Trial Outcomes & Findings for Targeted Intervention to Improve Medication Adherence in Cognitively Impaired Patients With HF (TARGET) (NCT NCT01602731)

NCT ID: NCT01602731

Last Updated: 2015-11-06

Results Overview

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

Recruitment status

COMPLETED

Study phase

Target enrollment

45 participants

Primary outcome timeframe

4 months

Results posted on

2015-11-06

Participant Flow

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.

Participant milestones

Participant milestones
Measure	Automated Medication Dispensing Device 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
Overall Study STARTED	45
Overall Study Cognitive Impairment	44
Overall Study Poor Medication Adherence	24
Overall Study COMPLETED	15
Overall Study NOT COMPLETED	30

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	AMDD n=45 Participants 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
Age, Continuous	67.3 years STANDARD_DEVIATION 8.5 • n=93 Participants
Sex: Female, Male Female	0 Participants n=93 Participants
Sex: Female, Male Male	45 Participants n=93 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants
Race (NIH/OMB) Asian	0 Participants n=93 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=93 Participants
Race (NIH/OMB) Black or African American	10 Participants n=93 Participants
Race (NIH/OMB) White	25 Participants n=93 Participants
Race (NIH/OMB) More than one race	9 Participants n=93 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants
Education level no high school	2 participants n=93 Participants
Education level high school or equivalent	10 participants n=93 Participants
Education level some college	23 participants n=93 Participants
Education level college degree	7 participants n=93 Participants
Education level postgraduate degree	3 participants n=93 Participants
Living arrangements live alone	11 participants n=93 Participants
Living arrangements live with others	34 participants n=93 Participants
Saint Louis University Mental Status score	20.9 units on a scale STANDARD_DEVIATION 5.8 • n=93 Participants
Medication adherence	69.9 Percentage STANDARD_DEVIATION 12 • n=93 Participants
Full Range of Saint Louis University Mental Status Scores	20.9 units on a scale n=93 Participants

PRIMARY outcome

Timeframe: 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.

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

Outcome measures

Outcome measures
Measure	Before AMDD n=45 Participants Adherence was measured by 30-day pill count before the use of AMDD	After AMDD Adherence was measured with the use of the AMDD as a 30-day pill count
Feasibility of AMDD to Improve Medication Adherence Via Completion Rate	15 participants	—

SECONDARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Before AMDD n=15 Participants Adherence was measured by 30-day pill count before the use of AMDD	After AMDD n=15 Participants Adherence was measured with the use of the AMDD as a 30-day pill count
Efficacy of AMDD to Improve Medication Adherence	65 percentage of adherence Interval 30.0 to 83.0	97 percentage of adherence Interval 91.0 to 100.0

Adverse Events

AMDD

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Helme Silvet, cardiologist

VA Loma Linda Healthcare System

Phone: 9095836097

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place