A feasibility study of the effectiveness and cost effectiveness of Medication Organisation DeviceS (MODS)

Authors
Category Primary study
Registry of TrialsISRCTN registry
Year 2012
INTERVENTION: Intentional non‐adherence will be ascertained by questionnaire and intentionally non‐adherent participants will be excluded from the randomised controlled trial (RCT). Full adherence will be measured by pill counts in a 3‐week pre‐trial observational study. Fully adherent participants will be excluded from the RCT. Neither intentionally non‐adherent nor fully adherent participants will provide optimal data for the RCT. The proportion of intentionally non‐adherent or fully adherent participants determined will also be used to inform future study design. RCT participants will be assessed for manual dexterity, cognitive ability and visual acuity. RCT participants (unintentionally non‐adherent) will be allocated to receive either a medication organisation device weekly, a medication organisation device 4‐weekly, usual medication supply weekly, or usual medication supply 4‐weekly. All participants will have solid oral dose form medications monitored electronically using proprietary films printed with an electronic circuit which records the time at which the circuit is broken by a pack‐opening event. CONDITION: Older people ; Not Applicable PRIMARY OUTCOME: Medication taking events will be measured using proprietary electronic films and results compared for pill boxes and usual supply and weekly and 4‐weekly medication supply. SECONDARY OUTCOME: Unintentionally non‐adherent RCT trial participants will be characterised using tests of visual acuity, finger dexterity and cognitive ability. These aspects are likely to be particularly important in the study population and results will be compared for medication organisation devices and usual packaging for monthly or weekly supply to ascertain differences. ; ; Participant satisfaction with their method of medication supply, participant perceived autonomy, quality of life data and carers' views on the effects of the medication supply on them and their caring routines will be measured using questionnaire‐based tools. Health care utilisation during the period of the study will be assessed using Healthcare Episode Statistics and GP‐provided data. Where applicable, results will be compared for pill boxes and usual packaging for monthly or weekly supply to ascertain differences. Information pertaining to health economics (quality of life and healthcare utilisation) will be used to determine cost effectiveness. In addition, views on acceptability, patient autonomy and quality of life in the study population and cost effectiveness will also be used to inform future study design. INCLUSION CRITERIA: 1. Aged 75 years or over 2. Are prescribed three or more solid oral dose form medications for the management of a chronic condition 3. Have a life expectancy equal to or in excess of one year 4. Are capable of providing informed consent
Epistemonikos ID: 616a4875eb1e873576c792347b9a6bd06d4ad14d
First added on: Aug 22, 2024