A Spanish Pillbox App for Elderly Patients Taking Multiple Medications
NCT ID: NCT02071498
Last Updated: 2014-02-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
99 participants
INTERVENTIONAL
2012-06-30
2013-05-31
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
SINGLE
Study Groups
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Pillbox app named ALICE
pillbox app for elderly patients taking multiple medications. App was used during three months
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
oral and written information
oral and written information regarding the main risks related to their medications and the most common errors of patients
oral and written information
oral and written information about the most common errors of patients
Interventions
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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
oral and written information
oral and written information about the most common errors of patients
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* More than 90 years old
65 Years
90 Years
ALL
No
Sponsors
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Basque Institute for Healthcare Innovation (O+berri), Bilbao, Spain
UNKNOWN
Andalusian Agency for Health Care Quality, Seville, Spain
UNKNOWN
Hospital Universitario Fundación Alcorcón
OTHER
Castilla-La Mancha Health Service
OTHER
Universidad Miguel Hernandez de Elche
OTHER
Responsible Party
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José Joaquín Mira
Principal researcher
Principal Investigators
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José J Mira, PhD
Role: PRINCIPAL_INVESTIGATOR
Universidad Miguel Hernández
Locations
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Universidad Miguel Hernández
Elche, Alicante, Spain
Countries
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References
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Dayer L, Heldenbrand S, Anderson P, Gubbins PO, Martin BC. Smartphone medication adherence apps: potential benefits to patients and providers. J Am Pharm Assoc (2003). 2013 Mar-Apr;53(2):172-81. doi: 10.1331/JAPhA.2013.12202.
Metlay JP, Cohen A, Polsky D, Kimmel SE, Koppel R, Hennessy S. Medication safety in older adults: home-based practice patterns. J Am Geriatr Soc. 2005 Jun;53(6):976-82. doi: 10.1111/j.1532-5415.2005.53308.x.
Hayakawa M, Uchimura Y, Omae K, Waki K, Fujita H, Ohe K. A smartphone-based medication self-management system with realtime medication monitoring. Appl Clin Inform. 2013 Jan 30;4(1):37-52. doi: 10.4338/ACI-2012-10-RA-0045. Print 2013.
Arsand E, Froisland DH, Skrovseth SO, Chomutare T, Tatara N, Hartvigsen G, Tufano JT. Mobile health applications to assist patients with diabetes: lessons learned and design implications. J Diabetes Sci Technol. 2012 Sep 1;6(5):1197-206. doi: 10.1177/193229681200600525.
Morales Suarez-Varela MT; GEMECOR. [Study on the use of a smart pillbox to improve treatment compliance]. Aten Primaria. 2009 Apr;41(4):185-91. doi: 10.1016/j.aprim.2008.07.003. Epub 2009 Mar 28. Spanish.
Mira JJ, Orozco-Beltran D, Perez-Jover V, Martinez-Jimeno L, Gil-Guillen VF, Carratala-Munuera C, Sanchez-Molla M, Pertusa-Martinez S, Asencio-Aznar A. Physician patient communication failure facilitates medication errors in older polymedicated patients with multiple comorbidities. Fam Pract. 2013 Feb;30(1):56-63. doi: 10.1093/fampra/cms046. Epub 2012 Aug 17.
Mira JJ, Navarro I, Botella F, Borras F, Nuno-Solinis R, Orozco D, Iglesias-Alonso F, Perez-Perez P, Lorenzo S, Toro N. A Spanish pillbox app for elderly patients taking multiple medications: randomized controlled trial. J Med Internet Res. 2014 Apr 4;16(4):e99. doi: 10.2196/jmir.3269.
Related Links
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research group site web
Other Identifiers
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ALICE
Identifier Type: REGISTRY
Identifier Source: secondary_id
EC11-527
Identifier Type: -
Identifier Source: org_study_id
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