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
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. Therefore, this study aims to conduct a prospective investigation and develop interventional strategies to prevent and manage frailty among hospitalized elderly patients with kidney disease. Purpose: 1. Develop an intelligent intervention program for frailty. 2. Evaluate the effectiveness of the intelligent frailty intervention program in reducing frailty levels among hospitalized elderly patients with kidney disease before discharge. 3. Assess the impact of the intelligent frailty intervention program on the daily functional abilities of hospitalized elderly patients with kidney disease. 4. Examine the effect of the intelligent frailty intervention program on the 30-day unplanned readmission rate of hospitalized elderly patients with kidney disease. Subjects: 1. Inclusion criteria: (1) Hospitalized patients aged 65 years and older.(2) Admitted to the nephrology department or undergoing dialysis.(3) Conscious, able to express themselves independently, follow instructions, and communicate in Mandarin or Taiwanese.(4) Expected hospital stay of at least six days.(5) 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. 2. Exclusion criteria: (1) Severe visual or hearing impairments that hinder communication or assessments.(2) Significant cognitive impairment, defined as a Montreal Cognitive Assessment (MoCA) score \< 24.(3) Patients who do not consent to participate in the study.(4) Individuals unable to personally complete the consent form.(5) Patients receiving palliative care.(6) Regular participants in rehabilitation therapy.(7) Charlson Comorbidity Index (CCI) score ≥ 5. 3. Number of subjects: 78 in the experimental group and 78 in the control group 4. Recruitment method: (1) Recruitment location: A medical ward in a regional teaching hospital in northern Taiwan. (2) Recruitment through: Participants will be referred by physicians. Research design: 1. Study design or implementation This study is a randomized clinical trial (RCT) investigating the effectiveness of an intelligent intervention program on frailty levels, daily living functions, and unexpected readmission rates among hospitalized elderly patients with kidney disease. The study adopts a double-blind, parallel-group randomized design. Eligible participants will be recruited through convenience sampling and subsequently assigned to two groups using block randomization. The experimental group will receive the intelligent intervention program, while the control group will receive standard care. The intervention involves a structured exercise program, with participants in the experimental group engaging in cycling exercises three times per week, each session lasting 30 minutes during hospitalization. After discharge, they will follow a walking program, increasing their daily step count by 1,000 steps above the average recorded during hospitalization, for a total of 12 weeks. Participant in the control group will wear a smart wristband but will only receive standard care. Structured questionnaires and medical records will be used for data collection at four time points: the first week of enrollment (T0), hospital discharge (T1), the eighth week post-enrollment (T2), and the twelfth week post-enrollment (T3). Additionally, a tri-axial accelerometer-equipped smart wristband will be used to monitor and record participants' heart rate, respiration, blood pressure, daily step count, and sleep quality. 2. Project duration and expected progress (1) This study was conducted after IRB and RCT were approved until 12/31/2025 (2) The case will be accepted after approval by both IRB and RCT. (3) Conduct data analysis and statistics after receiving the case 3. Statistical methods and results evaluation 1. Descriptive data analysis ①. Frequency distribution and percentages will be used to describe demographic variables, disease characteristics, and frailty, including age, gender, education level, marital status, economic status, body mass index (BMI), medication history, fall history, reason for hospitalization, types of chronic diseases, dialysis status, comorbidities, and frailty status. ②. Continuous variables, including physical function, nutritional status, cognitive function, depression index, frailty level, daily step count, and daily activity level, will be described using mean, standard deviation, minimum, maximum, and range. 2. Inferential Data Analysis To examine factors associated with the study participants, independent sample t-tests and one-way analysis of variance (ANOVA) will be used to analyze the relationships between basic characteristics, disease attributes, and frailty levels. Pearson's correlation will be used to explore the relationships between physical function, nutritional status, cognitive function, depression index, and frailty level. Logistic regression analysis will be conducted to identify predictors of frailty among hospitalized elderly patients. For evaluating the effectiveness of the intervention, independent sample t-tests and chi-square tests will be used to assess the homogeneity of demographic variables, disease characteristics, frailty, physical function, nutritional status, cognitive function, depression index, frailty level, daily step count, and daily activity level between the two groups. Repeated measures ANOVA and binary logistic regression analysis will be applied to assess between-group differences in the intervention group. Generalized estimating equations (GEE) will be used to analyze the differences in intervention effectiveness between the two groups, as well as the interaction effects between group and time.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
DOUBLE
Enrollment
156
The intervention involves a structured exercise program, with participants in the experimental group engaging in cycling exercises three times per week, each session lasting 30 minutes during hospitalization. After discharge, they will follow a walking program, increasing their daily step count by 1,000 steps above the average recorded during hospitalization, for a total of 12 weeks. Structured questionnaires and medical records will be used for data collection at four time points: the first week of enrollment (T0), hospital discharge (T1), the eighth week post-enrollment (T2), and the twelfth week post-enrollment (T3). Additionally, a tri-axial accelerometer-equipped smart wristband will be used to monitor and record participants' heart rate, respiration, blood pressure, daily step count, and sleep quality.
National Taipei University of Nursing and Health Sciences, Taipei,
Taipei, Taiwan
Fried frailty phenotype
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
Time frame: pre-intervention, baseline (T0)
Fried frailty phenotype
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
Time frame: 4 weeks after intervention, discharge(T1)
Fried frailty phenotype
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
Time frame: 8 weeks after intervention(T2)
Fried frailty phenotype
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
Time frame: 12 weeks after intervention(T3)
physical activity function- Activities of daily living(ADL)
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) .
Time frame: pre-intervention, baseline (T0)
physical activity function- Activities of daily living(ADL)
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).
Time frame: 4 weeks after intervention, discharge(T1)
physical activity function- Activities of daily living(ADL)
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) .
Time frame: 8 weeks after intervention(T2)
physical activity function- Activities of daily living(ADL)
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) .
Time frame: 12 weeks after intervention(T3)
physical activity function-Chair Stand Test
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 .
Time frame: pre-intervention, baseline (T0)
physical activity function-Chair Stand Test
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.
Time frame: 4 weeks after intervention, discharge(T1)
physical activity function-Chair Stand Test
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.
Time frame: 8 Weeks after intervention(T2)
physical activity function-Chair Stand Test
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.
Time frame: 12 Weeks after intervention(T3)
15-item geriatric depression scale(GDS-15)
This tool measures depressive symptoms through 15 questions, with total scores ranging from 0 to 15. A score above 5 is considered indicative of depressive symptoms, with higher scores reflecting greater severity of depression. The Cronbach's α coefficient of the scale is 0.76, with a sensitivity of 84% and specificity of 95%.
Time frame: pre-intervention, baseline (T0)
15-item geriatric depression scale(GDS-15)
This tool measures depressive symptoms through 15 questions, with total scores ranging from 0 to 15. A score above 5 is considered indicative of depressive symptoms, with higher scores reflecting greater severity of depression. The Cronbach's α coefficient of the scale is 0.76, with a sensitivity of 84% and specificity of 95%.
Time frame: 4 weeks after intervention, discharge(T1)
15-item geriatric depression scale(GDS-15)
This tool measures depressive symptoms through 15 questions, with total scores ranging from 0 to 15. A score above 5 is considered indicative of depressive symptoms, with higher scores reflecting greater severity of depression. The Cronbach's α coefficient of the scale is 0.76, with a sensitivity of 84% and specificity of 95%.
Time frame: 8 Weeks after intervention(T2)
15-item geriatric depression scale(GDS-15)
This tool measures depressive symptoms through 15 questions, with total scores ranging from 0 to 15. A score above 5 is considered indicative of depressive symptoms, with higher scores reflecting greater severity of depression. The Cronbach's α coefficient of the scale is 0.76, with a sensitivity of 84% and specificity of 95%.
Time frame: 12 Weeks after intervention(T3)
the Chinese version of the Pittsburgh Sleep Quality Index(CPSQI)
The PSQI assesses multiple dimensions of sleep over the past month using 19 individual items categorized into seven components: subjective sleep quality, sleep latency, sleep duration, sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. The total score of these components represents subjective sleep quality, ranging from 0 to 21, with higher scores indicating poorer sleep quality. A total score of ≤5 suggests good sleep quality, whereas a score \>5 indicates poor sleep quality. The internal consistency of the Chinese version of PSQI (CPSQI) is 0.82-0.83, with test-retest reliability of r=0.85, sensitivity of 98%, and specificity of 55%.
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Time frame: pre-intervention, baseline (T0)
the Chinese version of the Pittsburgh Sleep Quality Index(CPSQI)
The PSQI assesses multiple dimensions of sleep over the past month using 19 individual items categorized into seven components: subjective sleep quality, sleep latency, sleep duration, sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. The total score of these components represents subjective sleep quality, ranging from 0 to 21, with higher scores indicating poorer sleep quality. A total score of ≤5 suggests good sleep quality, whereas a score \>5 indicates poor sleep quality. The internal consistency of the Chinese version of PSQI (CPSQI) is 0.82-0.83, with test-retest reliability of r=0.85, sensitivity of 98%, and specificity of 55%.
Time frame: 4 weeks after intervention, discharge(T1)
the Chinese version of the Pittsburgh Sleep Quality Index(CPSQI)
The PSQI assesses multiple dimensions of sleep over the past month using 19 individual items categorized into seven components: subjective sleep quality, sleep latency, sleep duration, sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. The total score of these components represents subjective sleep quality, ranging from 0 to 21, with higher scores indicating poorer sleep quality. A total score of ≤5 suggests good sleep quality, whereas a score \>5 indicates poor sleep quality. The internal consistency of the Chinese version of PSQI (CPSQI) is 0.82-0.83, with test-retest reliability of r=0.85, sensitivity of 98%, and specificity of 55%.
Time frame: 8 Weeks after intervention(T2)
the Chinese version of the Pittsburgh Sleep Quality Index(CPSQI)
The PSQI assesses multiple dimensions of sleep over the past month using 19 individual items categorized into seven components: subjective sleep quality, sleep latency, sleep duration, sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. The total score of these components represents subjective sleep quality, ranging from 0 to 21, with higher scores indicating poorer sleep quality. A total score of ≤5 suggests good sleep quality, whereas a score \>5 indicates poor sleep quality. The internal consistency of the Chinese version of PSQI (CPSQI) is 0.82-0.83, with test-retest reliability of r=0.85, sensitivity of 98%, and specificity of 55%.
Time frame: 12 Weeks after intervention(T3)
Objective Sleep Quality
Smart wristbands are widely recognized tools for measuring sleep quality with good validity and reliability. Among hospitalized patients-especially older adults, psychiatric patients, and those in intensive care units-subjective reporting of sleep quality may be influenced by symptoms or cognitive changes. In such cases, smart wristbands are commonly used to assess sleep quality.
Time frame: pre-intervention, baseline (T0)
Objective Sleep Quality
Smart wristbands are widely recognized tools for measuring sleep quality with good validity and reliability. Among hospitalized patients-especially older adults, psychiatric patients, and those in intensive care units-subjective reporting of sleep quality may be influenced by symptoms or cognitive changes. In such cases, smart wristbands are commonly used to assess sleep quality.
Time frame: 4 weeks after intervention, discharge(T1)
Objective Sleep Quality
Smart wristbands are widely recognized tools for measuring sleep quality with good validity and reliability. Among hospitalized patients-especially older adults, psychiatric patients, and those in intensive care units-subjective reporting of sleep quality may be influenced by symptoms or cognitive changes. In such cases, smart wristbands are commonly used to assess sleep quality.
Time frame: 8 Weeks after intervention(T2)
Objective Sleep Quality
Smart wristbands are widely recognized tools for measuring sleep quality with good validity and reliability. Among hospitalized patients-especially older adults, psychiatric patients, and those in intensive care units-subjective reporting of sleep quality may be influenced by symptoms or cognitive changes. In such cases, smart wristbands are commonly used to assess sleep quality.
Time frame: 12 Weeks after intervention(T3)
Montreal Cognitive Assessment(MoCA)
The MoCA is considered one of the most commonly used tools for assessing cognitive function in clinical settings. It is a brief assessment that takes approximately 10 minutes and evaluates six cognitive domains: memory, visuospatial ability, executive function, attention, language, and orientation. The total score ranges from 0 to 30, with higher scores indicating better cognitive function. The test-retest reliability of the Chinese version of the MoCA is 0.82, and the inter-rater reliability has a Kappa value of 0.89. The MoCA has demonstrated good construct validity and has been widely used in research to assess cognitive function in older adults, indicating strong consistency, reliability, and validity in cognitive function evaluation.
Time frame: pre-intervention, baseline (T0)
Montreal Cognitive Assessment(MoCA)
The MoCA is considered one of the most commonly used tools for assessing cognitive function in clinical settings. It is a brief assessment that takes approximately 10 minutes and evaluates six cognitive domains: memory, visuospatial ability, executive function, attention, language, and orientation. The total score ranges from 0 to 30, with higher scores indicating better cognitive function. The test-retest reliability of the Chinese version of the MoCA is 0.82, and the inter-rater reliability has a Kappa value of 0.89. The MoCA has demonstrated good construct validity and has been widely used in research to assess cognitive function in older adults, indicating strong consistency, reliability, and validity in cognitive function evaluation.
Time frame: 4 weeks after intervention, discharge(T1)
Montreal Cognitive Assessment(MoCA)
The MoCA is considered one of the most commonly used tools for assessing cognitive function in clinical settings. It is a brief assessment that takes approximately 10 minutes and evaluates six cognitive domains: memory, visuospatial ability, executive function, attention, language, and orientation. The total score ranges from 0 to 30, with higher scores indicating better cognitive function. The test-retest reliability of the Chinese version of the MoCA is 0.82, and the inter-rater reliability has a Kappa value of 0.89. The MoCA has demonstrated good construct validity and has been widely used in research to assess cognitive function in older adults, indicating strong consistency, reliability, and validity in cognitive function evaluation.
Time frame: 8 Weeks after intervention(T2)
Montreal Cognitive Assessment(MoCA)
The MoCA is considered one of the most commonly used tools for assessing cognitive function in clinical settings. It is a brief assessment that takes approximately 10 minutes and evaluates six cognitive domains: memory, visuospatial ability, executive function, attention, language, and orientation. The total score ranges from 0 to 30, with higher scores indicating better cognitive function. The test-retest reliability of the Chinese version of the MoCA is 0.82, and the inter-rater reliability has a Kappa value of 0.89. The MoCA has demonstrated good construct validity and has been widely used in research to assess cognitive function in older adults, indicating strong consistency, reliability, and validity in cognitive function evaluation.
Time frame: 12 Weeks after intervention(T3)