Condition category
Mental and Behavioural Disorders
Date applied
25/02/2016
Date assigned
02/03/2016
Last edited
02/03/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Alzheimer’s disease (AD) is the most common cause of dementia, creating problems with memory, thinking and behaviour (cognitive function). People with AD often take more than one medication and managing this can be especially difficult for both the patient and their carer. The majority of people with dementia live in their own homes and wish to stay there as long as possible however when important medications are missed or taken incorrectly then the risk of symptoms worsening and of being admitted to a care home or hospital increases. This study offers patients and the carers the chance to try a new monitored dosage system called Biodose Connect. It consists of a tray containing small individual pods containing the patient’s medications. When each dose is due the pod lights up, and if the medicine is not taken then it can play a recorded voice reminder message. Information about when a patient takes their medication is automatically transmitted and stored on a computer and their carer or healthcare professional can be alerted if key doses are missed to help support the patient. The aim of this study is to test the find out if the Biodose Connect device together with a tailored support programme providing information about the importance of taking medications correctly is able to improve medication adherence in people suffering from AD.

Who can participate?
Adults with AD who live at home and are taking more than one oral (by mouth) medication.

What does the study involve?
All participants are given the Biodose Connect system to use for three months. Patients and their carers are also given an opportunity to take an educational programme designed to support the will and intent to take their mediation properly and provide a better understanding of the particular reasons why this is important. The Biodose Connect system is dispensed from a Rowlands pharmacy in the community and delivered directly to the patient’s home on a weekly basis for a total of 12 weeks. At the start of the study and after 12 weeks, particpants and their carers complete questionnaires in order to find out how well they feel the Biodose Connect system has worked for them with regards to patients taking their medications properly. The clinical team also review how well the patients are taking the medications using information that is automatically transmitted from the Biodose Connect system.

What are the possible benefits and risks of participating?
Participants could benefit from being able to better manage the medication that the patients need to take, which could make their treatment more effective (as they are taking it properly). Risks of taking part are very small, however there is a risk of confusion in some patients arising from the change to how they take their medication.

Where is the study run from?
Pinderfields Hospital (UK)

When is the study starting and how long is it expected to run for?
April 2014 to March 2015

Who is funding the study?
Quantum Pharmaceutical (UK)

Who is the main contact?
Mr Mark Dodd
info@protomed.co.uk

Trial website

Contact information

Type

Public

Primary contact

Mr Mark Dodd

ORCID ID

Contact details

Protomed Ltd.
6 John Bradshaw Court
Congleton Business Park
Congleton
CW12 1LB
United Kingdom
+44 1260 292840
info@protomed.co.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

BCDem001

Study information

Scientific title

Biodose Connect® combined with Psycho-education: A novel intervention enhancing medication adherence and assessment of associated outcomes in people with dementia in the community setting

Acronym

BioCPED

Study hypothesis

Within a community population of Alzheimer's Dementia patients where poor medication adherence has both clinical and resource implications, to demonstrate the value of the Biodose Connect device coupled with a tailored psycho-education adherence support programme through satisfaction and clinical utility scores from the patients and associated healthcare professionals. To evaluate the adherence support programme by showing an improved adherence score from study baseline to endpoint.

Ethics approval

Not provided at time of registration

Study design

Single-centre non-randomised study

Primary study design

Interventional

Secondary study design

Non randomised study

Trial setting

Community

Trial type

Other

Patient information sheet

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

Condition

Early Alzheimer’s Dementia

Intervention

People with early Alzheimer’s dementia known to the clinical team will be stratified and selected according to the selection criteria and inclusion and exclusion criteria. They will be offered the choice to enter the evaluation programme being provided with the combination of the novel new Biodose Connect® device together with psycho-educational support on their medication optimisation provided by nominated healthcare professional and offered to both patient and their carer. The Biodose Connect® intervention will consist of a permanent solid device into which the patient’s Biodose medication tray is placed and turned on. This will be delivered to the patient’s home by the community pharmacist team (Rowlands Pharmacy supporting this evaluation) and set up in the patient’s home. The patient’s individual medication requirements, windows of time which configure the dashboard and specific consented contacts are entered into the software programme for the patient at the start by the community pharmacist. This dictates the timings, content and to whom the reminders for missed medications are directed. It also provides details of when and to whom medication critical alerts should be sent via SMS messages or email. The real time secure dashboard for all patients patterns of medication adherence can be accessed by a secure password protected log in with nominated health care professional or carer only having access to this adherence data for review, actions and management follow up evaluation.

Each patient who consents to receive their medications in this device will be on the service for 12 weeks from baseline. At baseline the patient will be assessed using the 8-item Morisky Medication Adherence Scale (MMAS‐8) to establish the level of medication adherence. At the end the 12 week period the same assessment tool information will be gathered. Additionally the clinical team at the Trust will provide qualitative information on the historic pattern of adherence for each patient and resource implications related to any non-adherence e.g. re-admissions to care homes or nursing homes. The clinical team will review the patient during the 12 weeks on service with regards to enhanced patterns of adherence utilising the data from the patient’s Biodose Connect® dashboard showing the pattern of adherence, doses missed, late doses and time each dose of medication was accessed.

Once the 12 weeks on service are completed, if there is clinical support, patient preference and judgment of benefit, then there will be a request to primary care commissioners to support continuation on a value based assessment on Biodose Connect®. All patients will be able to continue on the same Biodose tray (un-connected) if they wish after the review is completed.

Intervention type

Device

Phase

Drug names

Primary outcome measures

Satisfaction and clinical utility of the adherence support programme is measured using patient note review and patient and carer interviews at baseline and after 12 weeks on service.

Secondary outcome measures

Medication adherence is measured at baseline and study end point using an adherence assessment tool (MMAS-8) to establish the level of medication adherence. In addition, data on medication adherence will be collected from the Biodose dashboard between baseline and three months.

Overall trial start date

01/04/2016

Overall trial end date

30/09/2016

Reason abandoned

Eligibility

Participant inclusion criteria

1. Male or female
2. Diagnosis of Alzheimer’s disease
3. Managed in community setting
4. On more than one oral medication
5. Willing and able to provide informed consent

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

12

Participant exclusion criteria

1. Unable to provide fully informed consent
2. Admitted to hospital or care home/nursing home
3. Non-Alzheimer's dementia

Recruitment start date

11/04/2016

Recruitment end date

01/07/2016

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Pinderfields Hospital
Mid Yorkshire Hospitals NHS Trust Aberford Road
Wakefield
WF1 4DG
United Kingdom

Sponsor information

Organisation

Quantum Pharmaceutical

Sponsor details

Hobson Industrial Estate
Hobson
Newcastle upon Tyne
NE16 6EA
United Kingdom
+44 1207 279400
enquiries@quantumpharma.co.uk

Sponsor type

Industry

Website

http://www.biodose.co.uk/index.php

Funders

Funder type

Industry

Funder name

Quantum Pharmaceutical

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Once completed and evaluated the intention is to utilise the outcomes for publication in a journal related to the management of Alzheimer’s dementia or care of the elderly and to use the outcomes to support a value proposition supporting such interventions in such cohorts of patients in the community setting enhancing patient benefits and reducing the burden and consequences of poor medication adherence.

Intention to publish date

01/11/2016

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes