Heart failure and polypharmacy Circulatory System
Conditions
Interventions
This is a randomized controlled trial
the Intervention Group will use the EMMA® device and the Control Group will receive and administer their medicines according to current usual practice.
Patients randomised to the intervention arm wi
Sponsors
INRange (USA)
Eligibility
Sex/Gender
All
Inclusion criteria
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
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Medication adherence will be assessed using the Morisky Scale and/or the Medication Adherence Rating Scale (MARS). Assessments are carried out at baseline (pre-randomisation) and follow-up is carried out at four months after randomisation. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. SF-12 2. Hospital Anxiety and Depression Scale (HADS) 3. Medication Understanding and Use Self-Efficacy Scale (MUSE) - the Taking Medication Sub-scale 4. The Caregiver Assessment of Difficulties index (CADI) and the Caregiver Assessment of Satisfaction Index (CASI) 5. Health service utilisation cost 6. Medication administration errors 7. In the intervention group only, the experiences of users, and acceptability of the EMMA® system to users (patients, carers, professionals (pharmacists and prescribers) Assessments are carried out at baseline (pre-randomisation) and follow-up is carried out at four months after randomisation. | — |
Countries
United Kingdom
Outcome results
None listed