NCT03112109

Brief 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. 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,111

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2014

Typical duration for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2014

Completed
3 years until next milestone

First Submitted

Initial submission to the registry

March 8, 2017

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 13, 2017

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2017

Completed
Last Updated

August 20, 2018

Status Verified

August 1, 2018

Enrollment Period

3.5 years

First QC Date

March 8, 2017

Last Update Submit

August 17, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

    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 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 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 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 (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 with questionnaire, at individual level, per individual client / citizen at baseline and end (24 months) of study

  • +10 more secondary outcomes

Study Arms (2)

Intervention Group

Patients receiving 'new care'

Other: 'New care'

Control group

Patients receiving 'old / usual care'

Interventions

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.

Intervention Group

Eligibility Criteria

Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
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.

You may qualify if:

  • Provided with both health and social care.
  • Congestive heart failure: for RSD pilot site.
  • Frail elderly: for Aragon pilot site.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 8, 2017

First Posted

April 13, 2017

Study Start

March 1, 2014

Primary Completion

September 1, 2017

Study Completion

October 1, 2017

Last Updated

August 20, 2018

Record last verified: 2018-08

Data Sharing

IPD Sharing
Will not share