<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02194790</url>
  </required_header>
  <id_info>
    <org_study_id>CICC program</org_study_id>
    <nct_id>NCT02194790</nct_id>
  </id_info>
  <brief_title>Effect of Integrated CKD Care Program in Early Diabetic Nephropathy in Primary Health Care Setting.</brief_title>
  <official_title>Effect of Integrated CKD Care Program in Early Diabetic Nephropathy in Primary Health Care Setting.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Bhumirajanagarindra Kidney Institute, Thailand</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Ministry of Health, Thailand</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Bhumirajanagarindra Kidney Institute, Thailand</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Chronic kidney disease (CKD) is a major health problem in Thailand. Previous studies have&#xD;
      demonstrated that integrated pre-dialysis care may slow the decline in renal function&#xD;
      (Nephrol Dial Transplant.2009 Nov;24(11):3426-33). It is interesting to know whether early&#xD;
      intervention especially in high risk groups like Diabetic may also improve outcome of these&#xD;
      patients in primary health care setting resulting in delay of CKD progression.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      We conducted a 12-month longitudinal study at district A (control) and B (intervention) at&#xD;
      Kamphaeng Phet Province, Thailand. Diabetic patients with eGFR ≥ 60 ml/min/1.73m2 were&#xD;
      recruited from both districts. Patients in district A (control group) received standard CKD&#xD;
      care according to NKF-K/DOQI guidelines1 whereas those in district B (intervention) received,&#xD;
      in addition to the standard care, educational activities provided by nutritionist, pharmacist&#xD;
      and physiotherapist, and quarterly home visits. Our home visits team consisted of nurse,&#xD;
      health care officers and village health volunteers. During each hospital visit of both groups&#xD;
      clinical data were assessed. All laboratory parameters were collected every 3 months, and LDL&#xD;
      and HbA1C every 6 months. The primary end point was rate of eGFR decline. Secondary outcomes&#xD;
      were random urine albumin to creatinine ratio (ACR), blood pressure, waist circumference,&#xD;
      HbA1C and LDL .&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>December 2012</start_date>
  <completion_date type="Actual">December 2013</completion_date>
  <primary_completion_date type="Actual">December 2013</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The difference of rate of estimated glomerular filtration(eGFR) decline</measure>
    <time_frame>12 months</time_frame>
    <description>We compare the difference of rate of eGFR decline from baseline end of the study between the intervention group and control group.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in Random Urine Albumin to Creatinine Ratio</measure>
    <time_frame>12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in waist circumference</measure>
    <time_frame>12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in low density lipoproteins(LDL)</measure>
    <time_frame>12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in systolic blood pressure</measure>
    <time_frame>12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in Hemoglobin A1C</measure>
    <time_frame>12 months</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">238</enrollment>
  <condition>Chronic Kidney Disease</condition>
  <condition>Diabetic Nephropathy</condition>
  <arm_group>
    <arm_group_label>community-based Integrated CKD care</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Standard CKD care + multidisciplinary team and home visit by community care team</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Conventional CKD care</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>standard CKD care</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Community-based Integrated CKD Care</intervention_name>
    <description>Patients received, in addition to the standard care, educational activities provided by nutritionist, pharmacist and physiotherapist, and quarterly home visits. Our home visits team consisted of nurse, health care officers and village health volunteers</description>
    <arm_group_label>community-based Integrated CKD care</arm_group_label>
    <other_name>Multidisciplnary clinic + home visit team</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diabetic patients with eGFR are equal or more than 60 ml/min/1.73m2 estimated twice at&#xD;
             3 months.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Active glomerular disease, obstructive uropathy, end-stage renal disease, HIV&#xD;
             infection, pregnancy, body mass index (BMI) less than 18 or more than 40 kg/m2, being&#xD;
             under treatment for malignancy, urine protein-creatinine ratio more than 3.5 g/g&#xD;
             creatinine and active urinary sediment (urine red blood cells &gt;3 cells/high power&#xD;
             field or urine white blood cells &gt;10 cells/high power field).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Kotcharat Vipattawat, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Bhumirajanagarindra Kidney Institute</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Bhumirajanagarindra Kidney Institute</name>
      <address>
        <city>Bangkok</city>
        <zip>10400</zip>
        <country>Thailand</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Thailand</country>
  </location_countries>
  <reference>
    <citation>KDOQI. KDOQI Clinical Practice Guidelines and Clinical Practice Recommendations for Diabetes and Chronic Kidney Disease. Am J Kidney Dis. 2007 Feb;49(2 Suppl 2):S12-154. doi: 10.1053/j.ajkd.2006.12.005. No abstract available.</citation>
    <PMID>17276798</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>22187469</PMID>
  </reference>
  <reference>
    <citation>Levin A, Stevens PE. Early detection of CKD: the benefits, limitations and effects on prognosis. Nat Rev Nephrol. 2011 Jun 28;7(8):446-57. doi: 10.1038/nrneph.2011.86.</citation>
    <PMID>21712852</PMID>
  </reference>
  <reference>
    <citation>Myers GL, Miller WG, Coresh J, Fleming J, Greenberg N, Greene T, Hostetter T, Levey AS, Panteghini M, Welch M, Eckfeldt JH; National Kidney Disease Education Program Laboratory Working Group. Recommendations for improving serum creatinine measurement: a report from the Laboratory Working Group of the National Kidney Disease Education Program. Clin Chem. 2006 Jan;52(1):5-18. doi: 10.1373/clinchem.2005.0525144. Epub 2005 Dec 6.</citation>
    <PMID>16332993</PMID>
  </reference>
  <reference>
    <citation>Black C, Sharma P, Scotland G, McCullough K, McGurn D, Robertson L, Fluck N, MacLeod A, McNamee P, Prescott G, Smith C. Early referral strategies for management of people with markers of renal disease: a systematic review of the evidence of clinical effectiveness, cost-effectiveness and economic analysis. Health Technol Assess. 2010 Apr;14(21):1-184. doi: 10.3310/hta14210.</citation>
    <PMID>20441712</PMID>
  </reference>
  <reference>
    <citation>Cueto-Manzano AM, Martinez-Ramirez HR, Cortes-Sanabria L. Comparison of primary health-care models in the management of chronic kidney disease. Kidney Int Suppl (2011). 2013 May;3(2):210-214. doi: 10.1038/kisup.2013.16.</citation>
    <PMID>25018986</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>21273376</PMID>
  </reference>
  <reference>
    <citation>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. Erratum In: JAMA. 2003 Jul 9;290(2):197.</citation>
    <PMID>12748199</PMID>
  </reference>
  <results_reference>
    <citation>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.</citation>
    <PMID>20037182</PMID>
  </results_reference>
  <results_reference>
    <citation>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. Erratum In: Ann Intern Med. 2011 Sep 20;155(6):408.</citation>
    <PMID>19414839</PMID>
  </results_reference>
  <results_reference>
    <citation>Kidney Disease Outcomes Quality Initiative (K/DOQI). K/DOQI clinical practice guidelines on hypertension and antihypertensive agents in chronic kidney disease. Am J Kidney Dis. 2004 May;43(5 Suppl 1):S1-290. No abstract available.</citation>
    <PMID>15114537</PMID>
  </results_reference>
  <results_reference>
    <citation>National Kidney Foundation. KDOQI Clinical Practice Guideline for Diabetes and CKD: 2012 Update. Am J Kidney Dis. 2012 Nov;60(5):850-86. doi: 10.1053/j.ajkd.2012.07.005. Erratum In: Am J Kidney Dis. 2013 Jun;61(6):1049.</citation>
    <PMID>23067652</PMID>
  </results_reference>
  <verification_date>July 2014</verification_date>
  <study_first_submitted>July 17, 2014</study_first_submitted>
  <study_first_submitted_qc>July 17, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 18, 2014</study_first_posted>
  <last_update_submitted>July 17, 2014</last_update_submitted>
  <last_update_submitted_qc>July 17, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 18, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Chronic Kidney Disease</keyword>
  <keyword>Diabetic Nephropathy</keyword>
  <keyword>Integrated Chronic Kidney Disease Care</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Kidney Diseases</mesh_term>
    <mesh_term>Renal Insufficiency, Chronic</mesh_term>
    <mesh_term>Diabetic Nephropathies</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02194790
org study id: CICC program
nct id: NCT02194790
lead sponsor: 
collaborator: 
has dmc: Yes
Chronic kidney disease (CKD) is a major health problem in Thailand. Previous studies have
      demonstrated that integrated pre-dialysis care may slow the decline in renal function
      (Nephrol Dial Transplant.2009 Nov;24(11):3426-33). It is interesting to know whether early
      intervention especially in high risk groups like Diabetic may also improve outcome of these
      patients in primary health care setting resulting in delay of CKD progression.
We conducted a 12-month longitudinal study at district A (control) and B (intervention) at
      Kamphaeng Phet Province, Thailand. Diabetic patients with eGFR ≥ 60 ml/min/1.73m2 were
      recruited from both districts. Patients in district A (control group) received standard CKD
      care according to NKF-K/DOQI guidelines1 whereas those in district B (intervention) received,
      in addition to the standard care, educational activities provided by nutritionist, pharmacist
      and physiotherapist, and quarterly home visits. Our home visits team consisted of nurse,
      health care officers and village health volunteers. During each hospital visit of both groups
      clinical data were assessed. All laboratory parameters were collected every 3 months, and LDL
      and HbA1C every 6 months. The primary end point was rate of eGFR decline. Secondary outcomes
      were random urine albumin to creatinine ratio (ACR), blood pressure, waist circumference,
      HbA1C and LDL .
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: The difference of rate of estimated glomerular filtration(eGFR) decline
time frame: 12 months
description: We compare the difference of rate of eGFR decline from baseline end of the study between the intervention group and control group.
measure: Change from baseline in Random Urine Albumin to Creatinine Ratio
time frame: 12 months
measure: Change from baseline in waist circumference
time frame: 12 months
measure: Change from baseline in low density lipoproteins(LDL)
time frame: 12 months
measure: Change from baseline in systolic blood pressure
time frame: 12 months
measure: Change from baseline in Hemoglobin A1C
time frame: 12 months
arm group label: community-based Integrated CKD care
arm group type: Experimental
description: Standard CKD care + multidisciplinary team and home visit by community care team
arm group label: Conventional CKD care
arm group type: No Intervention
description: standard CKD care
intervention type: Behavioral
intervention name: Community-based Integrated CKD Care
description: Patients received, in addition to the standard care, educational activities provided by nutritionist, pharmacist and physiotherapist, and quarterly home visits. Our home visits team consisted of nurse, health care officers and village health volunteers
arm group label: community-based Integrated CKD care
other name: Multidisciplnary clinic + home visit team
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: Kotcharat Vipattawat, M.D.
role: Principal Investigator
affiliation: Bhumirajanagarindra Kidney Institute
facility: 
country: Thailand
citation: KDOQI. KDOQI Clinical Practice Guidelines and Clinical Practice Recommendations for Diabetes and Chronic Kidney Disease. Am J Kidney Dis. 2007 Feb;49(2 Suppl 2):S12-154. doi: 10.1053/j.ajkd.2006.12.005. No abstract available.
PMID: 17276798
citation: 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.
PMID: 22187469
citation: Levin A, Stevens PE. Early detection of CKD: the benefits, limitations and effects on prognosis. Nat Rev Nephrol. 2011 Jun 28;7(8):446-57. doi: 10.1038/nrneph.2011.86.
PMID: 21712852
citation: Myers GL, Miller WG, Coresh J, Fleming J, Greenberg N, Greene T, Hostetter T, Levey AS, Panteghini M, Welch M, Eckfeldt JH; National Kidney Disease Education Program Laboratory Working Group. Recommendations for improving serum creatinine measurement: a report from the Laboratory Working Group of the National Kidney Disease Education Program. Clin Chem. 2006 Jan;52(1):5-18. doi: 10.1373/clinchem.2005.0525144. Epub 2005 Dec 6.
PMID: 16332993
citation: Black C, Sharma P, Scotland G, McCullough K, McGurn D, Robertson L, Fluck N, MacLeod A, McNamee P, Prescott G, Smith C. Early referral strategies for management of people with markers of renal disease: a systematic review of the evidence of clinical effectiveness, cost-effectiveness and economic analysis. Health Technol Assess. 2010 Apr;14(21):1-184. doi: 10.3310/hta14210.
PMID: 20441712
citation: Cueto-Manzano AM, Martinez-Ramirez HR, Cortes-Sanabria L. Comparison of primary health-care models in the management of chronic kidney disease. Kidney Int Suppl (2011). 2013 May;3(2):210-214. doi: 10.1038/kisup.2013.16.
PMID: 25018986
citation: 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.
PMID: 21273376
citation: 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. Erratum In: JAMA. 2003 Jul 9;290(2):197.
PMID: 12748199
citation: 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.
PMID: 20037182
citation: 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. Erratum In: Ann Intern Med. 2011 Sep 20;155(6):408.
PMID: 19414839
citation: Kidney Disease Outcomes Quality Initiative (K/DOQI). K/DOQI clinical practice guidelines on hypertension and antihypertensive agents in chronic kidney disease. Am J Kidney Dis. 2004 May;43(5 Suppl 1):S1-290. No abstract available.
PMID: 15114537
citation: National Kidney Foundation. KDOQI Clinical Practice Guideline for Diabetes and CKD: 2012 Update. Am J Kidney Dis. 2012 Nov;60(5):850-86. doi: 10.1053/j.ajkd.2012.07.005. Erratum In: Am J Kidney Dis. 2013 Jun;61(6):1049.
PMID: 23067652
responsible party type: Sponsor
mesh term: Kidney Diseases
mesh term: Renal Insufficiency, Chronic
mesh term: Diabetic Nephropathies