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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01602731
Acronym
TARGET
Enrollment
45
Registered
2012-05-21
Start date
2012-10-31
Completion date
2014-02-28
Last updated
2015-11-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Failure

Keywords

medication adherence

Brief summary

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

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.

Interventions

DEVICEAutomated 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.

Sponsors

VA Office of Research and Development
Lead SponsorFED

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Feasibility of AMDD to Improve Medication Adherence Via Completion Rate4 monthsRate that patient population completed set-up of AMDD was evaluated quantitatively.

Secondary

MeasureTime frameDescription
Efficacy of AMDD to Improve Medication Adherence30-day pill count before the use of AMDD and with AMDDChange in medication adherence (proportion of pills taken of prescribed, as measured by pillcount) after the implementation of the AMDD

Countries

United States

Participant flow

Recruitment details

This project was opened for recruitment as of July 1, 2012. Enrollment for the study originally took place in the heart failure (HF) clinic and Investigator's circle of confidentiality, but after poorer than anticipated enrollment, screening was expanded to all outpatients at the VALLHS with a diagnosis of HF.

Participants by arm

ArmCount
AMDD
Subjects with \<88% medication adherence, determined by 30-day pillcount, will proceed to AMDD portion of study Automated Medication Dispensing Device: A pre-filled medication dispensing machine with a safety phone call if doses are missed
45
Total45

Baseline characteristics

CharacteristicAMDD
Age, Continuous67.3 years
STANDARD_DEVIATION 8.5
Education level
college degree
7 participants
Education level
high school or equivalent
10 participants
Education level
no high school
2 participants
Education level
postgraduate degree
3 participants
Education level
some college
23 participants
Full Range of Saint Louis University Mental Status Scores20.9 units on a scale
Living arrangements
live alone
11 participants
Living arrangements
live with others
34 participants
Medication adherence69.9 Percentage
STANDARD_DEVIATION 12
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
Race (NIH/OMB)
Asian
0 Participants
Race (NIH/OMB)
Black or African American
10 Participants
Race (NIH/OMB)
More than one race
9 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
1 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
Race (NIH/OMB)
White
25 Participants
Saint Louis University Mental Status score20.9 units on a scale
STANDARD_DEVIATION 5.8
Sex: Female, Male
Female
0 Participants
Sex: Female, Male
Male
45 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
— / —
other
Total, other adverse events
0 / 45
serious
Total, serious adverse events
0 / 45

Outcome results

Primary

Feasibility of AMDD to Improve Medication Adherence Via Completion Rate

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

Time frame: 4 months

Population: Of 45 patients who started the study, 24 patients met the predetermined criteria for AMDD. Though all of the patients had agreed to set up the AMDD in their home, only 15 out of 24 ended up completing the setup in their home.

ArmMeasureValue (NUMBER)
Before AMDDFeasibility of AMDD to Improve Medication Adherence Via Completion Rate15 participants
Secondary

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

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

ArmMeasureValue (MEAN)
Before AMDDEfficacy of AMDD to Improve Medication Adherence65 percentage of adherence
After AMDDEfficacy of AMDD to Improve Medication Adherence97 percentage of adherence

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026