A study of an Electronic Medicine Management Assistant (EMMA®) system

Completed

Conditions: Heart failure and polypharmacy
Circulatory System

Registration Number: ISRCTN51444951

Lead Sponsor: INRange (USA)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 312

Inclusion Criteria

Detailed inclusion criteria are that patients must use participating pharmacies and:
1. Be at least 18 years of age
2. Be alert and oriented to person, place, and time
3. Primarily use English language for written and oral communication
4. Be on a regular prescription for furosemide or be taking four or more (but less than 20) different prescription medications
5. Have a self-reported history of inconsistent patient self-medication management
6. Be living in the study area
7. Achieve a score of >24 on the Mini-Mental State Exam (Folstein, Folstein and McHugh 1975)
8. Have dexterity and visual acuity to open the individual unit dose medicine packages used in EMMA®
9. Have the facility in their home to permit EMMA® to communicate with its server either utilising an internet connection or utilising the EMMA® device?s built-in cellular modem

Exclusion Criteria

1. Have disabilities preventing safe use of the EMMA® Device (e.g. blindness, amputation, paralysis)
2. Have an anticipated life expectancy of less than three months
3. Are, in the opinion of either the responsible general practitioners (GP) or the pharmacist, unsuitable for the trial e.g. severe mental illness; other family circumstances
4. Are known to be intentionally non-adherent to their medication regimen
5. Are already receiving their medication in an MDS (monitored dosage system)

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Medication adherence will be assessed using the Morisky Scale and/or the Medication Adherence Rating Scale (MARS).<br><br>Assessments are carried out at baseline (pre-randomisation) and follow-up is carried out at four months after randomisation.

Secondary Outcome Measures

Name	Time	Method
1. SF-12<br>2. Hospital Anxiety and Depression Scale (HADS)<br>3. Medication Understanding and Use Self-Efficacy Scale (MUSE) - the Taking Medication Sub-scale<br>4. The Caregiver Assessment of Difficulties index (CADI) and the Caregiver Assessment of Satisfaction Index (CASI)<br>5. Health service utilisation cost<br>6. Medication administration errors<br>7. In the intervention group only, the experiences of users, and acceptability of the EMMA® system to users (patients, carers, professionals (pharmacists and prescribers)<br> <br>Assessments are carried out at baseline (pre-randomisation) and follow-up is carried out at four months after randomisation.