Recruiting
Phase 1
Phase 2

Observational Study

Sponsor:

Harvard Pilgrim Health Care

Code:

NCT01087255

Conditions

Chronic Kidney Disease

Medication Adherence

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Electronic Pillbox Monitoring System

Study Details

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

Study ID

NCT01087255

Start date

Nov, 2009

Status verified date

Mar, 2010

Completion date

Dec, 2011

Anticipated

Primary completion date

Apr, 2011

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

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

Interventions

Electronic Pillbox Monitoring System

Daily exposure for six months

Primary outcome measure

  • medication adherence [ Time Frame: 6 months ]

Central Contacts and Locations

Central contacts

Connie M Trinacty, PhD

617-509-9955connie_trinacty@hphc.org

Ashley J Beard, PhD

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

Locations

Harvard Pilgrim Health Care

Recruiting

Wellesley, Massachusetts, United States, 02481

Contacts

Carla Rosenkras, RN, MPH

617-509-7565carla_rosenkras@hphc.org

More Information

Sponsor

Harvard Pilgrim Health Care

Last update posted

Jun 22, 2011

Last verified

Mar, 2010

Keywords

  • Caregiver-based interventions
  • Chronic Kidney Disease
  • Medication Adherence

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Harvard Pilgrim Health Care on 2011-06-22.