Chronic Obstructive Pulmonary DiseaseCAREWELLNCT03042039
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
An observational study of Chronic Obstructive Pulmonary Disease and Diabetes, run by Him SA at 5 sites in 5 countries.
Trial summary
CareWell will enable the delivery of integrated healthcare to frail elderly patients in a pilot setting through comprehensive multidisciplinary integrated care programmes where the role of ICTs can foster the coordination and patient centered delivery care. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease, Diabetes, Chronic Heart Failure
- What is being tested?
- New Care
- How many people
- 1,712 participants
- Where
- 5 sitesin 5 countries
- Study dates
- 1 Jan 2015to 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
- Older adult
Study population: Frail elderly living in one of the 6 CareWell sites
Who may be able to join
- Age ≥65 years.
- 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).
- Fulfilling local/national/organisational criteria of frailty: increased vulnerability, complex health needs, and at high risk of hospital or care home admission.
- Participants have to be able to understand and to comply with study instructions and requirement, either independently or with help from a carer.
Who cannot join
- 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.
- Subjects who are candidates for palliative care (with life expectancy less than one year, clinically evaluated).
- People with an AIDS diagnosis.
- 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.
Trial locations and contacts
5 sites in 5 countries.
5 sites in 5 countries
About this study
Official title: CareWell - Multi-level Integration for Patients With Complex Needs
CareWell will enable the delivery of integrated healthcare to frail elderly patients in a pilot setting through comprehensive multidisciplinary integrated care programmes where the role of ICTs can foster the coordination and patient centered delivery care. Carewell will focus in particular complex, multi-morbid elderly patients, who the patients most in need of health and social care resources (35% the total cost of Health Care System) and more complex interventions due to their frailty and comorbidities (health and social care coordination, monitoring, self-management of the patient and informal care giver). ICT platforms and communication channels that allow sharing information between healthcare and social care professionals involved in the delivery care of these patients, facilitating their coordination, increasing their resoluteness and avoiding duplicities when tackling patients´ diagnostic, therapeutic, rehabilitation or monitoring needs. Additionally, ICT-based platforms can improve the adherence to treatment, enhance self-care and increase patient awareness about their health status , as well as, improve the empowerment of informal caregivers, who usually take care of these patients.
According to this, it is hypothesized that the benefit of integrated care programmes based on (1) integrated care coordination and (2) patient empowerment \& home support pathways supported by ICT is greater and essential for these patients. Care pathways will cut across organisational boundaries and will activate the most appropriate resources across the entire spectrum of healthcare and social care services available for both scheduled and emergency care. CareWell aims to scale up the services in pioneer regions and share their approach, learning from and supporting the other pilot sites which are at different levels of maturity in respect to designing, developing and implementing new ways of providing integrated care services.
Read the detailed description
Frail elderly patients are characterised as having complex health and social care needs; they are at risk of hospital or residential care home admission, and require a range of high level interventions due to their frailty and multiple chronic conditions. A growing proportion of the population in OECD countries are age 65 and over: 15% in 2010, and expected to reach 22% by 2030. More than half of all older people have at least three chronic conditions, and a significant proportion have five or more.
A recent US study indicates that more than 95% of Medicare patients with a chronic disease such as congestive heart failure, depression, or diabetes have at least one other chronic condition, and the majority (80%, 71%, and 56%, respectively) have four or more chronic conditions. The CareWell project deals with multimorbid frail patients. Typically these patients have several diagnoses, the most frequent ones are:
- Chronic Obstructive Pulmonary Disease (COPD),
- Diabetes and
- Congestive Heart Failure (CHF).
The main objective of the CareWell study is to explore the data collection and analysis of health services' use. All sites are requested to upload their available data regarding service use, their flow chart on recruitment, and the demographic characteristics of end users. The evaluation has been conducted using the MAST multi-dimensional evaluation methodology adapted to the needs of CareWell project focusing on integrated healthcare.
MAST includes assessment of the outcomes of telemedicine applications divided into the following seven domains:
- health problem and characteristics of the application;
- safety;
- clinical effectiveness;
- patient perspectives;
- economic aspects;
- organisational aspects and
- socio-cultural, ethical and legal aspects. Each domain will be addressed and studied through a range of methodological approaches, quantitative, qualitative and modelling.
Patients distributed in six sites will be recruited and assessed at baseline and be followed up during a period of six months. Data is to be collected from different sources, including administrative databases, questionnaires and personal interviews.
All 6 CareWell sites are to conduct cohort studies, which means that a group of people with similar characteristics are followed over a period of time. Potential participants are selected by screening electronic healthcare records and/or the hospital / national databases and/or during long term condition annual reviews in the community setting.
Candidates are informed about the nature and the objectives of the evaluation. Once candidates have signed the informed consent form, if necessary, they participate in the evaluation.
- Conditions
- Chronic Obstructive Pulmonary Disease, Diabetes, Chronic Heart Failure, Frail Elderly Syndrome
- Being tested
- New Care
- Medical subject headings
- 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
New organisational care model delivering integrated healthcare (IHC) supported by ICT infrastructure (electronically shared-care platform).
| Study group | Role | What they receive |
|---|---|---|
| Study group 'New Care' | Frail elderly receiving care within new organisational models delivering integrated healthcare (IHC) supported by ICT infrastructure (electronically shared-care platform) as provided by pilot sites individually. Receives: Other: New Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total number of hospital admissions per participant measured at end of study (at approx 12 months)
The total of (planned and unplanned) hospital admissions
Measured: Total of hospital admissions as measured after (approximately) 12 months (= end of study)
Secondary outcomes (26)
Change in generic health related/functional quality of life (1) by assessing Charlson Comorbidity Index (CCI)
Charlson Comorbidity Index (CCI)
Measured: Change in CCI between baseline and after (approximately) 12 months (=end of study)
Change in Generic health related/functional quality of life (2) by assessing Barthel index
Barthel index
Measured: 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)
Change in Psychological measures (1) by assessing Geriatric Depression Scale
Geriatric Depression Scale (GDS Short Form)
Measured: 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)
Change in Psychological measures (2) by measuring Hospital Anxiety and Depression Scale
Hospital Anxiety and Depression Scale (HADS Scale)
Measured: 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)
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
Policy Research Unit in Policy Innovation Research (PIRU) questionnaire on user experience of Integrated Care (IC)
Measured: 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)
Changes in User perspectives (3) by measuring Carer perspectives of integration according to eCCIS
Carer perspectives of integration according to eCCIS
Measured: 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)
Changes in User perspectives (4) by measurement of NHS LTC6 Questionnaire
National Health Services (NHS) LTC6 Questionnaire
Measured: Changes in NHS-LTC6 measurements between baseline, midterm (after approximately 6 months) and after (approximately) 12 months (=end of study)
Economic aspects (1) as measured based on the total of Efforts related to service development & implementation during the study (between start and 12 months)
Efforts related to service development \& implementation
Measured: 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)
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)
Efforts related to service operation or use
Measured: 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 Economic aspects (3) as measured based on the total of Equipment costs during the project, between start and after 12 months
Equipment costs
Measured: 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 (4) based on measurements of Service effectiveness benefits during study (between start and 12 months)
Service effectiveness benefits
Measured: Total of Benefits in Effectiveness of Services during the period between baseline and after (approximately) 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)
Service efficiency benefits
Measured: 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 Economic aspects (6) based on changes in measurements Changes Willingness to pay between start en end of study (12 months)
Changes Willingness to pay
Measured: 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)
Impact on Organisational aspects (1) as measured with impact on staff between start and study end (after 12 months)
Impacts on staff
Measured: Total of Services' Impact On Staff during the period between baseline 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)
Impacts on organisation
Measured: Total of Services' Impact On Organisations 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
Admission-Discharge Duration
Measured: 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)
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)
Indication for hospitalisation
Measured: 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)
Re-hospitalisation within 30 days
Measured: 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)
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)
Origin before Admission
Measured: 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)
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)
Discharge destiny
Measured: 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)
HbA1c
Measured: 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 (2) as measured with blood glucose levels of all diabetes patients between start and end of study (12 months)
Blood glucose
Measured: Changes in Disease specific health status based on measurements of Blood Glucose between baseline and 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)
Heart rate
Measured: Changes in Disease specific health status based on measurements of Heart Rate 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)
Blood pressure
Measured: Changes in Disease specific health status based on measurements of blood Pressure 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)
Weight
Measured: Changes in Disease specific health status based on measurements of Weight 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)
BMI
Measured: Changes in BMI between baseline and after (approximately) 12 months (=end of study)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2017 (estimated)
- Study start1 Jan 2015
- Primary completion30 Apr 2016
- Study completion1 Oct 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 1,712 participants (actual)
Sponsor and investigators
- Lead sponsor
- Him SA
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wouter A Keijser, Him SA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03042039
- Sponsor's protocol ID
- CareWell_EC_Grant No. 620983
- Acronym
- CAREWELL
- Status last verified
- Aug 2017
- First submitted
- 24 Jan 2017
- Last updated
- 9 Aug 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 22617736Agha Z, Schapira RM, Maker AH. Cost effectiveness of telemedicine for the delivery of outpatient pulmonary care to a rural population. Telemed J E Health. 2002 Fall;8(3):281-91. doi: 10.1089/15305620260353171.
PubMed 12419022Zwarenstein M, Treweek S, Gagnier JJ, Altman DG, Tunis S, Haynes B, Oxman AD, Moher D; CONSORT group; Pragmatic Trials in Healthcare (Practihc) group. Improving the reporting of pragmatic trials: an extension of the CONSORT statement. BMJ. 2008 Nov 11;337:a2390. doi: 10.1136/bmj.a2390.
PubMed 19001484Kopec JA, Fines P, Manuel DG, Buckeridge DL, Flanagan WM, Oderkirk J, Abrahamowicz M, Harper S, Sharif B, Okhmatovskaia A, Sayre EC, Rahman MM, Wolfson MC. Validation of population-based disease simulation models: a review of concepts and methods. BMC Public Health. 2010 Nov 18;10:710. doi: 10.1186/1471-2458-10-710.
PubMed 21087466Speroff T, O'Connor GT. Study designs for PDSA quality improvement research. Qual Manag Health Care. 2004 Jan-Mar;13(1):17-32. doi: 10.1097/00019514-200401000-00002.
PubMed 14976904Hiligsmann M, Gathon HJ, Bruyere O, Ethgen O, Rabenda V, Reginster JY. Cost-effectiveness of osteoporosis screening followed by treatment: the impact of medication adherence. Value Health. 2010 Jun-Jul;13(4):394-401. doi: 10.1111/j.1524-4733.2009.00687.x. Epub 2010 Jan 21.
PubMed 20102558Lega F, DePietro C. Converging patterns in hospital organization: beyond the professional bureaucracy. Health Policy. 2005 Nov;74(3):261-81. doi: 10.1016/j.healthpol.2005.01.010.
PubMed 16226138Mateo-Abad M, Gonzalez N, Fullaondo A, Merino M, Azkargorta L, Gine A, Verdoy D, Vergara I, de Manuel Keenoy E. Impact of the CareWell integrated care model for older patients with multimorbidity: a quasi-experimental controlled study in the Basque Country. BMC Health Serv Res. 2020 Jul 3;20(1):613. doi: 10.1186/s12913-020-05473-2.
PubMed 32620116
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CareWell - Multi-level Integration for Patients With Complex Needs
- ClinicalTrials.gov ID
- NCT03042039
- Acronym / sponsor ID
- CAREWELL / CareWell_EC_Grant No. 620983
- Conditions
- Chronic Obstructive Pulmonary Disease, Diabetes, Chronic Heart Failure, Frail Elderly Syndrome
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,712 participants (actual)
- Lead sponsor
- Him SAUniversity, hospital or other
- Study start
- 1 Jan 2015 (actual)
- Primary completion
- 30 Apr 2016 (actual)
- Study completion
- 1 Oct 2017 (estimated)
- First posted
- 3 Feb 2017 (estimated)
- 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.
CareWell will enable the delivery of integrated healthcare to frail elderly patients in a pilot setting through comprehensive multidisciplinary integrated care programmes where the role of ICTs can foster the coordination and patient centered delivery care. Carewell will focus in particular complex, multi-morbid elderly patients, who the patients most in need of health and social care resources (35% the total cost of Health Care System) and more complex interventions due to their frailty and comorbidities (health and social care coordination, monitoring, self-management of the patient and informal care giver). ICT platforms and communication channels that allow sharing information between healthcare and social care professionals involved in the delivery care of these patients, facilitating their coordination, increasing their resoluteness and avoiding duplicities when tackling patients´ diagnostic, therapeutic, rehabilitation or monitoring needs. Additionally, ICT-based platforms can improve the adherence to treatment, enhance self-care and increase patient awareness about their health status , as well as, improve the empowerment of informal caregivers, who usually take care of these patients.
According to this, it is hypothesized that the benefit of integrated care programmes based on (1) integrated care coordination and (2) patient empowerment \& home support pathways supported by ICT is greater and essential for these patients. Care pathways will cut across organisational boundaries and will activate the most appropriate resources across the entire spectrum of healthcare and social care services available for both scheduled and emergency care. CareWell aims to scale up the services in pioneer regions and share their approach, learning from and supporting the other pilot sites which are at different levels of maturity in respect to designing, developing and implementing new ways of providing integrated care services.
Detailed description
Frail elderly patients are characterised as having complex health and social care needs; they are at risk of hospital or residential care home admission, and require a range of high level interventions due to their frailty and multiple chronic conditions. A growing proportion of the population in OECD countries are age 65 and over: 15% in 2010, and expected to reach 22% by 2030. More than half of all older people have at least three chronic conditions, and a significant proportion have five or more.
A recent US study indicates that more than 95% of Medicare patients with a chronic disease such as congestive heart failure, depression, or diabetes have at least one other chronic condition, and the majority (80%, 71%, and 56%, respectively) have four or more chronic conditions. The CareWell project deals with multimorbid frail patients. Typically these patients have several diagnoses, the most frequent ones are:
- Chronic Obstructive Pulmonary Disease (COPD),
- Diabetes and
- Congestive Heart Failure (CHF).
The main objective of the CareWell study is to explore the data collection and analysis of health services' use. All sites are requested to upload their available data regarding service use, their flow chart on recruitment, and the demographic characteristics of end users. The evaluation has been conducted using the MAST multi-dimensional evaluation methodology adapted to the needs of CareWell project focusing on integrated healthcare.
MAST includes assessment of the outcomes of telemedicine applications divided into the following seven domains:
- health problem and characteristics of the application;
- safety;
- clinical effectiveness;
- patient perspectives;
- economic aspects;
- organisational aspects and
- socio-cultural, ethical and legal aspects. Each domain will be addressed and studied through a range of methodological approaches, quantitative, qualitative and modelling.
Patients distributed in six sites will be recruited and assessed at baseline and be followed up during a period of six months. Data is to be collected from different sources, including administrative databases, questionnaires and personal interviews.
All 6 CareWell sites are to conduct cohort studies, which means that a group of people with similar characteristics are followed over a period of time. Potential participants are selected by screening electronic healthcare records and/or the hospital / national databases and/or during long term condition annual reviews in the community setting.
Candidates are informed about the nature and the objectives of the evaluation. Once candidates have signed the informed consent form, if necessary, they participate in the evaluation.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study group 'New Care' | – | Other: New CareFrail elderly receiving care within new organisational models delivering integrated healthcare (IHC) supported by ICT infrastructure (electronically shared-care platform) as provided by pilot sites individually. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Age groups
- Older adult
- Study population
- Frail elderly living in one of the 6 CareWell sites
Key inclusion criteria (4 listed)
- Age ≥65 years.
- 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).
- Fulfilling local/national/organisational criteria of frailty: increased vulnerability, complex health needs, and at high risk of hospital or care home admission.
- Participants have to be able to understand and to comply with study instructions and requirement, either independently or with help from a carer.
Key exclusion criteria (4 listed)
- 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.
- Subjects who are candidates for palliative care (with life expectancy less than one year, clinically evaluated).
- People with an AIDS diagnosis.
- 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.
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 CareNew organisational care model delivering integrated healthcare (IHC) supported by ICT infrastructure (electronically shared-care platform). | Other | Study group 'New Care' |
Primary outcome
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)
The total of (planned and unplanned) hospital admissions
26 secondary outcomes
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)
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)
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)
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)
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)
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)
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)
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)
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 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 (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 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 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)
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)
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)
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)
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)
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)
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 (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 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 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 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 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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2017.
- 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 12419022Agha Z, Schapira RM, Maker AH. Cost effectiveness of telemedicine for the delivery of outpatient pulmonary care to a rural population. Telemed J E Health. 2002 Fall;8(3):281-91. doi: 10.1089/15305620260353171.
- Background: PubMed 19001484Zwarenstein M, Treweek S, Gagnier JJ, Altman DG, Tunis S, Haynes B, Oxman AD, Moher D; CONSORT group; Pragmatic Trials in Healthcare (Practihc) group. Improving the reporting of pragmatic trials: an extension of the CONSORT statement. BMJ. 2008 Nov 11;337:a2390. doi: 10.1136/bmj.a2390.
- Background: PubMed 21087466Kopec JA, Fines P, Manuel DG, Buckeridge DL, Flanagan WM, Oderkirk J, Abrahamowicz M, Harper S, Sharif B, Okhmatovskaia A, Sayre EC, Rahman MM, Wolfson MC. Validation of population-based disease simulation models: a review of concepts and methods. BMC Public Health. 2010 Nov 18;10:710. doi: 10.1186/1471-2458-10-710.
- Background: PubMed 14976904Speroff T, O'Connor GT. Study designs for PDSA quality improvement research. Qual Manag Health Care. 2004 Jan-Mar;13(1):17-32. doi: 10.1097/00019514-200401000-00002.
- Background: PubMed 20102558Hiligsmann M, Gathon HJ, Bruyere O, Ethgen O, Rabenda V, Reginster JY. Cost-effectiveness of osteoporosis screening followed by treatment: the impact of medication adherence. Value Health. 2010 Jun-Jul;13(4):394-401. doi: 10.1111/j.1524-4733.2009.00687.x. Epub 2010 Jan 21.
- Background: PubMed 16226138Lega F, DePietro C. Converging patterns in hospital organization: beyond the professional bureaucracy. Health Policy. 2005 Nov;74(3):261-81. doi: 10.1016/j.healthpol.2005.01.010.
- Derived from this study: PubMed 32620116Mateo-Abad M, Gonzalez N, Fullaondo A, Merino M, Azkargorta L, Gine A, Verdoy D, Vergara I, de Manuel Keenoy E. Impact of the CareWell integrated care model for older patients with multimorbidity: a quasi-experimental controlled study in the Basque Country. BMC Health Serv Res. 2020 Jul 3;20(1):613. doi: 10.1186/s12913-020-05473-2.
- Project Website CareWellLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Obstructive Pulmonary Disease and Diabetes, run by Him SA at 5 sites in 5 countries.
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 4 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 9 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Croatia, Italy, Poland, Spain, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
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?
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)). 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 NCT03042039, which also lists 8 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 9 Aug 2017; AzTrials last refreshed its copy on 28 Oct 2026.