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

March 29, 2014 updated by: Dr.Teerayut Jiamjariyaporn, Bhumirajanagarindra Kidney Institute, Thailand

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

443

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Thailand
      • Bangkok, Thailand, 10400
        • Bhumirajanagarindra Kidney Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Integrated Chronic Kidney Disease care
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
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.
Other Names:
  • Multidisciplinary team + Community CKD care network
ACTIVE_COMPARATOR: Conventional CKD care
standard guidelines of CKD treatment
Behavioral: Conventional CKD care
group counselling about optimal diets for CKD patients
Other Names:
  • group counselling

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cardiovascular Morbidity or Event
Time Frame: 24 months
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
Time Frame: 24 months
Incidence of initiation of renal replacement therapy consisting of hemodialysis, peritoneal dialysis, and kidney transplantation.
24 months
Hospitalization
Time Frame: 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.
24 months
Change from baseline in Systolic Blood Pressure at 24 months
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bhumirajanagarindra Kidney Institute, Thailand

Collaborators

Ministry of Health, Thailand

Investigators

  • Principal Investigator: Teerayuth Jiamjariyaporn, M.D., Bhumirajanagarindra Kidney Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2011

Primary Completion (ACTUAL)

July 1, 2013

Study Completion (ACTUAL)

December 1, 2013

Study Registration Dates

First Submitted

December 8, 2012

First Submitted That Met QC Criteria

November 3, 2013

First Posted (ESTIMATE)

November 8, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

April 1, 2014

Last Update Submitted That Met QC Criteria

March 29, 2014

Last Verified

March 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • #07-004

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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