BeyondSilos - More Personalised and Coordinated Care and Improved Outcomes for Elderly Patients (BeyondSilos)

August 17, 2018 updated by: Him SA

BeyondSilos - Integrated Care Leading to a More Personalised and Coordinated Care, Improving Outcomes for Elderly Patients, Delivering More Effective Care and Support, and Provide More Cost Efficient Health and Social Services

The study evaluates the impact of the new organisational models developed in the framework of the BeyondSilos pilot service in order to provide ICT supported integrated health and social care to elderly patients

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The overall aim of the evaluation carried out in BeyondSilos is to identify the differences introduced by implementing ICT supported integrated care in different domains according to the MAST evaluation framework, including safety, clinical and social outcomes, resource use and cost of care, user/carer experience and organisational changes.

The focus of the evaluation will be the impact of so called "horizontal" integration, which is the integration between social care and health care, and the changing organisational models for elderly patients.

The hypothesis in this study is that integrated care (IC) will lead to a more personalised and coordinated care, improve outcomes for elderly patients, deliver more effective care and support, and provide more cost efficient health and social services.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1840

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Elderly living independently at home with diagnosed chronic disease(s).

Description

Potential participants are selected by screening electronic healthcare and social care records or/and the hospital / national databases and/or during long term condition annual reviews in the community setting. If necessary, candidates are informed about the nature and the objectives of the evaluation. If a candidate passes the inclusion/exclusion criteria and signs the informed consent form, if necessary, they participate in the evaluation.

Inclusion Criteria:

  • Age ≥65 years.
  • Presence of health needs specified as: Presence of heart failure, stroke, COPD or diabetes (diagnosed at hospital or at specialist visit) plus at least one additional chronic disease / condition included in the Charlson Comorbidity Index (CCI).
  • Presence of social needs based on Barthel Index of Activities of Daily Living and Instrumental Activities of Daily Living (IADL).
  • Reasonable expectation of permanence in the BeyondSilos project for the whole data collection period (18 months).
  • Informed consent, signed if necessary (by the subject or his/her delegate).
  • Capability to handle ICT equipment / devices alone, or with the help from a delegate.
  • Presence of good/reliable communication connection at home (internet, telephone or what is needed for the ICT connection).

Exclusion Criteria:

Subjects who have been registered with an active cancer diagnosis and undergoing treatment, has undergone an organ transplant, or is undergoing dialysis prior to enrolment.

  • Subjects in a terminal state
  • People with an AIDS diagnose.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Study Group
The Study Group receives 'new care' (integrated health and social care)
Other: New Care
All settings that are in any way relevant to the provision of health and social care are integrated, including: out-of-hospital (community) services as well as hospitals, GPs' offices, community nurses, and any type of care practitioners, users' homes and volunteer service providers' offices
Other Names:
  • integrated health care and social care
Comparator Group
The comparator group receives usual care

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in length of the hospital stay
Time Frame: Days between admission and discharge of patient's admission episodes, measured based on follow up during whole length of study and accumulated at END of study (at month 18)
Change in the duration of hospitalization (calculated from admission date and discharge date) measured in days
Days between admission and discharge of patient's admission episodes, measured based on follow up during whole length of study and accumulated at END of study (at month 18)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Re-hospitalisation period
Time Frame: Days between last discharge of patient and her/his re-hospitalization, measured based on follow up during whole length of study and accumulated at END of study (at month 18)
Re-hospitalisation within 30 days (calculate from admission date and discharge date) measured in days
Days between last discharge of patient and her/his re-hospitalization, measured based on follow up during whole length of study and accumulated at END of study (at month 18)
Patient encounters
Time Frame: Number of registered encounters/contacts between patient and GP, Specialists, Nurse, other involved healthcare providers within the timeframe based on total count in period between start (month 0) end (month 18) of study
Encounters and contacts between patient and GP, Specialists, Nurse, other involved healthcare providers
Number of registered encounters/contacts between patient and GP, Specialists, Nurse, other involved healthcare providers within the timeframe based on total count in period between start (month 0) end (month 18) of study
Weight
Time Frame: Weight measured in kilo grams (kg) at baseline (month 0) and at end (month 18) of study duration
Weight as disease specific health status measurement
Weight measured in kilo grams (kg) at baseline (month 0) and at end (month 18) of study duration
Blood pressure
Time Frame: Blood pressure measured in mmHg at baseline (month 0) and at end (month 18) of study duration
Blood pressure as disease specific health status measurement
Blood pressure measured in mmHg at baseline (month 0) and at end (month 18) of study duration
Heart rate
Time Frame: Heart rate measured in beats per minute (bpm) at baseline and at end of study duration
Heart rate pressure as disease specific health status measurement
Heart rate measured in beats per minute (bpm) at baseline and at end of study duration
Oxygen saturation
Time Frame: Oxygen saturation measured in SpO2 (or %) based on measurement at baseline (month 0) and at end (month 18) of study duration
Oxygen saturation pressure as disease specific health status measurement
Oxygen saturation measured in SpO2 (or %) based on measurement at baseline (month 0) and at end (month 18) of study duration
Blood glucose
Time Frame: Blood glucose measured in mg/dl based on measurement at baseline (month 0) and at end (month 18) of study duration
Blood glucose pressure as disease specific health status measurement
Blood glucose measured in mg/dl based on measurement at baseline (month 0) and at end (month 18) of study duration
HbA1c
Time Frame: HbA1c measured in percentage (%) based on measurement at baseline and at end of study duration
HbA1c pressure as disease specific health status measurement
HbA1c measured in percentage (%) based on measurement at baseline and at end of study duration
Creatinine
Time Frame: Creatinine measured in mg/dl based on measurement at baseline (month 0) and at end (month 18) of study duration
Creatinine pressure as disease specific health status measurement
Creatinine measured in mg/dl based on measurement at baseline (month 0) and at end (month 18) of study duration
Charlson Comorbidity Index (CCI)
Time Frame: Charlson Comorbidity Index (CCI) measured in (a) ICD-10-CM and (b) CCI scale based on measurement at baseline (month 0) and at end (month 18) of study duration
Charlson Comorbidity Index (CCI) as a generic health related / functional quality of life
Charlson Comorbidity Index (CCI) measured in (a) ICD-10-CM and (b) CCI scale based on measurement at baseline (month 0) and at end (month 18) of study duration
Barthel index
Time Frame: Barthel index measured in index scale based on measurement at baseline (month 0) and at end (month 18) of study duration
Barthel index as a generic health related / functional quality of life
Barthel index measured in index scale based on measurement at baseline (month 0) and at end (month 18) of study duration
Self-maintaining and instrumental activities of daily living (IADL)
Time Frame: Self-maintaining and instrumental activities of daily living (IADL) measured in (IADL) scale based on measurement at baseline (month 0) and at end (month 18) of study duration
Self-maintaining and instrumental activities of daily living (IADL) as a generic health related / functional quality of life
Self-maintaining and instrumental activities of daily living (IADL) measured in (IADL) scale based on measurement at baseline (month 0) and at end (month 18) of study duration
Geriatric Depression Scale (GDS Short Form)
Time Frame: GDS measured in GDSsf-scale based on measurement at baseline (month 0) and at end (month 18) of study duration
Geriatric Depression Scale (GDS Short Form) as a psychological measure
GDS measured in GDSsf-scale based on measurement at baseline (month 0) and at end (month 18) of study duration
Anxiety and depression based on HADS
Time Frame: Anxiety and depression according to HADS-scale measurements based on measurement at baseline (month 0) and at end (month 18) of study duration
Anxiety and depression (according to HADScale) as a psychological measure
Anxiety and depression according to HADS-scale measurements based on measurement at baseline (month 0) and at end (month 18) of study duration
PIRU questionnaire on user experience (selected questions) of Integrated Care (IC)
Time Frame: User experience (PIRU) measurements based on PIRU-scale measurement at baseline and at end of study duration
PIRU questionnaire on user experience of IC as a user perspectives measure
User experience (PIRU) measurements based on PIRU-scale measurement at baseline and at end of study duration
End user perception of service utility according to eCCIS (selected questions)
Time Frame: End user perception of service utility based on eCCIS-scale measurement at baseline (month 0) and at end (month 18) of study duration
End user perception of service utility (eCCIS) as a user perspectives measure
End user perception of service utility based on eCCIS-scale measurement at baseline (month 0) and at end (month 18) of study duration
Carer perception of service utility according to eCCIS (selected questions)
Time Frame: Carer perception of service utility based on eCCIS-scale measurement at baseline (month 0) and at end (month 18) of study duration
Carer perception of service utility (eCCIS) as a user perspectives measure
Carer perception of service utility based on eCCIS-scale measurement at baseline (month 0) and at end (month 18) of study duration

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Him SA

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Panos A Stafylas, Him SA

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 7, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 6, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 12, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 20, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 17, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • BeyondSilos_CIP_No.621069

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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