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.
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
443
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.
group counselling about optimal diets for CKD patients
Bhumirajanagarindra Kidney Institute
Bangkok, Bangkok, Thailand
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.
Time frame: 30 months
Cardiovascular Morbidity or Event
The definitions of cardiovascular event in this study are the numbers of myocardial infarction, stroke including ischemic and hemorrhagic event.
Time frame: 24 months
Incidence of Initiation of Renal Replacement Therapy
Incidence of initiation of renal replacement therapy consisting of hemodialysis, peritoneal dialysis, and kidney transplantation.
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 24 months
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