A Spanish Pillbox App for Elderly Patients Taking Multiple Medications

NCT ID: NCT02071498

Last Updated: 2014-02-26

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

99 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-06-30

Study Completion Date

2013-05-31

Brief Summary

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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

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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.

Conditions

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Diabetes Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Investigators

Study Groups

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Pillbox app named ALICE

pillbox app for elderly patients taking multiple medications. App was used during three months

Group Type EXPERIMENTAL

Pillbox app named ALICE

Intervention Type DEVICE

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

Group Type ACTIVE_COMPARATOR

oral and written information

Intervention Type OTHER

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

Intervention Type DEVICE

oral and written information

oral and written information about the most common errors of patients

Intervention Type OTHER

Other Intervention Names

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information regarding common errors of patients

Eligibility Criteria

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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
Minimum Eligible Age

65 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Basque Institute for Healthcare Innovation (O+berri), Bilbao, Spain

UNKNOWN

Sponsor Role collaborator

Andalusian Agency for Health Care Quality, Seville, Spain

UNKNOWN

Sponsor Role collaborator

Hospital Universitario Fundación Alcorcón

OTHER

Sponsor Role collaborator

Castilla-La Mancha Health Service

OTHER

Sponsor Role collaborator

Universidad Miguel Hernandez de Elche

OTHER

Sponsor Role lead

Responsible Party

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José Joaquín Mira

Principal researcher

Responsibility Role PRINCIPAL_INVESTIGATOR

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

Site Status

Countries

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Spain

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.

Reference Type BACKGROUND
PMID: 23571625 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15935020 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23650486 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23063047 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19328598 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22904014 (View on PubMed)

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.

Reference Type DERIVED
PMID: 24705022 (View on PubMed)

Related Links

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http://calite.umh.es

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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