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Chronic Kidney DiseaseESCORTNCT01978951

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

A study testing Integrated Chronic Kidney Disease care and Conventional CKD care in people with Chronic Kidney Disease, run by Bhumirajanagarindra Kidney Institute, Thailand at 1 site in Thailand.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Chronic Kidney Disease
What is being tested?
Integrated Chronic Kidney Disease care and Conventional CKD care
Could I receive a placebo?
No, everyone receives an active treatment
How many people
443 participants
Where
1 siteThailand
Study dates
Jul 2011to Dec 2013
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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).

Trial locations and contacts

1 site in 1 country.

Thailand1 site
  • Bhumirajanagarindra Kidney Institute

    Bangkok, Bangkok, 10400

Other trials in Thailand

About this study

Official title: 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.

Read the 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.

Being tested
Integrated Chronic Kidney Disease care, Conventional CKD care
Keywords
Chronic Kidney Disease, Integrated Chronic Kidney Disease Care, Village Health Volunteers
Medical subject headings
Renal Insufficiency, Chronic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Integrated Chronic Kidney Disease careBehavioural

    Also called Multidisciplinary team + Community CKD care network

    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 careBehavioural

    Also called group counselling

    group counselling about optimal diets for CKD patients

Study groups in NCT01978951
Study groupRoleWhat they receive
Integrated Chronic Kidney Disease careExperimentalstandard guidelines of CKD treatment + Integrated CKD care consisting of multidisciplinary team care and home visit by community care network
Receives: Behavioral: Integrated Chronic Kidney Disease care
Conventional CKD careActive comparatorstandard guidelines of CKD treatment
Receives: Behavioral: Conventional CKD care

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 30 months

Secondary outcomes (8)
  1. Cardiovascular Morbidity or Event

    The definitions of cardiovascular event in this study are the numbers of myocardial infarction, stroke including ischemic and hemorrhagic event.

    Measured: 24 months

  2. Incidence of Initiation of Renal Replacement Therapy

    Incidence of initiation of renal replacement therapy consisting of hemodialysis, peritoneal dialysis, and kidney transplantation.

    Measured: 24 months

  3. 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.

    Measured: 24 months

  4. 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

    Measured: 24 months

  5. Change from baseline in amount of proteinuria at 24 months

    Changes in amount of proteinuria which is measured by using urine protein-creatinine ratio.

    Measured: 24 months

  6. Change from Baseline in Hemoglobin A1C at 24 months

    We compare the difference of hemoglobin A1C of diabetic patients between intervention and control group.

    Measured: 24 months

  7. 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.

    Measured: 24 months

  8. 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.

    Measured: 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Nov 2013 (estimated)
  2. Study startJul 2011
  3. Primary completionJul 2013
  4. Study completionDec 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
443 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01978951
Sponsor's protocol ID
#07-004
Acronym
ESCORT
Status last verified
Mar 2014
First submitted
8 Dec 2012
Last updated
1 Apr 2014
Results posted
No
Data monitoring committee
Yes

Publications

  • Ingsathit A, Thakkinstian A, Chaiprasert A, Sangthawan P, Gojaseni P, Kiattisunthorn K, Ongaiyooth L, Vanavanan S, Sirivongs D, Thirakhupt P, Mittal B, Singh AK; Thai-SEEK Group. Prevalence and risk factors of chronic kidney disease in the Thai adult population: Thai SEEK study. Nephrol Dial Transplant. 2010 May;25(5):1567-75. doi: 10.1093/ndt/gfp669. Epub 2009 Dec 27.

    PubMed 20037182
  • Rastogi A, Linden A, Nissenson AR. Disease management in chronic kidney disease. Adv Chronic Kidney Dis. 2008 Jan;15(1):19-28. doi: 10.1053/j.ackd.2007.10.011.

    PubMed 18155106
  • Wu IW, Wang SY, Hsu KH, Lee CC, Sun CY, Tsai CJ, Wu MS. Multidisciplinary predialysis education decreases the incidence of dialysis and reduces mortality--a controlled cohort study based on the NKF/DOQI guidelines. Nephrol Dial Transplant. 2009 Nov;24(11):3426-33. doi: 10.1093/ndt/gfp259. Epub 2009 Jun 2.

    PubMed 19491379
  • Barrett BJ, Garg AX, Goeree R, Levin A, Molzahn A, Rigatto C, Singer J, Soltys G, Soroka S, Ayers D, Parfrey PS. A nurse-coordinated model of care versus usual care for stage 3/4 chronic kidney disease in the community: a randomized controlled trial. Clin J Am Soc Nephrol. 2011 Jun;6(6):1241-7. doi: 10.2215/CJN.07160810. Epub 2011 May 26.

    PubMed 21617090
  • Bayliss EA, Bhardwaja B, Ross C, Beck A, Lanese DM. Multidisciplinary team care may slow the rate of decline in renal function. Clin J Am Soc Nephrol. 2011 Apr;6(4):704-10. doi: 10.2215/CJN.06610810. Epub 2011 Jan 27.

    PubMed 21273376
  • 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

  • Witmer A, Seifer SD, Finocchio L, Leslie J, O'Neil EH. Community health workers: integral members of the health care work force. Am J Public Health. 1995 Aug;85(8 Pt 1):1055-8. doi: 10.2105/ajph.85.8_pt_1.1055.

    PubMed 7625495
  • Levey AS, Stevens LA, Schmid CH, Zhang YL, Castro AF 3rd, Feldman HI, Kusek JW, Eggers P, Van Lente F, Greene T, Coresh J; CKD-EPI (Chronic Kidney Disease Epidemiology Collaboration). A new equation to estimate glomerular filtration rate. Ann Intern Med. 2009 May 5;150(9):604-12. doi: 10.7326/0003-4819-150-9-200905050-00006.

    PubMed 19414839
  • Chobanian AV, Bakris GL, Black HR, Cushman WC, Green LA, Izzo JL Jr, Jones DW, Materson BJ, Oparil S, Wright JT Jr, Roccella EJ; National Heart, Lung, and Blood Institute Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure; National High Blood Pressure Education Program Coordinating Committee. The Seventh Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure: the JNC 7 report. JAMA. 2003 May 21;289(19):2560-72. doi: 10.1001/jama.289.19.2560. Epub 2003 May 14.

    PubMed 12748199
  • Rossing P, Rossing K, Gaede P, Pedersen O, Parving HH. Monitoring kidney function in type 2 diabetic patients with incipient and overt diabetic nephropathy. Diabetes Care. 2006 May;29(5):1024-30. doi: 10.2337/diacare.2951024.

    PubMed 16644632
  • American Diabetes Association. Standards of medical care in diabetes--2012. Diabetes Care. 2012 Jan;35 Suppl 1(Suppl 1):S11-63. doi: 10.2337/dc12-s011. No abstract available.

    PubMed 22187469
  • Dupont WD, Plummer WD Jr. Power and sample size calculations. A review and computer program. Control Clin Trials. 1990 Apr;11(2):116-28. doi: 10.1016/0197-2456(90)90005-m.

    PubMed 2161310
  • Dupont WD, Plummer WD Jr. Power and sample size calculations for studies involving linear regression. Control Clin Trials. 1998 Dec;19(6):589-601. doi: 10.1016/s0197-2456(98)00037-3.

    PubMed 9875838

Questions about this trial

What is this clinical trial studying?

A study testing Integrated Chronic Kidney Disease care and Conventional CKD care in people with Chronic Kidney Disease, run by Bhumirajanagarindra Kidney Institute, Thailand at 1 site in Thailand.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The difference of rate of estimated glomerular filtration rate (eGFR) decline (time frame: 30 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01978951, which also lists 25 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2014.

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