Outcome
Type |
Measure |
Description |
Time frame |
Safety issue |
Primary |
Change from baseline patient visits to the emergency (ER) department at 12 months |
Change from Baseline in the number of patient visits to the emergency (ER) department during a 12 month-period. Data collected from EHR. |
The primary outcome will be observed 12 months after the baseline. |
|
Secondary |
Change from baseline Patient-Reported Outcome Measurements (PROMs) on health-related quality of life at 12 months |
Outcome measure reported by patients by means of completion of the questionnaire EQ-5D-5L |
The change in the health related quality of life of the patient measured by means of EQ-5D-5L will be observed for a period up to 12 months, starting from the baseline |
|
Secondary |
Change from baseline PPatient-Reported Outcome Measurements (PROMs) on mood/emotional health at 12 months |
Outcome measure reported by patients by means of completion of the questionnaire HADS-Hospital Anxiety and Depression Scale |
The change in the mood/emotional health of patient measured by means of HADS-Hospital Anxiety and Depression Scale will be observed for a period up to 12 months, starting from the baseline. |
|
Secondary |
Change from baseline Patient-Reported Outcome Measurements (PROMs) on the ability of patients to perform tasks that are required to live independently in the community measured by Lawton scale at 12 months |
Outcome measure reported by patients by means of completion of the Lawton scale |
The change on the ability of patients to perform tasks that are required to live independently in the community measured by means of Lawton scale will be observed for a period up to 12 months, starting from the baseline |
|
Secondary |
Change from baseline capability of the patient to perform basic activities in daily life at 12 months. |
Outcome measured reported by patients by means of answering of the Barthel Index |
The change on the capability of the patient to perform basic activities in daily reflecting the ability to function independently life measured by means of Barthel index will be observed for a period up to 12 months, starting from the baseline |
|
Secondary |
Change from baseline Patient-Reported Outcome Measurements (PROMs) on health status in patients with heart failure at 12 months |
Outcome measure reported by patients by means of completion of the questionnaire Kansas City Cardiomyopathy Questionnaire score |
The change on health status in patients measured by means Kansas City Cardiomyopathy Questionnaire score questionnaire will be observed for a period up to 12 months, starting from the baseline |
|
Secondary |
Change from baseline Patient-Reported Outcome Measurements (PROMs) on the impact of COPD on the patients' health status at 12 months |
Outcome measure reported by patients by means of completion of the questionnaire COPD assessment test score |
The change on the impact of COPD on the patient's health status measured by means of COPD assessment test score will be observed for a period up to 12 month, starting from the baseline |
|
Secondary |
Change from baseline Patient-Reported Outcome Measurements (PROMs) on complexity at 12 months. |
Outcome measure reported by patients by means of completion of the Modified Medical Research Council -mMRC- Dyspnea Scale |
The change on the complexity measured by means of Modified Medical Research Council -mMRC- Dyspnea Scale will be observed for a period up to 12 months, starting from the baseline |
|
Secondary |
Resource use due to patient healthcare visits |
Outcome measured by means of number and type of patient healthcare visits |
Resource use of intervention patients will be measured during the 12-months before and after the baseline |
|
Secondary |
Resource use due to number of patient hospital admissions |
Outcome measured by means of the number of patient hospital admissions |
Resource use of intervention patients will be measured during the 12-months before and after the baseline |
|
Secondary |
Resource use due to duration of patient hospital admissions |
Outcome measured by means of the number of the days of the patient hospital admissions |
Resource use of intervention patients will be measured during the 12-months before and after the baseline |
|
Secondary |
Associated costs to resource use due to number and type of patient healthcare visits |
Outcome measured by cost of patient healthcare visits (considering the number, duration and the unit costs) |
Resource use of intervention patients will be measured during the 12-months before and after the baseline |
|
Secondary |
Associated costs to resource use due to patient hospital admissions |
Outcome measured by cost of patient hospital admissions (taking into account the number, duration and the unit costs of hospitalisations) |
Resource use of intervention patients will be measured during the 12-months before and after the baseline |
|
Secondary |
Change from baseline burden of care of the informal caregivers at 12 months |
Outcome measured by completion of Zarit Burden Interview, ZBI by the informal caregivers |
The change on the Burden of care measured by means of Zarit Burden Interview will be observed for a period up to 12 months, starting from the baseline |
|
Secondary |
Associated costs to drug prescription |
Outcome measured by total drug prescription cost that patients have |
Resource use of intervention patients will be measured during the 12-months before and after the baseline |
|
Secondary |
Change from baseline mental well-being of informal caregivers at 12 months. |
Outcome measured by completion of Warwick-Edinburgh Mental Wellbeing Scale, WEMWBS by the informal caregivers |
The change on the Mental well-being of informal caregivers measured by means of of Warwick-Edinburgh Mental Wellbeing Scale will be will be observed for a period up to 12 months, starting from the baseline |
|
Secondary |
Change from baseline Technology acceptance and future adoption of the ADLIFE intervention by ADLIFE participants (patients, informal caregivers and health care professionals) at 12 months |
Outcome measured by completion of the Unified Theory of Acceptance and Use of Technology (UTAUT) |
The change on the technology acceptance measured by means of the Unified Theory of Acceptance and Use of Technology will be observed for a period up to 12 months, starting from the baseline |
|
Secondary |
Satisfaction with accessibility, security and Personalized Care Plans by ADLIFE participants (patients, informal caregivers and health care professionals) |
Outcome measured by qualitative analyses (semi-structured interviews) |
The satisfaction with accessibility, security and Personalized Care Plans measured by means of semi-structured interviews will be observed after 12 months from the baseline |
|
Secondary |
Barriers/facilitators related to the implementation process, by ADLIFE participants (patients, informal caregivers and health care professionals) |
Outcome measured by qualitative analyses (semi-structured interviews) |
The change on the barriers/facilitators related to the implementation process measured by means of semi-structured interviews will be observed after 12 months from the baseline |
|
Secondary |
Perceived coordination among settings by health care professionals |
Outcome measured by qualitative analyses (semi-structured interviews) |
The change on the perceived coordination among settings measured by means of semi-structured interviews will be observed after 12 months from the baseline |
|
Secondary |
Quality of care related to integration of care, decision making process and working condition by health care professionals |
Outcome measured by qualitative analyses (semi-structured interviews) |
The change on the quality of care related to integration of care, decision making process and working condition measured by means of semi-structured interviews will be observed after 12 months from the baseline |
|
Secondary |
Perceptions on healthcare visits and hospital admissions burden by health care professionals |
Outcome measured by qualitative analyses (semi-structured interviews) |
The change on the perceptions on healthcare visits and hospital admissions burden measured by means of semi-structured interviews will be observed after 12 months from the baseline |
|
Secondary |
Implementation assessment by health care professionals, IT staff and clinical managers |
Outcome measured by contextual factors focusing on local technological, organizational, and human factor (semi-structured interviews) |
The change on the implementation assessment measured by means of semi-structured interviews will be observed after 12 months from the baseline. |
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