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A Study of the Usefulness & Usability of a Healthcare IT System for Managing Multi-morbidity and Poly-pharmacy (C3-Cloud)

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ClinicalTrials.gov Identifier: NCT03834207
Recruitment Status : Recruiting
First Posted : February 7, 2019
Last Update Posted : February 7, 2019
Sponsor:
Collaborators:
University of Warwick
Kronikgune
Medixine
SRDC
Institut National de la Santé Et de la Recherche Médicale, France
Eurorec
Empirica
Örebro University, Sweden
Osakidetza
Region Jamtland Harjedalen
Cambio Healthcare
Information provided by (Responsible Party):
Dr Christopher Marguerie, South Warwickshire NHS Foundation Trust

Brief 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.

Condition or disease Intervention/treatment Phase
Diabetes Type 2 Renal Failure Heart Failure Depression Chronic Disease Aging Device: Use of the C3-Cloud IT system Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 672 participants
Intervention Model: Single Group Assignment
Intervention Model Description: A single intervention group that will use and evaluate the C3-Cloud system during the 12 month study. Please note that an anonymous group of patients meeting the same criteria will be identified retrospectively at the end of the study so that healthcare resource utilisation during the same period can be compared.
Masking: None (Open Label)
Primary Purpose: Other
Official Title: A Federated Collaborative Care Cure Cloud Architecture for Addressing the Needs of Multi-morbidity and Managing Poly-pharmacy
Actual Study Start Date : October 1, 2018
Estimated Primary Completion Date : January 31, 2020
Estimated Study Completion Date : April 30, 2020

Arm Intervention/treatment
Experimental: Intervention Group
Use of the C3-Cloud IT system
Device: Use of the C3-Cloud IT system
Patients who are recruited to the intervention arm will use the C3-Cloud system during the pilot study.




Primary Outcome Measures :
  1. Acceptability & usefulness of the C3-Cloud system [ Time Frame: 12 months ]
    This is qualitative research so the primary outcome measure will be the acceptability and usefulness of the technology by patients, informal care givers and health & care professionals. The UTAUT questionnaire (Unified Theory of Acceptance and User of Technology) will be performed to determine C3-Cloud user responses along the following UTAUT categories: performance expectancy, effort expectancy, social influence, cultural and language factors, technology anxiety, adoption timeline and associated facilitating conditions on the intended adoption behaviour. The questionnaire will be performed online and data will be aggregated completely anonymously using the online questionnaire platform "LimeSurvey", hosted on servers of empirica. The ordinal responses (e.g. "I strongly disagree" or "I strongly agree") are clustered along the UTAUT categories analsed anonymously.



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Ages Eligible for Study:   55 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

PATIENTS - Inclusion Criteria:-

  • They are aged 55 or older
  • They are multimorbid patients that suffer from two or more of the following four conditions in various disease combinations (two conditions set as the minimum threshold):-
  • Diabetes type 2
  • Renal Failure with eGFR/GFR 30 - 59 (measured or estimated glomerular filtration rate)
  • Heart Failure in compliance with NYHA I-II (New York Heart Association classification of heart failure)
  • Mild or moderate depression
  • They still live and generally plan on living in their home (or in the community) for the 12-month trial duration.
  • They or their informal caregiver pass the ICT Handling Self-Check (see Deliverable D10.4, Annex 8.3) (i.e. they have access to and some familiarity with the use of ICT).
  • They, or their informal caregiver, have stable access to the internet and at least one of the following devices readily available to use the C3-Cloud components: Computer; Notebook; Smartphone; Tablet. This includes the use of Internet Browsers to open the C3-Cloud patient dashboards online.
  • They are able to provide informed consent.

PATIENTS - Exclusion Criteria:-

•The exclusion criteria include almost completely the reverse of the inclusion criteria. Patients are not eligible for recruitment if:-

  • They are aged 54 or below
  • They suffer from any of the following conditions:
  • Severe Renal Failure with eGFR/GFR <30
  • Severe Heart Failure in compliance with NYHA III-IV
  • Severe depression
  • They have other debilitating conditions that impair their decision making capability or their life expectancy (e.g. end-of-life patients or cancer patients)
  • They or their informal caregivers do not pass the ICT Handling Self-Check (i.e. they do not have access to suitable IT devices and do not have some familiarity with the use of ICT).
  • They have disabilities or other health conditions that would prevent their active involvement in the study project or which prevent them from carrying out essential functions of the trial.
  • They live in a care institution, for instance in a residential home or nursing home.
  • Their health care expenses are covered by a private insurance: in the C3-Cloud pilot sites, private insurances have no data exchange with EHRs.
  • They do not speak the regional language: English for SWFT; Spanish for the Basque country; Swedish for RJH
  • They are unable to provide informed consent for study participation.

Patients with further chronic diseases and other co-morbidities or symptoms, for example, frailty, sleeping problems, malnourishment or anxiety, will not be excluded from recruitment. Informal caregivers who pass the ICT Handling Self-Check can substitute for the patient if the patient does not pass the ICT Handling Self-Check - the patient-informal caregiver pair can then still be recruited.

PATIENT'S HELPERS/CARERS - Exclusion Criteria:-

There are no specific inclusion criteria for informal caregivers. However, the following exclusion criteria apply:-

  • They are aged 17 or below
  • They do not have some familiarity with the use of ICT or do not have the capability to help the patient out with ICT usage if necessary.
  • They do not have stable access to the internet and at least one of the following devices readily available to use the C3-Cloud components: Computer; Notebook; Smartphone; Tablet. This includes the use of Internet Browsers to open the C3-Cloud patient dashboards online.
  • They are not available most of the time in person or via telephone, email, SMS or other means as to respond to calls for help.
  • They have debilitating conditions that impair their decision-making capability.
  • They do not speak the local language: English for SWFT; Spanish for the Basque country; Swedish for RJH

HEALTHCARE PROFESSIONALS - Inclusion Criteria:-

  • normally be involved in the selected patients care
  • open to new ways of working, specifically as part of a MDT (including GPs; consultant nurses or specialist nurses; district nurses; social workers; consultants; physiotherapists or pharmacists)
  • open to the use of new technology: MDT members do not have to be technologically knowledgeable but they should be willing to learn how to use technology to support their work.

HEALTHCARE PROFESSIONALS - Exclusion Criteria:-

  • None specific. Reverse of the above

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03834207


Contacts
Contact: Theodoros N. Arvanitis +44 (0)24 7615 1601 T.Arvanitis@warwick.ac.uk
Contact: Sarah Lim Choi Keung +44 (0)247 657 3776 S.N.Lim-Choi-Keung@warwick.ac.uk

Locations
Spain
Osakidetza Not yet recruiting
Vitoria-Gasteiz, Araba, Spain, 01006
Contact: Dolores Verdoy, PhD    944007797    dverdoy@kronikgune.org   
Contact: Ane Fullaondo, PhD    +34 944007792    afullaondo@kronikgune.org   
Sub-Investigator: Antonio de Blas         
Sub-Investigator: Nicolas Gonzalez         
Sub-Investigator: Javier Urraca         
Sub-Investigator: Rafael Rotaeche         
Principal Investigator: Esteban de Manuel         
Sub-Investigator: Ane Fullaondo         
Sub-Investigator: Amaia Saenz de Ormijana         
Sub-Investigator: Remedios Vega         
Sweden
Region Jamtland Harjedalen Recruiting
Ostersund, Sweden, S-831 27
Contact: Mikael Lilja, Md, PhD    +4663(0)153005    mikael.lilja@regionjh.se   
Contact: Anna Eriksson, RN    +46(0)702426192    anna.eriksson@regionjh.se   
Sub-Investigator: Anna Eriksson, RN         
Principal Investigator: Mikael Lilja, Md, Phd         
United Kingdom
South Warwickshire NHS Foundation Trust Not yet recruiting
Warwick, Warwickshire, United Kingdom, CV34 5BW
Contact: Christopher Marguerie, Medicine    01926 495321 ext 4414    Christopher.Marguerie@swft.nhs.uk   
Contact: Marie Beach, History    01926 600853 ext 3085    marie.beach@swft.nhs.uk   
Principal Investigator: Christopher Marguerie, Medicine         
Principal Investigator: Christina Ramos, Medicine         
Sponsors and Collaborators
Dr Christopher Marguerie
University of Warwick
Kronikgune
Medixine
SRDC
Institut National de la Santé Et de la Recherche Médicale, France
Eurorec
Empirica
Örebro University, Sweden
Osakidetza
Region Jamtland Harjedalen
Cambio Healthcare
Investigators
Study Chair: Theodoros N. Arvanitis University of Warwick

Additional Information:
Responsible Party: Dr Christopher Marguerie, Consultant Rheumatologist/Associate Medical Director for Research, South Warwickshire NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT03834207     History of Changes
Other Study ID Numbers: 689181
First Posted: February 7, 2019    Key Record Dates
Last Update Posted: February 7, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Only anonymised, aggregated data will be shared with researchers.

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Dr Christopher Marguerie, South Warwickshire NHS Foundation Trust:
C3-Cloud
Multimorbidity
Diabetes Type 2
Heart Failure
Cardiac Failure
Depression
Renal Failure
Kidney Failure
Ageing
Computer System
Information Technology
Patient Empowerment
Guideline Reconciliation
Polypharmacy
Integrated Care
Clinical Decision Support

Additional relevant MeSH terms:
Depression
Heart Failure
Renal Insufficiency
Chronic Disease
Diabetes Mellitus, Type 2
Behavioral Symptoms
Heart Diseases
Cardiovascular Diseases
Kidney Diseases
Urologic Diseases
Disease Attributes
Pathologic Processes
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases