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

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ClinicalTrials.gov Identifier: NCT01978951
Recruitment Status : Completed
First Posted : November 8, 2013
Last Update Posted : April 1, 2014
Sponsor:
Collaborator:
Ministry of Health, Thailand
Information provided by (Responsible Party):
Dr.Teerayut Jiamjariyaporn, Bhumirajanagarindra Kidney Institute, Thailand

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.

Condition or disease Intervention/treatment Phase
Chronic Kidney Disease Behavioral: Integrated Chronic Kidney Disease care Behavioral: Conventional CKD care Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 443 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effectiveness of Integrated Care on Delaying Chronic Kidney Disease Progression in Rural Communities of Thailand (ESCORT Study)
Study Start Date : July 2011
Actual Primary Completion Date : July 2013
Actual Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases

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 Name: 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 Name: group counselling




Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01978951


Locations
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Thailand
Bhumirajanagarindra Kidney Institute
Bangkok, Thailand, 10400
Sponsors and Collaborators
Bhumirajanagarindra Kidney Institute, Thailand
Ministry of Health, Thailand
Investigators
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Principal Investigator: Teerayuth Jiamjariyaporn, M.D. Bhumirajanagarindra Kidney Institute

Publications:
WHO, Role of Village Health Volunteers in Avian Influenza Surveillance in Thailand, WHO SEARO 2007
WHO, Role of health volunteers in strengthening community action for health, Report of an Intercountry Consultation, Yangon 20-24 February 1995, WHO SEARO (SEA/HSD/198-1996)
Kahssay, MH, Taylor, ME and Berman, PA, Community health workers: the way forward, WHO Geneva, 1998

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Dr.Teerayut Jiamjariyaporn, Principal Investigator, Nephrologist, Bhumirajanagarindra Kidney Institute, Thailand
ClinicalTrials.gov Identifier: NCT01978951     History of Changes
Other Study ID Numbers: #07-004
First Posted: November 8, 2013    Key Record Dates
Last Update Posted: April 1, 2014
Last Verified: March 2014

Keywords provided by Dr.Teerayut Jiamjariyaporn, Bhumirajanagarindra Kidney Institute, Thailand:
Chronic Kidney Disease
Integrated Chronic Kidney Disease Care
Village Health Volunteers

Additional relevant MeSH terms:
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Kidney Diseases
Renal Insufficiency, Chronic
Disease Progression
Urologic Diseases
Renal Insufficiency
Disease Attributes
Pathologic Processes