2.1. Design of the study
The ValueCare methodology is based on an interactive process that focuses on the needs and requirements of the end users as well as ethical and data protection aspects. The goal and aim of the ValueCare study are to develop a new, outcome-based model of integrated social and health care supported by a digital solution that promotes the health and social goals of older citizens, supports informal caregivers, and improves the working conditions of professionals. The ValueCare study work plan has been divided into eight work packages to implement and achieve objectives while optimizing time, resources, and quality. The vision of integrated, value-based care will be supported by a robust, secure, and scalable digital solution that will be tested and evaluated at pilot sites in Europe according to a methodology developed by the project partners together with end users within a predefined protocol for codesign activities. The seven pilot sites included, in alphabetical order, are Athens, Greece; Coimbra, Portugal; Cork/Kerry, Ireland; Rijeka, Croatia; Rotterdam, The Netherlands; Treviso, Italy; and Valencia, Spain [17].
The integrated care approach will be developed to shift care away from acute episodic hospital care to community-based, planned, proactive and coordinated care. The ValueCare study will use the International Consortium for Health Outcomes Measurement (ICHOM) dataset for older people as well as for specific conditions (e.g., stroke, diabetes) and contribute to their further development by analysing the outcome parameters together with the global ICHOM working group to determine if they are complete and still appropriate [17, 18].
The first step of the ValueCare study will be to carry out codesign activities. Codesign activities involve cooperation and interactivity in the development of the study methodology, which is based on the needs of the end users and developed together with the relevant stakeholders (health and social care professionals, informal caregivers, IT experts, managers, and exploitation stakeholders). In this context, the main objective of codesign activities is to give older people, as well as other stakeholders involved, the opportunity to influence their present and future care pathways and to personalize the services they receive. The codesign activities will consist of three main approaches: targeted semi structured interviews, focus groups and a national seminar, as they are the main tools used in codesign implementation within healthcare systems for digital solution deployment [19]. The key principle of codesign is the central role of end users and stakeholders and their involvement and engagement throughout the process. In this context, the intervention of ValueCare will improve the quality of life, independence, and satisfaction of older people through the development of digital solutions, enabling them to remain independent [19].
Based on the results of the codesign activities, the ValueCare digital solution will be developed. It will provide health information to health and social care professionals so that they can interpret this information, make value-based decisions in real time and personalize the care services provided. The digital solution developed as part of the ValueCare study will consist of two main segments: the Vida24 ValueCare web application and the ValueCare mobile application. The Vida24 ValueCare web application is the main dashboard for health and social care professionals and researchers and will be used to develop personalized value-based care plans by a multidisciplinary team (cardiologists, patronage nurses and physiotherapists). The most important function of the ValueCare mobile application is the Virtual Coach, a virtual chat bot that contains conversation patterns developed specifically for each participant based on their values and needs.
When the activities of the previously mentioned codesign and the testing of the digital solution are completed, the researchers, together with health professionals and other stakeholders, will start the inclusion of the participants. The design of the ValueCare study for the Rijeka pilot site is summarized in Fig. 1.
Figure 1. Design of the ValueCare Study at the Rijeka pilot site
2.2. Selection and inclusion of the participants
The participants in this study will consist of older people, informal caregivers, and health and social care professionals.
The criteria for inclusion in the older group were individuals aged 65 years and older, of both sexes, who had suffered MI and had completed the rehabilitation process. They should live in their own household in the city of Rijeka or its surroundings. The exclusion criteria were dementia, terminal illness, inability to participate in the project for 20 months and institutionalization. These criteria were agreed upon within the ValueCare project consortium since it is a community-based intervention in an urban environment. Participants will be identified and selected in cooperation with health professionals (cardiologists, nurses) from the Clinic for Rehabilitation, Treatment and Prevention of Cardiovascular Diseases, Thalassotherapia Opatija [20] and Community Health Centre of Primorje-Gorski Kotar County [21]. Participants who meet the inclusion criteria and have successfully completed the rehabilitation process after an MI will be introduced to the ValueCare approach a few days before they are discharged from Thalassotherapia Opatija so that they can familiarize themselves with the project and the study. After the presentation of the ValueCare project, interested participants will formally join the study. A total of 240 older people will participate in the study. They will be divided into two groups. Half of them (120 people) will participate in the intervention phase for 12 months and receive enhanced care supported by the ValueCare digital solution, while the remaining 120 participants will form the control group and receive usual care.
The group of informal caregivers will consist of family members who are nominated by the older person (participant) and who is involved in older people’s care for MI. In total, 50–70 informal caregivers will be involved. The group of informal caregivers supported their family members (older people) during the intervention.
The group of health professionals will be specifically selected from public administrations and local and regional healthcare providers. The group included general practitioners and nurses from the Community Health Centre of Primorje-Gorski Kotar County as well as cardiologists from the Clinical Hospital Centre Rijeka [22] and Thalassotherapia Opatija.
For all target groups invited to participate in the study, only those who signed the informed consent will participate in the study.
2.3. Interventional methods
A total of 120 older people who had MI and completed rehabilitation in the city of Rijeka and its surroundings participated in the intervention phase. In addition, their informal caregivers, i.e., family members (50–70) and healthcare professionals (30–40), will be involved in the intervention phase to provide continuous support and monitoring to the participants.
After the intervention participants completed the baseline questionnaires (T0), an initial meeting with the healthcare professionals/cardiologists was organized. During the first meeting, the healthcare provider and the older person will discuss the results of the questionnaire and set a personalized, value-based care plan that will be periodically reviewed as part of a shared decision-making process.
During the 12-month intervention period, each participant will have access to the ValueCare mobile application (Vodafone Innovus, Athens, Greece) [23], which is based on the virtual coach developed by Fondazione Bruno Kessler, Trento, Italy [24]. The content of the mobile application will be based on the patients’ needs and values and will be defined through codesign activities.
In addition to the ValueCare mobile application, which is constantly synchronized with the Vida24 ValueCare web platform, participants will also receive the LifeVit Vital smartwatch (LifeVit, Barcelona, Spain) [25], which will monitor and track heart rate, number of steps, distance covered during the day, calories burned, number of inactive hours and sleep patterns. These multisource data will constantly be uploaded to the cloud service and visible on the Vida24 ValueCare web platform, providing healthcare professionals real-time insight into the physical activity patterns of intervention participants.
Informal caregivers (family members and volunteers) and healthcare professionals will play an active role during the intervention phase. Informal caregivers will have limited access to the Vida24 ValueCare web platform to gain insight into the progress of intervention phase participants. On the other hand, healthcare professionals play several roles during the intervention period. First, they will participate in the first consultation meeting with the participants and develop the personalized value-based care plan. During the intervention, they will have full access to the web platform to evaluate the progress of their participants, to redefine the goals set up at the initial meeting via a shared decision-making process with the participants and to communicate with them. Healthcare professionals will also participate in additional health parameter measurements at the Public Health Laboratory.
To enhance the intervention phase, the Public Health Lab at the Department of Social Medicine and Epidemiology of the Faculty of Medicine, University of Rijeka, was established. The participants will be examined every three months during the intervention phase, and additional analyses of health parameters such as height, weight, visceral fat [%], total body fat [%], skeletal muscle [%], body mass index (BMI), resting metabolism [kcal] (Omron Viva Smart Scale, Omron Healthcare, Kyoto, Japan) [26], blood pressure [mmHg] (MicroLife BP B3 AFIB sphygmomanometer, Taipei, Taiwan) [27], heart rate [b/min], oxygen saturation [%] (ChoiceMMed MD300C29 pulse oximeter, Kinsmedic Sdn Bhd, Malaysia) [28], subcutaneous fat [mm] (digital calliper), left- and right-hand dynamometry [kg] (Camry Digital dynamometer, California, USA) [29], ECG (Eko Duo ECG and Digital Stethoscope, Oakland, California, USA) [30], spirometry (MIR Spirobank II Advanced Sprometer, Wisconsin, USA) [31] and blood sugar level [mmol/L] (Wellmed Glucometer, Texas, USA) [32] will be performed. These analyses will broaden the personalized care approach and provide opportunities for healthcare professionals to better adapt the needed care pathway for each participant.
Before the start of the intervention phase, the study received ethical approval from the Ethical Committee for Biomedical Research of the Faculty of Medicine, University of University of Rijeka, Croatia (class: 003–08/20 − 01/53; registry number: 2170-24-09-8-20-2 and class: 003–08/21 − 01/48; registry number: 2170-24-04-3-21-11), as well as from the Ethics Committee of the Community Health Centre of Primorje-Gorski Kotar County, Rijeka, Croatia (registry number: 01–43/1-2-22).
2.4. Outcome assessment and statistical analysis
After they formally join the study, the intervention phase study participants complete the baseline questionnaire (T0) to evaluate their frailty (Tilburg Frailty Indicator) [33], falls (Visual Analogue Scale for Fear of Falling) [34], medication adherence (Medication Risk Questionnaire – MRQ-10) [35], lifestyle (BMI, smoking status, consumption of alcohol, physical activity, nutrition) [17, 36–38], daily living activities (10-item Barthel Index, which was modified) [39], physical and mental health-related quality of life (PROMIS-10) [40], comorbidities [17], loneliness (UCLA 3-Item Loneliness Scale) [41], healthcare utilization (SMRC Healthcare Utilization questionnaire) [42] and sociodemographic data (age, gender, education level, type of household income, net monthly household income, marital status and household composition). The baseline questionnaire was developed by the International Consortium for Outcome Measurement (ICHOM) as a standard for older persons. The included informal caregivers and health and social care professionals will also complete baseline questionnaires. The informal caregivers’ questionnaires will evaluate their physical and mental health-related quality of life (PROMIS-10) [40], burden of informal care (iMTA Valuation of Informal Care Questionnaire – iVICQ and 4-item Zarit Burden Interview) [43, 44], level of autonomy (Adult Social Care Outcomes Toolkit) [45] and sociodemographic data. Health and social care professionals will answer questions regarding their job satisfaction (a short form of the Minnesota Satisfaction Questionnaire) [46], work-related burnout (the Copenhagen Burnout Inventory) [47], working conditions (the Culture of Care Barometer tool) [48] and sociodemographic data (age, gender, education level, occupation, net monthly household income, marital status, and household composition). The questionnaires could be completed via paper forms or on personal computers (PCs), laptops and tablets depending on target group preferences.
The questionnaire was input through the web based GemsTracker (GEneric Medical Survey Tracker, Erasmus MC, Rotterdam, The Netherlands) [49] system, which enables automatic evaluation via a predefined data scoring framework and data extraction in portable document format (PDF) form. Healthcare professionals will receive the questionnaire results on a pilot-specific cloud-based Vida24 ValueCare web platform (Vidavo S.A., Thessaloniki, Greece) [50].
After the one-year intervention and six-month follow-up period, all target groups who participated in the project completed two more questionnaires (T1 and T2) to evaluate the value-based approach in its entirety. The categorical variable data are presented as frequencies (N) and relative frequencies (%) and were compared with appropriate test data. Depending on the distribution of the data and the results of the Kolmogorov‒Smirnov test, parametric or nonparametric statistical tests will be used to assess changes before and after the intervention and at the T2 follow-up time point. A p value of 0.05 was considered to indicate statistical significance.