Depression Clinical Trial
Official title:
A Federated Collaborative Care Cure Cloud Architecture for Addressing the Needs of Multi-morbidity and Managing Poly-pharmacy
To assess the acceptability of a personalised ICT tool that facilitates coordinated care planning, treatment optimisation and patient self-management for patients with multiple long term conditions and their team of health professionals.
C3-CLOUD is a 4 year research project (information technology trial) funded by the EC to
develop, pilot & evaluate a new clinical IT system to improve the management of elderly
patients with multi-morbidity & poly-pharmacy. It will optimise patient education &
self-management and foster closer collaborative working and shared decision making between
healthcare professionals & patients using electronic multi-disciplinary care plans.
The main research question is - "Is the use of a personalised ICT tool that facilitates
coordinated care planning, treatment optimisation and patient self-management acceptable to
patients with multiple long term conditions and their team of health professionals?".
The 1st phase has focused on the development & testing of the system. The 2nd phase will
involve a 12 month pilot (Feb 17-Jan 18) with max 602 patients (+/- the support of their
informal care givers), and a minimum of 62 healthcare professionals in 3 European pilot sites
in the UK, Sweden & Spain. An evaluation will be conducted using healthcare/treatment data &
the completion of questionnaires by the study participants.
The C3-Cloud project structure is as follows:- Funded by the EC; Co-ordinated by Warwick
University; 12 European partners involved, supplying technical, clinical & research
expertise. These partners are based in the UK, Spain, Sweden, France, Turkey, Finland &
Germany; and 3 European pilot sites involved in the study - Basque Country in Spain, Region
Jamtland in Sweden and South Warwickshire in the UK.
The C3-CLOUD system consists of the following 2 integrated components. (i) C3DP - this
component will be used by healthcare professionals in all 3 pilot sites to manage the care of
the study patients. This system records e.g. patient identifiers, contact information,
diagnoses, medication, treatments, encounters, risk factors, goals & activities for the
patients etc. It also provides professionals with a clinical decision support module. (ii) a
Patient Empowerment Platform (PEP) - used by patients (& carers where applicable) so that
they can view & update their care plan. Patients can record information about themselves,
their condition and their care, can view training materials & upload readings such as blood
pressure etc. PEP also automatically takes information from the C3DP system above.
The study is aiming to recruit a minimum of 602 patients to the C3-CLOUD pilot study across
all 3 pilot sites. Informed consent to participate in the study will be obtained. The
patients must be aged 55+ and have at least 2 or more of the following chronic diseases -
diabetes type 2, mild to moderate heart failure, moderate kidney failure and mild to moderate
depression. They must also have a sufficiently high level of IT understanding and access to a
suitable device/the internet, or must nominate a carer, family member or friend who does.
The patients who are recruited will receive care and treatment using the C3-CLOUD system and
will have identifiable data collected about them by healthcare professionals in C3DP, and
will use, and provide information about themselves, in the PEP system.
A separate cohort of max 602 patients will be identified retrospectively from local health
records at the end of the study to create a 'control' group. These patients will match the
same inclusion criteria. However, this control group will have no active role in the study
and only their anonymised data will be utilised so that resource utilisation, medication use
etc, can be compared for the two groups over the same period.
In the UK, the system will be used by a cross-section of healthcare professionals (minimum
62) across the 3 pilot sites. These will be the healthcare professionals who are most likely
to be involved ordinarily in treating the patients during the study.
In addition to the clinical data captured above, the intervention group patients, their
carers and the healthcare professionals involved in the project will participate in a series
of system/project evaluations before, during and after the study. This will be done through
anonymised questionnaires.
Healthcare utilisation & outcome data will be collected about intervention AND control group
patients from local health records systems in an anonymised format. Evaluation data for the
intervention group patients will also be extracted from the C3-Cloud system itself in an
anonymised format.
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