Depression Clinical Trial
— C3-CloudOfficial title:
A Federated Collaborative Care Cure Cloud Architecture for Addressing the Needs of Multi-morbidity and Managing Poly-pharmacy
NCT number | NCT03834207 |
Other study ID # | 689181 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | October 1, 2018 |
Est. completion date | April 30, 2020 |
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.
Status | Recruiting |
Enrollment | 672 |
Est. completion date | April 30, 2020 |
Est. primary completion date | January 31, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 55 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Spain | Osakidetza | Vitoria-Gasteiz | Araba |
Sweden | Region Jamtland Harjedalen | Ostersund | |
United Kingdom | South Warwickshire NHS Foundation Trust | Warwick | Warwickshire |
Lead Sponsor | Collaborator |
---|---|
Dr Christopher Marguerie | Cambio Healthcare, Empirica, Eurorec, Institut National de la Santé Et de la Recherche Médicale, France, Kronikgune, Medixine, Örebro University, Sweden, Osakidetza, Region Jamtland Harjedalen, SRDC, University of Warwick |
Spain, Sweden, United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 |
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