A Spanish Pillbox App for Elderly Patients Taking Multiple Medications

NCT02071498 | Completed

• 2 other identifiers: EC11-527ALICE
• Study Type: interventional
• Target: 99
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes; Hypertension

Keywords

Pillbox; Non-adherence; Applications; Patient safety; Elderly

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• safety medication use

  participants will be followed using ALICE, an expected average of 3 months

Study Arms (2)

Pillbox app named ALICE

EXPERIMENTAL

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

Device: Pillbox app named ALICE

oral and written information

ACTIVE COMPARATOR

oral and written information regarding the main risks related to their medications and the most common errors of patients

Other: oral and written information

Interventions

Pillbox app named ALICE 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

Pillbox app named ALICE

oral and written information OTHER

oral and written information about the most common errors of patients

Also known as: information regarding common errors of patients

oral and written information

Eligibility Criteria

• Age: 65 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Universidad Miguel Hernandez de Elche: lead
• Basque Institute for Healthcare Innovation (O+berri), Bilbao, Spain: collaborator
• Andalusian Agency for Health Care Quality, Seville, Spain: collaborator
• Hospital Universitario Fundación Alcorcón: collaborator
• Castilla-La Mancha Health Service: collaborator

Study Sites (1)

Universidad Miguel Hernández

Elche, Alicante, 03202, Spain

Location

Related Publications (7)

• 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.

  PMID: 23571625 BACKGROUND

• 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.

  PMID: 15935020 BACKGROUND

• 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.

  PMID: 23650486 BACKGROUND

• 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.

  PMID: 23063047 BACKGROUND

• 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.

  PMID: 19328598 BACKGROUND

• 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.

  PMID: 22904014 BACKGROUND

• 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.

  PMID: 24705022 DERIVED

Related Links

• research group site web

MeSH Terms

Conditions

Diabetes Mellitus; Hypertension

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• José J Mira, PhD

  Universidad Miguel Hernández

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal researcher

Study Record Dates

• First Submitted: February 20, 2014
• First Posted: February 26, 2014
• Study Start: June 1, 2012
• Primary Completion: May 1, 2013
• Study Completion: May 1, 2013
• Last Updated: February 26, 2014

Record last verified: 2014-02

Locations

ES (1)