Clinical trial NCT05721599: Effectiveness of Integrated Care Combined Nutrition and Lifestyle Counselling in Frail Older Patients With Diabetes
Official title: Effectiveness of Integrated Care Combined Nutrition and Lifestyle Counselling in Frail Older Patients With Diabetes
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Frailty
Diabetes
Lifestyle
Keywords: Frailty
Diabetes
Older adult
Integrated care
Nutrition
Lifestyle
Lead sponsor: Buddhist Tzu Chi General Hospital
Sponsor class: OTHER
First posted: 2023-02-10
Enrollment: 100
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

* People aged 65 years or older.
* People with Clinical Frailty Scale: 4-7.
* People with a history of type II diabetes, use of diabetes medications, or HbA1c greater than or equal to 6.5%.
* People can understand the research process, meet the requirements of the research, and can sign the informed consent and participate in the following tracking.

Exclusion Criteria:

* People that are unable to cooperate with or accept intervention or follow-up.
* People with a history of type I diabetes.
* People use insulin injections or pumps.
* According to the PI's judgment, people with severe or poorly controlled conditions include acute diseases, severe infections, severe abnormal laboratory tests, or serious medical conditions with the following systems: cardiovascular, pulmonary, hepatic, nervous, mental, metabolic, renal, musculoskeletal, gastrointestinal, etc.
* People with severe visual or hearing impairment that prevent the completion of assessment and testing.
* People with malignant tumors that have just been diagnosed or are undergoing treatment or are still at risk of recurrence.
* People have received hormone therapy within three months before the trial or are expected to receive hormone therapy during the trial.
* People are currently or expected to join any other physical training courses or nutrition plans during the trial.
* Others are based on the judgment of the PI that participating in this trial may adversely affect the safety of the subjects, hinder the progress of the experiment, or interfere with the evaluation of the outcomes of the trial.

Primary outcomes:
measure: Changes from baseline frailty
timeFrame: baseline, 4 weeks, 8 weeks, 12 weeks, 24 weeks
measure: Changes from baseline frail status
timeFrame: baseline, 4 weeks, 8 weeks, 12 weeks, 24 weeks
measure: Changes from baseline activities of daily living
timeFrame: baseline, 4 weeks, 8 weeks, 12 weeks, 24 weeks
measure: Changes from instrumental activities of daily living
timeFrame: baseline, 4 weeks, 8 weeks, 12 weeks, 24 weeks
measure: Changes from baseline cognition
timeFrame: baseline, 4 weeks, 8 weeks, 12 weeks, 24 weeks
measure: Changes from baseline depression
timeFrame: baseline, 4 weeks, 8 weeks, 12 weeks, 24 weeks
measure: Changes from baseline nutritional status
timeFrame: baseline, 4 weeks, 8 weeks, 12 weeks, 24 weeks
measure: Changes from baseline fall risk assessment
timeFrame: baseline, 4 weeks, 8 weeks, 12 weeks, 24 weeks
measure: Changes from baseline risk of sarcopenia
timeFrame: baseline, 4 weeks, 8 weeks, 12 weeks, 24 weeks
measure: Changes from baseline physical activity
timeFrame: baseline, 4 weeks, 8 weeks, 12 weeks, 24 weeks
measure: Changes from baseline quality of life
timeFrame: baseline, 4 weeks, 8 weeks, 12 weeks, 24 weeks
measure: Changes from baseline muscle strength measure by hand grip strength
timeFrame: baseline, 4 weeks, 8 weeks, 12 weeks, 24 weeks
measure: Changes from baseline walking speed
timeFrame: baseline, 4 weeks, 8 weeks, 12 weeks, 24 weeks
measure: Changes from baseline physical performance
timeFrame: baseline, 4 weeks, 8 weeks, 12 weeks, 24 weeks
measure: Change from baseline percentage of glycated hemoglobin (HbA1c)
timeFrame: baseline, 12 weeks, 24 weeks
measure: Change from baseline concentration of low-density lipoprotein cholesterol (LDL-C)
timeFrame: baseline, 12 weeks, 24 weeks
measure: Change from baseline concentration of triglycerides
timeFrame: baseline, 12 weeks, 24 weeks
measure: Change from baseline concentration of high-density lipoprotein cholesterol (HDL-C)
timeFrame: baseline, 12 weeks, 24 weeks
measure: Change from baseline concentration of total cholesterol
timeFrame: baseline, 12 weeks, 24 weeks
measure: Change from baseline body weight
timeFrame: baseline, 12 weeks, 24 weeks
measure: Change from baseline fat mass
timeFrame: baseline, 12 weeks, 24 weeks
measure: Change from baseline muscle mass
timeFrame: baseline, 12 weeks, 24 weeks
measure: Change from baseline abdominal circumference
timeFrame: baseline, 12 weeks, 24 weeks
measure: Change from baseline calf circumference
timeFrame: baseline, 12 weeks, 24 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Hualien City
country: Taiwan
facility: Buddhist Tzu Chi General Hospital
Study officials:
affiliation: Buddhist Tzu Chi General Hospital
name: Sheng-Lun Kao, MD.PhD.
role: PRINCIPAL_INVESTIGATOR
References: