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

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.

Study Overview

• Status: Recruiting
• Conditions: Diabetes; Frailty; Lifestyle
• Intervention / Treatment: Behavioral: Integrated care with nutrition and lifestyle counselling

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.

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sheng-Lun Kao, MD.PhD.; Phone Number: 15599 +886-3-8561825; Email: stevenkao7434@gmail.com

Study Locations

• Taiwan
  • Hualien City, Taiwan, 97071
    • Recruiting
    • Buddhist Tzu Chi General Hospital
    • Contact: Sheng-Lun Kao, MD.PhD.; Phone Number: 15599 +886-3-8561825; Email: stevenkao7434@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention group; Structured integrated care model	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.
No Intervention: Control group; General outpatient care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes from baseline fall risk assessment	measured by fall risk assessment	baseline, 4 weeks, 8 weeks, 12 weeks, 24 weeks
Changes from baseline physical activity	measured by International Physical Activity Questionnaire	baseline, 4 weeks, 8 weeks, 12 weeks, 24 weeks
Changes from baseline quality of life	measured by Likert 7-point	baseline, 4 weeks, 8 weeks, 12 weeks, 24 weeks
Changes from baseline muscle strength measure by hand grip strength	measured by hand grip strength	baseline, 4 weeks, 8 weeks, 12 weeks, 24 weeks
Changes from baseline walking speed	measured by six-meter walking speed	baseline, 4 weeks, 8 weeks, 12 weeks, 24 weeks
Changes from baseline physical performance	measured by Short Physical Performance Battery	baseline, 4 weeks, 8 weeks, 12 weeks, 24 weeks
Change from baseline percentage of glycated hemoglobin (HbA1c)	Change from baseline percentage of glycated hemoglobin (HbA1c)	baseline, 12 weeks, 24 weeks
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
Change from baseline concentration of triglycerides	Change from baseline concentration of triglycerides	baseline, 12 weeks, 24 weeks
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
Change from baseline concentration of total cholesterol	Change from baseline concentration of total cholesterol	baseline, 12 weeks, 24 weeks
Change from baseline body weight	Change from baseline body weight	baseline, 12 weeks, 24 weeks
Change from baseline fat mass	Change from baseline fat mass	baseline, 12 weeks, 24 weeks
Change from baseline muscle mass	Change from baseline muscle mass	baseline, 12 weeks, 24 weeks
Change from baseline abdominal circumference	Change from baseline abdominal circumference	baseline, 12 weeks, 24 weeks
Change from baseline calf circumference	Change from baseline calf circumference	baseline, 12 weeks, 24 weeks
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
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
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Buddhist Tzu Chi General Hospital
• Investigators: Principal Investigator: Sheng-Lun Kao, MD.PhD., Buddhist Tzu Chi General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 13, 2023
• Primary Completion (Estimated): June 30, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: February 1, 2023
• First Submitted That Met QC Criteria: February 1, 2023
• First Posted (Actual): February 10, 2023

Study Record Updates

• Last Update Posted (Actual): August 23, 2023
• Last Update Submitted That Met QC Criteria: August 20, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: Diabetes; Nutrition; Integrated care; Frailty; Lifestyle; Older adult
• Additional Relevant MeSH Terms: Pathologic Processes; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Frailty
• Other Study ID Numbers: IRB111-262-B

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No