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

NCT03111004 | Completed DMC

• 1 other identifier: BeyondSilos_CIP_No.621069
• Study Type: observational
• Target: 1,840
• Locations: 0 countries
• Sites: N/A

Brief 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

Conditions

Heart Failure; Stroke; COPD; Diabetes

Keywords

information technology; telemedicine; integrated care; MAST framework; organizational change; social care; elderly patients

Outcome Measures

Primary Outcomes (1)

• Change in length of the hospital stay

  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 Outcomes (17)

• Re-hospitalisation period

  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

  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 measured in kilo grams (kg) at baseline (month 0) and at end (month 18) of study duration

• Blood pressure

  Blood pressure measured in mmHg at baseline (month 0) and at end (month 18) of study duration

• Heart rate

  Heart rate measured in beats per minute (bpm) at baseline and at end of study duration

Study Arms (2)

Study Group

The Study Group receives 'new care' (integrated health and social care)

Other: New Care

Comparator Group

The comparator group receives usual care

Interventions

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

Also known as: integrated health care and social care

Study Group

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may not qualify if:

• 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).
• 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.

Sponsors & Collaborators

• Him SA: lead

Related Publications (5)

• 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.

  PMID: 25046751 BACKGROUND

• Kidholm 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.

  PMID: 22617736 BACKGROUND

• Berger 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.

  PMID: 22433752 BACKGROUND

• Charlson 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.

  PMID: 3558716 BACKGROUND

• Piera-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.

  PMID: 33021490 DERIVED

Related Links

• Project Website BeyondSilos

MeSH Terms

Conditions

Heart Failure; Stroke; Pulmonary Disease, Chronic Obstructive; Diabetes Mellitus

Condition Hierarchy (Ancestors)

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

Study Officials

• Panos A Stafylas

  Him SA

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: March 7, 2017
• First Posted: April 12, 2017
• Study Start: September 1, 2014
• Primary Completion: June 30, 2016
• Study Completion: October 1, 2017
• Last Updated: August 20, 2018

Record last verified: 2018-08