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

October 7, 2015 updated by: VA Office of Research and Development

Targeted Intervention to Improve Medication Adherence in Cognitively Impaired Patients With Heart Failure

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

45

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Loma Linda, California, United States, 92357
        • VA Medical Center, Loma Linda

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Automated Medication Dispensing Device
Subjects with <88% medication adherence, determined by 30-day pillcount, and with cognitive impairment (determined by Saint Louis University Mental Status score) proceeded to AMDD portion of study.
Device: Automated Medication Dispensing Device
All patients had a pre-filled medication dispensing machine set up at their homes, filled by home health nurses once a month. Safety phone call was made by the AMDD company if doses were missed.
Other Names:
  • AMDD

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasibility of AMDD to Improve Medication Adherence Via Completion Rate
Time Frame: 4 months
Rate that patient population completed set-up of AMDD was evaluated quantitatively.
4 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Efficacy of AMDD to Improve Medication Adherence
Time Frame: 30-day pill count before the use of AMDD and with AMDD
Change in medication adherence (proportion of pills taken of prescribed, as measured by pillcount) after the implementation of the AMDD
30-day pill count before the use of AMDD and with AMDD

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

VA Office of Research and Development

Investigators

  • Principal Investigator: Helme Silvet, MD, VA Medical Center, Loma Linda

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2012

Primary Completion (Actual)

February 1, 2014

Study Completion (Actual)

February 1, 2014

Study Registration Dates

First Submitted

May 17, 2012

First Submitted That Met QC Criteria

May 17, 2012

First Posted (Estimate)

May 21, 2012

Study Record Updates

Last Update Posted (Estimate)

November 6, 2015

Last Update Submitted That Met QC Criteria

October 7, 2015

Last Verified

October 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RRP 12-198

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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