Socialization for Frailty

Phase-Based Estimates
3
Effectiveness
3
Safety
McMaster University - St. Peter's Hospital, Hamilton, Canada
Frailty
Socialization - Behavioral
Eligibility
65+
All Sexes
Eligible conditions
Frailty

Study Summary

This study is evaluating whether a program of rehabilitation can improve physical function in frail older adults.

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Treatment Effectiveness

Effectiveness Estimate

3 of 3
This is better than 93% of similar trials

Study Objectives

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.

Baseline and 4-months
Change in Balance Confidence
Change in Basic Activities of Daily Living
Change in Cognition
Change in Depression / Mood
Change in Falls
Change in Fear of Falling
Change in Fitness
Change in Frailty
Change in Functional Mobility
Change in Health-related Quality of Life
Change in Instrumental Activities of Daily Living
Change in Life Space Mobility
Change in Muscle Mass
Change in Nutrition
Change in Physical Performance
Change in Sarcopenia
Change in Strength
Change in Walking Speed
Baseline, 4-months and additional 6-month follow-up
Change in Emergency Room Visits
Change in Hospitalizations
Change in Institutionalization
Individual-level Economic Evaluation

Trial Safety

Safety Estimate

3 of 3
This is better than 85% of similar trials

Trial Design

4 Treatment Groups

No Control Group
Arm1.Socialization

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.

Arm1.SocializationParticipants will attend twice-weekly classes (one-hour each) at the YMCA led by an experienced instructor and volunteers who will help facilitate social interactions. Sessions will include structured social activities (such as icebreakers and cards) and guest speakers with topics relevant to seniors. Light refreshments will be served at each session.
Arm1.ControlParticipants randomized to the control arm will not receive any of the Frailty Rehabilitation Interventions. Participants in the control arm will receive Vitamin D.
Arm3.Multi-modal InterventionGroup Exercise/Supplemental Home Exercise: This will be delivered identically to Arm 2. Nutrition, protein supplementation, and a medication review will also be implemented.
Arm2.Group ExerciseParticipants will attend the exercise program, twice-weekly, for 4-months with supplemental home exercise.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Protein Supplement
2009
N/A
~80
Vitamin D
2013
Completed Phase 4
~28970
Socialization
2020
N/A
~70

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: baseline, 4-months and additional 6-month follow-up
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly baseline, 4-months and additional 6-month follow-up for reporting.

Closest Location

McMaster University - St. Peter's Hospital - Hamilton, Canada

Eligibility Criteria

This trial is for patients born any sex aged 65 and older. There are 6 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
You are fully vaccinated against COVID-19 and you have proof of identification. show original
You are community-dwelling. show original
Able to independently ambulate 25m with or without walking aid
At high risk for mobility disability/functional limitations
Received medical clearance
Can arrange transportation to the YMCA up to 2x/week

Patient Q&A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Can frailty be cured?

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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.

Unverified Answer

What causes frailty?

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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.

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What are common treatments for frailty?

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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.

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How many people get frailty a year in the United States?

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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.

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What is frailty?

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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.

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What are the signs of frailty?

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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.

Unverified Answer

What does socialization usually treat?

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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.

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Is socialization typically used in combination with any other treatments?

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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.

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Does socialization improve quality of life for those with frailty?

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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.

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Who should consider clinical trials for frailty?

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[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.

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How does socialization work?

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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.

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What is the primary cause of frailty?

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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.

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