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

Chronic Kidney Disease Clinical Trial

— ESCORT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01978951
• Other study ID #: #07-004
• Status: Completed
• Phase: N/A
• First received: December 8, 2012
• Last updated: March 29, 2014
• Start date: July 2011
• Est. completion date: December 2013

Study information

• Verified date: March 2014
• Source: Bhumirajanagarindra Kidney Institute, Thailand
• Contact: n/a
• Is FDA regulated: No
• Health authority: Thailand: Ministry of Public Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 443
• Est. completion date: December 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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).

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Kidney Disease
• Disease Progression
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

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.
• Conventional CKD care
group counselling about optimal diets for CKD patients

Locations

Country	Name	City	State
Thailand	Bhumirajanagarindra Kidney Institute	Bangkok

Sponsors (2)

Lead Sponsor	Collaborator
Bhumirajanagarindra Kidney Institute, Thailand	Ministry of Health, Thailand

Country where clinical trial is conducted

Thailand, 

References & Publications (22)

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Kidney Disease Outcomes Quality Initiative (K/DOQI). K/DOQI clinical practice guidelines on hypertension and antihypertensive agents in chronic kidney disease. Am J Kidney Dis. 2004 May;43(5 Suppl 1):S1-290. — View Citation

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WHO, Role of Village Health Volunteers in Avian Influenza Surveillance in Thailand, WHO SEARO 2007

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* Note: There are 22 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	Yes
Secondary	Incidence of Initiation of Renal Replacement Therapy	Incidence of initiation of renal replacement therapy consisting of hemodialysis, peritoneal dialysis, and kidney transplantation.	24 months	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes