Impact of CAMP in an Ambulatory Renal Clinic

NCT00599365 | Unknown DMC

• 2 other identifiers: H45161-31657-01T0986
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to see if a pharmacist can help patients understand how he/she should be taking their medications. The study is also being done to see if meeting with the pharmacist can help patients better control chronic kidney disease and the medical problems that can occur.

Conditions

Chronic Kidney Disease

Keywords

adherence; pharmacist intervention; persistence; renal clinic; pill count

Outcome Measures

Primary Outcomes (1)

• MPR cumulative persistence rates pill counts blood glucose HgbA1c hemoglobin concentration iron ferritin transferrin saturation SBP/DBP corrected calcium phosphorous calcium-phosphorus product uAlb/Cr eGFR.

  2 years

Study Arms (2)

Pharmacy Care arm

EXPERIMENTAL

The pharmacist: * will take all the patient's medication bottles, and give medication boxes filled with medications in the order the patient should take them in. * will need to obtain a complete list of medications. * will teach the patient about the medications. * will provide a medication schedule, and other papers about the medications. * will count the pills in the medication boxes. * will review all the medications with the patient and answer any question. * will check to see if the medication is working for the patient. * will work with the patient's kidney doctor to adjust medications if needed. * will give the medication boxes filled with medications to take home.

Other: Pharmacy care arm

Control

NO INTERVENTION

The pharmacist: * will obtain a complete list of medications. * will count the pills in the patients' medication bottles. * will inform patients to take their medications from these bottles.

Interventions

Pharmacy care arm OTHER

* The pharmacist will take all your medication bottles, and give you medication boxes filled with your medications in the order you should take them in. * You will need to give a complete list of medications to the pharmacist. * You will need to describe how you take these medications. * The pharmacist will teach you about the medications. This includes side effects, drug interactions, and directions. * The pharmacist will give you a medication schedule, and other papers about your medications.

Pharmacy Care arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients will be eligible for enrollment if they are \> 18 year old men or women receiving care from the VAMCSF Renal Clinic with a documented diagnosis of CKD stage 2-5, and are receiving pharmacological treatment for one or more medical conditions of CKD, including hypertension, diabetes, CKD-mineral and bone disorders, and/or anemia of chronic disease.

You may not qualify if:

• Patients will be excluded from the study if they obtain medications prescribed for the above medical conditions from a facility outside the VAMCSF, are enrolled in Medi-Set clinic, are kidney transplant patients, are diagnosed with CKD stage 1, require assistance in the administration of their medications (i.e. caregiver), lack adequate transportation to clinic, and/or lack telephone access.

Sponsors & Collaborators

• San Francisco Veterans Affairs Medical Center: lead
• University of California, San Francisco: collaborator

Study Sites (1)

VA Medical Center San Francisco

San Francisco, California, 94121, United States

RECRUITING

Related Publications (17)

• Levey AS, Bosch JP, Lewis JB, Greene T, Rogers N, Roth D. A more accurate method to estimate glomerular filtration rate from serum creatinine: a new prediction equation. Modification of Diet in Renal Disease Study Group. Ann Intern Med. 1999 Mar 16;130(6):461-70. doi: 10.7326/0003-4819-130-6-199903160-00002.

  PMID: 10075613 BACKGROUND

• Chen RA, Scott S, Mattern WD, Mohini R, Nissenson AR. The case for disease management in chronic kidney disease. Dis Manag. 2006 Apr;9(2):86-92. doi: 10.1089/dis.2006.9.86.

  PMID: 16620194 BACKGROUND

• National Kidney Foundation. K/DOQI clinical practice guidelines for chronic kidney disease: evaluation, classification, and stratification. Am J Kidney Dis. 2002 Feb;39(2 Suppl 1):S1-266. No abstract available.

  PMID: 11904577 BACKGROUND

• Haynes RB, Yao X, Degani A, Kripalani S, Garg A, McDonald HP. Interventions to enhance medication adherence. Cochrane Database Syst Rev. 2005 Oct 19;(4):CD000011. doi: 10.1002/14651858.CD000011.pub2.

  PMID: 16235271 BACKGROUND

• Kripalani S, Yao X, Haynes RB. Interventions to enhance medication adherence in chronic medical conditions: a systematic review. Arch Intern Med. 2007 Mar 26;167(6):540-50. doi: 10.1001/archinte.167.6.540.

  PMID: 17389285 BACKGROUND

• Dezii CM. Medication noncompliance: what is the problem? Manag Care. 2000 Sep;9(9 Suppl):7-12. No abstract available.

  PMID: 11729418 BACKGROUND

• Loghman-Adham M. Medication noncompliance in patients with chronic disease: issues in dialysis and renal transplantation. Am J Manag Care. 2003 Feb;9(2):155-71.

  PMID: 12597603 BACKGROUND

• Reddy SS, Holley JL. Management of the pregnant chronic dialysis patient. Adv Chronic Kidney Dis. 2007 Apr;14(2):146-55. doi: 10.1053/j.ackd.2007.01.005.

  PMID: 17395117 BACKGROUND

• Lee JK, Grace KA, Taylor AJ. Effect of a pharmacy care program on medication adherence and persistence, blood pressure, and low-density lipoprotein cholesterol: a randomized controlled trial. JAMA. 2006 Dec 6;296(21):2563-71. doi: 10.1001/jama.296.21.joc60162. Epub 2006 Nov 13.

  PMID: 17101639 BACKGROUND

• Murray MD, Young J, Hoke S, Tu W, Weiner M, Morrow D, Stroupe KT, Wu J, Clark D, Smith F, Gradus-Pizlo I, Weinberger M, Brater DC. Pharmacist intervention to improve medication adherence in heart failure: a randomized trial. Ann Intern Med. 2007 May 15;146(10):714-25. doi: 10.7326/0003-4819-146-10-200705150-00005.

  PMID: 17502632 BACKGROUND

• Chisholm MA, Mulloy LL, Jagadeesan M, Martin BC, DiPiro JT. Effect of clinical pharmacy services on the blood pressure of African-American renal transplant patients. Ethn Dis. 2002 Summer;12(3):392-7.

  PMID: 12148711 BACKGROUND

• Allenet B, Chen C, Romanet T, Vialtel P, Calop J. Assessing a pharmacist-run anaemia educational programme for patients with chronic renal insufficiency. Pharm World Sci. 2007 Feb;29(1):7-11. doi: 10.1007/s11096-005-4800-4.

  PMID: 17268940 BACKGROUND

• 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.

  PMID: 12748199 BACKGROUND

• Rodbard HW, Blonde L, Braithwaite SS, Brett EM, Cobin RH, Handelsman Y, Hellman R, Jellinger PS, Jovanovic LG, Levy P, Mechanick JI, Zangeneh F; AACE Diabetes Mellitus Clinical Practice Guidelines Task Force. American Association of Clinical Endocrinologists medical guidelines for clinical practice for the management of diabetes mellitus. Endocr Pract. 2007 May-Jun;13 Suppl 1:1-68. doi: 10.4158/EP.13.S1.1. No abstract available.

  PMID: 17613449 BACKGROUND

• Halpern MT, Khan ZM, Schmier JK, Burnier M, Caro JJ, Cramer J, Daley WL, Gurwitz J, Hollenberg NK. Recommendations for evaluating compliance and persistence with hypertension therapy using retrospective data. Hypertension. 2006 Jun;47(6):1039-48. doi: 10.1161/01.HYP.0000222373.59104.3d. Epub 2006 May 1. No abstract available.

  PMID: 16651464 BACKGROUND

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  PMID: 16044982 BACKGROUND

• American Diabetes Association. Standards of medical care in diabetes--2007. Diabetes Care. 2007 Jan;30 Suppl 1:S4-S41. doi: 10.2337/dc07-S004. No abstract available.

  PMID: 17192377 BACKGROUND

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

• Nelson Chee, Pharm.D

  VA Medical Center San Francisco

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jenin Lee, Pharm.D

CONTACT

(415) 221-4810; Jenin.Lee@va.gov

Nelson Chee, Pharm.D

CONTACT

(415) 221-4810; Nelson.Chee2@va.gov

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: FED

Study Record Dates

• First Submitted: January 4, 2008
• First Posted: January 23, 2008
• Study Start: December 1, 2007
• Primary Completion: October 1, 2009
• Study Completion: December 1, 2009
• Last Updated: February 15, 2008

Record last verified: 2007-11

Locations

US (1)