Heart FailureBeyondSilosNCT03111004
BeyondSilos - More Personalised and Coordinated Care and Improved Outcomes for Elderly Patients
An observational study of Heart Failure and Stroke, run by Him SA.
Trial summary
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 Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Heart Failure, Stroke, COPD
- What is being tested?
- New Care
- How many people
- 1,840 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Elderly living independently at home with diagnosed chronic disease(s).
Who may be able to join
- 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).
Who cannot join
- 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.
About this study
Official title: 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
Read the 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.
- Conditions
- Heart Failure, Stroke, COPD, Diabetes
- Being tested
- New Care
- Keywords
- information technology, telemedicine, integrated care, MAST framework, organizational change, social care, elderly patients
- Medical subject headings
- Heart Failure, Stroke, Pulmonary Disease, Chronic Obstructive, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
New CareOther
Also called integrated health care and social 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
| Study group | Role | What they receive |
|---|---|---|
| Study Group | The Study Group receives 'new care' (integrated health and social care) Receives: Other: New Care | |
| Comparator Group | The comparator group receives usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in length of the hospital stay
Change in the duration of hospitalization (calculated from admission date and discharge date) measured in days
Measured: 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 outcomes (17)
Re-hospitalisation period
Re-hospitalisation within 30 days (calculate from admission date and discharge date) measured in days
Measured: 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
Encounters and contacts between patient and GP, Specialists, Nurse, other involved healthcare providers
Measured: 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
Weight as disease specific health status measurement
Measured: Weight measured in kilo grams (kg) at baseline (month 0) and at end (month 18) of study duration
Blood pressure
Blood pressure as disease specific health status measurement
Measured: Blood pressure measured in mmHg at baseline (month 0) and at end (month 18) of study duration
Heart rate
Heart rate pressure as disease specific health status measurement
Measured: Heart rate measured in beats per minute (bpm) at baseline and at end of study duration
Oxygen saturation
Oxygen saturation pressure as disease specific health status measurement
Measured: Oxygen saturation measured in SpO2 (or %) based on measurement at baseline (month 0) and at end (month 18) of study duration
Blood glucose
Blood glucose pressure as disease specific health status measurement
Measured: Blood glucose measured in mg/dl based on measurement at baseline (month 0) and at end (month 18) of study duration
HbA1c
HbA1c pressure as disease specific health status measurement
Measured: HbA1c measured in percentage (%) based on measurement at baseline and at end of study duration
Creatinine
Creatinine pressure as disease specific health status measurement
Measured: Creatinine measured in mg/dl based on measurement at baseline (month 0) and at end (month 18) of study duration
Charlson Comorbidity Index (CCI)
Charlson Comorbidity Index (CCI) as a generic health related / functional quality of life
Measured: 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
Barthel index as a generic health related / functional quality of life
Measured: 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)
Self-maintaining and instrumental activities of daily living (IADL) as a generic health related / functional quality of life
Measured: 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)
Geriatric Depression Scale (GDS Short Form) as a psychological measure
Measured: 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
Anxiety and depression (according to HADScale) as a psychological measure
Measured: 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)
PIRU questionnaire on user experience of IC as a user perspectives measure
Measured: 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)
End user perception of service utility (eCCIS) as a user perspectives measure
Measured: 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)
Carer perception of service utility (eCCIS) as a user perspectives measure
Measured: Carer perception of service utility based on eCCIS-scale measurement at baseline (month 0) and at end (month 18) of study duration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2017
- Study start1 Sep 2014
- Primary completion30 Jun 2016
- Study completion1 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies 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
- 1,840 participants (actual)
Sponsor and investigators
- Lead sponsor
- Him SA
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Panos A Stafylas, Study director, Him SA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03111004
- Sponsor's protocol ID
- BeyondSilos_CIP_No.621069
- Acronym
- BeyondSilos
- Status last verified
- Aug 2018
- First submitted
- 7 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
- Undecided
Publications
Vandenbroucke JP, von Elm E, Altman DG, Gotzsche PC, Mulrow CD, Pocock SJ, Poole C, Schlesselman JJ, Egger M; STROBE Initiative. Strengthening the Reporting of Observational Studies in Epidemiology (STROBE): explanation and elaboration. Int J Surg. 2014 Dec;12(12):1500-24. doi: 10.1016/j.ijsu.2014.07.014. Epub 2014 Jul 18.
PubMed 25046751Kidholm K, Ekeland AG, Jensen LK, Rasmussen J, Pedersen CD, Bowes A, Flottorp SA, Bech M. A model for assessment of telemedicine applications: mast. Int J Technol Assess Health Care. 2012 Jan;28(1):44-51. doi: 10.1017/S0266462311000638.
PubMed 22617736Berger ML, Dreyer N, Anderson F, Towse A, Sedrakyan A, Normand SL. Prospective observational studies to assess comparative effectiveness: the ISPOR good research practices task force report. Value Health. 2012 Mar-Apr;15(2):217-30. doi: 10.1016/j.jval.2011.12.010.
PubMed 22433752Charlson ME, Pompei P, Ales KL, MacKenzie CR. A new method of classifying prognostic comorbidity in longitudinal studies: development and validation. J Chronic Dis. 1987;40(5):373-83. doi: 10.1016/0021-9681(87)90171-8.
PubMed 3558716Piera-Jimenez J, Daugbjerg S, Stafylas P, Meyer I, Muller S, Lewis L, da Col P, Folkvord F, Lupianez-Villanueva F. BeyondSilos, a Telehealth-Enhanced Integrated Care Model in the Domiciliary Setting for Older Patients: Observational Prospective Cohort Study for Effectiveness and Cost-Effectiveness Assessments. JMIR Med Inform. 2020 Oct 6;8(10):e20938. doi: 10.2196/20938.
PubMed 33021490
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
- 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
- ClinicalTrials.gov ID
- NCT03111004
- Acronym / sponsor ID
- BeyondSilos / BeyondSilos_CIP_No.621069
- Conditions
- Heart Failure, Stroke, COPD, Diabetes
- Keywords
- information technology, telemedicine, integrated care, MAST framework, organizational change, social care, elderly patients
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,840 participants (actual)
- Lead sponsor
- Him SAUniversity, hospital or other
- Study start
- 1 Sep 2014 (actual)
- Primary completion
- 30 Jun 2016 (actual)
- Study completion
- 1 Oct 2017 (actual)
- First posted
- 12 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.
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
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study Group | – | Other: New CareThe Study Group receives 'new care' (integrated health and social care) |
| Comparator Group | – | –The comparator group receives usual care |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Elderly living independently at home with diagnosed chronic disease(s).
Key inclusion criteria (7 listed)
- 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).
Key exclusion criteria (3 listed)
- 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.
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 CareAlso: integrated health care and social careAll 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 | Study Group |
Primary outcome
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
17 secondary outcomes
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)
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
Weight
Time frame: 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
Heart rate
Time frame: 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
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
HbA1c
Time frame: 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
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
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
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
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
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
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
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
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
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.
- Background: PubMed 25046751Vandenbroucke JP, von Elm E, Altman DG, Gotzsche PC, Mulrow CD, Pocock SJ, Poole C, Schlesselman JJ, Egger M; STROBE Initiative. Strengthening the Reporting of Observational Studies in Epidemiology (STROBE): explanation and elaboration. Int J Surg. 2014 Dec;12(12):1500-24. doi: 10.1016/j.ijsu.2014.07.014. Epub 2014 Jul 18.
- Background: PubMed 22617736Kidholm K, Ekeland AG, Jensen LK, Rasmussen J, Pedersen CD, Bowes A, Flottorp SA, Bech M. A model for assessment of telemedicine applications: mast. Int J Technol Assess Health Care. 2012 Jan;28(1):44-51. doi: 10.1017/S0266462311000638.
- Background: PubMed 22433752Berger ML, Dreyer N, Anderson F, Towse A, Sedrakyan A, Normand SL. Prospective observational studies to assess comparative effectiveness: the ISPOR good research practices task force report. Value Health. 2012 Mar-Apr;15(2):217-30. doi: 10.1016/j.jval.2011.12.010.
- Background: PubMed 3558716Charlson ME, Pompei P, Ales KL, MacKenzie CR. A new method of classifying prognostic comorbidity in longitudinal studies: development and validation. J Chronic Dis. 1987;40(5):373-83. doi: 10.1016/0021-9681(87)90171-8.
- Derived from this study: PubMed 33021490Piera-Jimenez J, Daugbjerg S, Stafylas P, Meyer I, Muller S, Lewis L, da Col P, Folkvord F, Lupianez-Villanueva F. BeyondSilos, a Telehealth-Enhanced Integrated Care Model in the Domiciliary Setting for Older Patients: Observational Prospective Cohort Study for Effectiveness and Cost-Effectiveness Assessments. JMIR Med Inform. 2020 Oct 6;8(10):e20938. doi: 10.2196/20938.
- Project Website BeyondSilosLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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.
Panos A Stafylas study director
Him SA
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure and Stroke, 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 7 inclusion and 3 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 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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03111004, which also lists 5 linked publications.
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; AzTrials last refreshed its copy on 31 Oct 2026.