Chronic Kidney Disease
Conditions
Keywords
Chronic Kidney Disease, Integrated Chronic Kidney Disease Care, Village Health Volunteers
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.
Interventions
BEHAVIORALIntegrated 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.
BEHAVIORALConventional CKD care
group counselling about optimal diets for CKD patients
Sponsors
Ministry of Health, Thailand
Bhumirajanagarindra Kidney Institute, Thailand
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The difference of rate of estimated glomerular filtration rate (eGFR) decline | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cardiovascular Morbidity or Event | 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 | 24 months | Incidence of initiation of renal replacement therapy consisting of hemodialysis, peritoneal dialysis, and kidney transplantation. |
| Hospitalization | 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 | 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 | 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 | 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 | 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 | 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. |
Countries
Thailand
Outcome results
None listed