Effectiveness of Integrated Care on Delaying Chronic Kidney Disease Progression in Rural Communities of Thailand

Study Overview
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Brief Summary
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If primary health-care officers and Villages Health Volunteers (VHVs) be trained to render proper CKD care, it is interesting if their intimate relationship and commitment to their responsible village households will result in better outcomes when compared with the conventional care model as mention above. In this project, we plan to compare the effectiveness of a conventional care program against an integrated multidisciplinary CKD care program provided by nephrologists in conjunction with well-trained paramedical personnel and VHVs on CKD progression.

Detailed Description
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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.

Official Title
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Effectiveness of Integrated Care on Delaying Chronic Kidney Disease Progression in Rural Communities of Thailand (ESCORT Study)

Conditions
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Chronic Kidney Disease

Intervention / Treatment
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* Behavioral: Integrated Chronic Kidney Disease care
* Behavioral: Conventional CKD care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ages 18-70 years and known to have diabetes and/or hypertension. eGFR are in a range of 15 - 59 ml/min/1.73m2 estimated twice at 3 months. Exclusion Criteria: unstable/advanced cardiovascular disease 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).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Integrated Chronic Kidney Disease care<br>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<br>* 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.<br>* Other names: Multidisciplinary team + Community CKD care network;|
| Active Comparator: Conventional CKD care<br>standard guidelines of CKD treatment | Behavioral: Conventional CKD care<br>* group counselling about optimal diets for CKD patients<br>* Other names: group counselling;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The difference of rate of estimated glomerular filtration rate (eGFR) decline | 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. | 30 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiovascular Morbidity or Event | The definitions of cardiovascular event in this study are the numbers of myocardial infarction, stroke including ischemic and hemorrhagic event. | 24 months | 
| Incidence of Initiation of Renal Replacement Therapy | Incidence of initiation of renal replacement therapy consisting of hemodialysis, peritoneal dialysis, and kidney transplantation. | 24 months | 
| Hospitalization | 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. | 24 months | 
| Change from baseline in Systolic Blood Pressure at 24 months | Blood pressure will be recorded twice with a sphygmomanometer with a 15-minute rest interval during each hospital visit of both groups | 24 months | 
| Change from baseline in amount of proteinuria at 24 months | Changes in amount of proteinuria which is measured by using urine protein-creatinine ratio. | 24 months | 
| Change from Baseline in Hemoglobin A1C at 24 months | We compare the difference of hemoglobin A1C of diabetic patients between intervention and control group. | 24 months | 
| Change from baseline in 24 hour urine sodium at 24 months | To evaluate amount of sodium intake, we compare the difference of 24 hour urine sodium between intervention group and control group. | 24 months | 
| Change from baseline in Protein Intake at 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. | 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chronic Kidney Disease, Integrated Chronic Kidney Disease Care, Village Health Volunteers