An Interventional Study of Geriatric Frailty, Osteoporosis, and Depression

This study has been completed.
Sponsor:
Collaborator:
National Taiwan University Hospital
Information provided by (Responsible Party):
National Health Research Institutes, Taiwan
ClinicalTrials.gov Identifier:
NCT00718432
First received: July 16, 2008
Last updated: June 24, 2015
Last verified: June 2009
  Purpose

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.


Condition Intervention
Frailty
Osteoporosis
Depression
Behavioral: Exercise and nutritional integrated care
Behavioral: Usual care with education
Behavioral: Problem solving therapy (PST) integrated care

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Interventional Study of Geriatric Frailty, Osteoporosis, and Depression in a Community Based Randomized Trial.

Resource links provided by NLM:


Further study details as provided by National Health Research Institutes, Taiwan:

Primary Outcome Measures:
  • improvement of frailty [ Time Frame: baseline, 3, 6, and 12 months ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Bone Mineral Density [ Time Frame: baseline and 12 months ] [ Designated as safety issue: No ]
    Dual-emission X-ray absorptiometry (DXA) of both Hip and spine

  • quality of life assessment [ Time Frame: pilot study: baseline, 3, 6, and 12 months, 2009 study: baseline, 6, and 12 months ] [ Designated as safety issue: No ]
    EQ-5D index-Taiwan utility

  • QUALEFFO_31 [ Time Frame: pilot study: baseline, 3, 6, and 12 months, 2009 study: baseline, 6, and 12 months ] [ Designated as safety issue: No ]
    pain, physical function,mental function

  • barthel index [ Time Frame: pilot study: baseline, 3, 6, and 12 months, 2009 study: baseline and 12 months ] [ Designated as safety issue: No ]
  • PRIME-MD (only measured in pilot study) [ Time Frame: baseline, 3, 6, and 12 months ] [ Designated as safety issue: No ]
    The Primary Care Evaluation of Mental Disorders

  • BDI-II (only measured in 2009 study) [ Time Frame: baseline, 6, and 12 months ] [ Designated as safety issue: No ]
    Beck Depression Inventory Second Edition

  • health-resource utilization [ Time Frame: pilot study: baseline, 3, 6, and 12 months, 2009 study: baseline, 6, and 12 months ] [ Designated as safety issue: No ]
  • Original Frailty Indicators [ Time Frame: baseline, 3, 6, and 12 months ] [ Designated as safety issue: No ]
    Weight loss, Exhaustion, Low level physical activity, Slow walking speed, Weak grip strength

  • timed up and go [ Time Frame: baseline, 3, 6, and 12 months ] [ Designated as safety issue: No ]
  • one leg stand time [ Time Frame: baseline, 3, 6, and 12 months ] [ Designated as safety issue: No ]
  • dominant hand grip strength [ Time Frame: baseline, 3, 6, and 12 months ] [ Designated as safety issue: No ]
  • dominant knee extension power [ Time Frame: baseline, 3, 6, and 12 months ] [ Designated as safety issue: No ]
  • vitamin B12 in blood [ Time Frame: pilot study: baseline and 12 month, 2009 study: baseline and 6 months ] [ Designated as safety issue: No ]
  • vitamin D in blood [ Time Frame: pilot study: baseline and 12 month, 2009 study: baseline and 6 months ] [ Designated as safety issue: No ]
  • CRP in blood [ Time Frame: pilot study: baseline and 12 month, 2009 study: baseline and 6 months ] [ Designated as safety issue: No ]
  • testosterone in blood [ Time Frame: pilot study: baseline and 12 month, 2009 study: baseline and 6 months ] [ Designated as safety issue: No ]
  • IL-6 in blood [ Time Frame: pilot study: baseline and 12 month, 2009 study: baseline and 6 months ] [ Designated as safety issue: No ]

Enrollment: 406
Study Start Date: April 2008
Study Completion Date: December 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: UC group
Usual care with education
Behavioral: Usual care with education
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.
Experimental: ENIC group (IC group in 2009 study)
Exercise and nutritional integrated care
Behavioral: Exercise and nutritional integrated care
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.
Experimental: PSTIC group (IC group in 2009 study)
Problem solving therapy integrated care
Behavioral: Problem solving therapy (PST) integrated care
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.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   65 Years to 79 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00718432

Locations
Taiwan
National Health Research Institutes
Zhunan, Taiwan
Sponsors and Collaborators
National Health Research Institutes, Taiwan
National Taiwan University Hospital
Investigators
Study Chair: Ken N Kuo, M.D. Natoinal Health Research Institutes
Principal Investigator: 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
  More Information

No publications provided

Responsible Party: National Health Research Institutes, Taiwan
ClinicalTrials.gov Identifier: NCT00718432     History of Changes
Other Study ID Numbers: EC0970301
Study First Received: July 16, 2008
Last Updated: June 24, 2015
Health Authority: Taiwan: Department of Health

Keywords provided by National Health Research Institutes, Taiwan:
Frailty
Osteoporosis
Depression

Additional relevant MeSH terms:
Depression
Depressive Disorder
Osteoporosis
Behavioral Symptoms
Bone Diseases
Bone Diseases, Metabolic
Mental Disorders
Mood Disorders
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on August 27, 2015