DiabetesALICENCT02071498
A Spanish Pillbox App for Elderly Patients Taking Multiple Medications
A study testing Pillbox app named ALICE and oral and written information in people with Diabetes and Hypertension, run by Universidad Miguel Hernandez de Elche at 1 site in Spain.
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… Read more about this study
- Who is it for?
- Ages 65 to 90 years
- Conditions the study is for
- Diabetes, Hypertension
- What is being tested?
- Pillbox app named ALICE and oral and written information
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 99 participants
- Where
- 1 siteSpain
- Study dates
- Jun 2012to May 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 90 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Who cannot join
- Refusing to participate in the study
- More than 90 years old
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Diabetes, Hypertension
- Being tested
- Pillbox app named ALICE, oral and written information
- Keywords
- Pillbox, Non-adherence, Applications, Patient safety, Elderly
- Medical subject headings
- Diabetes Mellitus, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pillbox app named ALICEDevice
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 informationOther
Also called information regarding common errors of patients
oral and written information about the most common errors of patients
| Study group | Role | What they receive |
|---|---|---|
| Pillbox app named ALICE | Experimental | pillbox app for elderly patients taking multiple medications. App was used during three months Receives: 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 Receives: Other: oral and written information |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: participants will be followed using ALICE, an expected average of 3 months
Secondary outcomes (1)
safety medication use
avoid most common errors of patients when taking medications (overdoses or confounding pills)
Measured: participants will be followed using ALICE, an expected average of 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2014 (estimated)
- Study startJun 2012
- Primary completionMay 2013
- Study completionMay 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 99 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Miguel Hernandez de Elche
- Sponsor type
- University, hospital or other
- 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
- Responsible party
- Principal investigator, José Joaquín Mira, Universidad Miguel Hernandez de Elche
- Investigators
- José J Mira, PhD, Principal investigator, Universidad Miguel Hernández
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02071498
- Sponsor's protocol ID
- EC11-527
- Other IDs
- ALICE
- Acronym
- ALICE
- Status last verified
- Feb 2014
- First submitted
- 20 Feb 2014
- Last updated
- 26 Feb 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 23571625Metlay 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.
PubMed 15935020Hayakawa 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.
PubMed 23650486Arsand 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.
PubMed 23063047Morales 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.
PubMed 19328598Mira 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.
PubMed 22904014Mira 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.
PubMed 24705022
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02071498
- Acronym / sponsor ID
- ALICE / EC11-527
- Conditions
- Diabetes, Hypertension
- Keywords
- Pillbox, Non-adherence, Applications, Patient safety, Elderly
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 99 participants (actual)
- Lead sponsor
- Universidad Miguel Hernandez de ElcheUniversity, hospital or other
- 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
- Study start
- Jun 2012
- Primary completion
- May 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 26 Feb 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pillbox app named ALICE | Experimental | Device: Pillbox app named ALICEpillbox app for elderly patients taking multiple medications. App was used during three months |
| oral and written information | Active comparator | Other: oral and written informationoral and written information regarding the main risks related to their medications and the most common errors of patients |
Who may qualify
- Ages
- 65 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Refusing to participate in the study
- More than 90 years old
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pillbox app named ALICEParticipants 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 | Device | Pillbox app named ALICE |
| oral and written informationAlso: information regarding common errors of patientsoral and written information about the most common errors of patients | Other | oral and written information |
Primary outcome
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
1 secondary outcome
safety medication use
Time frame: participants will be followed using ALICE, an expected average of 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2014.
- Background: PubMed 23571625Dayer 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.
- Background: PubMed 15935020Metlay 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.
- Background: PubMed 23650486Hayakawa 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.
- Background: PubMed 23063047Arsand 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.
- Background: PubMed 19328598Morales 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.
- Background: PubMed 22904014Mira 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.
- Derived from this study: PubMed 24705022Mira 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.
- research group site webLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
José J Mira, PhD principal investigator
Universidad Miguel Hernández
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pillbox app named ALICE and oral and written information in people with Diabetes and Hypertension, run by Universidad Miguel Hernandez de Elche at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
adherence (time frame: participants will be followed using ALICE, an expected average of 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02071498, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Feb 2014.