Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Impact of CAMP in an Ambulatory Renal Clinic

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2007 by San Francisco Veterans Administration Medical Center.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
University of California, San Francisco
Information provided by:
San Francisco Veterans Administration Medical Center
ClinicalTrials.gov Identifier:
NCT00599365
First received: January 4, 2008
Last updated: February 14, 2008
Last verified: November 2007
  Purpose

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
Chronic Kidney Disease
Other: Pharmacy care arm

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by San Francisco Veterans Administration Medical Center:

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 ]

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
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.

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00599365

Contacts
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

Locations
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 Administration Medical Center
University of California, San Francisco
Investigators
Principal Investigator: Nelson Chee, Pharm.D VA Medical Center San Francisco
  More Information

Publications:

Responsible Party: Nelson Chee Pharm.D, VA Medical Center, San Francisco
ClinicalTrials.gov Identifier: NCT00599365     History of Changes
Other Study ID Numbers: H45161-31657-01, T0986
Study First Received: January 4, 2008
Last Updated: February 14, 2008
Health Authority: United States: Federal Government

Keywords provided by San Francisco Veterans Administration Medical Center:
adherence
pharmacist intervention
persistence
renal clinic
pill count

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

ClinicalTrials.gov processed this record on November 20, 2014