A Spanish Pillbox App for Elderly Patients Taking Multiple Medications

Hypertension Clinical Trial

— ALICE  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02071498
• Other study ID #: EC11-527
• Secondary ID: ALICE
• Status: Completed
• Phase: N/A
• First received: February 20, 2014
• Last updated: February 21, 2014
• Start date: June 2012
• Est. completion date: May 2013

Study information

• Verified date: February 2014
• Source: Universidad Miguel Hernandez de Elche
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Ministerio de Sanidad, Servicios Sociales e Igualdad
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 99
• Est. completion date: May 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 65 Years to 90 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Diabetes
• Hypertension

Intervention

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

Other:
• oral and written information
oral and written information about the most common errors of patients

Locations

Country	Name	City	State
Spain	Universidad Miguel Hernández	Elche	Alicante

Sponsors (5)

Lead Sponsor	Collaborator
Universidad Miguel Hernandez de Elche	Andalusian Agency for Health Care Quality, Seville, Spain, Basque Institute for Healthcare Innovation (O+berri), Bilbao, Spain, Castilla La Mancha Health Service (SESCAM), Toledo, Spain, Hospital Universitario Fundación Alcorcón

Country where clinical trial is conducted

Spain, 

References & Publications (6)

Årsand E, Frøisland DH, Skrøvseth 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. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Mira JJ, Orozco-Beltrán D, Pérez-Jover V, Martínez-Jimeno L, Gil-Guillén VF, Carratala-Munuera C, Sánchez-Molla M, Pertusa-Martínez 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. — View Citation

Morales Suárez-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. Erratum in: Aten Primaria. 2010 Mar;42(3):190. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	adherence	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	participants will be followed using ALICE, an expected average of 3 months	No
Secondary	safety medication use	avoid most common errors of patients when taking medications (overdoses or confounding pills)	participants will be followed using ALICE, an expected average of 3 months	Yes

External Links

•   research group site web