Frail Elderly SyndromeSmartCareNCT03112109
SMARTCARE Project: Deploying Integrated Health & Social Services for Independent Living by Older People
An observational study of Frail Elderly Syndrome and Congestive Heart Failure, run by Him SA.
Trial summary
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Frail Elderly Syndrome, Congestive Heart Failure, Falls Prevention
- What is being tested?
- 'New care'
- How many people
- 2,111 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2014to 1 Oct 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Child, Adult, Older adult
Study population: 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.
Who may be able to join
- Provided with both health and social care.
- Congestive heart failure: for RSD pilot site.
- Frail elderly: for Aragon pilot site.
Who cannot join
- No exclusion criteria.
About this study
Official title: SmartCare Project: Joining up ICT and Service Processes for Quality Integrated Care in Europe
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.
Read more
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.
Read the detailed description
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:
- Difference in number of contacts to health care.
- Difference in number of contacts to social care.
- Differences in use of health care services.
- Differences in use of social care services.
- Differences in costs.
- Differences in organisational aspects caused by implementing ICT supported integrated care.
- Difference in end-user empowerment.
- Difference in end-user satisfaction.
- Being tested
- 'New care'
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
'New care'Other
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Patients receiving 'new care' Receives: Other: 'New care' | |
| Control group | Patients receiving 'old / usual care' |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Secondary outcomes (15)
Blood pressure
Blood pressure as part of disease specific health status measurements
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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)
Measured: 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
Measured: 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)
Measured: 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
Measured: 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
Measured: 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)
Measured: 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)
Measured: 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
Measured: 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
Measured: Death as adverse outcome measure as registered at end of study (24 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2017
- Study start1 Mar 2014
- Primary completion1 Sep 2017
- Study completion1 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Frail Elderly SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,111 participants (actual)
Sponsor and investigators
- Lead sponsor
- Him SA
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03112109
- Sponsor's protocol ID
- SmartCare_EC_Grant_No.325158
- Acronym
- SmartCare
- Status last verified
- Aug 2018
- First submitted
- 8 Mar 2017
- Last updated
- 20 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SmartCare Project: Joining up ICT and Service Processes for Quality Integrated Care in Europe
- ClinicalTrials.gov ID
- NCT03112109
- Acronym / sponsor ID
- SmartCare / SmartCare_EC_Grant_No.325158
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,111 participants (actual)
- Lead sponsor
- Him SAUniversity, hospital or other
- Study start
- 1 Mar 2014 (actual)
- Primary completion
- 1 Sep 2017 (actual)
- Study completion
- 1 Oct 2017 (actual)
- First posted
- 13 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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:
- Difference in number of contacts to health care.
- Difference in number of contacts to social care.
- Differences in use of health care services.
- Differences in use of social care services.
- Differences in costs.
- Differences in organisational aspects caused by implementing ICT supported integrated care.
- Difference in end-user empowerment.
- Difference in end-user satisfaction.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | – | Other: 'New care'Patients receiving 'new care' |
| Control group | – | –Patients receiving 'old / usual care' |
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- 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.
Key inclusion criteria (3 listed)
- Provided with both health and social care.
- Congestive heart failure: for RSD pilot site.
- Frail elderly: for Aragon pilot site.
Key exclusion criteria (1 listed)
- No exclusion criteria.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 'New 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. | Other | Intervention Group |
Primary outcome
Change in services consumption
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
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
15 secondary outcomes
Blood pressure
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
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
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
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
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
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
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
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
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
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
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
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
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
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
Time frame: Death as adverse outcome measure as registered at end of study (24 months)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2018.
- Individual participant dataSharing planned: No
Related trials for Frail Elderly Syndrome
Recruiting
Comparıson of the Effıcacy of Conventıonal Exercıse and Pılates ın Pre-fraıl and Fraıl Older Adults
Frailty Syndrome, Prefrail Elderly
Not yet recruiting
Effect of Animation-Based Digital Education on Risk Knowledge and Frailty in Older Adults
Aging, Frail Elderly
Active, not recruiting
Implementing, Evaluating, and Scaling Up of the Strengthening a Palliative Approach in Long Term Care (SPA-LTC) Program
Frail Elderly Syndrome
Recruiting
Feasibility and Effects of Inspiratory Muscle Training Combined With Blood Flow Restriction for Frail Older Adults
Frailty Syndrome, Older Adults
Recruiting
Involvement of Muscle Mitochondrial Dysfunction in Frailty in Older Adults. Role of Exercise
Diabetes Type 2, Frail Elderly Syndrome
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Frail Elderly Syndrome and Congestive Heart Failure, run by Him SA.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in services consumption (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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2018.