Condition category
Not Applicable
Date applied
18/04/2012
Date assigned
23/04/2012
Last edited
08/07/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
It is important that medicines are taken as prescribed in order to obtain maximum health gain. However, we know that taking medicines exactly as prescribed can be very difficult. We also know that there are many factors that can affect the way that people take their medicines. For example, some people may be forgetful, others may have difficulty getting pills out of their packaging and others may simply not want to take their pills. It would be beneficial in both health and economic terms if medicines were taken exactly as prescribed. Pill boxes which are sectioned into days of the week and times of the day are tools that may help some people to take their medicines as prescribed. Medication is usually received from the pharmacy every month but pill boxes are usually provided every week. At the moment we do not know whether pill boxes are helpful or whether receiving medication weekly compared with monthly makes a difference to whether medicines are taken correctly.

Who can participate?
The greatest difficulty in taking medicines correctly occurs where people regularly take several different kinds of medicine and this most often happens with older people. We will ask people who are 75 years or older and who take at least three different types of pills to take part in our study.

What does the study involve?
Our aim is to carry out a small study that will eventually lead to a much bigger study to confirm whether pill boxes and weekly medication supply help people to take their medicines correctly. We will test two different ways of inviting patients to be involved in the study: by letter and in person. People participating in the study will be randomly allocated to get their medication supplied in the usual packaging either weekly or monthly or in a pill box supplied either weekly or monthly. We will measure whether medicines are taken correctly during the study using an electronic film which will be stuck to the medication packaging of pill box. Every time a patient removes a tablet from its packaging or pill box, this information will be recorded in the film. When the medication packaging or pill box is returned to the pharmacy, an electronic reader can be used to obtain information about how often medication was removed from the packaging or pill box. At the end of the study we will invite a selection of patients to attend a group discussion to obtain their thoughts and experiences of being involved in the study. This information will help us to make any necessary changes to improve the design of a larger study.

What are the possible benefits and risks of participating?
Study involvement poses no risks to patients but may be inconvenient because there will be questionnaires to complete, home visits from researchers and a change of routine if their method of medication supply is changed from monthly to weekly or usual packaging to a pill box.

Where is the study run from?
The study will be run by researchers at the University of East Anglia and Aberdeen University. Six medical practices and community pharmacies based in Norfolk will help with running the study. Researchers will visit participants in their own homes.

When is the study starting and how long is it expected to run for?
July 2012 to March 2013

Who is funding the project?
National Institute for Health Research Health Technology Assessment programme.

Who is the main contact?
Mrs Clare Aldus

Trial website

Contact information

Type

Scientific

Primary contact

Mrs Clare Aldus

ORCID ID

Contact details

University of East Anglia
School of Pharmacy
Norwich Research Park
Norwich
NR7 7TJ
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

HTA 09/34/03

Study information

Scientific title

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.

Acronym

MODS

Study hypothesis

This study will inform the design of a full scale RCT to determine the effectiveness and cost effectiveness of medication organisation devices. There are many complex factors that affect medicine taking behaviours. This study aims to elucidate key factors important in medication-taking behaviour and experimental design that will allow clear elucidation of the effectiveness and cost effectiveness of multi-compartment medication devices by enabling informed design of a future full-scale RCT.

More details can be found at: http://www.nets.nihr.ac.uk/projects/hta/093403
Protocol can be found at: http://www.nets.nihr.ac.uk/__data/assets/pdf_file/0011/54389/PRO-09-34-03.pdf

Ethics approval

Not provided at time of registration

Study design

Randomised controlled 2x2 factorial feasibility study of 3 months duration

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Community

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Older people

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.

Intervention type

Device

Phase

Not Applicable

Drug names

Primary outcome measures

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 measures

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.

Overall trial start date

02/07/2012

Overall trial end date

30/03/2013

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Senior

Gender

Both

Target number of participants

120 participants are desired for the RCT

Participant 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

Recruitment start date

02/07/2012

Recruitment end date

30/03/2013

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University of East Anglia
Norwich
NR7 7TJ
United Kingdom

Sponsor information

Organisation

University of East Anglia (UK)

Sponsor details

c/o Ms Sue Steel
Research Enterprise and Engagement Office
Norwich Research Park
Norwich
NR7 7TJ
United Kingdom
+44 (0)1603 456161
sue.steel@uea.ac.uk

Sponsor type

University/education

Website

http://www.uea.ac.uk/

Funders

Funder type

Government

Funder name

NIHR Health Technology Assessment programme - HTA (UK) ref: 09/34/03

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

01/07/2015

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2016 results in: http://www.ncbi.nlm.nih.gov/pubmed/27385430

Publication citations

Additional files

Editorial Notes

08/07/2016: Publication reference added.