Multi-level Integration for Patients With Complex Needs Facilitated by ICTs. A Shared Approach, Mutual Learning and Evaluation Are Expected to Create Synergies Among the Partners and to Bring Forward Integration of Care in Europe

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT03042039
• Date of registration: 24/01/2017
• Prospective Registration: No
• Primary sponsor: Him SA
• Public title: Multi-level Integration for Patients With Complex Needs Facilitated by ICTs. A Shared Approach, Mutual Learning and Evaluation Are Expected to Create Synergies Among the Partners and to Bring Forward Integration of Care in Europe CAREWELL
• Scientific title: CareWell - Multi-level Integration for Patients With Complex Needs
• Date of first enrolment: January 1, 2015
• Target sample size: 1712
• Recruitment status: Active, not recruiting
• URL: https://clinicaltrials.gov/show/NCT03042039
• Study type: Observational
• Phase: N/A

Countries of recruitment

Croatia, Italy, Poland, Spain, United Kingdom

Key inclusion & exclusion criteria

Inclusion Criteria:

1. Age =65 years.

2. Presence of at least two chronic diseases included in the Charlson Comorbidity Index
(CCI) [4]. At least one of the comorbid conditions must be one of the following
conditions: Chronic obstructive pulmonary disease (COPD), diabetes mellitus (both
insulin-dependent and noninsulin-dependent) or chronic heart failure (CHF).

3. Fulfilling local/national/organisational criteria of frailty: increased vulnerability,
complex health needs, and at high risk of hospital or care home admission.

4. Participants have to be able to understand and to comply with study instructions and
requirement, either independently or with help from a carer.

Exclusion Criteria:

1. Subjects who have either been registered with an active cancer diagnosis under
treatment, have undergone an organ transplant, or are undergoing dialysis prior to
enrolment.

2. Subjects who are candidates for palliative care (with life expectancy less than one
year, clinically evaluated).

3. People with an AIDS diagnosis.

4. People living in care homes where their daily health, care and wellbeing needs are met
by staff (nurses and support staff) employed within the home.



Age minimum: 65 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Chronic Obstructive Pulmonary Disease

Frail Elderly Syndrome

Chronic Heart Failure

Diabetes

Intervention(s)

Other: New Care

Primary Outcome(s)

Total number of hospital admissions per participant measured at end of study (at approx 12 months) [Time Frame: Total of hospital admissions as measured after (approximately) 12 months (= end of study)]

Secondary Outcome(s)

Change in Psychological measures (2) by measuring Hospital Anxiety and Depression Scale [Time Frame: Changes in Psychological measures as assessed based on HADS measurements between baseline, midterm (after approximately 6 months) and after (approximately) 12 months (=end of study)]

Change in Disease specific health status measurement (2) as measured with blood glucose levels of all diabetes patients between start and end of study (12 months) [Time Frame: Changes in Disease specific health status based on measurements of Blood Glucose between baseline and after (approximately) 12 months (=end of study)]

Change of Disease specific health status measurement (5) as measured with weight of all patients with chronic heart failure between start and end of study (12 months) [Time Frame: Changes in Disease specific health status based on measurements of Weight between baseline and after (approximately) 12 months (=end of study)]

Change in generic health related/functional quality of life (1) by assessing Charlson Comorbidity Index (CCI) [Time Frame: Change in CCI between baseline and after (approximately) 12 months (=end of study)]

Changes in the User perspectives (1) by measuring PIRU questionnaire on user experience of Integrated Care (IC) by measuring Policy Research Unit in Policy Innovation Research questionnaire [Time Frame: Changes in User perspectives as assessed based on PIRU scores between baseline, midterm (after approximately 6 months) and after (approximately) 12 months (=end of study)]

Change in Overall service effectiveness and specific outcome measures (4) as assessed with Origin before Admission of all admissions between start and end of study (12 months) [Time Frame: Changes in Overall service effectiveness and specific outcome by recording of Origin ad each Admission throughout study between baseline and after (approximately) 12 months (=end of study)]

Changes in Overall service effectiveness and specific outcome measures (2) as measured with Indication for hospitalisation of all admissions between start and study end (12 months) [Time Frame: Changes in Overall service effectiveness and specific outcome by recording of Admission Indication throughout study between baseline and after (approximately) 12 months (=end of study)]

Changes in Overall service effectiveness and specific outcome measures (3) as measured with Re-hospitalisation rates within 30 days after dismissal between start and end study (12 months) [Time Frame: Changes in Overall service effectiveness and specific outcome as assessed based on change between measurements of total of re-hospitalization within 30 days after last admission throughout study between baseline and after (approx.) 12 months (=study end)]

Economic aspects (1) as measured based on the total of Efforts related to service development & implementation during the study (between start and 12 months) [Time Frame: Economic aspects as assessed based on measurements of total efforts related to Development and Implementation of Services during the period between baseline and after (approximately) 12 months (=end of study)]

Impact on Organisational aspects (1) as measured with impact on staff between start and study end (after 12 months) [Time Frame: Total of Services' Impact On Staff during the period between baseline after (approximately) 12 months (=end of study)]

Change in Disease specific health status measurement (3) as measured with heart rate measurements of all chronic heart failure patients between start and study end (12 months) [Time Frame: Changes in Disease specific health status based on measurements of Heart Rate between baseline and after (approximately) 12 months (=end of study)]

Change in Overall service effectiveness and specific outcome measures (5) as assessed with Discharge destiny of all discharges between start and end of study (12 months) [Time Frame: Changes in Overall service effectiveness and specific outcome by recording of Destiny after each discharge throughout study between baseline and end of study (12 months)]

Change in Disease specific health status measurement (1) as measured with HbA1c of diabetes patients between start and end of study (12 months) [Time Frame: Changes in Disease specific health status based on measurements of HbA1c between baseline and after (approximately) 12 months (=end of study)]

Change in Disease specific health status measurement (4) as measured with blood pressure of all patients with chronic heart failure between start and end of study (12 months) [Time Frame: Changes in Disease specific health status based on measurements of blood Pressure between baseline and after (approximately) 12 months (=end of study)]

Change in Generic health related/functional quality of life (2) by assessing Barthel index [Time Frame: Change in Generic health related/functional quality of life as assessed based on BARTHEL INDEX scores between baseline and (approximately) after 12 months (=end of study)]

Changes in of Economic aspects (5) based on measurements of Service efficiency benefits during study (between start and 12 months) [Time Frame: Economic aspects as assessed based on measurements of total of Benefits in Efficiency of Services during the period between baseline and after (approximately) 12 months (=end of study)]

Changes in User perspectives (3) by measuring Carer perspectives of integration according to eCCIS [Time Frame: Changes in User perspectives as assessed based on eCCIS measurements of CARERS between baseline, midterm (after approximately 6 months) and after (approximately) 12 months (=end of study)]

Impact on Organisational aspects (2) as measured with impact on involved organisations between start study and end (12 months) [Time Frame: Total of Services' Impact On Organisations during the period between baseline and after (approximately) 12 months (=end of study)]

Change in Disease specific health status measurement (6) as measured with BMI of all patients with chronic heart failure between start and end of study (12 months) [Time Frame: Changes in BMI between baseline and after (approximately) 12 months (=end of study)]

Changes in Economic aspects (4) based on measurements of Service effectiveness benefits during study (between start and 12 months) [Time Frame: Total of Benefits in Effectiveness of Services during the period between baseline and after (approximately) 12 months (=end of study)]

Changes in User perspectives (4) by measurement of NHS LTC6 Questionnaire [Time Frame: Changes in NHS-LTC6 measurements between baseline, midterm (after approximately 6 months) and after (approximately) 12 months (=end of study)]

Changes in Economic aspects (2) as measured based on the total of Efforts related to service during the operation or use of the study (between starts and 12 months) [Time Frame: Economic aspects as assessed based on measurements of total efforts related to Service Operations during the period between baseline and after (approximately) 12 months (=end of study)]

Changes in Overall service effectiveness and specific outcome measures (1) as measured with Admission-Discharge Duration of admissions between start and study end [Time Frame: Changes in Overall service effectiveness and specific outcome assessed based on change between Average of Duration of each Admission throughout study between baseline and after (approximately) 12 months (=end of study)]

Change in Psychological measures (1) by assessing Geriatric Depression Scale [Time Frame: Changes in Psychological measures as assessed based on GDS-SF between baseline, midterm (after approximately 6 months) and after (approximately) 12 months (=end of study)]

Changes in Economic aspects (3) as measured based on the total of Equipment costs during the project, between start and after 12 months [Time Frame: Economic aspects as assessed based on measurements of total of Costs of Equipment during the period between baseline and after (approximately) 12 months (=end of study)]

Changes in Economic aspects (6) based on changes in measurements Changes Willingness to pay between start en end of study (12 months) [Time Frame: Economic aspects as assessed based on measurements of Changes in Willingness To Pay for Services between baseline and after (approximately) 12 months (=end of study)]

Secondary ID(s)

CareWell_EC_Grant No. 620983

Source(s) of Monetary Support

Please refer to primary and secondary sponsors