Clinical trial NCT01978951: Effectiveness of Integrated Care on Delaying Chronic Kidney Disease Progression in Rural Communities of Thailand
Official title: Effectiveness of Integrated Care on Delaying Chronic Kidney Disease Progression in Rural Communities of Thailand (ESCORT Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Kidney Disease
Keywords: Chronic Kidney Disease
Integrated Chronic Kidney Disease Care
Village Health Volunteers
Lead sponsor: Bhumirajanagarindra Kidney Institute, Thailand
Sponsor class: OTHER
Collaborators: name: Ministry of Health, Thailand
First posted: 2013-11-08
Enrollment: 443
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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).

Primary outcomes:
measure: The difference of rate of estimated glomerular filtration rate (eGFR) decline
timeFrame: 30 months
Secondary outcomes:
measure: Cardiovascular Morbidity or Event
timeFrame: 24 months
measure: Incidence of Initiation of Renal Replacement Therapy
timeFrame: 24 months
measure: Hospitalization
timeFrame: 24 months
measure: Change from baseline in Systolic Blood Pressure at 24 months
timeFrame: 24 months
measure: Change from baseline in amount of proteinuria at 24 months
timeFrame: 24 months
measure: Change from Baseline in Hemoglobin A1C at 24 months
timeFrame: 24 months
measure: Change from baseline in 24 hour urine sodium at 24 months
timeFrame: 24 months
measure: Change from baseline in Protein Intake at 24 months
timeFrame: 24 months
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Bhumirajanagarindra Kidney Institute
Study officials:
affiliation: Bhumirajanagarindra Kidney Institute
name: Teerayuth Jiamjariyaporn, M.D.
role: PRINCIPAL_INVESTIGATOR
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