Impact of CAMP in an Ambulatory Renal Clinic (CAMP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00599365
Recruitment Status : Unknown
Verified November 2007 by San Francisco Veterans Affairs Medical Center.
Recruitment status was:  Recruiting
First Posted : January 23, 2008
Last Update Posted : February 15, 2008
University of California, San Francisco
Information provided by:
San Francisco Veterans Affairs Medical Center

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.

Condition or disease Intervention/treatment Phase
Chronic Kidney Disease Other: Pharmacy care arm Not Applicable

Detailed Description:
Chronic kidney disease (CKD) is a serious condition associated with premature mortality, decrease quality of life, and increase health-care costs. An estimated 19 million Americans (1 in 9 US adults) have non-dialysis dependent CKD (Stages 1-4).1 The health care expenditures for caring for patients with CKD are substantial. According to Centers for Medicare and Medicaid Services (CMS), the estimated annual health cost per patient for managing patients with CKD is markedly higher ($28,000) compared to the costs for caring for diabetic patients ($10,000 per patient) and heart failure patients ($5000 per patient). 2 According to the National Kidney Foundation, as renal function declines, the number of renal complications, notably high blood pressure, anemia, malnutrition, and mineral and bone disorders, increases along with the severity. A large proportion of patients with CKD also develop multiple co-morbidities, particularly hypertension, diabetes, and hyperlipidemia. Fortunately, accumulating evidence indicates that treatment of earlier stages of chronic kidney disease can prevent the development of kidney failure (Stage 5)3. In addition, early prevention of cardiovascular risk factors in patients with CKD may reduce cardiovascular events before and after the onset of kidney failure.3 Because many patients, particularly in the later stages of CKD, have multiple renal complications and chronic co-morbidities, these patients are potentially at high risk of medication non-adherence and non-persistence (defined as premature discontinuation of medication therapy). Studies have demonstrated that patients with chronic diseases typically take only 50% of prescribed doses of medication, leading to increased disease severity, clinic visits, and hospital admissions, resulting in substantial healthcare expenditures.4,5 In the United States alone, the cost of illness, due to non-adherence was estimated to be $170 billion per year.6 In addition, the associated total cost of treating the complications resulting from poor adherence in dialysis and transplant patients exceeds $950 million.7 Potential barriers to medication adherence for patients with chronic diseases include, but are not limited to, complex medication regimens, multiple drug doses, treatment of asymptomatic conditions, and cognitive factors. Although not well-studied in pre-dialysis patients, limited data suggests that important causes of medication non-adherence in chronic dialysis patients include inadequate prescription coverage or high medication costs, lack of transportation, and adverse effects. 8

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Impact of a Pharmacist's Collaborative Management, Adherence,and Medication Education Program (CAMP) in an Ambulatory Renal Clinic
Study Start Date : December 2007
Estimated Primary Completion Date : October 2009
Estimated Study Completion Date : December 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases

Arm Intervention/treatment
Experimental: Pharmacy Care arm

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
  • 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.

No Intervention: Control

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.

Primary Outcome Measures :
  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. [ Time Frame: 2 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

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.

Exclusion Criteria:

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.

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 identifier (NCT number): NCT00599365

Contact: Jenin Lee, Pharm.D (415) 221-4810 ext 3261
Contact: Nelson Chee, Pharm.D (415) 221-4810 ext 3491

United States, California
VA Medical Center San Francisco Recruiting
San Francisco, California, United States, 94121
Principal Investigator: Nelson Chee, Pharm.D         
Sub-Investigator: Jenin Lee, Pharm.D         
Sub-Investigator: Audrey Lee, Pharm.D         
Sub-Investigator: Kristen Johansen, MD         
Sub-Investigator: Philip Chiao, Pharm.D         
Sub-Investigator: David Lovett, MD         
Sponsors and Collaborators
San Francisco Veterans Affairs Medical Center
University of California, San Francisco
Principal Investigator: Nelson Chee, Pharm.D VA Medical Center San Francisco


Responsible Party: Nelson Chee Pharm.D, VA Medical Center, San Francisco Identifier: NCT00599365     History of Changes
Other Study ID Numbers: H45161-31657-01
First Posted: January 23, 2008    Key Record Dates
Last Update Posted: February 15, 2008
Last Verified: November 2007

Keywords provided by San Francisco Veterans Affairs Medical Center:
pharmacist intervention
renal clinic
pill count

Additional relevant MeSH terms:
Kidney Diseases
Renal Insufficiency, Chronic
Urologic Diseases
Renal Insufficiency