Frailty | An Interventional Study of Geriatric Frailty, Osteoporosis, and Depression
Frailty research study
What is the primary objective of this study?
Frailty, osteoporosis, and depression are three highly prevalent geriatric syndromes. Having these conditions are associated with adverse outcome in physical health, mental health, quality of life, and daily functioning. They are associated with higher mortality rates as well as increased health care cost. Risk factors, pathogenesis, clinical phenotypes, and interventions of these three geriatric syndromes are often related. Frailty is often defined as accumulations of multi-system deficiencies with increased vulnerability to multiple worse outcomes. Multifactorial, interdisciplinary integrated care models targeting frail older adults may have positive impacts on measurements associated with not only frailty, but also depression, or osteoporosis. The objective of this proposed study is to conduct a randomized control trial (RCT) to exam the effectiveness of integrated interventions on multiple outcomes among community-dwelling Taiwanese elders with high risks for frailty and/or osteoporosis, depression. We also plan to determine the differential effects of intervention between urban and rural area.
Who is eligible to participate?
Inclusion Criteria: - Scored 3-6 with the \"Canadian Study of Health and Aging Clinical Frailty Scale (CSHA- CFS) Chinese Telephone Interview Version\" (Telephone Interview Version is replaced by In-Person Interview Version in 2009 study) - Frailty index ≥ 1 Exclusion criteria: - Nursing home residents - Cannot speak any of the following three dialogues: Mandarin, Taiwanese and Haga - Hearing impairment interfering with communication or daily activities - Visual impairment interfering with communication or daily activities. - Cannot complete the screening instrument with the CSHA-CFS Chinese Telephone/In-Person Interview Version - Scored 1, 2, or 7 with the CSHA-CFS Chinese Telephone/In-Person Interview Version - Cognitive impairment defined as 3-item recall ≤ 1 - Functional Impairment defined as not able to walk for 5 meters without assistance - Suicidal Ideation defined as Suicide Subscale of The Mini-International Neuropsychiatric Interview (M.I.N.I.) ≥ 6 - Alcohol abuse disorders active within the last year. (score ≥ 2 on the CAGE) - Organic mental disorders (Seizure, brain tumor, brain surgeries), History of schizophrenia or bipolar diagnosed from psychiatrist
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Behavioral:Exercise and nutritional integrated careBesides the information sharing and the educational booklets, the ENIC group subjects are invited to take a structured exercise course at the participating hospital 3 times a week for 3 months. (twice a week for 24 weeks in 2009 study) The exercise program included warm up; a range of motion, stretching, and postural-correction activities; aerobic strengthening; balance; and cool down. The research team also inquired about the subjects' dietary compliance and responded to their dietary questions during the exercise sessions.
Behavioral:Usual care with educationThe study educational booklet (plus CD-ROM in 2009 study) on frailty, depression, osteoporosis, healthy diets, exercise protocols, and coping strategies are given to the participants. UC group subjects will receive a 2-hour education based on the content of study booklet including 1-hour demonstration of study exercise program in 2009 study. Subjects are contacted monthly (bimonthly in 2009 study ) for frequencies of reading this booklet and the compliance on the suggested diet and exercise protocols. Subjects are also encouraged to follow with their primary care physicians for abnormal results identified from our assessments.
Behavioral:Problem solving therapy (PST) integrated careBesides the information sharing and the educational booklets, the PSTIC group subjects will receive 6 sessions of PST (within 12 weeks in pilot study, within 24 weeks in 2009 study) aiming at solving the 'here-and-now' problems contributing to their mood-related condition and helps increase their self-efficacy. If major depressions are found, subjects are referred to their primary care physicians for further medical managements.
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
UC groupUsual care with education
ENIC group (IC group in 2009 study)Exercise and nutritional integrated care
PSTIC group (IC group in 2009 study)Problem solving therapy integrated care
Start Date: April 2008
Completed Date: December 2010
Primary Outcome: improvement of frailty
Secondary Outcome: Bone Mineral Density
Study sponsors, principal investigator, and references
Principal Investigator: Ken N Kuo, M.D.
Lead Sponsor: National Health Research Institutes, Taiwan
Collaborator: National Taiwan University Hospital