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Medication AdherenceNCT04289246

Supporting the Medication Adherence of Older Mexican Adults Through External Cues Provided With Ambient Displays

A study testing Medication Ambient Display (MAD) in people with Medication Adherence and Medication Compliance, run by Universidad Autonoma de Baja California at 1 site in Mexico.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 60 to 100 yearsHealthy volunteers can take part
Conditions the study is for
Medication Adherence, Medication Compliance
What is being tested?
Medication Ambient Display (MAD)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
16 participants
Where
1 siteMexico
Study dates
25 Aug 2017to 22 Dec 2017
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 60 to 100 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • be older than 60 years
  • take at least three medications prescribed by a physician (ie, polypharmacy),
  • have mild cognitive impairment
  • report medication-forgetting events,
  • live with a relative who could report the assistance required by the study participants to take their medications.

Who cannot join

  • being unable to self-administer medications due to a functionality problem or severe cognitive impairment,
  • not taking pill-based medications (it may be difficult to assess adherence otherwise).
  • To participate in the study, it was not a requirement that older adults have experience in the use of the internet or mobile devices.

Trial locations and contacts

1 site in 1 country.

Mexico1 site
  • Universidad Autonoma de Baja California

    Mexicali, B.C., 21100

Other trials in Mexico

About this study

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:

Read more
  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.

Read the detailed description
  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.
  1. 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.

  1. 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.

  1. 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.

Being tested
Medication Ambient Display (MAD)
Keywords
older adult, frail elderly, mobile health
Medical subject headings
Medication Adherence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Medication Ambient Display (MAD)Device

    MAD was implemented for Android tablets to provide the following external cues:

    • Abstract and stylized representations of medication adherence. The MAD shows a virtual birdcage, which has the aim of raising elders' consciousness about how they have to take responsibility for caring for their health, in a way similar to willingly caring for a pet. Each day, a newborn pet grows to represent medication compliance. By touching any point on the parakeet's virtual cage, the MAD presents information on the participants' daily medication compliance.
    • Auditory and visual reminders. The parakeet provides auditory reminders (a parakeet whistle) and pictograms to inform the medication to take.

    After participants take their medication, they move the MAD closer to the pill container to indicate that the medication was taken. This functionality was implemented through Near Field Communication (NFC) technology. Afterward, the parakeet acknowledges that the medication was registered as taken.

Study groups in NCT04289246
Study groupRoleWhat they receive
Treatment Group (TG)ExperimentalOn the first day of the intervention phase, research assistants visited TG's participants to introduce the MAD in the presence of caregivers. After the training session, which lasted 40 min approximately, the MAD was personalized according to the participant's prescriptions and through discussions with them on an appropriate schedule for presenting the reminders. Research assistants used the MAD administrator sub-system to enter the medication names, health problems to address, timetables, and the frequency at which medications should be taken. Then, they attached and configured NFC tags to each of the pill containers, which included selecting the images that best represented the pills and their containers to be used to form the visual reminders. Afterward, the MAD was placed in the homes' area where participants reported taking medications. MAD was used for 5 weeks during which data on medication adherence and system adoption was collected from the TG.
Receives: Device: Medication Ambient Display (MAD)
Control Group (CG)No interventionParticipants in the CG followed their medication routine as usual. During 5 weeks data on medication adherence was collected.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change from Baseline Dosage_pill

    It measures whether the medication is not being taken as prescribed before using MAD. It is the result of dividing the number of pills taken by participants in a period by the number of pills expected to be taken for that period. To assess the dosage_pill, research assistants collected data weekly from each participant through the pill counting technique. It was estimated for each group (TG and CG).

    Measured: 5-week period for baseline

  2. Change from Intervention Dosage_pill

    It measures whether the medication is not being taken as prescribed during the use of MAD. It is the result of dividing the number of pills taken by participants in a period by the number of pills expected to be taken for that period. To assess the dosage_pill, research assistants collected data weekly from each participant through the pill counting technique. It was estimated for each group (TG and CG).

    Measured: 5-week period for intervention

  3. Change from Post-Intervention Dosage_pill

    It measures whether the medication is not being taken as prescribed after the withdrawal of MAD. It is the result of dividing the number of pills taken by participants in a period by the number of pills expected to be taken for that period. To assess the dosage_pill, research assistants collected data weekly from each participant through the pill counting technique. It was estimated for TG.

    Measured: 2-week period after withdrawal of MAD

Secondary outcomes (4)
  1. Dosage_MAD

    It is the number of medication episodes reported as taken by participants in a period divided by the number of episodes expected to be recorded for that period.

    Measured: 5-week period for intervention

  2. Timely

    It indicates whether the medication was taken in a time window (ie, 30 min) before or after the time expected to take the medication. This is the number of medication episodes registered during a period as taken in the pre-defined time window divided by the total number of medication episodes registered for that period. It was obtained for the TG.

    Measured: 5-week period for intervention

  3. Baseline Self-reported medication adherence

    It is a score estimated through the 8-item Medication Adherence Questionnaire to identify participants' perception about their medication adherence. Minimum value is 0, and maximum value is 8. Higher scores mean a worse outcome (i.e., a lower medication adherence).

    Measured: Once, in the last day of baseline period

  4. Change from Intervention Self-reported medication adherence

    It is a score estimated through the 8-item Medication Adherence Questionnaire to identify participants' perception about their medication adherence. Minimum value is 0, and maximum value is 8. Higher scores mean a worse outcome (i.e., a lower medication adherence).

    Measured: Once, in the last day of the intervention period

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Feb 2020
  2. Study start25 Aug 2017
  3. Primary completion8 Dec 2017
  4. Study completion22 Dec 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Model description
The study included 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). During the study phases, research assistants measured medication adherence weekly through the pill counting technique.
Masking
None (open label)
Enrolment
16 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04289246
Sponsor's protocol ID
105/6/C/103/18
Status last verified
Mar 2025
First submitted
11 Feb 2020
Last updated
27 Mar 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Lavsa SM, Holzworth A, Ansani NT. Selection of a validated scale for measuring medication adherence. J Am Pharm Assoc (2003). 2011 Jan-Feb;51(1):90-4. doi: 10.1331/JAPhA.2011.09154.

    PubMed 21247831
  • Insel KC, Einstein GO, Morrow DG, Koerner KM, Hepworth JT. Multifaceted Prospective Memory Intervention to Improve Medication Adherence. J Am Geriatr Soc. 2016 Mar;64(3):561-8. doi: 10.1111/jgs.14032.

    PubMed 27000329
  • García-Vázquez, J.P., Rodríguez, M.D., Andrade, Á.G. et al. Personal and Ubiquitous Computing Journal 15(4): 389-397, 2011. https://doi.org/10.1007/s00779-010-0362-0

  • Cramer JA, Roy A, Burrell A, Fairchild CJ, Fuldeore MJ, Ollendorf DA, Wong PK. Medication compliance and persistence: terminology and definitions. Value Health. 2008 Jan-Feb;11(1):44-7. doi: 10.1111/j.1524-4733.2007.00213.x.

    PubMed 18237359
  • Martinez de la Iglesia J, Duenas Herrero R, Onis Vilches MC, Aguado Taberne C, Albert Colomer C, Luque Luque R. [Spanish language adaptation and validation of the Pfeiffer's questionnaire (SPMSQ) to detect cognitive deterioration in people over 65 years of age]. Med Clin (Barc). 2001 Jun 30;117(4):129-34. doi: 10.1016/s0025-7753(01)72040-4. Spanish.

    PubMed 11472684
  • Orwig D, Brandt N, Gruber-Baldini AL. Medication management assessment for older adults in the community. Gerontologist. 2006 Oct;46(5):661-8. doi: 10.1093/geront/46.5.661.

    PubMed 17050757
  • Zarate-Bravo E, Garcia-Vazquez JP, Torres-Cervantes E, Ponce G, Andrade AG, Valenzuela-Beltran M, Rodriguez MD. Supporting the Medication Adherence of Older Mexican Adults Through External Cues Provided With Ambient Displays: Feasibility Randomized Controlled Trial. JMIR Mhealth Uhealth. 2020 Mar 2;8(3):e14680. doi: 10.2196/14680.

    PubMed 32130164

Questions about this trial

What is this clinical trial studying?

A study testing Medication Ambient Display (MAD) in people with Medication Adherence and Medication Compliance, run by Universidad Autonoma de Baja California at 1 site in Mexico.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from Baseline Dosage_pill (time frame: 5-week period for baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04289246, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2025.

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