This trial is evaluating whether Socialization will improve 2 primary outcomes, 19 secondary outcomes, and 1 other outcome in patients with Frailty. Measurement will happen over the course of Baseline and 4-months.
This trial requires 324 total participants across 4 different treatment groups
This trial involves 4 different treatments. Socialization is the primary treatment being studied. Participants will be divided into 4 treatment groups. There is no placebo group. The treatments being tested are in Phase 4 and have been shown to be safe and effective in humans.
Although frail patients had greater disability and lower life span than nonfrails, the association with disability, life span, or mortality was attenuated by increased physical activity independent of frailty. Even after adjustment for age, comorbidity, and disability, frailty is associated with increased mortality. Data from a recent study suggest that frailty can be improved in frail patients, with increased physical activity.
The most widely held belief that frailty is a function of age. However, there is evidence that it is not a function of age. Other potential causes include biology and lifestyles issues, but these are not necessarily fully understood, and the evidence supporting them is conflicting. It is likely that most determinants of frailty are combinations of many elements with minor effects.
The common treatments are based on the principle that frailty is the result of the additive effects of different risk factors. Frailty treatment often includes: multifactorial interventions, in which patients manage their risks (e.g. by diet, lifestyle changes) in combination with preventive therapies aimed at specific diseases (e.g. treatment of arthritis with analgesics); medication for specific risk factors (e.g. use of vasodilators for hypertension); and treatments aimed at specific diseases (e.g. treatment of hypercholesterolemia with statins). Treatment of diabetes type 2 with metformin may reduce the risk of cardiovascular morbidity and mortality for patients with frailty.
More than 3 million older adults (ages 65 years and over) in the United States are classified as frail in 2004. Those persons are more likely to experience adverse events in their daily lives and to die from complications within just six months of the age. In 2001, the oldest persons (85 and older) accounted for just 11 percent of the population, but more than 45 percent of deaths. Frailty has increased steadily over the past two decades.
Results from a recent clinical trial has revealed that the frailty index was a powerful predictor for a hospitalization due to an acute exacerbation of a chronic disease such as congestive heart failure or a chronic lung disease. This implies that the frailty index can help us to select patients who are at risk of an acute exacerbation of a chronic disease, and to identify high-risk patients who need careful medical surveillance and careful management of their disease.
Most people with frailty exhibit a combination of physical and cognitive signs of frailty. The frail older adults with the most symptoms of cognitive or physical dysfunction have the highest risk for all-cause mortality by a significant margin. Although the combination of cognitive and physical deficits most strongly predicts mortality, even the presence of one of these abnormalities alone is predictive of mortality by a significant margin, particularly in men. The combination of cognitive and physical deficits is the most predictive of all-cause mortality and can be used as an indicator of frailty severity and an indicator of the potential benefit of frailty-related interventions.
The findings suggest that the social support that can be provided to patients during end-of-life care is a core element of the intervention, and that this should therefore be a high priority intervention.
Participants were treated with a socialization intervention at a frequency appropriate to their level of functioning. Future studies should include an assessment of how socialization may act through the treatment of depression to promote greater social engagement among people with dementia and their carers.
Overall socialization was found to be associated with better QoL specifically at the group level. Frailty was positively associated with worse QoL at the individual level. Interventions may positively impact QoL and should aim at reducing frailty.
[Frailty (defined by the Gagne criteria) is an important criterion in clinical trials that include patients with disabilities. It also allows a better evaluation of patients' preferences towards clinical trials. As frailty is a reversible, dynamic process, early intervention must be aimed at restoring normal functions to maintain the independence and quality of life of frail patients. This paper emphasizes the importance of frailty in clinical trials and shows the benefit of using frail patients in clinical trials.
Interventions that focus on socialization during the hospital stay may improve the mental health and quality of life of the frail elderly patient. However, a larger multi-centered study is needed to explore a larger sample size of frail older adults, and to confirm these results.
Recent findings showed that frailty is [predominantly] associated with functional impairment and cognitive deficits. This may be related to comorbid conditions or to a reduction in physiological reserve resulting from multiple organ failure.