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Clinical Trial Summary

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.

Clinical Trial Description

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. ;

Study Design

Related Conditions & MeSH terms

NCT number NCT03834207
Study type Interventional
Source South Warwickshire NHS Foundation Trust
Contact Theodoros N. Arvanitis
Phone +44 (0)24 7615 1601
Status Recruiting
Phase N/A
Start date October 1, 2018
Completion date April 30, 2020

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