Caregivers and Electronic Medication Monitoring in Chronic Kidney Disease

NCT01087255 | Unknown Phase 1

• 1 other identifier: PF000123
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Kidney Disease; Medication Adherence

Keywords

Caregiver-based interventions; Chronic Kidney Disease; Medication Adherence

Outcome Measures

Primary Outcomes (1)

• 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.

  6 months

Study Arms (2)

Usual Care

NO INTERVENTION

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

Electronic Pillbox Monitoring System

EXPERIMENTAL

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

Device: Electronic Pillbox Monitoring System

Interventions

Electronic Pillbox Monitoring System DEVICE

Daily exposure for six months

Also known as: MedMinder

Electronic Pillbox Monitoring System

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Harvard Pilgrim Health Care: lead

Study Sites (1)

Harvard Pilgrim Health Care

Wellesley, Massachusetts, 02481, United States

RECRUITING

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Medication Adherence

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Connie M Trinacty, PhD

  Harvard Medical School and Harvard Pilgrim Health Care Institute

  PRINCIPAL INVESTIGATOR

• Ashley J Beard, PhD

  University of Michigan

  STUDY DIRECTOR

Central Study Contacts

Connie M Trinacty, PhD

CONTACT

617-509-9955; connie_trinacty@hphc.org

Ashley J Beard, PhD

CONTACT

734-845-3813; ashlbear@med.umich.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 15, 2010
• First Posted: March 16, 2010
• Study Start: November 1, 2009
• Primary Completion: April 1, 2011
• Study Completion: December 1, 2011
• Last Updated: June 22, 2011

Record last verified: 2010-03

Locations

US (1)