Targeted Intervention to Improve Medication Adherence in Cognitively Impaired Patients With HF (TARGET)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT01602731
First received: May 17, 2012
Last updated: March 25, 2014
Last verified: March 2014
  Purpose

Trialing an automated medication dispensing device (AMDD) to improve medication adherence in patients with heart failure.


Condition Intervention
Heart Failure
Device: Automated Medication Dispensing Device

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Targeted Intervention to Improve Medication Adherence in Cognitively Impaired Patients With Heart Failure

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • Efficacy of AMDD to improve medication adherence [ Time Frame: 4 months ] [ Designated as safety issue: No ]
    Change in medication adherence (proportion of pills taken of prescribed, as measured by pillcount) after the implementation of the AMDD


Secondary Outcome Measures:
  • Feasibility of AMDD to improve medication adherence [ Time Frame: 4 months ] [ Designated as safety issue: No ]
    Ease of the setup of the AMDD will be evaluated, as well as patient and family acceptance of the AMDD


Estimated Enrollment: 50
Study Start Date: October 2012
Study Completion Date: February 2014
Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: AMDD
Subjects with <88% medication adherence, determined by 30-day pillcount, will proceed to AMDD portion of study
Device: Automated Medication Dispensing Device
A pre-filled medication dispensing machine with a safety phone call if doses are missed
Other Name: AMDD

Detailed Description:

Background:

Medication adherence [MA] is a complex issue depending on both patient and healthcare factors. Non-adherence due to patient-dependent factors is common; analyses of large broad-based clinical trials in the general population demonstrate that 20-30% of study medication doses may be missed. In community-dwelling HF patients with polypharmacy this percentage is likely even higher. One of the factors in poor adherence in elderly non-HF patients has been shown to be cognitive impairment [CI]. Non-adherence to medical regimen is one factor that is associated with worse outcomes in patients with HF, including readmissions. Measures that improve MA are also likely to improve outcomes.

Objectives:

We evaluated a novel intervention incorporating new technology with the goal of improving adherence in patients with HF and CI. Specific objectives of the study were (1) to assess the feasibility of using the Automated Medication Dispensing Device (AMDD) in veterans with HF and CI by measuring patient qualifying rate, consent rate, user rate, patient-level response rate, medication-level response rate, and success rate, (2) to calculate the improvement of MA based on pill counts before and after the introduction of the AMDD, and (3) qualitatively describe patient satisfaction with the AMDD and the reasons for not using the AMDD.

Methods:

This pilot was designed as a feasibility study testing an intervention using a commercially available, off the shelf Automated Medication Dispensing Device (AMDD) with subjects serving as their own controls. The study was conducted at the VALLHS, Loma Linda, CA which serves a population of 246,000 veterans. The study planned to enroll 50 patients with HF and CI (defined as SLUMS score of <27 in a person with high school education or <25 in a person with less than high school education) from the outpatient HF clinic. Baseline adherence to prescribed medications was measured by an initial 30-day pill count (month 1). Subjects with baseline adherence <88% were given the AMDD to use for 90 days (one month to familiarize the study subjects with the device, two months to collect outcome data). This dispenser was pre-filled by home health nurses once a month; the dispenser is equipped with an alarm mechanism that alerts the patient to take the medications; when the patient pushes the button on the device, it will dispense the medications. 30-day pill counts were performed while patients were using the AMDD on months 3 and 4. The study was powered to detect the success rate of the AMDD, defined as both patient acceptance and a clinical response to the AMDD.

Status:

Complete. This project was opened for recruitment as of July 1, 2012. The study is now closed for recruitment and all enrolled patients have completed the intervention. Manuscript outlining the findings of this study and discussing the available interventions to improve medication adherence is in progress.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with established diagnosis of clinical heart failure
  • English-speaking
  • Able to provide informed consent
  • Able to participate in cognitive function testing
  • Age over 18

Exclusion Criteria:

  • Life expectancy < 6 months
  • Documented dementia requiring a caregiver
  • inability to set up the AMDD at the patient's home due to technical limitations
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01602731

Locations
United States, California
VA Medical Center, Loma Linda
Loma Linda, California, United States, 92357
Sponsors and Collaborators
Investigators
Principal Investigator: Helme Silvet, MD VA Medical Center, Loma Linda
  More Information

No publications provided

Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT01602731     History of Changes
Other Study ID Numbers: RRP 12-198
Study First Received: May 17, 2012
Last Updated: March 25, 2014
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
medication adherence

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on April 17, 2014