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

NCT01978951 | Completed DMC

• 1 other identifier: #07-004
• Study Type: interventional
• Target: 443
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Kidney Disease

Keywords

Chronic Kidney Disease; Integrated Chronic Kidney Disease Care; Village Health Volunteers

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (8)

• Cardiovascular Morbidity or Event

  24 months

• Incidence of Initiation of Renal Replacement Therapy

  24 months

• Hospitalization

  24 months

• Change from baseline in Systolic Blood Pressure at 24 months

  24 months

• Change from baseline in amount of proteinuria at 24 months

  24 months

Study Arms (2)

Integrated Chronic Kidney Disease care

EXPERIMENTAL

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

Conventional CKD care

ACTIVE COMPARATOR

standard guidelines of CKD treatment

Behavioral: Conventional CKD care

Interventions

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.

Also known as: Multidisciplinary team + Community CKD care network

Integrated Chronic Kidney Disease care

Conventional CKD care BEHAVIORAL

group counselling about optimal diets for CKD patients

Also known as: group counselling

Conventional CKD care

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Bhumirajanagarindra Kidney Institute, Thailand: lead
• Ministry of Health, Thailand: collaborator

Study Sites (1)

Bhumirajanagarindra Kidney Institute

Bangkok, Bangkok, 10400, Thailand

Location

Related Publications (25)

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  BACKGROUND

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  BACKGROUND

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  BACKGROUND

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• Clinical practice guidelines for nutrition in chronic renal failure. K/DOQI, National Kidney Foundation. Am J Kidney Dis. 2000 Jun;35(6 Suppl 2):S17-S104. doi: 10.1053/ajkd.2000.v35.aajkd03517. No abstract available.

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• Kidney Disease: Improving Global Outcomes (KDIGO) CKD-MBD Work Group. KDIGO clinical practice guideline for the diagnosis, evaluation, prevention, and treatment of Chronic Kidney Disease-Mineral and Bone Disorder (CKD-MBD). Kidney Int Suppl. 2009 Aug;(113):S1-130. doi: 10.1038/ki.2009.188.

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• Peralta CA, Frigaard M, Rubinsky AD, Rolon L, Lo L, Voora S, Seal K, Tuot D, Chao S, Lui K, Chiao P, Powe N, Shlipak M. Implementation of a pragmatic randomized trial of screening for chronic kidney disease to improve care among non-diabetic hypertensive veterans. BMC Nephrol. 2017 Apr 12;18(1):132. doi: 10.1186/s12882-017-0541-6.

  PMID: 28399844 DERIVED

• Jiamjariyapon T, Ingsathit A, Pongpirul K, Vipattawat K, Kanchanakorn S, Saetie A, Kanistanon D, Wongprompitak P, Leesmidt V, Watcharasaksilp W, Wang W, Chandraker AK, Tungsanga K. Effectiveness of Integrated Care on Delaying Progression of stage 3-4 Chronic Kidney Disease in Rural Communities of Thailand (ESCORT study): a cluster randomized controlled trial. BMC Nephrol. 2017 Mar 2;18(1):83. doi: 10.1186/s12882-016-0414-4.

  PMID: 28253839 DERIVED

• Jiamjariyaporn T, Ingsathit A, Tungsanga K, Banchuin C, Vipattawat K, Kanchanakorn S, Leesmidt V, Watcharasaksilp W, Saetie A, Pachotikarn C, Taechangam S, Teerapornlertratt T, Chantarojsiri T, Sitprija V. Effectiveness of integrated care on delaying chronic kidney disease progression in rural communities of Thailand (ESCORT study): rationale and design of the study [NCT01978951]. BMC Nephrol. 2014 Jun 25;15:99. doi: 10.1186/1471-2369-15-99.

  PMID: 24966007 DERIVED

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Teerayuth Jiamjariyaporn, M.D.

  Bhumirajanagarindra Kidney Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Nephrologist

Study Record Dates

• First Submitted: December 8, 2012
• First Posted: November 8, 2013
• Study Start: July 1, 2011
• Primary Completion: July 1, 2013
• Study Completion: December 1, 2013
• Last Updated: April 1, 2014

Record last verified: 2014-03

Locations

TH (1)