An Interventional Study of Geriatric Frailty, Osteoporosis, and Depression

NCT00718432 | Completed DMC

• 1 other identifier: EC0970301
• Study Type: interventional
• Target: 406
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Frailty; Osteoporosis; Depression

Keywords

Frailty; Osteoporosis; Depression

Outcome Measures

Primary Outcomes (1)

• improvement of frailty

  Improvement of Cardiovascular Health Study Phenotypical Classification of Frailty (CHS\_PCF) by at least one category (from pre-frail to robust, or from frail to pre-frail or robust) from baseline assessments.

  baseline, 3, 6, and 12 months

Secondary Outcomes (17)

• Bone Mineral Density

  baseline and 12 months

• quality of life assessment

  pilot study: baseline, 3, 6, and 12 months, 2009 study: baseline, 6, and 12 months

• QUALEFFO_31

  pilot study: baseline, 3, 6, and 12 months, 2009 study: baseline, 6, and 12 months

• barthel index

  pilot study: baseline, 3, 6, and 12 months, 2009 study: baseline and 12 months

• PRIME-MD (only measured in pilot study)

  baseline, 3, 6, and 12 months

Study Arms (3)

UC group

ACTIVE COMPARATOR

Usual care with education

Behavioral: Usual care with education

ENIC group (IC group in 2009 study)

EXPERIMENTAL

Exercise and nutritional integrated care

Behavioral: Exercise and nutritional integrated care

PSTIC group (IC group in 2009 study)

EXPERIMENTAL

Problem solving therapy integrated care

Behavioral: Problem solving therapy (PST) integrated care

Interventions

Exercise and nutritional integrated care BEHAVIORAL

Besides 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.

ENIC group (IC group in 2009 study)

Usual care with education BEHAVIORAL

The 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.

UC group

Problem solving therapy (PST) integrated care BEHAVIORAL

Besides 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.

PSTIC group (IC group in 2009 study)

Eligibility Criteria

• Age: 65 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Health Research Institutes, Taiwan: lead
• National Taiwan University Hospital: collaborator

Study Sites (1)

National Health Research Institutes

Zhunan, Taiwan

Location

Related Publications (1)

• Chan DC, Tsou HH, Yang RS, Tsauo JY, Chen CY, Hsiung CA, Kuo KN. A pilot randomized controlled trial to improve geriatric frailty. BMC Geriatr. 2012 Sep 25;12:58. doi: 10.1186/1471-2318-12-58.

  PMID: 23009149 DERIVED

MeSH Terms

Conditions

Frailty; Osteoporosis; Depression

Interventions

Exercise; Educational Status

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Socioeconomic Factors; Population Characteristics

Study Officials

• Ken N Kuo, M.D.

  Natoinal Health Research Institutes

  STUDY CHAIR

• Ching-Yu Chen, M.D.

  Natoinal Health Research Institutes

  PRINCIPAL INVESTIGATOR

• Rong-Sen Yang, M.D.

  Natoinal Health Research Institutes

  PRINCIPAL INVESTIGATOR

• Keh-Ming Lin, M.D.

  Natoinal Health Research Institutes

  PRINCIPAL INVESTIGATOR

• Chao Agnes Hsiung, M.D.

  Natoinal Health Research Institutes

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 16, 2008
• First Posted: July 18, 2008
• Study Start: April 1, 2008
• Primary Completion: June 1, 2010
• Study Completion: December 1, 2010
• Last Updated: June 25, 2015

Record last verified: 2009-06

Locations

TW (1)