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Heart FailureTARGETNCT01602731

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

A study testing Automated Medication Dispensing Device in people with Heart Failure, run by VA Office of Research and Development at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Trialing an automated medication dispensing device (AMDD) to improve medication adherence in patients with heart failure. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Heart Failure
What is being tested?
Automated Medication Dispensing Device
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
45 participants
Where
1 siteUnited States
Study dates
Oct 2012to Feb 2014
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • Life expectancy < 6 months
  • Documented dementia requiring a caregiver
  • inability to set up the AMDD at the patient's home due to technical limitations

Trial locations and contacts

1 site in 1 country.

United States1 site
  • VA Medical Center, Loma Linda

    Loma Linda, California, 92357

Other trials in United States

About this study

Official title: 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.

Read the 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.

Conditions
Heart Failure
Being tested
Automated Medication Dispensing Device
Keywords
medication adherence
Medical subject headings
Heart Failure, Medication Adherence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Automated Medication Dispensing DeviceDevice

    Also called AMDD

    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.

Study groups in NCT01602731
Study groupRoleWhat they receive
Automated Medication Dispensing DeviceExperimentalSubjects 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.
Receives: Device: Automated Medication Dispensing Device

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Feasibility of AMDD to Improve Medication Adherence Via Completion Rate

    Rate that patient population completed set-up of AMDD was evaluated quantitatively.

    Measured: 4 months

Secondary outcomes (1)
  1. Efficacy of AMDD to Improve Medication Adherence

    Change in medication adherence (proportion of pills taken of prescribed, as measured by pillcount) after the implementation of the AMDD

    Measured: 30-day pill count before the use of AMDD and with AMDD

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 May 2012 (estimated)
  2. Study startOct 2012
  3. Primary completionFeb 2014
  4. Study completionFeb 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
45 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01602731
Sponsor's protocol ID
RRP 12-198
Acronym
TARGET
Status last verified
Oct 2015
First submitted
17 May 2012
Last updated
6 Nov 2015
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A study testing Automated Medication Dispensing Device in people with Heart Failure, run by VA Office of Research and Development at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 6 Nov 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Feasibility of AMDD to Improve Medication Adherence Via Completion Rate (time frame: 4 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2015.

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