A Series of Studies on Influencing Factors and Intelligent Intervention Programs for Hospitalized Elderly People With Frailty
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 156
- 试验地点
- 1
- 主要终点
- Fried frailty phenotype
研究概览
简要总结
Background: As the aging population grows, hospitalized elderly individuals with frailty have become a major concern. Frailty is a complex syndrome linked to aging, marked by dependency and vulnerability. Elderly patients often face chronic diseases, making them more susceptible to frailty. Studies show frailty prevalence in hospitalized elderly patients is 88.7%, and 75.3% among kidney disease patients. Frailty is associated with advanced age, female gender, low body mass index, comorbidities, and poor nutrition, increasing the risks of falls, hospitalization, and mortality. Frail kidney disease patients face worse outcomes. However, frailty is reversible with early intervention. Current treatments, based on comprehensive geriatric assessment (CGA), require significant resources. This study aims to explore frailty prevention and care through research and intervention development.
Purpose: To explore the effectiveness of an intelligent intervention program in improving frailty among hospitalized elderly individuals.
Methods: An experimental research design was adopted. A total of 156 hospitalized elderly patients with kidney disease who met the inclusion criteria were recruited through convenience sampling. Participants were randomly assigned to either the experimental group (n = 78) or the control group (n = 78). The experimental group received a 12-week intelligent intervention program, while the control group received routine care.Subsequently, data on frailty level, daily living function 30 days after discharge, and unexpected readmission rate 30 days after discharge will be collected by researchers and analyzed using SPSS 22.0, including chi-square tests, repeated measures ANOVA, and Generalized Estimating Equations (GEE) for intra-group and inter-group comparisons of each outcome variable.
Expected research results: This study aims to understand the current status and influencing factors of frailty among hospitalized elderly patients with kidney disease and to develop an intelligent intervention program. The goal is to provide clinical nursing staff with a frailty care strategy for hospitalized patients, effectively reducing frailty among elderly inpatients, improving their daily functional ability after discharge, and decreasing hospital readmission rates.
Condition or disease: frailty Intervention/treatment: intelligent intervention program
详细描述
Background:
Frailty is an aging-related syndrome with a prevalence that increases with age. However, frailty should not be considered a natural part of aging; rather, it involves multiple factors such as dependency, dynamic processes, and vulnerability . Hospitalized elderly individuals often suffer from chronic diseases and are in a stage of aging with declining physical function. During acute illness, they experience physical weakness and disease burden, which, combined with the stress and physical strain of hospitalization, prolonged bed rest, and reduced activity levels, makes them more susceptible to frailty. According to domestic research, the prevalence of frailty among hospitalized elderly patients in Taiwan is as high as 88.7% .
Frailty is significantly associated with advanced age, female gender, body mass index, comorbidities, activities of daily living (ADL), and poor nutritional status. Among patients with kidney disease, frailty-related risk factors such as fatigue, reduced activity, and decreased albumin levels are more common. Studies indicate that the prevalence of frailty among patients with kidney disease reaches 75.3%. Additionally, compared to non-frail patients with kidney disease, frail patients with kidney disease have a 2.75-fold increased risk of mortality, a 3.79-fold higher risk of discharge to long-term care facilities, an extended hospitalization duration of 4.87 days, and an increased hospital cost of $41,025.03. These findings suggest that frailty significantly increases the risk of adverse health outcomes in patients with kidney disease .
Current research indicates that frailty is reversible. A large-scale study in Europe found that early intervention during the pre-frailty or mild frailty stage is far more effective than intervention at later stages. In recent years, studies have explored multimodal interventions to mitigate frailty in hospitalized elderly patients. However, the number of randomized controlled trials remains limited, and existing studies are of low quality, with inconsistent intervention strategies and outcomes.
Furthermore, most interventional studies have been based on comprehensive geriatric assessment (CGA) and employed the Acute Care for Elderly (ACE) model, requiring interdisciplinary coordination and integration across multiple specialties . However, the organizational requirements for CGA and ACE models are substantial, making it difficult for clinical settings lacking the necessary infrastructure to implement these interventions effectively.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Hospitalized patients aged 65 years and older. (、
- •Admitted to the nephrology department or undergoing dialysis.
- •Conscious, able to express themselves independently, follow instructions, and communicate in Mandarin or Taiwanese.
- •Expected hospital stay of at least six days.
- •Assessed using the Physical Activity Readiness Questionnaire for Everyone (PAR-Q+) and deemed to have no immediate risk for exercise participation, with normal capability for physical activity.
排除标准
- •Severe visual or hearing impairments that hinder communication or assessments.
- •Significant cognitive impairment, defined as a Montreal Cognitive Assessment (MoCA) score <
- •Patients who do not consent to participate in the study.
- •Individuals unable to personally complete the consent form.
- •Patients receiving palliative care.
- •Regular participants in rehabilitation therapy.
- •Charlson Comorbidity Index (CCI) score ≥ 5.
研究组 & 干预措施
Control group
The control group received usual care.
Experimental group
The experimental group will receive an intelligent intervention program, which includes cycling training during hospitalization and daily walking training after discharge, supplemented by monitoring and tracking using a smart wristband.
干预措施: Intelligent intervention programs (Behavioral)
结局指标
主要结局
Fried frailty phenotype
时间窗: 12 weeks after intervention(T3)
Number of Participants Classified as Frail or Pre-Frail Based on the Fried Frailty Phenotype Criteria: Unintentional Weight Loss, Exhaustion, Weak Grip Strength, Slow Walking Speed, and Low Physical Activity
physical activity function- Activities of daily living(ADL)
时间窗: 12 weeks after intervention(T3)
This tool evaluates an individual's ability to perform self-care activities in daily life, including eating, mobility, personal hygiene, toileting, bathing, walking, stair climbing, dressing, bowel control, and bladder control. Each activity is scored based on the individual's level of independence, with total scores ranging from 0 to 100, where higher scores indicate better daily functioning . The Cronbach's α of the scale is 0.82, test-retest reliability is 0.89, and inter-rater reliability is 0.95 (0.91-0.97) .
physical activity function-Chair Stand Test
时间窗: 12 Weeks after intervention(T3)
A tool for assessing lower limb muscular endurance in older adults, as part of the Senior Fitness Test developed by the Sports Administration, Ministry of Education, Taiwan. The test involves the participant sitting on a chair with their arms crossed over their chest. They are instructed to stand up and sit down once, which is counted as one repetition. The total number of repetitions completed within 30 seconds is recorded. The performance is classified into five levels-poor, below average, average, above average, and excellent-based on gender- and age-specific standards. This study follows the normative fitness standards for older adults established by the Sports Administration, Ministry of Education.
Fried frailty phenotype
时间窗: pre-intervention, baseline (T0)
Number of Participants Classified as Frail or Pre-Frail Based on the Fried Frailty Phenotype Criteria: Unintentional Weight Loss, Exhaustion, Weak Grip Strength, Slow Walking Speed, and Low Physical Activity
Fried frailty phenotype
时间窗: 4 weeks after intervention, discharge(T1)
Number of Participants Classified as Frail or Pre-Frail Based on the Fried Frailty Phenotype Criteria: Unintentional Weight Loss, Exhaustion, Weak Grip Strength, Slow Walking Speed, and Low Physical Activity
Fried frailty phenotype
时间窗: 8 weeks after intervention(T2)
Number of Participants Classified as Frail or Pre-Frail Based on the Fried Frailty Phenotype Criteria: Unintentional Weight Loss, Exhaustion, Weak Grip Strength, Slow Walking Speed, and Low Physical Activity
physical activity function- Activities of daily living(ADL)
时间窗: pre-intervention, baseline (T0)
This tool evaluates an individual's ability to perform self-care activities in daily life, including eating, mobility, personal hygiene, toileting, bathing, walking, stair climbing, dressing, bowel control, and bladder control. Each activity is scored based on the individual's level of independence, with total scores ranging from 0 to 100, where higher scores indicate better daily functioning . The Cronbach's α of the scale is 0.82, test-retest reliability is 0.89, and inter-rater reliability is 0.95 (0.91-0.97) .
physical activity function- Activities of daily living(ADL)
时间窗: 4 weeks after intervention, discharge(T1)
This tool evaluates an individual's ability to perform self-care activities in daily life, including eating, mobility, personal hygiene, toileting, bathing, walking, stair climbing, dressing, bowel control, and bladder control. Each activity is scored based on the individual's level of independence, with total scores ranging from 0 to 100, where higher scores indicate better daily functioning. The Cronbach's α of the scale is 0.82, test-retest reliability is 0.89, and inter-rater reliability is 0.95 (0.91-0.97).
physical activity function- Activities of daily living(ADL)
时间窗: 8 weeks after intervention(T2)
This tool evaluates an individual's ability to perform self-care activities in daily life, including eating, mobility, personal hygiene, toileting, bathing, walking, stair climbing, dressing, bowel control, and bladder control. Each activity is scored based on the individual's level of independence, with total scores ranging from 0 to 100, where higher scores indicate better daily functioning . The Cronbach's α of the scale is 0.82, test-retest reliability is 0.89, and inter-rater reliability is 0.95 (0.91-0.97) .
physical activity function-Chair Stand Test
时间窗: pre-intervention, baseline (T0)
A tool for assessing lower limb muscular endurance in older adults, as part of the Senior Fitness Test developed by the Sports Administration, Ministry of Education, Taiwan . The test involves the participant sitting on a chair with their arms crossed over their chest. They are instructed to stand up and sit down once, which is counted as one repetition. The total number of repetitions completed within 30 seconds is recorded. The performance is classified into five levels-poor, below average, average, above average, and excellent-based on gender- and age-specific standards. This study follows the normative fitness standards for older adults established by the Sports Administration, Ministry of Education .
physical activity function-Chair Stand Test
时间窗: 4 weeks after intervention, discharge(T1)
A tool for assessing lower limb muscular endurance in older adults, as part of the Senior Fitness Test developed by the Sports Administration, Ministry of Education, Taiwan. The test involves the participant sitting on a chair with their arms crossed over their chest. They are instructed to stand up and sit down once, which is counted as one repetition. The total number of repetitions completed within 30 seconds is recorded. The performance is classified into five levels-poor, below average, average, above average, and excellent-based on gender- and age-specific standards. This study follows the normative fitness standards for older adults established by the Sports Administration, Ministry of Education.
physical activity function-Chair Stand Test
时间窗: 8 Weeks after intervention(T2)
A tool for assessing lower limb muscular endurance in older adults, as part of the Senior Fitness Test developed by the Sports Administration, Ministry of Education, Taiwan. The test involves the participant sitting on a chair with their arms crossed over their chest. They are instructed to stand up and sit down once, which is counted as one repetition. The total number of repetitions completed within 30 seconds is recorded. The performance is classified into five levels-poor, below average, average, above average, and excellent-based on gender- and age-specific standards. This study follows the normative fitness standards for older adults established by the Sports Administration, Ministry of Education.
次要结局
- 15-item geriatric depression scale(GDS-15)(12 Weeks after intervention(T3))
- the Chinese version of the Pittsburgh Sleep Quality Index(CPSQI)(12 Weeks after intervention(T3))
- Montreal Cognitive Assessment(MoCA)(12 Weeks after intervention(T3))
- Objective Sleep Quality(12 Weeks after intervention(T3))
- 15-item geriatric depression scale(GDS-15)(pre-intervention, baseline (T0))
- 15-item geriatric depression scale(GDS-15)(4 weeks after intervention, discharge(T1))
- 15-item geriatric depression scale(GDS-15)(8 Weeks after intervention(T2))
- the Chinese version of the Pittsburgh Sleep Quality Index(CPSQI)(pre-intervention, baseline (T0))
- the Chinese version of the Pittsburgh Sleep Quality Index(CPSQI)(4 weeks after intervention, discharge(T1))
- the Chinese version of the Pittsburgh Sleep Quality Index(CPSQI)(8 Weeks after intervention(T2))
- Objective Sleep Quality(pre-intervention, baseline (T0))
- Objective Sleep Quality(4 weeks after intervention, discharge(T1))
- Objective Sleep Quality(8 Weeks after intervention(T2))
- Montreal Cognitive Assessment(MoCA)(pre-intervention, baseline (T0))
- Montreal Cognitive Assessment(MoCA)(4 weeks after intervention, discharge(T1))
- Montreal Cognitive Assessment(MoCA)(8 Weeks after intervention(T2))
研究者
Chia Jung Hsieh
professor
National Taipei University of Nursing and Health Sciences