NCT02820753

A Universal Medication Schedule to Promote Adherence to Complex Drug Regimens

Completed NA Results posted Last updated 1 February 2022

What this trial tests

NA trial testing EHR + (Text or Portal) in Adherence in 677 participants. Completed in 21 September 2020.

Timeline

3 April 2017

Primary endpoint
21 September 2020

21 September 2020

Quick facts

Lead sponsor	Northwestern University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	factorial
Masking	none
Primary purpose	health services research
Enrollment	677
Start date	3 April 2017
Primary completion	21 September 2020
Estimated completion	21 September 2020
Sites	1 location across United States

Drugs / interventions tested

• EHR + (Text or Portal)

Conditions studied

• Adherence — all drugs for Adherence →

Sponsor

Northwestern University

Who can join

50 and older, any sex, with Adherence. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Medication Adherence - Pill Count Primary · 6 months after Baseline

Pill Count is conducted for all pill form medications using an electronic pill counter at baseline and 6 months. The proportion of pills taken over pills prescribed (PT/PP) will be calculated for each medication at each time point. Pills taken will be calculated by subtracting the number of pills from the total quantity prescribed. Pills prescribed will be calculated by multiplying the number of pills prescribed each day by the number of days since the medication was filled. A proportion of pills taken over pills prescribed (PT/PP) of 80% or more is considered adherent. Analyses were performe

Group	Value	95% CI
Enhanced Usual Care	0.46	0.41 – 0.52
Text or Portal	0.53	0.48 – 0.57

Medication Adherence - Proper Use Primary · 6 Months after Baseline

Participants are asked questions about their 24 hour recall of medication use for each of their medications; they are asked to specify the amount taken (dose), the number of times the med was taken (frequency), the total number of pills taken, and when the doses were taken (to calculate spacing: hours between doses). Proper Use will be scored as yes or no, reflecting having demonstrated all of the following: correct dose, frequency, total and spacing based on the medication bottle instructions. Results are presented as predicted probabilities with 95% Confidence Intervals. Analyses were perfo

Group	Value	95% CI
Enhanced Usual Care	0.71	0.68 – 0.73
Text or Portal	0.71	0.69 – 0.73

Medication Adherence - ASK12 Primary · 6 Months after Baseline

Participants completed the ASK-12 questionnaire, a brief measure of adherence that cover three key domains: inconvenience/forgetfulness, treatment beliefs and behavior. The ASK-12 is scored by summing the selected responses (with scores ranging from 12 to 60) with higher scores indicating greater barriers to adherence. Analyses were performed using Generalized linear models (PROC GENMOD), with a repeated subject effect, and an identity link. Confounding variables such as health status, gender, age, health activation (CHAI), language, time effect and number of chronic conditions were include

Group	Value	95% CI
Enhanced Usual Care	22.40	21.75 – 23.05
Text or Portal	22.06	21.48 – 22.65

Systolic Blood Pressure Secondary · 6 months after Baseline

Systolic blood pressure will be collected on all participants at baseline and 6 months. Change of Systolic blood pressure from baseline will be measured, only in those who are diagnosed with hypertension. Negative Least Square Means indicate a decrease of systolic blood pressure, whereas a positive Least Square Means indicate an increase of systolic blood pressure by 6 Months. Analyses were performed using Generalized linear models (PROC GENMOD), with an identity link. Confounding variables, such as mean systolic blood pressure at baseline, gender, age, race, and number of prescribed medica

Group	Value	95% CI
Enhanced Usual Care	-0.04	-3.73 – 3.64
Text or Portal	1.79	-1.60 – 5.18

Hemoglobin A1c Secondary · 6 months after Baseline

Hemoglobin A1c (hbA1c) will be collected on diabetic patients only, at baseline and 6 months. Change of hbA1c from baseline is modelled. A positive Least Square Mean indicates an increase of hbA1c at 6 months, whereas a negative Least Square Mean indicates a decrease of hbA1c. Analyses were performed using Generalized linear models (PROC GENMOD), with an identity link. Confounding variables, such as hbA1c at baseline, gender, age, health status, language, medication regimen complexity index (MRCI), and health literacy (Newest Vital Sign) were included as fixed effects in the models. Results

Group	Value	95% CI
Enhanced Usual Care	0.23	-0.18 – 0.64
Text or Portal	0.003	-0.28 – 0.29

Sponsor's own description

This study will leverage available technologies and test strategies to impart the Universal Medication Schedule (UMS) in primary care to help patients understand, consolidate, safely use, and adhere to their complex medication regimens.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Development and rationale for a multifactorial, randomized controlled trial to test strategies to promote adherence to complex drug regimens among older adults.
   Bailey SC, Wismer GA, Parker RM, Walton SM, et al · · 2017 · cited 16× · PMID 28823927 · DOI 10.1016/j.cct.2017.08.013