A Spanish Pillbox App for Elderly Patients Taking Multiple Medications
Condition: Diabetes; Hypertension
MeSH terms: Hypertension
Study type: Interventional

Summary: 
      Background: Non-adherence and medication errors are common among patients with complex drug
      regimens. Applications for smartphones and tablets are known to be effective for improving
      adherence but they have not been tested in elderly patients with such complex chronic
      conditions, their older age meaning they tend to have less experience with this type of
      technology.

      Objective: to design, implement and evaluate a medication self-management application for
      elderly patients taking multiple medications called ALICE with the intention of improving
      adherence and safe medication use.

      Methods: A single-blind randomized controlled trial was conducted with a control and an
      experimental group (N=99) in Spain in 2013. The characteristics of ALICE were specified based
      on the suggestions of 3 nominal groups with a total of 23 patients and a focus group with 7
      professionals. ALICE was designed for Android and iOS and to allow the personalisation of
      prescriptions and medical advice, showing images of each of the medications (the packaging
      and the medication itself) together with alerts and multiple reminders for each alert. The
      randomly subjects in the control group received oral and written information on the safe use
      of their medications and the experimental group used ALICE for three months. Pre- and post-
      measures included: rate of missed doses and medication errors reported by patients, Morisky
      Medication Adherence 4 items Scale scores, level of independence, self-perceived health
      status and biochemical test results of the patients. In the experimental group, data were
      also collected on their previous experience with information and communication technologies,
      their rating of ALICE and their perception of the level of independence they had achieved.
      The inter-group intervention effects were calculated by univariate linear models and ANOVA,
      with the pre- to post-intervention differences as the dependent variables.
    

Detailed description: 
      A tablet-based medication self-management app (called ALICE) was designed to help patients to
      remember to take all their medications, at the correct doses, distinguish between drugs to
      avoid confusions, avoid known potential interactions and common errors in use of the
      medications and know how to properly store the medications. The app design was based on
      suggestions extracted from 3 nominal groups with a total of 23 patients and a focus group
      with 7 professionals (3 physicians and 4 pharmacists).

      The tablet used was selected on the basis of the need for a device with an at least 7-inch,
      easy to use touch screen, ensuring that users would only have to follow simple instructions
      and tap on some icons on the screen. Specifically, the BQ Verne Plus 3G with an LCD Tactile
      screen was chosen in the case of Android, and an iPad 2 with Wi-Fi + 3G in the case of the
      iOS.

      This study has been approved and financed by the Spanish Ministry of Health, Equality, and
      Social Policy. The Spanish Research Health Agency (FIS), Independent Clinical Research,
      project number EC11-527. The Experimental Research Ethics Committee of Miguel Hernández
      University (DPS-JJM-003-11) approved the trial.
    

Intervention name(s): Pillbox app named ALICE; oral and written information
Intervention type(s): Device; Other
Intervention description(s): Participants in the experimental group were given a BQ tablet or an iPad with the ALICE app installed and personalised according to the medications they had been prescribed as listed in their medical record; oral and written information about the most common errors of patients
Other intervention name(s): information regarding common errors of patients
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Supportive Care
Keywords: Pillbox; Non-adherence; Applications; Patient safety; Elderly