Status:
UNKNOWN
A Study of the Usefulness & Usability of a Healthcare IT System for Managing Multi-morbidity and Poly-pharmacy
Lead Sponsor:
Dr Christopher Marguerie
Collaborating Sponsors:
University of Warwick
Biosistemak Institute for Health Systems Research
Conditions:
Diabetes Type 2
Renal Failure
Eligibility:
All Genders
55+ years
Phase:
NA
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 an...
Detailed 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-mo...
Eligibility Criteria
Inclusion
- PATIENTS - -
- 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
- •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 -
Key Trial Info
Start Date :
October 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 30 2020
Estimated Enrollment :
672 Patients enrolled
Trial Details
Trial ID
NCT03834207
Start Date
October 1 2018
End Date
April 30 2020
Last Update
February 7 2019
Active Locations (3)
Enter a location and click search to find clinical trials sorted by distance.
1
Osakidetza
Vitoria-Gasteiz, Araba, Spain, 01006
2
Region Jamtland Harjedalen
Östersund, Sweden, S-831 27
3
South Warwickshire NHS Foundation Trust
Warwick, Warwickshire, United Kingdom, CV34 5BW