Effectiveness of Integrated Care Combined Nutrition and Lifestyle Counselling in Frail Older Patients With Diabetes

Diabetes Clinical Trial

Official title:

Effectiveness of Integrated Care Combined Nutrition and Lifestyle Counselling in Frail Older Patients With Diabetes

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05721599
• Other study ID #: IRB111-262-B
• Status: Recruiting
• Phase: N/A
• Start date: April 13, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: February 2023
• Source: Buddhist Tzu Chi General Hospital
• Contact: Sheng-Lun Kao, MD.PhD.
• Phone: +886-3-8561825
• Email: stevenkao7434[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 31, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus
• Frailty
• Lifestyle

Intervention

Behavioral:
• Integrated care with nutrition and lifestyle counselling
The structured care includes specialist care, integrated assessment, group health education, one-on-one nutrition and lifestyle guidance, online and face-to-face support group and case management.

Locations

Country	Name	City	State
Taiwan	Buddhist Tzu Chi General Hospital	Hualien City

Sponsors (1)

Lead Sponsor	Collaborator
Buddhist Tzu Chi General Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes from baseline frailty	measured by Clinical Frailty Scale, max: 9, min: 1; higher score means worse outcome	baseline, 4 weeks, 8 weeks, 12 weeks, 24 weeks
Primary	Changes from baseline frail status	measured by Fatigue, Resistance, Ambulation, Illnesses, & Loss of Weight scale; max: 5, min: 0; higher score means worse outcome	baseline, 4 weeks, 8 weeks, 12 weeks, 24 weeks
Primary	Changes from baseline activities of daily living	measured by Barthel Index, max: 100, min: 0; higher score means better outcome	baseline, 4 weeks, 8 weeks, 12 weeks, 24 weeks
Primary	Changes from instrumental activities of daily living	measured by Instrumental Activities of Daily Living, max: 8, min: 0; higher score means better outcome	baseline, 4 weeks, 8 weeks, 12 weeks, 24 weeks
Primary	Changes from baseline cognition	measured by Mini-Mental Status Examination, max: 30, min: 0; higher score means better outcome	baseline, 4 weeks, 8 weeks, 12 weeks, 24 weeks
Primary	Changes from baseline depression	measured by Geriatric Depression Scale, max: 15, min 0; higher score means worse outcome	baseline, 4 weeks, 8 weeks, 12 weeks, 24 weeks
Primary	Changes from baseline nutritional status	measured by Mini-Nutritional Assessment-Short Form, max: 14, min: 0; higher score means better outcome	baseline, 4 weeks, 8 weeks, 12 weeks, 24 weeks
Primary	Changes from baseline fall risk assessment	measured by fall risk assessment	baseline, 4 weeks, 8 weeks, 12 weeks, 24 weeks
Primary	Changes from baseline risk of sarcopenia	measured by SARC-CalF, max: 20, min: 0; higher score means worse outcome	baseline, 4 weeks, 8 weeks, 12 weeks, 24 weeks
Primary	Changes from baseline physical activity	measured by International Physical Activity Questionnaire	baseline, 4 weeks, 8 weeks, 12 weeks, 24 weeks
Primary	Changes from baseline quality of life	measured by Likert 7-point	baseline, 4 weeks, 8 weeks, 12 weeks, 24 weeks
Primary	Changes from baseline muscle strength measure by hand grip strength	measured by hand grip strength	baseline, 4 weeks, 8 weeks, 12 weeks, 24 weeks
Primary	Changes from baseline walking speed	measured by six-meter walking speed	baseline, 4 weeks, 8 weeks, 12 weeks, 24 weeks
Primary	Changes from baseline physical performance	measured by Short Physical Performance Battery	baseline, 4 weeks, 8 weeks, 12 weeks, 24 weeks
Primary	Change from baseline percentage of glycated hemoglobin (HbA1c)	Change from baseline percentage of glycated hemoglobin (HbA1c)	baseline, 12 weeks, 24 weeks
Primary	Change from baseline concentration of low-density lipoprotein cholesterol (LDL-C)	Change from baseline concentration of low-density lipoprotein cholesterol (LDL-C)	baseline, 12 weeks, 24 weeks
Primary	Change from baseline concentration of triglycerides	Change from baseline concentration of triglycerides	baseline, 12 weeks, 24 weeks
Primary	Change from baseline concentration of high-density lipoprotein cholesterol (HDL-C)	Change from baseline concentration of high-density lipoprotein cholesterol (HDL-C)	baseline, 12 weeks, 24 weeks
Primary	Change from baseline concentration of total cholesterol	Change from baseline concentration of total cholesterol	baseline, 12 weeks, 24 weeks
Primary	Change from baseline body weight	Change from baseline body weight	baseline, 12 weeks, 24 weeks
Primary	Change from baseline fat mass	Change from baseline fat mass	baseline, 12 weeks, 24 weeks
Primary	Change from baseline muscle mass	Change from baseline muscle mass	baseline, 12 weeks, 24 weeks
Primary	Change from baseline abdominal circumference	Change from baseline abdominal circumference	baseline, 12 weeks, 24 weeks
Primary	Change from baseline calf circumference	Change from baseline calf circumference	baseline, 12 weeks, 24 weeks