying Chronic Kidney Disease Progression in Rural Communities of Thailand (ESCORT Study)|
|Study Start Date :||July 2011|
|Actual Primary Completion Date :||July 2013|
|Actual Study Completion Date :||December 2013|
Experimental: 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
Behavioral: 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.
Other Name: Multidisciplinary team + Community CKD care network
Active Comparator: Conventional CKD care
standard guidelines of CKD treatment
Behavioral: Conventional CKD care
group counselling about optimal diets for CKD patients
Other Name: group counselling
- The difference of rate of estimated glomerular filtration rate (eGFR) decline [ Time Frame: 30 months ]We compare the difference of rate of estimated glomerular filtration rate (eGFR) decline between intervention group and control group from baseline to the end of the study.
- Cardiovascular Morbidity or Event [ Time Frame: 24 months ]The definitions of cardiovascular event in this study are the numbers of myocardial infarction, stroke including ischemic and hemorrhagic event.
- Incidence of Initiation of Renal Replacement Therapy [ Time Frame: 24 months ]Incidence of initiation of renal replacement therapy consisting of hemodialysis, peritoneal dialysis, and kidney transplantation.
- Hospitalization [ Time Frame: 24 months ]The definitions of hospitalization in the study are any medical problem that relevant to cardiovascular disease and kidney problem which physician decide to admit the patients.
- Change from baseline in Systolic Blood Pressure at 24 months [ Time Frame: 24 months ]Blood pressure will be recorded twice with a sphygmomanometer with a 15-minute rest interval during each hospital visit of both groups
- Change from baseline in amount of proteinuria at 24 months [ Time Frame: 24 months ]Changes in amount of proteinuria which is measured by using urine protein-creatinine ratio.
- Change from Baseline in Hemoglobin A1C at 24 months [ Time Frame: 24 months ]We compare the difference of hemoglobin A1C of diabetic patients between intervention and control group.
- Change from baseline in 24 hour urine sodium at 24 months [ Time Frame: 24 months ]To evaluate amount of sodium intake, we compare the difference of 24 hour urine sodium between intervention group and control group.
- Change from baseline in Protein Intake at 24 months [ Time Frame: 24 months ]We compare the amount of protein intake by using normalized Protein Nitrogen Appearance, which will be calculated from 24 hour urine urea and ideal body weight.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01978951
|Bhumirajanagarindra Kidney Institute|
|Bangkok, Thailand, 10400|
|Principal Investigator:||Teerayuth Jiamjariyaporn, M.D.||Bhumirajanagarindra Kidney Institute|