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A Spanish Pillbox App for Elderly Patients Taking Multiple Medications (ALICE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02071498
Recruitment Status : Completed
First Posted : February 26, 2014
Last Update Posted : February 26, 2014
Sponsor:
Collaborators:
Basque Institute for Healthcare Innovation (O+berri), Bilbao, Spain
Andalusian Agency for Health Care Quality, Seville, Spain
Hospital Universitario Fundación Alcorcón
Castilla-La Mancha Health Service
Information provided by (Responsible Party):
José Joaquín Mira, Universidad Miguel Hernandez de Elche

Brief 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.


Condition or disease Intervention/treatment Phase
Diabetes Hypertension Device: Pillbox app named ALICE Other: oral and written information Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 99 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Supportive Care
Official Title: Effectiveness and Utility of a Virtual Custom Tool to Reduce the Medication Errors of Patients Older Than 65 Years Pluripatologic With Complex Therapeutic Regimens
Study Start Date : June 2012
Actual Primary Completion Date : May 2013
Actual Study Completion Date : May 2013

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Pillbox app named ALICE
pillbox app for elderly patients taking multiple medications. App was used during three months
Device: Pillbox app named ALICE
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

Active Comparator: oral and written information
oral and written information regarding the main risks related to their medications and the most common errors of patients
Other: oral and written information
oral and written information about the most common errors of patients
Other Name: information regarding common errors of patients




Primary Outcome Measures :
  1. adherence [ Time Frame: participants will be followed using ALICE, an expected average of 3 months ]
    All the participating patients completed a questionnaire (The Morisky Medication Adherence 4 items Scale) to assess the rates of missed doses Number of alerts of the pillbox app that were not dealt


Secondary Outcome Measures :
  1. safety medication use [ Time Frame: participants will be followed using ALICE, an expected average of 3 months ]
    avoid most common errors of patients when taking medications (overdoses or confounding pills)



Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years to 90 Years   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Multimorbid patients taking multiple medications
  • Over 65 years old, with a Barthel score of more than 60
  • Living in their own home
  • Able to manage the administration of their medication at home

Exclusion Criteria:

  • Refusing to participate in the study
  • More than 90 years old

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02071498


Locations
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Spain
Universidad Miguel Hernández
Elche, Alicante, Spain, 03202
Sponsors and Collaborators
Universidad Miguel Hernandez de Elche
Basque Institute for Healthcare Innovation (O+berri), Bilbao, Spain
Andalusian Agency for Health Care Quality, Seville, Spain
Hospital Universitario Fundación Alcorcón
Castilla-La Mancha Health Service
Investigators
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Principal Investigator: José J Mira, PhD Universidad Miguel Hernández
Additional Information:
Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: José Joaquín Mira, Principal researcher, Universidad Miguel Hernandez de Elche
ClinicalTrials.gov Identifier: NCT02071498    
Other Study ID Numbers: EC11-527
ALICE ( Registry Identifier: EC11-527 )
First Posted: February 26, 2014    Key Record Dates
Last Update Posted: February 26, 2014
Last Verified: February 2014
Keywords provided by José Joaquín Mira, Universidad Miguel Hernandez de Elche:
Pillbox
Non-adherence
Applications
Patient safety
Elderly
Additional relevant MeSH terms:
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Hypertension
Vascular Diseases
Cardiovascular Diseases