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| Tracking Information | |||||||||
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| First Received Date † | January 4, 2008 | ||||||||
| Last Updated Date | February 14, 2008 | ||||||||
| Start Date † | December 2007 | ||||||||
| Current Primary Outcome Measures † |
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 ] [ Designated as safety issue: No ] | ||||||||
| Original Primary Outcome Measures † | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT00599365 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures † | |||||||||
| Original Secondary Outcome Measures † | |||||||||
| Descriptive Information | |||||||||
| Brief Title † | Impact of CAMP in an Ambulatory Renal Clinic | ||||||||
| Official Title † | Impact of a Pharmacist's Collaborative Management, Adherence,and Medication Education Program (CAMP) in an Ambulatory Renal Clinic | ||||||||
| 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. |
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| 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 |
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| Study Phase | |||||||||
| Study Type † | Interventional | ||||||||
| Study Design † | Prevention, Randomized, Open Label, Active Control, Parallel Assignment | ||||||||
| Condition † | Chronic Kidney Disease | ||||||||
| Intervention † | Other: Pharmacy care arm | ||||||||
| Study Arms / Comparison Groups |
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| Publications * |
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status † | Recruiting | ||||||||
| Estimated Enrollment † | 100 | ||||||||
| Estimated Completion Date | December 2009 | ||||||||
| Estimated Primary Completion Date | October 2009 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria † | 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. |
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| Gender | Both | ||||||||
| Ages | 18 Years and older | ||||||||
| Accepts Healthy Volunteers | Yes | ||||||||
| Contacts †† |
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| Location Countries † | United States | ||||||||
| Expanded Access Status | |||||||||
| Administrative Information | |||||||||
| NCT ID † | NCT00599365 | ||||||||
| Responsible Party | Nelson Chee Pharm.D, VA Medical Center, San Francisco | ||||||||
| Secondary IDs †† | T0986 | ||||||||
| Study Sponsor † | San Francisco Veterans Administration Medical Center | ||||||||
| Collaborators †† | University of California, San Francisco | ||||||||
| Investigators † |
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| Information Provided By | San Francisco Veterans Administration Medical Center | ||||||||
| Verification Date | November 2007 | ||||||||
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† Required WHO trial registration data element. †† WHO trial registration data element that is required only if it exists. |
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