Trial Outcomes & Findings for Tailored Approaches to Improve Medication Adherence (NCT NCT01643473)

NCT ID: NCT01643473

Last Updated: 2019-09-26

Results Overview

Feasibility is assessed as the absolute number of patients that are retained in the study once they are consented and enrolled at baseline.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 42 participants
• Primary outcome timeframe: 3 months
• Results posted on: 2019-09-26

Participant Flow

Participant milestones

Measure	Attention Control Health education videos on topics unrelated to medication adherence, hypertension or type 2 diabetes Attention Control: Health education videos on topics unrelated to medication adherence, hypertension or type 2 diabetes	Tailored Adherence Intervention Tablet-based tailored adherence intervention matched to patients' most salient adherence barriers Adherence Intervention: Patients randomized to the TAI group will complete a tailoring survey at the baseline visit to identify the most salient adherence barriers to the individual, which will be used to create an individualized adherence profile. Following completion of the tailoring survey, patients will collaborate with the RA to identify the most suitable mix of intervention strategies for improving medication adherence (i.e., reminder aids, motivational interviewing, case management) that are matched to the barriers outlined on patients' individualized adherence profiles.
Overall Study STARTED	21	21
Overall Study COMPLETED	20	21
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal

Measure	Attention Control Health education videos on topics unrelated to medication adherence, hypertension or type 2 diabetes Attention Control: Health education videos on topics unrelated to medication adherence, hypertension or type 2 diabetes	Tailored Adherence Intervention Tablet-based tailored adherence intervention matched to patients' most salient adherence barriers Adherence Intervention: Patients randomized to the TAI group will complete a tailoring survey at the baseline visit to identify the most salient adherence barriers to the individual, which will be used to create an individualized adherence profile. Following completion of the tailoring survey, patients will collaborate with the RA to identify the most suitable mix of intervention strategies for improving medication adherence (i.e., reminder aids, motivational interviewing, case management) that are matched to the barriers outlined on patients' individualized adherence profiles.
Overall Study Lost to Follow-up	1	0

Baseline Characteristics

Tailored Approaches to Improve Medication Adherence

Baseline characteristics by cohort

Measure	Attention Control n=21 Participants Health education videos on topics unrelated to medication adherence, hypertension or type 2 diabetes Attention Control: Health education videos on topics unrelated to medication adherence, hypertension or type 2 diabetes	Tailored Adherence Intervention n=21 Participants Tablet-based tailored adherence intervention matched to patients' most salient adherence barriers Adherence Intervention: Patients randomized to the TAI group will complete a tailoring survey at the baseline visit to identify the most salient adherence barriers to the individual, which will be used to create an individualized adherence profile. Following completion of the tailoring survey, patients will collaborate with the RA to identify the most suitable mix of intervention strategies for improving medication adherence (i.e., reminder aids, motivational interviewing, case management) that are matched to the barriers outlined on patients' individualized adherence profiles.	Total n=42 Participants Total of all reporting groups
Age, Continuous	54.5 years STANDARD_DEVIATION 11.3 • n=5 Participants	59.7 years STANDARD_DEVIATION 10.7 • n=7 Participants	57.6 years STANDARD_DEVIATION 11.1 • n=5 Participants
Sex: Female, Male Female	9 Participants n=5 Participants	10 Participants n=7 Participants	19 Participants n=5 Participants
Sex: Female, Male Male	12 Participants n=5 Participants	11 Participants n=7 Participants	23 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	20 Participants n=5 Participants	19 Participants n=7 Participants	39 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Educational Status Less than High School	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants
Educational Status High School Degree	10 Participants n=5 Participants	13 Participants n=7 Participants	23 Participants n=5 Participants
Educational Status Some College and above	8 Participants n=5 Participants	6 Participants n=7 Participants	14 Participants n=5 Participants
Unemployed	9 Participants n=5 Participants	20 Participants n=7 Participants	29 Participants n=5 Participants
Annual income less than $40,000	17 Participants n=5 Participants	19 Participants n=7 Participants	36 Participants n=5 Participants

PRIMARY outcome

Timeframe: 3 months

Population: The number of participants that were retained in the study from baseline to 3 months.

Feasibility is assessed as the absolute number of patients that are retained in the study once they are consented and enrolled at baseline.

Outcome measures

Measure	Attention Control n=20 Participants Health education videos on topics unrelated to medication adherence, hypertension or type 2 diabetes Attention Control: Health education videos on topics unrelated to medication adherence, hypertension or type 2 diabetes	Tailored Adherence Intervention n=21 Participants Tablet-based tailored adherence intervention matched to patients' most salient adherence barriers Adherence Intervention: Patients randomized to the TAI group will complete a tailoring survey at the baseline visit to identify the most salient adherence barriers to the individual, which will be used to create an individualized adherence profile. Following completion of the tailoring survey, patients will collaborate with the RA to identify the most suitable mix of intervention strategies for improving medication adherence (i.e., reminder aids, motivational interviewing, case management) that are matched to the barriers outlined on patients' individualized adherence profiles.
Feasibility of Retaining Study Participants Through the 3 Month Trial	20 Participants	21 Participants

SECONDARY outcome

Timeframe: baseline and 3 months

Change in mean systolic and diastolic blood pressure readings from baseline to 3 months. Systolic and diastolic blood pressure are measured in mmHg using a validated automated blood pressure monitor. The average of three readings was used as the blood pressure measurements for the baseline and 3 month study visit.

Outcome measures

Measure	Attention Control n=20 Participants Health education videos on topics unrelated to medication adherence, hypertension or type 2 diabetes Attention Control: Health education videos on topics unrelated to medication adherence, hypertension or type 2 diabetes	Tailored Adherence Intervention n=21 Participants Tablet-based tailored adherence intervention matched to patients' most salient adherence barriers Adherence Intervention: Patients randomized to the TAI group will complete a tailoring survey at the baseline visit to identify the most salient adherence barriers to the individual, which will be used to create an individualized adherence profile. Following completion of the tailoring survey, patients will collaborate with the RA to identify the most suitable mix of intervention strategies for improving medication adherence (i.e., reminder aids, motivational interviewing, case management) that are matched to the barriers outlined on patients' individualized adherence profiles.
Change From Baseline in Mean Systolic and Diastolic Blood Pressure at 3 Months Systolic blood pressure	-6.1 mmHg Standard Error 3.9	-7.2 mmHg Standard Error 3.7
Change From Baseline in Mean Systolic and Diastolic Blood Pressure at 3 Months Diastolic blood pressure	-1.9 mmHg Standard Error 2.3	-3.5 mmHg Standard Error 2.0

SECONDARY outcome

Timeframe: baseline and 3 months

Change in HbA1c from baseline to 3 months using a validated point-of-care device (Afinion AS100 Analyzer) at baseline and 3 months.

Outcome measures

Measure	Attention Control n=20 Participants Health education videos on topics unrelated to medication adherence, hypertension or type 2 diabetes Attention Control: Health education videos on topics unrelated to medication adherence, hypertension or type 2 diabetes	Tailored Adherence Intervention n=21 Participants Tablet-based tailored adherence intervention matched to patients' most salient adherence barriers Adherence Intervention: Patients randomized to the TAI group will complete a tailoring survey at the baseline visit to identify the most salient adherence barriers to the individual, which will be used to create an individualized adherence profile. Following completion of the tailoring survey, patients will collaborate with the RA to identify the most suitable mix of intervention strategies for improving medication adherence (i.e., reminder aids, motivational interviewing, case management) that are matched to the barriers outlined on patients' individualized adherence profiles.
Change From Baseline in HbA1c at 3 Months	0.6 percentage of A1c Standard Error 0.49	-0.5 percentage of A1c Standard Error 0.30

SECONDARY outcome

Timeframe: Baseline and 3 months

Medication adherence will be assessed by self-report using the validated 8-item Morisky Medication Adherence Scale. Scores range from 0-8, with higher scores indicative of better medication adherence.

Outcome measures

Measure	Attention Control n=20 Participants Health education videos on topics unrelated to medication adherence, hypertension or type 2 diabetes Attention Control: Health education videos on topics unrelated to medication adherence, hypertension or type 2 diabetes	Tailored Adherence Intervention n=21 Participants Tablet-based tailored adherence intervention matched to patients' most salient adherence barriers Adherence Intervention: Patients randomized to the TAI group will complete a tailoring survey at the baseline visit to identify the most salient adherence barriers to the individual, which will be used to create an individualized adherence profile. Following completion of the tailoring survey, patients will collaborate with the RA to identify the most suitable mix of intervention strategies for improving medication adherence (i.e., reminder aids, motivational interviewing, case management) that are matched to the barriers outlined on patients' individualized adherence profiles.
Change From Baseline in Self-reported Medication Adherence at 3 Months	1.8 score on a scale Standard Error 0.49	1.3 score on a scale Standard Error 0.48

Adverse Events

Attention Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Tailored Adherence Intervention

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

Antoinette Schoenthaler

NYU School of Medicine

Phone: 212-263-4205

Email: antoinette.schoenthaler@nyumc.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place