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Clinical Trial Summary

The goal of this clinical trial is to evaluate the effectiveness of innovative integrated care in pre-frail or frail patients with diabetes over 65 years old. The main questions it aims to answer are: - To establish innovative integrated care for frail elderly patients with diabetes combined with nutrition and lifestyle guidance. - To evaluate the effectiveness of the intervention compared with general outpatient care. Participants will receive 12 weeks of structured care including specialist care, integrated assessment, group health education, one-on-one nutrition and lifestyle guidance, online and face-to-face support group, and case management. Researchers will compare general outpatient care to see its effects on frailty, physical function, and blood sugar control.


Clinical Trial Description

Frailty refers to a condition in which the body's reserves diminish with age, leading to a decreased ability to respond to stressors, making it difficult for individuals to maintain physiological stability and increasing susceptibility to diseases. The development of frailty often involves complex imbalances within the body's systems, such as the nervous system, endocrine system, immune system, and musculoskeletal system. Given the multifactorial nature of frailty, comprehensive assessments, and multifactorial interventions can improve functioning and reduce adverse outcomes in frail elderly individuals, including falls, hospitalization, or admission to nursing homes. According to the American Diabetes Association guidelines, different A1c control targets can be established for elderly patients with diabetes based on their disease complexity, functionality, and cognitive status. Frailty, as a determinant of mortality in older adults, is also an important consideration in the treatment of diabetes. Furthermore, elderly patients with diabetes may experience a reduction in muscle strength and muscle mass, potentially leading to sarcopenia and subsequent frailty. Therefore, frailty and diabetes, two common health issues in the elderly, may mutually influence each other, altering the severity and treatment patterns of underlying diseases. Nutritional and lifestyle changes have the potential to slow down disability in frail elderly individuals with diabetes. While these recommendations are generally supported by guidelines, clinical evidence to support them is still needed. Past literature reviews have yet to conduct structured assessments of the effectiveness of nutritional and lifestyle guidance for frail elderly individuals with diabetes. Furthermore, in geriatric outpatient settings, a comprehensive integrated assessment should be used to establish treatment directions and plans for elderly patients with both frailty and diabetes, with ongoing monitoring. In summary, aging is accompanied by disruptions in bodily systems, leading to the co-occurrence of frailty and diabetes, making them significant health issues during the aging process. Structured integrated care for frail elderly patients with diabetes, combining nutritional and lifestyle guidance, has the potential to reverse frailty, control blood sugar, and consequently delay disability. This study aims to investigate the effectiveness of innovative comprehensive assessments and care, including specialized care, integrated assessments, group health education, one-on-one nutritional and lifestyle guidance, online and face-to-face support group, and case management, on the improvement of frailty levels and blood sugar control in frail elderly patients with diabetes. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05721599
Study type Interventional
Source Buddhist Tzu Chi General Hospital
Contact Sheng-Lun Kao, MD.PhD.
Phone +886-3-8561825
Email stevenkao7434@gmail.com
Status Recruiting
Phase N/A
Start date April 13, 2023
Completion date December 31, 2024

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