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Caregivers and Electronic Medication Monitoring in Chronic Kidney Disease

Primary Purpose

Chronic Kidney Disease, Medication Adherence

Status
Unknown status
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Electronic Pillbox Monitoring System
Sponsored by
Harvard Pilgrim Health Care
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Chronic Kidney Disease focused on measuring Caregiver-based interventions, Chronic Kidney Disease, Medication Adherence

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Harvard Pilgrim Health CareRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Usual Care

Electronic Pillbox Monitoring System

Arm Description

Usual care patients will have outpatient care and monitoring procedures, as determined by them and their health care providers.

Usual care plus receive use of the wireless electronic pillbox and medication monitoring system

Outcomes

Primary Outcome Measures

medication adherence
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.

Secondary Outcome Measures

Full Information

First Posted
March 15, 2010
Last Updated
June 21, 2011
Sponsor
Harvard Pilgrim Health Care
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1. Study Identification

Unique Protocol Identification Number
NCT01087255
Brief Title
Caregivers and Electronic Medication Monitoring in Chronic Kidney Disease
Official Title
Caregivers and Internet Based Monitoring to Improve Medication Use in HPHC Enrollees With Chronic Kidney Disease
Study Type
Interventional

2. Study Status

Record Verification Date
March 2010
Overall Recruitment Status
Unknown status
Study Start Date
November 2009 (undefined)
Primary Completion Date
April 2011 (Actual)
Study Completion Date
December 2011 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Harvard Pilgrim Health Care

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Disease, Medication Adherence
Keywords
Caregiver-based interventions, Chronic Kidney Disease, Medication Adherence

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Usual Care
Arm Type
No Intervention
Arm Description
Usual care patients will have outpatient care and monitoring procedures, as determined by them and their health care providers.
Arm Title
Electronic Pillbox Monitoring System
Arm Type
Experimental
Arm Description
Usual care plus receive use of the wireless electronic pillbox and medication monitoring system
Intervention Type
Device
Intervention Name(s)
Electronic Pillbox Monitoring System
Other Intervention Name(s)
MedMinder
Intervention Description
Daily exposure for six months
Primary Outcome Measure Information:
Title
medication adherence
Description
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.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Connie M Trinacty, PhD
Phone
617-509-9955
Email
connie_trinacty@hphc.org
First Name & Middle Initial & Last Name or Official Title & Degree
Ashley J Beard, PhD
Phone
734-845-3813
Email
ashlbear@med.umich.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Connie M Trinacty, PhD
Organizational Affiliation
Harvard Medical School and Harvard Pilgrim Health Care Institute
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ashley J Beard, PhD
Organizational Affiliation
University of Michigan
Official's Role
Study Director
Facility Information:
Facility Name
Harvard Pilgrim Health Care
City
Wellesley
State/Province
Massachusetts
ZIP/Postal Code
02481
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carla Rosenkras, RN, MPH
Phone
617-509-7565
Email
carla_rosenkras@hphc.org

12. IPD Sharing Statement

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Caregivers and Electronic Medication Monitoring in Chronic Kidney Disease

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