Clinical trial NCT00718432: An Interventional Study of Geriatric Frailty, Osteoporosis, and Depression
Official title: Interventional Study of Geriatric Frailty, Osteoporosis, and Depression in a Community Based Randomized Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Frailty
Osteoporosis
Depression
Keywords: Frailty
Osteoporosis
Depression
Lead sponsor: National Health Research Institutes, Taiwan
Sponsor class: OTHER
Collaborators: name: National Taiwan University Hospital
First posted: 2008-07-18
Enrollment: 406
Sex: ALL
Minimum age (years): 65
Maximum age (years): 79
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

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.

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.

Eligibility 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

Primary outcomes:
measure: improvement of frailty
timeFrame: baseline, 3, 6, and 12 months
Secondary outcomes:
measure: Bone Mineral Density
timeFrame: baseline and 12 months
measure: quality of life assessment
timeFrame: pilot study: baseline, 3, 6, and 12 months, 2009 study: baseline, 6, and 12 months
measure: QUALEFFO_31
timeFrame: pilot study: baseline, 3, 6, and 12 months, 2009 study: baseline, 6, and 12 months
measure: barthel index
timeFrame: pilot study: baseline, 3, 6, and 12 months, 2009 study: baseline and 12 months
measure: PRIME-MD (only measured in pilot study)
timeFrame: baseline, 3, 6, and 12 months
measure: BDI-II (only measured in 2009 study)
timeFrame: baseline, 6, and 12 months
measure: health-resource utilization
timeFrame: pilot study: baseline, 3, 6, and 12 months, 2009 study: baseline, 6, and 12 months
measure: Original Frailty Indicators
timeFrame: baseline, 3, 6, and 12 months
measure: timed up and go
timeFrame: baseline, 3, 6, and 12 months
measure: one leg stand time
timeFrame: baseline, 3, 6, and 12 months
measure: dominant hand grip strength
timeFrame: baseline, 3, 6, and 12 months
measure: dominant knee extension power
timeFrame: baseline, 3, 6, and 12 months
measure: vitamin B12 in blood
timeFrame: pilot study: baseline and 12 month, 2009 study: baseline and 6 months
measure: vitamin D in blood
timeFrame: pilot study: baseline and 12 month, 2009 study: baseline and 6 months
measure: CRP in blood
timeFrame: pilot study: baseline and 12 month, 2009 study: baseline and 6 months
measure: testosterone in blood
timeFrame: pilot study: baseline and 12 month, 2009 study: baseline and 6 months
measure: IL-6 in blood
timeFrame: pilot study: baseline and 12 month, 2009 study: baseline and 6 months
Other outcomes:
Locations:
city: Zhunan
country: Taiwan
facility: National Health Research Institutes
Study officials:
affiliation: Natoinal Health Research Institutes
name: Ken N Kuo, M.D.
role: STUDY_CHAIR
affiliation: Natoinal Health Research Institutes
name: Ching-Yu Chen, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Natoinal Health Research Institutes
name: Rong-Sen Yang, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Natoinal Health Research Institutes
name: Keh-Ming Lin, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Natoinal Health Research Institutes
name: Chao Agnes Hsiung, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.