An observational study in Frail Elderly Syndrome, Congestive Heart Failure and Falls Prevention, sponsored by Him SA. Completed. Per ClinicalTrials.gov, last updated 2018-08-20.
Sponsored by Him SA · Observational
Against the background of the European Innovation Partnership on Active \& Healthy Ageing, SmartCare aims to define a common set of standard functional specifications for an open ICT platform enabling the delivery of integrated care to older European citizens.
In the context of SmartCare, a total of 23 regions and their key stakeholders will define a comprehensive set of integration building blocks around the challenges of data-sharing, coordination and communication. Nine regions will then deploy integrated health \& social services to combat a range of threats to independent living commonly faced by older people, while the others will prepare for early adoption, possibly in the framework of new ICT PSP projects. In a rigorous evaluation approach, the deployment sites will produce and document much needed evidence on the impact of integrated care, developing a common framework suitable for other regions in Europe. The organisational and legal ramifications of integrated care will be analysed to support long term sustainability and upscaling of the services.
SmartCare services will provide full support to cooperative delivery of care, integrated with self-care and across organisational silos, including essential coordination tools such as shared data access, care pathway design and execution, as well as real time communication support to care teams and multi-organisation access to home platforms. In addition, they will empower all older people according to their mental faculties to take part in effective management of their health, wellness, and chronic conditions, and maintain their independence despite increasing frailty.
The SmartCare services build on advanced ICT already deployed in the pioneer regions, including high penetrations of telecare and telemonitoring home platforms. In SmartCare, these platforms are to be opened to cross-sectorial care teams, improving the ability of older people to better manage their chronic conditions at home and deal with their increasing frailty. System integration will be based, whenever possible, on open standards' multivendor interoperability will be strongly encouraged.
This trial will evaluate the functions and impacts of the SmartCare pilot services from the point of view of the different principal roles/stakeholders, such as end users (care recipients), voluntary and non-voluntary informal carers, formal care staff/professionals, managers and fund-holders. Evaluation of integrated care service delivery processes (process evaluation) will improve the current scientifically based knowledge base on barriers and facilitators towards integrated care delivery.
Comparators were chosen to be current delivery of health and social care processes ('normal care'), as provided by pilot sites individually. The project uses local scenarios as the comparator in order to enable the evidence generated to contribute to local decision making on using the technologies. Thus, the control groups were as similar as possible to the intervention groups (receiving 'new care'). In addition, a number of possible confounding factors were measured for all participants.
The overall aim of the scientific studies carried out in SmartCare is: To identify the differences induced by implementing ICT supported integrated health and social care.
Any impact that ICT supported integrated health and social care might have on all users will be the subject of analyses according to the framework presented in the MAST model (Kidholm et al. 2012).
In addition, the objectives that will be tested in SmartCare are:
5,701 studies on the registry are indexed under Heart Failure; 1,220 are open to participants now.
This study's enrollment of 2,111 is above the median of 200 across 1,679 observational studies indexed under Heart Failure.
Browse Heart Failure studies →Him SA is the lead sponsor of 4 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Interventions will be provided by a combination of health care, social care, volunteer sector care providers, and informal carers to the population samples to be drawn either by randomisation or consecutive inclusion of either intervention or control end-users determined by geographical areas (pilot sites). Additionally, these inclusion criteria for end users are applicable:
Thus, the professionals that are involved in providing any type of health and/or social care for the included citizens will be enrolled as intervention performers and as users of the interventions.
Exclusion criteria for end users:
Patients receiving 'new care'
Other: 'New care'
Patients receiving 'old / usual care'
Frail elderly receiving care within new organisational models delivering integrated healthcare (IHC) supported by ICT infrastructure (electronically shared-care platform) as provided by pilot sites individually.
Change in services consumption
Change in healthcare and social care services consumption measured based on total count of healthcare services consumption, measured based on total count of number of contacts with healthcare services/professionals
Time frame: Healthcare services consumption measured at individual level, per individual client / citizen / carer, based on differences ('change') between measurements at (a) baseline (month 0), (b) midterm (12 months) and (c) end (24 months) of study
Blood pressure
Blood pressure as part of disease specific health status measurements
Time frame: Blood pressure measured in mmHG, at individual level, per individual client / citizen at baseline, midterm (12 months) and end (24 months) of study
Blood glucose
Blood glucose as part of disease specific health status measurements
Time frame: Blood glucose measured in mg/dl, at individual level, per individual client / citizen / carer at baseline, midterm (12 months) and end (24 months) of study
Cholesterol
Cholesterol as part of disease specific health status measurements
Time frame: Cholesterol measured in mmol/ltr, at individual level, per individual client / citizen at baseline, midterm (12 months) and end (24 months) of study
General health and wellbeing / Indicator for health status
General health and wellbeing based on v2 of the SF 36 questionnaire
Time frame: General health and wellbeing (SF 36 v2) measured with questionnaire, at individual level, per individual client / citizen at baseline and end (24 months) of study
Indicator for health status: Barthel
Indicator for health status as measured with Barthel Index
Time frame: Indicator for health status as measured with Barthel Index measured with questionnaire, at individual level, per individual client / citizen at baseline and end (24 months) of study
Indicator for health status: Timed up & go
Indicator for health status as measured with Timed up and Go test
Time frame: Indicator for health status measured with Timed up and Go test, at individual level, per individual client / citizen at baseline and end (24 months) of study
Quality of Life of family carers: CASP
Quality of Life of family carers, based on levels of Control, Autonomy, Pleasure and Self-realization (with CASP-19 questionnaire)
Time frame: Quality of Life of family carers measured with CASP-19, at individual level, per carer at baseline and end (24 months) of study
Anxiety and depression
Anxiety and depression according as part of psychological status, based on HADS scale
Time frame: Anxiety and depression levels in end users Quality of Life of family carers measured with HADS Scale, at individual level, per citizen / client at baseline and end (24 months) of study
Depression in elderly
Depression in elderly as part of psychological status, based on Geriatric Depression Scale-15 (GDS-15)
Time frame: Depression in elderly in end users measured with (GDS-15), at individual level, per citizen / client at baseline and end (24 months) of study
Isolation
Level of isolation according to Perceived Isolation Questionnaire as part of psychological status
Time frame: Level of isolation in elderly in end users measured with Perceived Isolation Questionnaire, at individual level, per citizen / client at baseline and end (24 months) of study
Carer burden
Level carer burden according to Zarit Burden Interview (ZBI) as part of psychological status
Time frame: Level of carer burden measured with ZBI in carers measured at individual level, per caregivers at baseline and end (24 months) of study
Carer difficulties, satisfaction and management in caring - I
Level of carer difficulties, satisfaction and management in caring according to: Carer Assessment of Difficulty Index (CADI)
Time frame: Level of carer difficulties, satisfaction and management in caring measured with CADI in carers measured at individual level, per caregivers at baseline and end (24 months) of study
Carer difficulties, satisfaction and management in caring - II
Level of carer difficulties, satisfaction and management in caring according to Carer Assessment of Satisfaction Index (CASI)
Time frame: Level of carer difficulties, satisfaction and management in caring measured with CASI suite in carers measured at individual level, per caregivers at baseline and end (24 months) of study
Carer difficulties, satisfaction and management in caring - III
Level of carer difficulties, satisfaction and management in caring according to: Carer Assessment of Management Index (CAMI) as part of psychological status
Time frame: Level of carer difficulties, satisfaction and management in caring measured with CAMI suite in carers measured at individual level, per caregivers at baseline and end (24 months) of study
Death
Death as adverse outcome measure
Time frame: Death as adverse outcome measure as registered at end of study (24 months)
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Aug 2018. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Him SA