A Study of the Usefulness & Usability of a Healthcare IT System for Managing Multi-morbidity and Poly-pharmacy
C3-Cloud
A Federated Collaborative Care Cure Cloud Architecture for Addressing the Needs of Multi-morbidity and Managing Poly-pharmacy
1 other identifier
interventional
672
3 countries
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2018
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2018
CompletedFirst Submitted
Initial submission to the registry
January 2, 2019
CompletedFirst Posted
Study publicly available on registry
February 7, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 31, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
April 30, 2020
CompletedFebruary 7, 2019
February 1, 2019
1.3 years
January 2, 2019
February 5, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Acceptability & usefulness of the C3-Cloud system
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.
12 months
Study Arms (1)
Intervention Group
EXPERIMENTALUse of the C3-Cloud IT system
Interventions
Patients who are recruited to the intervention arm will use the C3-Cloud system during the pilot study.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify 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.
- 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.
- +8 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Dr Christopher Marguerielead
- University of Warwickcollaborator
- Biosistemak Institute for Health Systems Researchcollaborator
- Medixinecollaborator
- SRDCcollaborator
- Institut National de la Santé Et de la Recherche Médicale, Francecollaborator
- Euroreccollaborator
- Empiricacollaborator
- Örebro University, Swedencollaborator
- Osakidetzacollaborator
- Region Jämtland Härjedalencollaborator
- Cambio Healthcarecollaborator
Study Sites (3)
Osakidetza
Vitoria-Gasteiz, Araba, 01006, Spain
Region Jamtland Harjedalen
Östersund, S-831 27, Sweden
South Warwickshire NHS Foundation Trust
Warwick, Warwickshire, CV34 5BW, United Kingdom
Related Publications (1)
von Tottleben M, Grinyer K, Arfa A, Traore L, Verdoy D, Lim Choi Keung SN, Larranaga I, Jaulent MC, De Manuel Keenoy E, Lilja M, Beach M, Marguerie C, Yuksel M, Laleci Erturkmen GB, Klein GO, Lindman P, Mar J, Kalra D; C3-Cloud Research Team; Arvanitis TN. An Integrated Care Platform System (C3-Cloud) for Care Planning, Decision Support, and Empowerment of Patients With Multimorbidity: Protocol for a Technology Trial. JMIR Res Protoc. 2022 Jul 13;11(7):e21994. doi: 10.2196/21994.
PMID: 35830239DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Theodoros N. Arvanitis
University of Warwick
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Consultant Rheumatologist/Associate Medical Director for Research
Study Record Dates
First Submitted
January 2, 2019
First Posted
February 7, 2019
Study Start
October 1, 2018
Primary Completion
January 31, 2020
Study Completion
April 30, 2020
Last Updated
February 7, 2019
Record last verified: 2019-02
Data Sharing
- IPD Sharing
- Will not share
Only anonymised, aggregated data will be shared with researchers.