An Interventional Study of Geriatric Frailty, Osteoporosis, and Depression
Condition: Frailty; Osteoporosis; Depression
MeSH terms: Osteoporosis; Frailty; Depression; Depressive Disorder
Study type: Interventional

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.
    

Detailed description: 
      This is a three-year study. In the first year, we conducted a pilot study to test the
      feasibility of implementing integrated model on frailty, osteoporosis, depression, and other
      outcomes. Another objective is to determine optimal sample size for next level intervention
      in year 2 and 3 (2009 study).

      Subjects are community-dwelling Taiwanese elders (65-79 years of age) living in Toufen Town
      in Miaoli County, Taiwan. Subjects are first screened with telephone interviews with the
      Chinese Canadian Study of Health and Aging _Clinical Frailty Scale (CCSHA_CFS). Eligible
      subjects are invited to a community hospital to be screened with the Health Study Phenotypic
      Classification of Frailty (CHS_PCF). Subjects scored ≥ 1 on the CHS_PCF are enrolled. With a
      2 by 2 factorial design, subjects are first randomized into exercise/nutrition integrated
      care (ENIC) group and usual care (UC) group with education. Within each group, subjects are
      further randomized into problem solving therapy (PST) and usual care (UC) group with
      education by study care managers with pre-specified protocol. UC group subject received a
      study educational booklet with telephone follow up on compliance of booklet reading and
      suggested diet and exercise programs. Besides the booklets, ENIC group subjects received
      structured exercise 3 times/week with nutrition consultation as needed at hospital for 3
      months while PST group subjects received 6 sessions of PST at hospital in 3 months.

      Subjects were followed at 3, 6 and 12 months. Primary outcome is improvement of the CHS_PCF
      by at least one category (from pre-frail to robust, or from frail to pre-frail or robust)
      from baseline analysis. Secondary outcomes include the physical function and performance,
      cognition, depression, quality of life, healthcare resource utilizations and bone-mineral
      density (BMD). Intention-to-treat analysis was applied.

      The pilot study enrolled 117 subjects, after analysis of the preliminary results, the study
      protocol for the second and third year (2009 study) is modified as follows:

        1. The study is conducted at one urban (Wanhua) and one rural (Toufen) site with roughly
           150 participants at each site.

        2. Convenient samples referred from participant physicians' clinics instead of the
           population based samples in year 1 are used to decrease administration cost.

        3. Telephone based first stage screening instrument will be modified and validated for face
           to face interview.

        4. Longer intervention period (6-months) than year 1.

        5. Interventions provided in ENIC and PSTIC groups are combined into a single integrated
           care (IC) group. Interventions for IC group and UC group are minor changed, as described
           below.

      UC group: Inform the subjects about results of frailty, osteoporosis or depression
      assessment. The study educational booklet and CD-ROM on frailty, depression, osteoporosis,
      healthy diets, exercise protocols, and self-coping strategies will be given to participants.
      One 2-hour educational session is provided to participants to go through the booklet with
      demonstration of study exercise protocol. Subjects are encouraged to have balanced nutrition
      and regular exercises at home following the study protocol. Subjects were contacted bimonthly
      to check on how much they had read and watched the study material, and how well they had
      complied with the suggested diet and exercise protocols. However, it is at the subjects'
      discretion to discuss with their primary care physicians regarding the clinical
      interventions.

      IC group: Subjects will receive all interventions provided to the UC group. Furthermore,
      subjects will take exercise/rehabilitation courses at the participating hospitals twice a
      week for 24 weeks and 6 sessions of problem solving treatment (PST). If subjects do not
      improve on any of the 5 indicators from the (CHSPCF), comprehensive geriatric assessments
      (CGAs) are applied to identify more potential modifiable factors for frailty for
      individualized managements.

      Actual number of subjects enrolled in pilot study and 2009 study are 117 and 289 respectively
      and the total number of subjects enrolled in pilot study and 2009 study is 406.
    

Intervention name(s): Exercise and nutritional integrated care; Usual care with education; Problem solving therapy (PST) integrated care
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): 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.; 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.; 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.
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: Frailty; Osteoporosis; Depression