Silver Agri Age: Longevity, Intrinsic Capacity and Cognitive Impairment Into Farmlands and Natural Environments: Updating Contexts Following the "Montessori" Action
Promoting innovative activities following the "Montessori" action in the context of the agricultural multifunctionality, in order to leverage the intrinsic capacity in older people with cognitive impairment. - Identifying a rural environment with educational features. - Identifying individuals with mild cognitive impairments and relations with their families. - Outlining individual therapeutic goals for each participant through different activities: horticulture, pet therapy, occupational therapies, sensory laboratories, functional food laboratories for a healthy and balanced diet suitable for the first symptoms of dementia, physical activity and continuous social activity between different generations. - Horticulture, pet therapy, occupational therapy, sensory labs, physical activity, and social activities IN CONTINUITY between different generations. - Spreading the results to a wide National and International audience.
Phase
N/ASpan
61 weeksSponsor
Istituto Nazionale di Ricovero e Cura per AnzianiFermo
Recruiting
Innovative Models in the Rehabilitation of the Elderly With Hip Fractures Through Technological Innovation
Balance and deficit in walking are some of the main characteristics of aging and are considered among the risk factors for falls. Falls are a risk factor for future falls and are associated with other adverse health outcomes such as fear of falling or fractures. In particular, hip fracture in aged patients is an important health problem. In fact, one in three patients dies within the first year after injury, while survivors have poor quality of life For this reason, the development of prevention tools and innovative strategies in the rehabilitation field should be one of the main objectives in the treatment of the diseases afflicting the elderly, such as hip fractures. Effective interventions to promote hip recovery post hip fracture are characterized by intensive and repetitive movements. One treatment approach to increase number of steps during rehabilitation sessions and to improve the balance and the endurance of the patients is the use of robotic systems. This study is a randomized controlled trial. A total of 195 patients with hip fractures will be recruited and randomly divided into three groups, to receive a traditional rehabilitation program or a robotic rehabilitation in addition to the traditional therapy. Assessments will be performed at baseline, at the end of treatment and 6 months, 1 year and 2 years from the end of the treatment. For the study, post-hospitalization subjects will be taken into consideration, after four weeks from the hospitalization. A 20 treatment sessions will be conducted, divided into 3 training sessions per week, for 7 weeks. The control group will perform traditional therapy sessions lasting 50 minutes. The technological intervention group will carry out 30 minutes of traditional therapy and 20 minutes of treatment with a robotic system.
Phase
N/ASpan
227 weeksSponsor
Istituto Nazionale di Ricovero e Cura per AnzianiFermo
Recruiting
Clinical and Biological Predictors of COVID-19 Disease in Older Patients
Current knowledge about clinical and biological characteristics of COVID 19 among older people is very limited. A better comprehension of the clinical picture of older patients affected by COVID-19, (e.g. frailty, multimorbidity and polypharmacy patterns and functional performance) may significantly contribute to deepen our understanding of the clinical epidemiology knowledge of COVID-19 among hospitalized older people. Therefore, the ReportAge-COVID project aims to collect - using a minimum clinical and biological data set - a series of data and indicators on the conditions of elderly patients that are suspected of having a compatible clinical picture or were confirmed positive for COVID-19. Data will be collected at the patients' admission, during hospital stay, at discharge and 1, 3, 6, 12 months after discharge. In particular, the following specific pieces of information will be gathered: - routinely collected demographic, socioeconomic, clinical, biological and diagnostic data - frailty condition (by using the clinical frailty scale) - assessment of the functional capacities through ADL and IADL tests - health conditions; nutritional status; medications; treatments and procedures - biomarkers of aging including cytokines and anti-inflammatory molecules, previously identified in a focus group of experts Results and findings will help support changes in clinical practice and decision making, with the aim of reducing adverse outcomes, the worsening of health conditions in the elderly population, the use of healthcare services and, as a consequence, lower healthcare expenditure.
Phase
N/ASpan
213 weeksSponsor
Istituto Nazionale di Ricovero e Cura per AnzianiFermo
Recruiting
Innovative Models in the Rehabilitation of the Elderly With Stroke Through Technological Innovation
Stroke is a leading cause of disability, injury, and death in elderly people and represents a major public health problem with substantial medical and economic consequences. The incidence of stroke rapidly increases with age, doubling for each decade after age 55 years. Gait impairment is one of the most important problems after stroke and improve walking function is often a key component of any rehabilitation program. To achieve this goal, robotic gait trainer seems to be promising. In fact, some studies underline the efficacy of robotic gait training based on end-effector technology, for different diseases, in particular in stroke patients. In this randomized controlled trial, we verify the efficacy of the robotic treatment in terms of improving the gait and reducing the risk of falling and its long-term effects. In this single blind randomized controlled trial the investigators will include 150 elderly subacute stroke patients divided in two groups to receive a traditional rehabilitation program or a robotic rehabilitation using G-EO system, an end-effector device for the gait rehabilitation, in addition to the traditional therapy. A 20 treatment sessions will be conducted, divided into 3 training sessions per week, for 7 weeks. The control group will perform traditional therapy sessions lasting 50 minutes. The technological intervention group, using G-EO system, will carry out 30 minutes of traditional therapy and 20 minutes of treatment with a robotic system. The primary outcome of the study is the evaluation of the falling risk. Secondary outcomes are the assessment of the gait improvements and the fear of falling. Further evaluations, such as length and asymmetry of the step, walking and functional status, acceptance of the technology, will be carried.
Phase
N/ASpan
163 weeksSponsor
Istituto Nazionale di Ricovero e Cura per AnzianiFermo
Recruiting
Innovative Models in the Rehabilitation of the Elderly With Parkinson's Disease Through Technological Innovation
Parkinson's disease is one of the most frequent causes of disability among the elderly. It is a chronic-progressive neuro-degenerative disease, characterized by several motor disorders. The balance disorder is a symptom that involves the body axis; it is due to a reduction in the straightening reflexes, so the subject is not able to correct any imbalances. Balance disorders do not respond to dopaminergic therapy used in Parkinson's disease. Therefore, physiotherapy becomes an important intervention for the management of motor disorders. Originally, these rehabilitative approaches were based on empirical experiences, but several scientific evidence suggests that neuronal plasticity is exercise-dependent. In this context, robotic rehabilitation performs an important role because it allows to perform task-oriented exercises and to increase the number of repetitions and their intensity. This protocol study aims to evaluate an innovative rehabilitation treatment of the elderly patients with Parkinson's disease, designed to improve the gait and to reduce the risk of falling. The treatment involves the use of two robotic devices: Tymo system and Walker View. This study is a single-blinded randomized controlled trial. 195 patients with PD will be recruited and randomly divided into three groups, to receive a traditional rehabilitation program or a robotic rehabilitation using Tyro system or Walker View in addition to the traditional therapy. Assessments will be performed at baseline, at the end of treatment and 6 months, 1 year and 2 years from the end of the treatment. A 10 treatment sessions will be conducted, divided into 2 training sessions per week, for 5 weeks. The control group will perform traditional therapy sessions lasting 50 minutes. The technological intervention group will carry out 30 minutes of traditional therapy and 20 minutes of treatment with a robotic system.
Phase
N/ASpan
370 weeksSponsor
Istituto Nazionale di Ricovero e Cura per AnzianiFermo
Recruiting
Description of Adherence to the Main Preventive Health Campaigns of Persons With Multiple Sclerosis
Disease prevention is a set of "specific, population-based and individual-based interventions for primary and secondary (early detection) prevention, aiming to minimize the burden of diseases and associated risk factors.". Depending on the objectives and the type of intervention, three levels of prevention are distinguished: - "Primary prevention: intervening before health effects occur, through measures such as vaccinations, altering risky behaviours, and banning substances known to be associated with a disease or health condition" - "Secondary prevention: screening to identify diseases in the earliest stages, before the onset of signs and symptoms" - "Tertiary prevention: managing disease post diagnosis to slow or stop disease progression through measures" In this study the investigators will take in account primary prevention, including vaccine, tobacco smoke, alcohol consumption and body mass index, and secondary one, considering screening tests. Primary prevention: Vaccine is a biological preparation that provides active acquired immunity to a particular pathogen and it represent "a simple, safe, and effective way of protecting people against harmful diseases, before they come into contact with them.". Vaccination "represent one of the most effective and cost-effective medical and public health achievements of all time" with the aim to protect not only the individuals but also the population. According to WHO (world health organization), "immunization is a key component of primary health care and an indisputable human right". In Italy there is a lifetime immunization schedule establishes the timing of mandatory and recommended vaccinations during all life. Italian data on adult vaccination are available only for seasonal flu, reporting 15% of subjects vaccinated (53% >65, but only 9% in adults <64 even if with chronic diseases (22%)), and for rubella, showing that 39% of women of childbearing age are susceptible or unaware of their immune status. Considering healthy lifestyle, most of Italian adults under 69 does not smoke (57%), but 18% is an ex-smoker and 25% smokes. Considering alcohol consumption, 44% of Italian adults does not consume alcohol, but 17% has a harmful use of it and 9% is a binge drinker. In addition, more than one-third of the Italian population aged 18 and over (35%) is in overweight, while just over one in ten is obese (11%). Secondary prevention: Screening is defined as "the presumptive identification of unrecognized disease in an apparently healthy, asymptomatic population by means of tests, examinations or other procedures that can be applied rapidly and easily to the target population. A screening programme must include all the core components in the screening process from inviting the target population to accessing effective treatment for individuals diagnosed with disease". Mass screening involve the whole population, whereas the selective ones involve high-risk groups of population (but in certain cases they can be in large-scale, such as oncologic ones). Unlike diagnostic tests, used to make a diagnosis in symptomatic subjects, screening tests are aimed at asymptomatic but potentially at-risk people, indicating a suspicion of disease, and they can be repeated at regular interval. Screening must be safe, simple and easy to administer, acceptable (with a minimal discomfort for subjects), inexpensive, reliable and valid, distinguishing diseased and non-diseased people. In Italy, organized screenings include tests for the detection of cervical, breast and colorectal cancer. In addition to these, family doctors (GPs) can control blood pressure and request diagnostic tests to control cholesterol, blood glucose, bone density and dermatological visits to check moles. The measurement of prostate antigen levels is another preventive investigation but is not currently considered a true screening because its usefulness is still a topic of discussion because PSA (prostatic specific antigen) screening could have more risks than benefits, especially. For this reason, the National centre for screening monitoring (ONS) does not recommend population PSA screening, and it recommends the test for diagnostic and non-preventive purposes only, especially for men>70. In Italy, organized screening campaigns, the only ones monitored by the ONS and by Italian Behavioural Risk Factor Surveillance System (PASSI), have an adhesion rate varying according to geographical area. While coverage is almost complete in the Centre and the North, it remains insufficient in the South due to the smaller extension of organized programs and to the lower participation by citizens even with programs active. The coverage of mammography screening, recommended for women between 50 and 69 ys (in some Regions extended also to the age groups 45-49 and 70-74), reached 84% in the North, but only 62% in the South, although an increase was recorded also in this area. Cervical screening, recommended for women between 25 and 64 ys, reached 88% in the North, and 69% in the South. The coverage of colorectal screening, recommended for both sexes between 50 and 69 ys (in some Regions extended up to 74 ys), reached 69% in the North, while in the South still remained <28%. In addition, other variables can also affect the adherence to screening campaigns, such as nationality, level of education and economic difficulties. Moreover, the investigators have to consider that in the first 5 months of 2020, due to pandemic of Covid-19, ONS registered a decrease of more than one million of screening exams than the previous year. Preventive medicine among people with multiple sclerosis/disabilities: Studies in the USA report a reduced access to preventive medicine for people with PwMS, especially for those with severe disabilities. Studies on unhealthy lifestyle in PwMS report a higher prevalence of smokers in PwMS than in general population, whereas for alcohol literature studies published discordant results. Regarding BMI, a recent American case control study report no difference on prevalence of overweight or obesity among PwMS and controls. For Italy, however, there are no available study, and the American healthcare system differs greatly from the Italian one (mainly private vs public). Regarding access to preventive medicine for subjects with various types of disabilities, the Italian Health Observation Report analysed adherence to mammography, pap-test, colorectal and flu vaccination campaigns (only for people over 65). The analysis showed that the number of women with functional limitations who perform mammography and pap tests is reduced by more than 15 percentage points than the general population. Regarding colorectal screening, men with disabilities show no difference compared to the general population, while disabled women adhere to the screening with a lower percentage. Regarding the access to vaccinations, the one against influenza appears to be carried out by a higher percentage of men with disabilities than the Italian general population, but the study presents the bias of having a different demographic composition in the two considered cohorts since the one with functional limitation had more elders, for whom vaccination is more recommended. Also American studies report conflicting results: Diab et al. showed higher pneumococcal and seasonal flu vaccination rates in subjects with mild or medium disabilities compared to those without disabilities or with severe disabilities, while a previous study had found no difference between people with disabilities and the general population although both vaccinations are more recommended in people with disabilities or chronic diseases due to the greater risk of complications following infection. Rationale and specific aims MS by itself do not increase the risk of other diseases, such as cancer, cardiovascular or infectious ones. Although the risk of infection associated with disability as well as the use of DMDs is well known, as well as their potential role in causing cancer disease as an adverse event. This treatment scenario, with the increase in available DMDs in recent years, requires particular attention to tumour and infectious diseases both in the screening for therapy and follow-up. This could improve the adherence to screening campaigns due to a specific request of the neurologist. Regarding the adherence to screening, it should be considered that PwMS with disabilities might have difficulties to access to preventive medicine due to functional limitations. In Italy there are no specific studies on PwMS, although knowing the prevalence of patients who adhere to preventive medicine campaigns can be of great interest in public health decision-making, to launch eventual ad hoc preventive pathways for these subjects. In addition, having this information could help neurologists improving quality and timing in decision making for treatment selection. Adherence to preventive pathways can reduce screening time for access to specific treatments, increase safety within complex therapies and reduce the risk of comorbidities. The Italian National Health Service guarantees integrated care pathways to people with complex needs, and Tuscany, have set up care pathways for people with a severe disability or special needs to promote fair access to health services, including prevention. This pathway could be set up, if necessary, specifically for PwMS, in synergy with the neurologists of the MS Centres and GPs who can play a strategic role in this area. The purpose of the study will be to describe the adherence to preventive medicine by PwMS, investigating if there are differences between PwMS and people without MS (PwoMS) in the access to vaccinations and screenings. In addition, the investigators will try to identify, in both groups, the potential variables correlated to preventive medicine adherence, including the influence of the Covid-19 pandemic. Considering that at 18 years of age the subjects have already received the mandatory and recommended vaccines provided by the vaccine calendar for childhood and adolescence, and that the first institutional screening campaign (pap-test) starts from 25 years of age, the latter was considered as the minimum age of enrolment in the study. The enrolment of patients will be carried out on all macro-areas considered by the ONS in order to take into account the geographical differences present on the Italian Country. As previously mentioned, in fact, the coverage of screening campaigns and the adherence to them is lower in the South than in Central and Northern Italy. The study will be carried out in two phases. A first phase consisting in a cross-sectional study to describe the adherence to medicine preventive of PwMS and a second phase, where a case-control study will be used to investigate differences in preventive medicine adherence between PwMS and PwoMS. Phase 1 - Cross-sectional study Aim The specific aim will be to describe the adherence to medicine preventive of PwMS. Moreover, the investigators will evaluate variables which could affect the adherence to preventive medicine (screening and vaccines), such as sex, age, residence, nationality, education level, occupation, socio-economic status, quality of life, lifestyle (alcohol, smoke and BMI), MS forms, degree of MS-related disability and presence of chronic comorbidities. The possible impact of the ongoing Covid-19 pandemic will also be explored. Phase 2 - Case-Control study Aim The specific aim will be to evaluate compliance rates for main screening tests and vaccines between PwMS and PwoMS and to investigate any differences in preventive medicine adherence between 2 groups. The investigators will use the same variables considered in the first phase of the study to evaluate the real impact of MS and disability level in the access/adherence of preventive measures, controlling for potentially confounding factors. RESEARCH PLAN AND METHODS Phase 1 - Cross-sectional study Methods Design and sample The study design will be a multicentric cross-sectional. Participants will be recruited in the study among PwMS attending the medium-large sized MS clinical centres, rehabilitation units or among PwMS in contact with the Italian Multiple Sclerosis Association (AISM). In the first two cases the subjects will be enrolled consecutively during ambulatory activities and in the third case the subjects will be randomly selected from the list of AISM's members. Healthcare workers/research assistants, trained for the purpose, will present the project to patients during enrolment. Subjects who give their consent to participate will be contacted by research assistants for a phone interview. Data collection Subjects will complete an anonymous questionnaire combining socio-demographic, clinical and medicine preventive-related information and three scales validated in Italian, as described above. Two questionnaire form will be developed to take in account the sex difference (i.e. specific preventive screening such as mammography or prostate screening). In particular, collected data will be: - self-reported socio-demographic characteristics: age, sex, citizenship (if the interviewees are not Italian, the investigators will ask when they moved to Italy), province of birth, province of residence, level of education, marital status, employment status, income; - self-reported clinical characteristics and lifestyle: year of onset and diagnosis of MS, type of course, presence of comorbidities, BMI, smoking and drinking use; - self-reported preventive medicine-related information: main health screening (mammography and cervical screening -only for women-, colorectal screening, control of moles, blood pressure, cholesterol and blood sugar levels, bone density); main vaccines (dose booster of diphtheria/tetanus or diphtheria/tetanus/pertussis, the flu vaccine, the immunization status against rubella and chickenpox, the vaccine against HPV (Human papillomavirus, hepatitis B, meningococcus B, C and ACYW135, measles, pneumococcus and Herpes Zoster); - level of disability: Self-Expanded Disability Status Scale (self-EDSS) will be used to measure subjects' level of disability. It is a descriptive scale derived from the original EDSS and also from the patient-assessed Patient Determined Disease Steps (PDDS). A recent evaluation of the feasibility and reliability of self-assessed EDSS has found it acceptable; - level of independence in daily activities: Activities of Daily Living (ADL) Katz scale measures the ability of an individual to perform activities required in daily living. ADL scale consists of following six items: (1) bathing, (2) dressing, (3) transferring, (4) going to the toilet, (5) continence and (6) feeding. The total Katz ADL score indicates the degree of dependency. The range of the total score per item level is 1-4, with higher scores indicating a higher level of dependency: (1) independent, (2) requires some assistance, (3) requires full assistance and (4) completely dependent. - quality of life: Eq-5D-3L will be used to measure the quality of life. The EQ(EuroQol)-5D-3L consists of two sections. In the first part, the descriptive system includes five single item dimensions of health (mobility, self-care, usual activities, pain/discomfort and anxiety/depression). Each dimension is measured on a 3-point scale, and a single weighted score -the utility index- is obtained from these five questions. This score lies on a scale in which full health has a value of 1 and death has a value of 0, although negative values are allowed. In addition, specific questions will ask if the MS disease or pandemic impact on access on preventive medicine. Ethical considerations Informed consent Eligible subjects will consent to participate after reading information about the study and what participation would entail and after providing written informed consent, by personally signing and dating the document. It will not be possible to proceed with the compilation of the questionnaire if consent is not provided. Confidentiality The participation in the study is anonymous. The investigators must assure anonymity to enrolled subjects. For this reason, the documents sent to the coordinating Centre will be associated only with a number code identifying the patient and a letter code identifying the Center. However, the investigators of each Center must archive the listing of the identities of patients involved in the study. Statistical methods Calculation of the sample size The sample size calculation will be based on the prevalence of colorectal screening. A sample size will be estimated to ensure the recruitment of a sufficiently large number of participants stratified by geographical areas, to obtain statistically significant data. Assuming that the prevalence of colorectal screening in MS population is similar to that observed in a disable population given the chosen of margin error (5%), confidence interval (95%), assuming a 20% drop-out rate, it will be necessary an approximate population size of 1250 individuals. In particular sample size will consist of 460 persons resident in North, 460 in Centre and 330 in South Italy. Analysis Descriptive statistics including means, frequencies and percentages will be used to analyze data. Frequencies will be used to describe screenings and/or vaccinations performed. To evaluate the variables correlated to probability to carry out preventive medicine, Chi-square and Fisher's exact tests will be used to assess for significance between categorical variables, whereas continuous ones will be analyzed using independent t-tests and ANOVA. Independent variables, resulting as significant (p <0.20) in the univariate analyses, will be included in multivariate models to determine the association between potential predictors and preventive medicine related outcomes (screening or vaccines). Preventive medicine related outcome will be dichotomized taking the value of 1 for receipt of the service and 0 for not having received the service. Separate multivariate logistic regression models will be built to generate odds ratios (ORs) and 95% confidence intervals (CIs) for each preventive health service. . Phase 2 - Case-Control study (phase 1) Methods Design and sample The study design will be a multicentric matched case-control study (phase 1). The case and control subjects will be 1:1 matched to age, sex and residence area. Case subjects will be PwMS enrolled consecutively among the subjects participating in phase 1 of the study. Control subjects will be PwoMS volunteers. Control subjects will be enrolled among friends or neighbours of the cases. According to DL 15.07.1997, art 1.61, the enrolment of controls will not include vulnerable subjects, whose decision to volunteer in this project may be improperly influenced by the expectation, whether justified or not, of benefits associated with participation, or of possible retaliatory action by hierarchically superior individuals if they refuse to participate. Examples include members of hierarchically structured groups, such as medical, pharmacy, dental or nursing school students, subordinate hospital and laboratory staff, employees of a pharmaceutical industry, members of the armed forces, and prisoners. Other vulnerable individuals may include: patients with incurable diseases, persons housed in nursing homes, indigent persons, patients in emergency situations, ethnic minorities, homeless persons, nomads, refugees, minors, and persons incapable of giving consent. In addition, according to DL 24.0.2003 n 211, art 1, it is forbidden to offer, give or request financial incentives or benefits for the participation of the subjects in the study. Data collection Control subjects will complete the same anonymous questionnaire combining socio-demographic, clinical (i.e. presence of comorbidity), lifestyle and medicine preventive-related information and some validated scales in Italian (see section Data collection in Phase 1 of the protocol). In the same way as the cases, data regarding control subjects will be collected using a questionnaire that will completed during a telephone interview conducted by a research assistant trained ad hoc for the purpose. Ethical considerations Informed consent Eligible case and control subjects may only be included in the study after providing written informed consent, by personally signing and dating the written informed consent document. Informed consent must be obtained before any data collection. In particular, case patient's willingness to participate upon informed consent will be subsequently followed by a request for names and contact information of two friends/neighbours. Control subjects have to be similar in age (within 5 years), sex and city of residence to the case patient. Case patients will be asked to contact their respective controls first and then to provide the potential controls' name and contact information once the potential control will have given their permission in study participation. The investigators will attempt to recruit and interview each friend/neighbour for whom the investigators will obtain contact information and written informed consent. Confidentiality The participation in the study is anonymous. The investigators must assure anonymity to enrolled subjects. For this reason, the documents sent to the coordinating Centre will be associated only with a number code identifying the patient and a letter code identifying the Center. However, the investigators of each Center must archive the listing of the identities of patients involved in the study. Controls' questionnaire will have the same case code followed by the letter C. Statistical methods Calculation of the sample size For the case-control study, the sample size will be calculated using the method described by Dupont. The sample size will be calculated with a power of 80% and two-sided confidence level of 95%. The expected compliance rates for screening of colorectal cancer will be considered as approximately 45% and 33% respectively in control and case group. The sample size was calculated to detect a minimum OR of 0.60. For a matched case-control study at a case to control ratio of 1:1, the required sample size will be 256 pairs of cases and controls. Assuming a 15% drop-out rate, 300 cases and 300 matched controls will be enrolled. Analysis Descriptive statistics including means, frequencies and percentages will be used to analyze the data. Success of matching will be tested by comparing data between groups. For this purpose and to identify differences between groups in medicine preventive-related data, tests for matched pairs were used. Paired t- or Wilcoxon signed rank sum test (as appropriate) will be used for continuous data, while McNemar's or the Stuart-Maxwell test (as appropriate) for categorical data. Multivariable conditional logistic regression models, controlling for potentially confounding factors, will be used to compare preventive medicine adherence between the two groups. All statistical tests will be 2-sided, and p<0.05 will be considered statistically significant. Analyses will be performed using Stata software, Version 15 (Stata Corp, College Station, Texas).
Phase
N/ASpan
104 weeksSponsor
University of SienaFermo
Recruiting
Healthy Volunteers