Interventional Study of Geriatric Frailty, Osteoporosis, and Depression in a Community Based Randomized Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 406
- 试验地点
- 1
- 主要终点
- improvement of frailty
研究概览
简要总结
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.
详细描述
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:
- The study is conducted at one urban (Wanhua) and one rural (Toufen) site with roughly 150 participants at each site.
- Convenient samples referred from participant physicians' clinics instead of the population based samples in year 1 are used to decrease administration cost.
- Telephone based first stage screening instrument will be modified and validated for face to face interview.
- Longer intervention period (6-months) than year 1.
- 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 65 Years 至 79 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
UC group
Usual care with education
干预措施: Usual care with education (Behavioral)
ENIC group (IC group in 2009 study)
Exercise and nutritional integrated care
干预措施: Exercise and nutritional integrated care (Behavioral)
PSTIC group (IC group in 2009 study)
Problem solving therapy integrated care
干预措施: Problem solving therapy (PST) integrated care (Behavioral)
结局指标
主要结局
improvement of frailty
时间窗: baseline, 3, 6, and 12 months
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.
次要结局
- vitamin D in blood(pilot study: baseline and 12 month, 2009 study: baseline and 6 months)
- CRP in blood(pilot study: baseline and 12 month, 2009 study: baseline and 6 months)
- dominant knee extension power(baseline, 3, 6, and 12 months)
- 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)
- BDI-II (only measured in 2009 study)(baseline, 6, and 12 months)
- health-resource utilization(pilot study: baseline, 3, 6, and 12 months, 2009 study: baseline, 6, and 12 months)
- Original Frailty Indicators(baseline, 3, 6, and 12 months)
- timed up and go(baseline, 3, 6, and 12 months)
- one leg stand time(baseline, 3, 6, and 12 months)
- dominant hand grip strength(baseline, 3, 6, and 12 months)
- vitamin B12 in blood(pilot study: baseline and 12 month, 2009 study: baseline and 6 months)
- testosterone in blood(pilot study: baseline and 12 month, 2009 study: baseline and 6 months)
- IL-6 in blood(pilot study: baseline and 12 month, 2009 study: baseline and 6 months)