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Completed

NCT Number: NCT03111004

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

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

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Key information

Conditions

Heart Failure Brain Diseases COPD Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Chronic Disease Diabetes Diabetes Mellitus Disease Attributes Endocrine System Diseases Glucose Metabolism Disorders Heart Diseases Lung Diseases Lung Diseases, Obstructive Metabolic Diseases Nervous System Diseases Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases Stroke Vascular Diseases

Age range

65 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

New Care

Other

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

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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

  12. 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

  13. 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

  14. 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

  15. 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

  16. 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

  17. 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

Sponsors and collaborators

Lead sponsor

Him SA

Other

Registry information

Official study 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

Acronym: BeyondSilos

Important dates

Study start
2014
Primary completion
2016
Study completion
2017
First posted
Apr 12, 2017
Registry last updated
Aug 20, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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