Targeted Intervention to Improve Medication Adherence in Cognitively Impaired Patients With HF (TARGET)
TARGET
1 other identifier
interventional
45
1 country
1
Brief Summary
Trialing an automated medication dispensing device (AMDD) to improve medication adherence in patients with heart failure.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable heart-failure
Started Oct 2012
Shorter than P25 for not_applicable heart-failure
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 17, 2012
CompletedFirst Posted
Study publicly available on registry
May 21, 2012
CompletedStudy Start
First participant enrolled
October 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2014
CompletedResults Posted
Study results publicly available
November 6, 2015
CompletedNovember 6, 2015
October 1, 2015
1.3 years
May 17, 2012
April 22, 2015
October 7, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Feasibility of AMDD to Improve Medication Adherence Via Completion Rate
Rate that patient population completed set-up of AMDD was evaluated quantitatively.
4 months
Secondary Outcomes (1)
Efficacy of AMDD to Improve Medication Adherence
30-day pill count before the use of AMDD and with AMDD
Study Arms (1)
Automated Medication Dispensing Device
EXPERIMENTALSubjects 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Life expectancy \< 6 months
- Documented dementia requiring a caregiver
- inability to set up the AMDD at the patient's home due to technical limitations
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
VA Medical Center, Loma Linda
Loma Linda, California, 92357, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
Low enrollment in the study reflects the fact that many patients with HF do not admit the need for assistance with their medications. Patients should first be tested for the presence of cognitive impairment and baseline medication adherence problems.
Results Point of Contact
- Title
- Dr. Helme Silvet, cardiologist
- Organization
- VA Loma Linda Healthcare System
Study Officials
- PRINCIPAL INVESTIGATOR
Helme Silvet, MD
VA Medical Center, Loma Linda
Publication Agreements
- PI is Sponsor Employee
- Yes
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- FED
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 17, 2012
First Posted
May 21, 2012
Study Start
October 1, 2012
Primary Completion
February 1, 2014
Study Completion
February 1, 2014
Last Updated
November 6, 2015
Results First Posted
November 6, 2015
Record last verified: 2015-10