ISRCTN ISRCTN56622673
DOI https://doi.org/10.1186/ISRCTN56622673
IRAS number 177031
Secondary identifying numbers 319169, IRAS 177031
Submission date
27/01/2015
Registration date
10/02/2015
Last edited
02/09/2020
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Mental and Behavioural Disorders
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

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

Contact information

Miss Ayse Ibrahim
Public

Mednet
40 Otley Road
Leeds
LS6 2AL
United Kingdom

ORCiD logoORCID ID 0000-0002-1610-626X

Study information

Study designOpen-label single-centre pilot study
Primary study designInterventional
Secondary study designNon randomised study
Study setting(s)Home
Study typePrevention
Scientific titleSupporting medicines adherence in bipolar disorder through the use of psychoeducation and Biodose Connect™
Study objectivesTo demonstrate the value of an adherence support programme through satisfaction and clinical utility scores from patients and health-care professionals
Ethics approval(s)Approved 22/04/2015, Yorkshire & The Humber - Leeds West Research Ethics Committee, REC ref: 15/YH/0118
Health condition(s) or problem(s) studiedBipolar disorder, currently in remission
Intervention1. 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 typeMixed
Primary outcome measurePatient 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 measuresChanges 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 study start date05/01/2015
Completion date05/07/2015

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants10 to 12
Key inclusion criteria1. 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
Key exclusion criteria1. 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
Date of first enrolment16/03/2015
Date of final enrolment06/06/2015

Locations

Countries of recruitment

  • Northern Ireland
  • United Kingdom

Study participating centre

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

Sponsor information

Mednet Consult Ltd
Other

40 Otley Road
Leeds
LS6 2AL
United Kingdom

Funders

Funder type

Government

Small Business Research Initiative (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot expected to be made available
Publication and dissemination planA 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.
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
HRA research summary 28/06/2023 No No

Editorial Notes

02/09/2020: No publications found. IRAS Project ID and ethics approval details added.
08/08/2017: No publications found in PubMed, verifying study status with principal investigator.