Caregivers and Electronic Medication Monitoring in Chronic Kidney Disease
|ClinicalTrials.gov 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
|Condition or disease||Intervention/treatment||Phase|
|Chronic Kidney Disease Medication Adherence||Device: Electronic Pillbox Monitoring System||Phase 1 Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|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|
|Primary Completion Date :||April 2011|
|Estimated Study Completion Date :||December 2011|
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
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01087255
|Contact: Connie M Trinacty, PhDfirstname.lastname@example.org|
|Contact: Ashley J Beard, PhDemail@example.com|
|United States, Massachusetts|
|Harvard Pilgrim Health Care||Recruiting|
|Wellesley, Massachusetts, United States, 02481|
|Contact: Carla Rosenkras, RN, MPH 617-509-7565 firstname.lastname@example.org|
|Principal Investigator:||Connie M Trinacty, PhD||Harvard Medical School and Harvard Pilgrim Health Care Institute|
|Study Director:||Ashley J Beard, PhD||University of Michigan|