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.
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
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 group | Role | What they receive |
|---|---|---|
| Automated Medication Dispensing Device | Experimental | 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. Receives: Device: Automated Medication Dispensing Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
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.
- First posted21 May 2012 (estimated)
- Study startOct 2012
- Primary completionFeb 2014
- Study completionFeb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Helme Silvet, MD, Principal investigator, VA Medical Center, Loma Linda
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
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Targeted Intervention to Improve Medication Adherence in Cognitively Impaired Patients With Heart Failure
- ClinicalTrials.gov ID
- NCT01602731
- Acronym / sponsor ID
- TARGET / RRP 12-198
- Conditions
- Heart Failure
- Keywords
- medication adherence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- Oct 2012
- Primary completion
- Feb 2014 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 21 May 2012 (estimated)
- Results
- Posted 6 Nov 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Automated Medication Dispensing Device | Experimental | Device: Automated Medication Dispensing DeviceSubjects 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- Life expectancy < 6 months
- Documented dementia requiring a caregiver
- inability to set up the AMDD at the patient's home due to technical limitations
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Automated Medication Dispensing DeviceAlso: AMDDAll 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. | Device | Automated Medication Dispensing Device |
Primary outcome
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.
1 secondary outcome
Efficacy of AMDD to Improve Medication Adherence
Time frame: 30-day pill count before the use of AMDD and with AMDD
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Helme Silvet, MD principal investigator
VA Medical Center, Loma Linda
1 site in 1 country: see every site and its status.
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.