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Completed

NCT Number: NCT01978951

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Integrated Chronic Kidney Disease care

Behavioral

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

Conventional CKD care

Behavioral

group counselling about optimal diets for CKD patients

Other names: group counselling

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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

  5. 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.

  6. 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.

  7. 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.

  8. 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.

Sponsors and collaborators

Lead sponsor

Bhumirajanagarindra Kidney Institute, Thailand

Other

Collaborators

  • Ministry of Health, Thailand

Registry information

Official study title

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

Acronym: ESCORT

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Nov 8, 2013
Registry last updated
Apr 1, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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