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Caregivers and Electronic Medication Monitoring in Chronic Kidney Disease

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: NCT01087255
Recruitment Status : Unknown
Verified March 2010 by Harvard Pilgrim Health Care.
Recruitment status was:  Recruiting
First Posted : March 16, 2010
Last Update Posted : June 22, 2011
Information provided by:
Harvard Pilgrim Health Care

Brief Summary:
The objective of this pilot study is to explore barriers to medication adherence among HPHC members with CKD, particularly those not yet on dialysis, and to assess the feasibility and acceptability of a wireless, internet-based MedMinder system intervention among HPHC enrollees with CKD and their care partners. The investigators hypothesize that the intervention will improve medication use and adherence among patient members with CKD on complex medication treatment, and improve informal caregivers' ability to provide support for improved medication use among patient members.

Condition or disease Intervention/treatment Phase
Chronic Kidney Disease Medication Adherence Device: Electronic Pillbox Monitoring System Phase 1 Phase 2

Detailed Description:

Adherence to medications is critical in managing chronic disease, yet it remains an issue across chronic conditions. Poor medication adherence leads to deteriorating health and subsequently to increased costs as a result of higher hospitalizations rates. Medication adherence in chronic kidney disease (CKD) is especially important because successful treatment can slow the progression to end-stage renal disease (ESRD), yet little research has focused on adherence in patients with early CKD. Numerous barriers to medication adherence exist, including the prescription of complex medication regimens, the often asymptomatic nature of early CKD, and the lack of social support for treatment adherence. While technology and support-based interventions show promise, there currently is no gold-standard approach to improving medication adherence. Thus, it is essential to pursue novel interventions that address barriers for patients with CKD to improve medication adherence and slow the progression to ESRD.

The long-range goal of this application is to improve medication adherence in chronic illness through the development of effective interventions that capitalize on patients' medication-taking context. The objective of this application, which is the next step to achieving that goal, is to pilot test the impact and acceptability of the MedMinder, a pillbox device that transmits medication-taking data via a secure internet-interface to patients, family members, and care managers, in a group of adult, Harvard Pilgrim Health Care (HPHC) members with CKD. To achieve this objective, in partnership with HPHC, we will recruit 120 members with diagnosed CKD stage III or IV to participate in a 6-month pre-post randomized-controlled trial. Participants will be randomized to either receive use of the MedMinder over a six-month period with access to telephone care management, or receive usual care of regular pillboxes with access to telephone care management.

Our primary aim is to test the feasibility and acceptability of the MedMinder intervention. The main components of the intervention include: (1) a plastic weekly pill box with programmable visual and auditory cues to prompt medication use, (2) generation of missed-dose alerts that can be sent via email, text message, or telephone to patients, family members, and HPHC care managers, (3) a secure internet site that permits customization of alerts and has graphical representations of medication use, and (4) aggregate adherence reports available to CKD care managers for patients who are participating in HPHC care management.

Our secondary aim is to assess the impact and acceptability of family and friend involvement in CKD member medication taking. We will document family and friend activities related to medication taking, the acceptability of family and friend involvement in member medication taking, and the impact such involvement has on medication use.

Findings of this proposed project would provide information on the feasibility of a technology-based adherence intervention, with medication-taking support, in patients with chronic disease. The results from this pilot will inform a future application for a more adequately powered study examining the intervention and measurement of structured support from others in medication taking.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Caregivers and Internet Based Monitoring to Improve Medication Use in HPHC Enrollees With Chronic Kidney Disease
Study Start Date : November 2009
Actual Primary Completion Date : April 2011
Estimated Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
No Intervention: Usual Care
Usual care patients will have outpatient care and monitoring procedures, as determined by them and their health care providers.
Experimental: Electronic Pillbox Monitoring System
Usual care plus receive use of the wireless electronic pillbox and medication monitoring system
Device: Electronic Pillbox Monitoring System
Daily exposure for six months
Other Name: MedMinder

Primary Outcome Measures :
  1. medication adherence [ Time Frame: 6 months ]
    We will calculate the proportion of days over a six month follow up period. We will calculate quantity dispensed on all chronic prescriptions filled to measure the number of days a patient had chronic medications available during the study period ("days covered"). Patients who switch treatment from one medication to another within the same therapeutic category will count toward adherence. Adherence is indicated by patients using >80% of prescribed doses.

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:   No

Inclusion Criteria:

  • HPHC commercial- or Medicare-insured members with 2 or more distinct outpatient nephrology chronic kidney disease stage (CKD) III, IV, or V diagnoses in a 6-month period.
  • 18 years old or older at the time they are identified as having CKD.
  • An average of two prescription medications dispensed per month in the prior 6-months.
  • Residence in MA, ME, or NH
  • Residence in an area with MedMinder-participating cellular coverage (includes most major cellular carriers)

Exclusion Criteria:

  • Dialysis or dialysis-related complication medical service claims in 6-month period preceding study entry.
  • Atrius Health member
  • Serious mental illness or cognitive dysfunction medical service claim in 6-month period preceding study entry
  • Primary language other than English
  • Unable to use a pillbox
  • Have no eligible caregiver

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): NCT01087255

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Contact: Connie M Trinacty, PhD 617-509-9955
Contact: Ashley J Beard, PhD 734-845-3813

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United States, Massachusetts
Harvard Pilgrim Health Care Recruiting
Wellesley, Massachusetts, United States, 02481
Contact: Carla Rosenkras, RN, MPH    617-509-7565   
Sponsors and Collaborators
Harvard Pilgrim Health Care
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Principal Investigator: Connie M Trinacty, PhD Harvard Medical School and Harvard Pilgrim Health Care Institute
Study Director: Ashley J Beard, PhD University of Michigan
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Responsible Party: Connie Mah Trinacty, PhD, Assistant Professor, Department of Population Medicine, Harvard Pilgrim Health Care Institute Identifier: NCT01087255    
Other Study ID Numbers: PF000123
First Posted: March 16, 2010    Key Record Dates
Last Update Posted: June 22, 2011
Last Verified: March 2010
Keywords provided by Harvard Pilgrim Health Care:
Caregiver-based interventions
Chronic Kidney Disease
Medication Adherence
Additional relevant MeSH terms:
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Kidney Diseases
Renal Insufficiency, Chronic
Urologic Diseases
Renal Insufficiency