A Individualized Physical Function Improvement Program for Frailty Elderly Using Goal Attainment Scaling (GAS) as Evaluation Method: Protocol for a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 160
- 主要终点
- Goal Attainment Scaling (GAS) Formulation of intervention objectives and attainment of goals was assessed using the Goal Attainment Scaling (GAS). GAS is a structured, individualized method for setting and evaluating progress toward personalized goals.
研究概览
简要总结
Frailty refers to the age-related decline in physiological functions，that is associated with adverse outcomes. Frailty is a dynamic reversible state, that requires a comprehensive individualized management. Goal Attainment Scaling (GAS) is a structured, individualized method for setting and evaluating progress toward personalized goals.
We conducted a randomized clinical trial of an individualized intervention program using GAS as evaluation method designed to improve physical functional in frailty elderly. A total of 160 individuals aged ≥60 years, who fulfill the Fried scale of frailty will be recruited from Beijing Chaoyang Hospital, Capital Medical University. All participants set personalized goals through GAS. Patients in the intervention group receive individualized interventions, implement tailored measures based on personalized goals to reverse the frailty state.The participants will be followed-up for 3 months and 24 months.
This protocol would be established to examine the efficiency of targeted individualized intervention for frailty based on the GAS. If a positive consequence could be obtained, the results of this study will provide critical data for management of frailty in the elderly, that can be carried out in routine clinical practice.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The inclusion criteria were the following: (1)≥60-years old; (2) recognized as frailty by Fried scale.
排除标准
- •were the following: (1) considered with life expectancy < 1 year such as advanced cancer patients; (2) difficult to communicate with such as patients with severe cognitive impairment (Mini Mental State Examination score ≤ 17); (3) severe hearing disord.
研究组 & 干预措施
the intervention group
the intervention group will receive individualized interventions.
干预措施: Multicomponent frailty intervention (Combination Product)
The control group
The control group will receive routine diagnosis and treatment
结局指标
主要结局
Goal Attainment Scaling (GAS) Formulation of intervention objectives and attainment of goals was assessed using the Goal Attainment Scaling (GAS). GAS is a structured, individualized method for setting and evaluating progress toward personalized goals.
时间窗: The GAS score was calculated according to a standardized formula and assessed at baseline, 3 months, and 24 months.
A pool of potential goals was developed by the research team based on the International Classification of Functioning, Disability, and Health (ICF). Each participants selected three goals through collaborative discussions among physicians, the individual, and caregivers. Participants were actively involved in the goal-setting and goal-rating process with the guidance of the research team. Participants also should weigh their goals by importance and difficulty at baseline. Goals were weighted by multiplying the importance level and the anticipated difficulty level, both graded on a 0-3 scale. For each goal, create a 5-point scale(-2 to +2) to describe potential outcomes: -2: Much worse than expected;-1: Somewhat worse than expected; 0: Expected level of success;+1: Somewhat better than expected; +2: Much better than expected. An aggregated T score with a mean of 50 and an SD of 10 was obtained.The extent to which goals are achieved is standardised into a T score by the formula
次要结局
未报告次要终点