Medication Adherence Clinical Trial
Official title:
Supporting the Medication Adherence of Older Mexican Adults Through External Cues Provided With Ambient Displays: Protocol of a Feasibility Randomized Controlled Trial
Background: Problems with prospective memory, which refer to the ability to remember future
intentions, cause deficits in basic and instrumental activities of daily living, such as
taking medications. Older adults show minimal deficits when they rely on mostly preserved and
relatively automatic associative retrieval processes. On the basis of this, the investigators
of this study propose to provide external cues to support the automatic retrieval of an
intended action, that is, to take medicines. To reach this end, the Medication Ambient
Display (MAD) was developed. It is a system that unobtrusively presents relevant information
unless it requires the users' attention, It uses different abstract modalities to provide
external cues that enable older adults to easily take their medications on time and be aware
of their medication adherence.
Objective: This study aimed to assess the adoption and effect of external cues provided
through MAD on medication adherence in older adults. The study aimed to address the following
research questions:
1. What is the effect of the external cues provided by the MAD on older adults' medication
adherence?
2. How do the MAD design features promote its adoption?
Methods: A total of 16 older adults, who took at least three medications and had mild
cognitive impairment, participated in the study. It was a 17-week feasibility study in which
we used a mixed-methods approach to collect qualitative and quantitative evidence. The study
included participants' recruitment, baseline, intervention, and postintervention phases. Half
of the participants were randomly allocated to the treatment group (n=8), and the other half
was assigned to the control group (n=8). Research assistants measured medication adherence
weekly through the pill counting technique. Qualitative evidence about the system's adoption
was collected through semi-structured interviews. Participants of the treatment group were
interviewed regarding the system's functionalities that they perceived as most useful, less
useful, and the difficulties faced while using it.
1. Introduction
One of the most common reasons for medication nonadherence among older adults is
forgetfulness. Medication management technologies can help them not only with
forgetfulness or cognitive impairment but also with other reasons that contribute to the
lack of adherence to medications, such as polypharmacy (ie, the self-administration of
multiple drugs). Research has also shown that the use of external cues supports the
automatic recovery of a planned action. Therefore, this study proposes to support
external cues through a tablet-based ambient display designed to increase the retrieval
process of the planned action (ie, taking medications) and to provide awareness of
adherence behavior. To reach this end, the Medication Ambient Display (MAD) was
developed.
An ambient display unobtrusively presents relevant information unless it requires the
users' attention. In addition, users can easily monitor the display to obtain the
desired information because it uses abstract modalities to represent information, such
as pictures, sounds, and movement. Thus, different abstract modalities to provide
external cues that enable older adults to easily obtain relevant information to take
their medications on time and be aware of their medication adherence.
MAD was implemented for Android tablets to be placed as portrait frames in the older
adults' homes and to provide the following external cues:
- Abstract and stylized representations of their medication adherence
- Auditory and visual reminders to call older adults' attention
- Events that may enhance older adults' awareness about whether the medication was
taken.
In this study, the effect of the use of the above-mentioned approach was assessed by
using objective medication adherence measures. Moreover, qualitative findings were
obtained about the adoption of the MAD.
2. Study flow
2.a. Participant recruitment
For recruiting participants, research assistants (students of the Nursing Faculty) contacted
older adults affiliated in the Comunity Center of the University, in which students and
academic personnel offer older adults social and health-care services. To recruit
participants, research assistants administered a set of instruments to assess which older
adults met the eligibility criteria. The instruments used were the Short Portable Mental
State Questionnaire, the Medication Management Instrument for Deficiencies in the Elderly,
and the 8-item Medication Adherence Questionnaire, also known as Morisky scale. Relatives of
older adults were interviewed to identify their role in helping older adults follow their
medication routine. Older adults who met the eligibility criteria and expressed their
interest to participate were enrolled in the study. The recruitment procedure lasted
approximately 5 weeks (weeks 1-5).
2.b. Pre-Intervention activities
Baseline data were collected during weeks 6 to 10 on medication adherence by using the pill
counting technique. Research assistants noticed that participants accumulated containers with
the same medications. Under those circumstances, seniors were provided with a basket to
arrange the medications that should be taken each week, which facilitated data collection for
measuring the Dosage_pill adherence outcome.
2.c. Intervention activities
Research assistants made a random and blind allocation of the participants to the treatment
group (TG) and the control group (CG). On the first day of the intervention phase, research
assistants visited older adults in the TG to introduce the MAD in the presence of caregivers
by using the spaced retrieval approach, that is, teach, ask, wait, ask again, wait, and ask
again. After the completion of the training session, which lasted 40 minutes approximately,
the MAD was personalized according to the participant's prescriptions and through discussions
with the participants on an appropriate schedule for presenting the reminders. Afterward, the
MAD was placed in the area of participants' homes where they usually reported taking
medications, mostly the kitchen, living room, and bedroom. The intervention phase lasted 5
weeks, during which research assistants visited participants to collect data on medication
adherence (from both the TG and the CG) and system adoption (from the TG).
2.d. Postintervention activities
After the intervention was completed, MAD was removed from the participants' homes. Research
assistants then carried out weekly visits (weeks 16-17) to older adults from the TG to
collect data through semi-structured interviews about how MAD affected their medication
routine and adherence.
3. Outcome measures and data acquisition
A set of variables were identified as relevant for analyzing the effect of the external cues
provided by the MAD on the participants' medication adherence, such as dosage and timely
variables, which were used to address research question 1.
During the intervention phase, qualitative evidence about the system's adoption was collected
to address research question 2. The interview included questions regarding the system's
functionalities that the TG's participants perceived as most useful, less useful, and the
difficulties faced while using it. Similarly, at the end of the postintervention stage, TG's
participants were interviewed to obtain their perceptions of how withdrawal from the MAD
impacted their medication adherence. In addition, caregivers were interviewed to obtain
information on their involvement in the seniors' medication activities. The questions
centered on the specific activities associated with the older adults' medication regimens
that caregivers were involved in and how they knew if older adults took their pills in a
given week.
4. Data analysis
Student t tests and chi-square tests were used to measure the statistical difference in age,
the number of prescribed medicines, and self-reported medication adherence between the TG and
the CG. A one-way repeated measure analysis of variance (ANOVA), dependent t tests, and
independent t tests were used to find significant differences in medication adherence between
the study phases and between the TG and the CG. The McNemar test was used to verify
differences within the TG between the self-reported medication adherence in the recruitment
and intervention phases. To determine whether any of the differences between the means
estimated are statistically significant, the P value was compared with a significance level
set to .05.
For the qualitative analysis, the collected data were transcribed from their original Spanish
version, that is, audio and handwritten notes. The thematic analysis approach was followed
which consists of generating initial codes from the data, searching for potential themes,
contrasting the identified themes with the data, and iteratively refining them.
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