Clinical Research Directory

Elderly Care in Transition - Perspectives of the Elderly and the Staff

Elderly care in Sweden faces several significant challenges. The number of older people is increasing at the same time as there are fewer of working age. Elderly care staff, such as nurses, care assistants and nurses, have on average more sick days than many other professional groups and often experience high work-related stress. In some municipalities, there are also problems with high staff turnover and a lack of formal competence. At the same time, research shows that many employees experience work in elderly care as meaningful and valuable. Taking advantage of and strengthening these positive aspects is central to creating good conditions for the health and well-being of staff and for the quality of care and care for older people. An important area of development in elderly care is person-centred care, which means that care is based on the individual person's needs, wishes, life history and resources. Person-centred practice emphasises the relationship between the older person, the staff and, if the person so wishes, relatives. Although person-centered care is often seen as an obvious part of good care, research shows that it is not fully implemented in practice and that the introduction of person-centered working methods can be complex and demanding. This study is being carried out in collaboration between municipalities and the University of Gävle and is linked to the establishment of nursing homes for the elderly that will function as academic nursing homes. In these nursing homes, person-centered care will be a pronounced focus area. Through recurring measurements, the activities will be monitored and developed in close collaboration between practice and research. The overall aim of the study is to investigate older people's experience of academic nursing homes with a focus on person-centered care and nursing, outdoor environment, health and well-being, and to investigate the staff's experience of person-centered working methods, learning, structural conditions and work-related well-being. The study also aims to analyze the relationship between older people's experiences of person-centered care, outdoor environment, health and well-being, both among older people living in academic nursing homes and among older people living in their own homes. The study has a longitudinal design and data will be collected at several points in time using questionnaires and interviews, which enables both statistical analyses and an in-depth understanding of the participants' experiences over time. By highlighting the perspectives of both older people and staff, the study can contribute new knowledge about how person-centered care can be developed and maintained in practice. In the long term, the results can contribute to a more health-promoting, sustainable and attractive elderly care for both older people and staff.

Exploring the Acute and Dynamic Relationships Between Movement and Pain in Older Adults With Musculoskeletal Pain

The purpose of this research study is to evaluate the effect of brief bouts of intermittent walking on bodily pain, pain during movement, and how the body adapts to musculoskeletal pain in older adults.

Hemodiafiltration Versus Hemodialysis in Older People

This study will compare the impact of two hemodialysis techniques on fatigue and post-dialysis recovery time in patients aged 85 years and older. These two techniques are high-flux hemodialysis (HD) and hemodiafiltration (HDF). Patients will receive the treatment over two periods: if period 1 is HD then period 2 will be HDF. Every patient will be his/her own control, this is why it is called cross-over. Each period will last three months. Between the two periods, patients will receive a traditional low-flux hemodialysis. These two techniques are widely used worldwide and their side-effects are well-known and do not put the patients at risk. HDF has been shown to improve survival in patients with a mean age of 58 years. But a previous study from the investigators' group showed that HDF causes a prolonged recovery time in older patients. This randomized trial aims to elucidate this question.

Optimal Timing of Computerized Cognitive Training for Older Intensive Care Unit Survivors

More than 60% of intensive care unit (ICU) patients are adults ages 60 and older, who are at high risk for ICU-acquired cognitive impairment. After ICU discharge, ICU survivors often experience sleep disturbances and inactivity, and almost 80% of ICU patients experience disturbances in circadian rhythm, which may affect cognitive function. Understanding the optimal, chronotherapeutic timing of cognitive interventions is crucial to promote circadian realignment and cognitive function, and may improve intervention feasibility, acceptability, and efficacy. Specific Aim 1 will determine feasibility, acceptability, and preliminary effect sizes for: 1) a morning session of a computerized cognitive training intervention \[COG\]; and 2) a late afternoon/early evening session of the COG intervention; compared to 3) standard inpatient care/usual care \[UC\]. Specific Aim 2 will examine circadian rhythm parameters to determine the optimal timing of the daily COG intervention. Exploratory Aim 3 will explore if the effects of the COG intervention on cognitive function are mediated by daytime activity, and explore if selected biological and clinical factors moderate intervention effects on cognitive function.

Multicomponent Training Combined With Multi-professional Intervention Health Status in Hypertensive and Normotensive Older Women

Objective: The objective of this study was to analyze the effects of multicomponent training (MCT) combined with multidisciplinary intervention (nutritional and psychoeducation) on body composition, biochemical markers, and physical performance in hypertensive and normotensive older women. Methods: This longitudinal study included 40 hypertensive and normotensive older women. These older women performed MCT for 36 weeks, during which parameters associated with health status were evaluated (body composition: body fat, fat-free mass; cardiovascular variables: systolic blood pressure (SPBP), diastolic blood pressure (DBP); biochemical markers: glucose, LDL-cholesterol, HDL-cholesterol, total cholesterol, triglycerides; physical performance: arm curl, maximal isometric handgrip strength (MIHS), 30-second chair stand, 6-meter walking test (6MWT), and Timed Up and Go (TUG)). at four time points: baseline (T0), 12 weeks (T1), 24 weeks (T2), and 36 weeks (T3). A two-way mixed analysis of variance with repeated measures was performed.

Efficacy of Trazodone to Treat Insomnia in Older Adults (TRADITION Study)

This study aims to evaluate how effective trazodone is in treating insomnia in adults aged 65 years and older. The main question it aims to answer is : \- Is trazodone more effective than a placebo in reducing the severity of insomnia symptoms in older adults? Participants will : * Take 25 to 50 mg of trazodone or a matching placebo before bed for 28 days. After a 2-week break, they will then take the other medication for another 28 days. * Visit the clinic three times for checkup and test * Complete a sleep diary and wear an actimeter during the night.

Efficacy and Safety of Conventional Neoadjuvant Therapy Versus Total Neoadjuvant Therapy in Older Patients With Locally Advanced Rectal Cancer

The SHAPERS study is a multicentre, open-label, randomised, pragmatic clinical trial, comparing standard-of-care neoadjuvant treatment options for older (i.e., ≥70 years) subjects with high-risk stage II and stage III rectal cancer.

AquaReBal - Aquatic Reactive Balance Training for Older Adults

Falls are the second leading cause of accidental injury deaths worldwide, mostly in older adults. Injuries resulting from a fall are a leading cause of hospitalizations among older adults in Canada with a higher total injury cost than any other cause of injury. People must often perform rapid and complex movements to keep from falling. Reactive balance training (RBT) is a type of training that focuses on improving an individual's ability to perform those types of movements and respond to unexpected or sudden changes. RBT and aquatic therapy were identified as a research priority for fall prevention. There is evidence that RBT reduces the rate of falls by a half in daily life and improvements in reactive balance are maintained up to a year after the end of the program. When RBT is conducted on land, some adverse events such as fear of falling and joint pain may occur. The water environment could minimize the limitations and barriers associated with land-based RBT. To date, there are no studies showing the effects of water-based RBT on reactive balance control in older adults.The study aims to explore if water-based RBT is a practical intervention to reduce the number of falls in older adults. Older adults will be recruited from the Greater Toronto Area. They will receive training 2 times per week for 6 weeks. The main practical factors around the intervention, such as how participants adhere to the treatment and how they accept the intervention will be measured. It will be assessed how the water-based and land-based RBT affects falls, balance, mobility and quality of life. With this study, the aim is to inform the way for a larger study targeting falls - one of the biggest problems among older adults.

Probiotics and Active Aging: Enhancing Gut Health

The general objective of this clinical trial is to assess the physical fitness and gut microbiota of older adults, thereby highlighting the importance of focusing on health maintenance. By making use of available resources and fostering collaboration among the elements involved in the study, more specific objectives can be defined: 1. To determine the state of the gut flora in older adults through the analysis of the intestinal microbiota. 2. To identify changes in the intestinal microbiota resulting from the intake of probiotics in older adults. 3. To evaluate the effects of the intestinal microbiota in older adults participating in a training programme. 4. To assess the physical fitness and perceived quality of life in older adults who engage in sport activities supported by technology. Participants will: * Perform physical tests such as the 6-Minute Walk Test (6MWT), the Timed Up and Go (TUG), and the Sit-to-Stand test. * Complete wellbeing questionnaires to assess their perceived quality of life and health status. * Complete dietary habit questionnaires. * Provide stool samples for microbiota analysis. * Take part in exercise interventions or placebo exercise sessions, depending on their assigned group.

Carbon Ion Radiotherapy for Locally Advanced Lung Cancer in Elderly Patients

To observe the effect and toxicity of carbon ion radiotherapy on local advanced non-small cell lung cancer over 75 years old patients. Systemic therapy could be targeted therapy, chemotherapy or immunotherapy.

The Effect of Nature and Game Based Activities on Older People

The purpose of this study is determine the effect of nature and game based activities on happiness, spiritual well-being, frailty and cognitive status of older people in nursing home. Hypotheses of the Research H0: Nature and game-based activities don't affect the happiness, spiritual well-being, cognitive function and frailty of older people in nursing home. H1a: Happiness levels of older people in nursing home will be an increase after nature and game-based activities. H1b: Spiritual well-being levels of older people in nursing home will be an increase after nature and game-based activities. H1c: Cognitive function levels of older people in nursing home will be an increase after nature and game-based activities. H1d: Frailty status of older people in nursing home will be a decrease after nature and game-based activities.

A Socio-Technological Intervention in Community-Based Healthcare for Individuals With Mild Cognitive Impairment (DHEAL-COM-MCI)

The objectives of the intervention are to counteract the progression of cognitive decline, enhance the intrinsic abilities of users and support the well-being of elderly people with mild cognitive impairment (MCI) through a socio-technical intervention that includes cognitive stimulation, technology and robotics.

Tele-Rehabilitation Intervention in Community-Based Healthcare for Patients With Osteoporosis (DHEAL-COM-OP)

The DHEAL-COM-OP study is characterized as a feasibility study. The general objective is to evaluate the improvement in the physical performance of patients with osteoporosis detected through the Performance-Oriented Mobility Assessment (POMA) scale, following a rehabilitation intervention integrated with the BTS TELEREHAB technology.

Tele-Rehabilitation Intervention in Community-Based Healthcare for Patients With Parkinson's Disease (DHEAL-COM-PD)

The study aims to measure the improvement in functional capacity in a group of elderly people suffering from early-stage Parkinson's disease (Hoehn \& Yahr scale 1-3), following a telerehabilitation intervention integrated with BTS TELEREHAB technology.

Planning for Frailty: Optimal Health and Social Care Workforce Organisation Using Demand-led Simulation Modelling

What is the present, and expected, size and composition of the health and social care workforce required to provide care for the frail older population? As the population ages, robust workforce planning to meet future demands for health and social care by older people is needed. A lack of evidence in this areas has led to a mis-match between the health and social care demand from the ageing population and the current workforce capacity. The proposed study will use demand-led simulation modelling of the workforce required to address the specific challenge of providing health and social care for the growing numbers of older people living with frailty.

The Effects of Moderate Intensity Cycle Ergometer vs. Treadmill Training on Physiological Resilience in Older Adults

Government guidelines suggest that we should all take part in approximately two and a half hours each week of moderate-intensity aerobic exercise. Older adults are particularly important as their overall health may decline as they get older. Therefore, exercising is important especially for older adults to improve heart and muscle health and functioning in carrying out tasks of daily living. The overall effects of aging on the body can make people less likely to withstand challenges to the body - this is termed 'resilience'. Although aerobic exercise is not super easy and requires continuity, it is not extremely difficult to get used to. However, we still do not know if some types of aerobic exercise are better for you than others at improving resilience. Therefore, this study will look at cycling vs walking to see if one is better at improving resilience in older adults who are 60-80 years old. You will be trained on either a treadmill or cycle ergometer and these exercise sessions will be done over 5 weeks, 3 days a week. Each session will last 40 minutes, start with warm-up and end with cool-down sessions. Assessments will include heart, lung, muscle, and memory and thinking measurements, all of which will be taken before and after the intervention period. This work will help us to better understand how we can improve exercise prescriptions for older adults to sustain their health and functioning in their daily life.

Geriatric Assessment at Discharge From the Intensive Care Unit in Patients Aged 75 Years and Older: a Feasibility Study

The number of patients aged over 75 continues to grow, and, according to INSEE, will represent almost 10% of the French population in 2021, an increase of 2.4 points since 2000. This demographic change is also observed in the intensive care units, where admitted patients aged over 80 represent now up to 10-20% of critical care admissions, depending on the facility. The admission of these patients remains controversial, with questions about the benefit to elderly patients, both in terms of in-hospital and distant survival, as well as induced morbidity or subsequent quality of life: functional status is impaired in up to two-thirds of survivors. The challenge of identifying the patients most able to withstand a stay is a major one. Indeed, a stay in intensive care represents a major stress for the organism, due to the acute condition associated with one or more organ failure(s). Bed rest, immobilization and the use of drugs are responsible for formidable complications in the elderly: muscle-wasting, loss of adaptation to physical effort, loss of autonomy, delirium and agitation, all of which have their own long-term impact. While many studies have looked at the prognostic factors on admission of these patients, and the selection of the patient with the greatest probability of surviving the intensive care unit (ICU), improving the outcome of patients who survive to the ICU stay remains a little-investigated subject. However, the impact of physical and psychological disturbances induced by these patients' stay in intensive care is major, and their detection and management could be elements of interest in improving the care of this population. However, the feasibility of carrying out such an assessment immediately after an ICU stay has yet to be evaluated. The aim of this study would be to evaluate the feasibility of a geriatric assessment at the end of the ICU stay (or within 7 days of discharge) and at 6 months. This study is a prospective, randomized, single-center, open-label interventional study.

Underprescribing in Geriatric Patients: a Prevalence Study and Analysis of Factors Contributing to Potential Prescription Omissions (Under-PRES)

This observational study will determine the prevalence of underprescription in a cohort of elderly patients, recruited at the time of an outpatient geriatric visit, or hospitalized, upon admission to a geriatric ward.

A Service-Learning Program for Comprehensive Geriatric Assessment and Health Promotion in Older Adults

The GEROS Project aims to develop and implement a Service-Learning (S-L) program that integrates Comprehensive Geriatric Assessment (CGA) and health promotion, for students at the Faculty of Health Sciences and Welfare at the University of Vic - Central University of Catalonia (UVic-UCC). This initiative engages university students, healthcare professionals, and older adults (60+) in a participatory, intergenerational approach that fosters mutual learning and community engagement. The study follows a non-experimental mixed-method design, involving students from Nursing, Physiotherapy, Human Nutrition and Dietetics, Occupational Therapy, and Psychology. Participants include older adults (60+) who can independently travel to the university. The project is integrated into different subjects, in groups of 4-5 students, participants conduct a Comprehensive Geriatric Assessment (CGA), evaluating frailty using VIG-Frail, intrinsic capacity with ICOPE, quality of life with EUROQOL 5D-5L, and specific health indicators with Nursing Outcomes Classification (NOC). To assess the program's effectiveness, several outcome measures will be analyzed including students' perceived knowledge, competencies, and skills, as well as older adults' awareness of their health status, lifestyle, and risk factors. Additionally, the satisfaction levels of both will be evaluated. The items will be evaluated using a 1-5 Likert Scale, and the analysis will be conducted with SPSS. Data recording will be carried out through REDCap. The GEROS Project aligns with the United Nations' Sustainable Development Goals (SDGs), specifically SDG 3 (Good Health and Well-being) and SDG 10 (Reduced Inequalities). By offering care to the aging population and providing them with personalized health recommendations, the project promotes preventive strategies, active aging, and intergenerational learning. Furthermore, GEROS integrates innovative educational methodologies, encouraging experiential learning, collaboration with healthcare professionals, and the development of practical skills in real-world contexts. The program's scalability and adaptability could serve as a model for other universities and healthcare institutions aiming to enhance geriatric care through service-learning initiatives.

Active aGeing And Personalised Service's Ecosystem (AGAPE) Aims to Implement an Advanced Technology Platform That Provides Services to the Elderly, Formal and Informal Caregivers, and Caregiving Organizations

AGAPE aims to implement an advanced technology platform that provides services to older adults, formal and informal caregivers, and caregiving organizations.

Comprehensive Approach to Reduce Elderly Functional Decline in Diabetes: the CARED Study

Importance. Conventionally, treatment goals for diabetic patients primarily target glycemic levels and traditional cardiovascular risk factors (blood pressure, lipids) control to reduce macro- and micro-vascular complications. More recently, the relevance of assessing functional status in older diabetic patients has emerged. A knowledge gap exists regarding the risk of functional dependency in older diabetic patients and on the impact of Comprehensive Geriatric Assessment (CGA) on the achievement of easily calculated and objective patient-centered outcomes. Objective To investigate if a personalized plan of care base on CGA would reduce the risk of functional decline over time in older patients with diabetes as compared to usual care Design. Individual patient randomized controlled trial comparing intervention with usual care. Setting. Three hospitals in Cagliari, Ferrara, and Milano, Italy. Participants. One-hundred and eighty diabetic patients aged ≥75 years. Intervention. Usual care for both the Control and Intervention groups will be assured by a diabetologist according to in-use guidelines. After randomization, a geriatrician will administer a thorough CGA to all participants allocated to the intervention groups. CGA will be used to identify specific treatment goals according to the functional status of the patient and to incorporate Patient-preferred outcome in the management of diabetes and comorbidities. Using the results of the CGA the geriatricians along with the attending diabetologist and additional healthcare professionals, if needed, will implement a personalized diagnostic and therapeutic plan of care. Participants in the Control group will receive no additional intervention over and above usual care. Follow-up. Follow-up visit will be scheduled at 6 and 12 months after randomization. Main outcome measures. The primary outcome will be represented by the change in physical performance, assessed by change in the Short Physical Performance Battery (SPPB) score over time. Secondary outcomes will be represented by change in cognitive function, sarcopenia, dependency, glycated hemoglobin levels, and rate of hospitalization as well as Time-at-home. Expected Results. The CGA-driven intervention applied to older diabetic patients will have significant benefits on functional outcomes as compared to usual care. Implications. Multimodal intervention in older diabetic patients will significantly impact on the ageing population and allow a novel process to be developed for interventions that produce the maximum disability-free life years lived combined with the highest quality of life for this vulnerable and often neglected group of adults.

Reablement in Residential Aged Care - a Randomized Controlled Trail

Background: The global increase in older adults presents challenges for maintaining health and autonomy in residential aged care (RAC) facilities, where passivity has been shown to often diminish quality of life. However, the reablement approach, which enhances independence through personalized, multidisciplinary strategies, shows promise for addressing these issues and requires further evaluation, particularly in Swedish contexts. The research project Reablement in RAC (Re-RAC) aims to evaluate the impact of the Re-RAC intervention on activity performance and satisfaction, participation, quality of life and well-being, and health economic outcomes for older adults in RAC facilities, while also describe participant and staff experiences. Methods: This study is a multi-center prospective pragmatic randomized controlled trial with two parallel groups that will evaluate the Re-RAC intervention compared to treatment as usual, using quantitative, qualitative and health economic methods. The Re-RAC intervention begins with an interview according to Canadian Occupational Performance Measure (COPM) to identify a meaningful goal, followed by a personalized support plan with training activities, supported by nursing staff. The intervention lasts 8 weeks, with adjustments made based on progress, and ends with a COPM reassessment of the participant's performance and satisfaction. Eighty-six participants will be included, assessed for performance (COPM-performance), satisfaction (COPM-satisfaction), health-related quality of life (EQ-5D-5L), psychological well-being (WHO-5), and physical activity levels (measured by an accelerometer), before and after the intervention. Pain will also be assessed for potential associations with other outcomes. Participants' and staff's experiences will be described through interviews, and cost-effectiveness will be evaluated by calculating the cost per quality adjusted life-years gained. Discussion: The Re-RAC project evaluates the impact of a reablement intervention on activity performance, satisfaction, quality of life, well-being, and health outcomes for older adults in RAC facilities through a pragmatic randomized controlled trial, with assessments before and after the 8-week intervention. The study also explores participant and staff experiences and evaluates cost-effectiveness. The results of this study will offer valuable insights to inform the future implementation and assessment of reablement interventions in RAC settings.

Impact of a Musical Intervention in Older Adults (ARA Project - Armonía Recreativa Para El Adulto Mayor)

Currently, the world is facing the challenge of population aging. At this stage of life, various deteriorations, such as cognitive decline, begin to appear, significantly impairing the quality of life. Therefore, it is imperative to seek interventions that can positively impact the life trajectory of older adults. While the cognitive benefits of musical interventions for children and young people are well-documented, there is a lack of evidence regarding their effects on the cognitive and socioemotional well-being of institutionalized older adults. To address this, the investigators will conduct a non-randomized clinical trial at Fundación Las Rosas, which operates various homes for the elderly. The trial will involve two groups: a control group and an experimental group. The control group will attend concerts held within the care facility, while the experimental group will participate in a music workshop once a week for three months. To evaluate the outcomes, cognitive and socioemotional assessments will be conducted at three points: prior to the musical intervention (baseline), at the end of the intervention period, and one month after the interventions conclude (follow-up). The results will provide valuable insights to support the development and implementation of cost-effective non-pharmacological interventions, specifically musical interventions, to promote well-being in older adults by demonstrating their applicability and effectiveness within the national context. By assessing the intervention's impact on both cognitive and socioemotional dimensions, this study will also contribute to a deeper understanding of how these skills can be developed and promoted among older adults.

Improved Prescribing for Older Nursing Home Patients

Research aim: To investigate the effect of training health care professionals in medication assessments on the medication use of nursing home residents with a limited life expectancy (\< 1.5-2 years). The core of the training is to tailor medication use to (palliative) treatment goals of nursing home residents. Design: A cluster randomized controlled trial on long term care wards in nursing homes, with the nursing home care organisations as unit of randomisation. The investigators intent to include 6 organisations and 450 nursing home patients. The research starts in september and lasts 1 year and 3 months. Eligible patients are nursing home patients of 65 years and older with a limited life expectancy (\< 1.5-2 year) of long term care wards. Intervention: The intervention includes a method in which healthcare professionals (medical practitioner, pharmacist and care worker) are trained to tailor medication to the (palliative) treatment goals of nursing home patients with a limited life expectancy. The training consists of 2 components: 1) medication assessment, and 2) advance care planning (ACP). In the intervention group, healthcare professionals receive the training in combination with supporting tools and educational materials, in the control group care continues as normal. The allocation ratio for control and intervention groups is 1:1. A process evaluation will take place simultaneously with the intervention study. Data collection takes place before the start of the intervention (T0), after 6 months (T1) and after 12 months (T2). Outcome measures: The primary outcome measure is potential under- and over-treatment with medication. The secondary outcome measure is experienced involvement in decision-making (measured with a short questionnaire based on the revised PATD (patients' attitude towards deprescribing)). Tertiary outcome measures are: quality of life, deaths, falls, hospital admissions/acute first aid referrals and pain. Discussion: The intervention is expected to result in a decrease in chronic and preventive medication prescriptions, an increase in medication for symptom treatment and more involvement (and satisfaction) of the nursing home resident in decision-making, without adverse effects.