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

NCT04289246 | Completed

• 1 other identifier: 105/6/C/103/18
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief 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. 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. 1.What is the effect of the external cues provided by the MAD on older adults' medication adherence?
2. 2.How do the MAD design features promote its adoption?

Conditions

Medication Adherence; Medication Compliance

Keywords

older adult; frail elderly; mobile health

Outcome Measures

Primary Outcomes (3)

• 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).

  5-week period for baseline

• 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).

  5-week period for intervention

• 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.

  2-week period after withdrawal of MAD

Secondary Outcomes (4)

• Dosage_MAD

  5-week period for intervention

• Timely

  5-week period for intervention

• Baseline Self-reported medication adherence

  Once, in the last day of baseline period

• Change from Intervention Self-reported medication adherence

  Once, in the last day of the intervention period

Study Arms (2)

Treatment Group (TG)

EXPERIMENTAL

On 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.

Device: Medication Ambient Display (MAD)

Control Group (CG)

NO INTERVENTION

Participants in the CG followed their medication routine as usual. During 5 weeks data on medication adherence was collected.

Interventions

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.

Treatment Group (TG)

Eligibility Criteria

• Age: 60 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad Autonoma de Baja California: lead

Study Sites (1)

Universidad Autonoma de Baja California

Mexicali, B.C., 21100, Mexico

Location

Related Publications (7)

• 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.

  PMID: 21247831 BACKGROUND

• 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.

  PMID: 27000329 BACKGROUND

• 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

  BACKGROUND

• 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.

  PMID: 18237359 BACKGROUND

• 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.

  PMID: 11472684 BACKGROUND

• 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.

  PMID: 17050757 BACKGROUND

• 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.

  PMID: 32130164 DERIVED

MeSH Terms

Conditions

Medication Adherence

Condition Hierarchy (Ancestors)

Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Marcela D. Rodriguez, PhD

  Universidad Autonoma de Baja California

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full Time Professor

Model Details: 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.

Study Record Dates

• First Submitted: February 11, 2020
• First Posted: February 28, 2020
• Study Start: August 25, 2017
• Primary Completion: December 8, 2017
• Study Completion: December 22, 2017
• Last Updated: March 27, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)