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

A feasibility study to determine the effectiveness and cost effectiveness of medication organisation devices in facilitating health benefit and medication adherence in a population aged 75 years and over and taking three or more solid oral dose form medications compared to usual care which will inform future trial design.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN30626972
Enrollment
120
Registered
2012-04-23
Start date
2012-07-02
Completion date
Unknown
Last updated
2016-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Older people Not Applicable

Interventions

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

Sponsors

University of East Anglia (UK)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria

Exclusion criteria: 1. Participants in receipt of a prescribed medication organisation device or with a history of having received amedication organisation device 2. Are resident in a care home 3. Are currently or have recently been involved in medication intervention trials 4. Have been diagnosed with Parkinson's disease 5. Have a severe mental health disorder such as schizophrenia or other clinical contraindications which in the opinion of the healthcare team renders the patient inappropriate for trial participation

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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.

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026