Condition category
Mental and Behavioural Disorders
Date applied
27/01/2015
Date assigned
10/02/2015
Last edited
10/02/2015
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
People with bipolar disorder will have periods of depression, during which they will feel very low and lethargic, and mania, during which they will feel very high and overactive. Biodose Connect™ is a medicines adherence service that can be used to provide medications for patients with bipolar disorder and co-medications for other medical conditions. The aim in this study is to offer patients with bipolar disorder, who have or have had issues with medication adherence, medication adherence support with web-based psychoeducation module on relapse prevention and Biodose Connect™.

Who can participate?
Adults with bipolar disorder

What does the study involve?
The community pharmacist will dispense the patient’s medication into the Biodose Connect™ system and the tray will be delivered to the patient’s chosen location. The community psychiatric nurse (CPN) will assign the psychoeducation module to the patient. A link will be sent by email to the patient with details of how to access the module. The patient will complete the online interactive module and take their medication as instructed. The Biodose Connect™ system will trigger a short message service text reminder to the patient if they have not taken their medication in the timeframe. It will also alert the CPN that the patient has not taken his or her medication. At the study endpoint, the patient and patient’s CPN will be required to complete an assessment to evaluate the programme.

What are the possible benefits and risks of participating?
Benefits and risks not provided at time of registration.

Where is the study run from?
White Abbey Hospital (UK)

When is the study starting and how long is it expected to run for?
From January 2015 to July 2015

Who is funding the study?
Small Business Research Initiative (UK)

Who is the main contact?
Miss Ayse Ibrahim

Trial website

Contact information

Type

Public

Primary contact

Miss Ayse Ibrahim

ORCID ID

http://orcid.org/0000-0002-1610-626X

Contact details

Mednet
40 Otley Road
Leeds
LS6 2AL
Leeds
LS6 2AL
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

319169

Study information

Scientific title

Supporting medicines adherence in bipolar disorder through the use of psychoeducation and Biodose Connect™

Acronym

Study hypothesis

To demonstrate the value of an adherence support programme through satisfaction and clinical utility scores from patients and health-care professionals

Ethics approval

National Health Service/Health and Social Care Research and Development office, 28/01/2015

Study design

Open-label single-centre pilot study

Primary study design

Interventional

Secondary study design

Non randomised study

Trial setting

Home

Trial type

Prevention

Patient information sheet

Condition

Bipolar disorder, currently in remission

Intervention

1. Support will be provided as a medication internet-based psychoeducation module on relapse prevention and Biodose Connect™, which is an advanced medication and adherence management system using state-of-the-art technologies.
2. The patient will complete an education module on relapse prevention, designed to increase their knowledge of their disorder and enable them to create their own individual profile to recognise early signs and triggers of a relapse.
3. The patient's medication will be given in the Biodose Connect™ system and the patient will receive reminder texts if medication is not taken in the allocated timeframe.

Intervention type

Mixed

Phase

Drug names

Primary outcome measures

Patient and health-care professional satisfaction scores will be captured with a satisfaction survey including rating scales and net promoter score at the end of the study (3 months after the start of study).

Secondary outcome measures

Changes in adherence scores from study baseline to end of the study (3 months after the start of study) will be measured with an adherence assessment tool, which includes the Medication Adherence Rating Scale score and the Clinical Global Impression score.

Overall trial start date

05/01/2015

Overall trial end date

05/07/2015

Reason abandoned

Eligibility

Participant inclusion criteria

1. International Statistical Classification of Diseases and Related Health Problems diagnosis: F31.7 bipolar disorder, currently in remission
2. Taking medication for bipolar disorder
3. Will be treated by Northern Health and Social Care Trust (UK)
4. Medication Adherence Rating Scale score of 6 or less
5. Clinical Global Impression score of 3 or less (mildly ill)
6. Home access to the internet via a laptop or desktop computer
7. Informed consent and registration forms
8. Co-medications and liquid medications can be administered via Biodose Connect™
9. Age 18–64 years old

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

10 to 12

Participant exclusion criteria

1. Significant cognitive impairment
2. Taking medication that is identified by the Medicines and Healthcare Products Regulatory Agency (UK) as not suitable for blister/biodose packaging
3. Poor communication and/or reading skills

Recruitment start date

16/03/2015

Recruitment end date

06/06/2015

Locations

Countries of recruitment

United Kingdom

Trial participating centre

White Abbey Hospital
Oakview House Doagh Road Newtownabbey
County Antrim
BT37 9RH
United Kingdom

Sponsor information

Organisation

Mednet Consult Ltd

Sponsor details

40 Otley Road
Leeds
LS6 2AL
United Kingdom

Sponsor type

Other

Website

Funders

Funder type

Government

Funder name

Small Business Research Initiative (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

A report will be produced for internal use. It will also be submitted to the Small Businesss Research Initiative (UK). The report will be used to assess the feasibility of the study and whether to provide further funding for phase 2.

Intention to publish date

Participant level data

Not expected to be available

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes