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Sponsors and Collaborators: |
San Francisco Veterans Administration Medical Center University of California, San Francisco |
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Information provided by: | San Francisco Veterans Administration Medical Center |
ClinicalTrials.gov Identifier: | NCT00599365 |
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 | Intervention |
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Chronic Kidney Disease |
Other: Pharmacy care arm |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Open Label, Active Control, Parallel Assignment |
Official Title: | Impact of a Pharmacist's Collaborative Management, Adherence,and Medication Education Program (CAMP) in an Ambulatory Renal Clinic |
Estimated Enrollment: | 100 |
Study Start Date: | December 2007 |
Estimated Study Completion Date: | December 2009 |
Estimated Primary Completion Date: | October 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Pharmacy Care arm: Experimental
The pharmacist:
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Other: Pharmacy care arm
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Control: No Intervention
The pharmacist:
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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
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
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.
Contact: Jenin Lee, Pharm.D | (415) 221-4810 ext 3261 | Jenin.Lee@va.gov |
Contact: Nelson Chee, Pharm.D | (415) 221-4810 ext 3491 | Nelson.Chee2@va.gov |
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 |
Principal Investigator: | Nelson Chee, Pharm.D | VA Medical Center San Francisco |
Responsible Party: | VA Medical Center, San Francisco ( Nelson Chee Pharm.D ) |
Study ID Numbers: | H45161-31657-01, T0986 |
Study First Received: | January 4, 2008 |
Last Updated: | February 14, 2008 |
ClinicalTrials.gov Identifier: | NCT00599365 |
Health Authority: | United States: Federal Government |
adherence pharmacist intervention persistence renal clinic pill count |
Renal Insufficiency Urologic Diseases Renal Insufficiency, Chronic |
Kidney Failure, Chronic Kidney Diseases Kidney Failure |