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

Primary Purpose

Frailty, Diabetes, Lifestyle

Status
Recruiting
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Integrated care with nutrition and lifestyle counselling
Sponsored by
Buddhist Tzu Chi General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Frailty focused on measuring Frailty, Diabetes, Older adult, Integrated care, Nutrition, Lifestyle

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Buddhist Tzu Chi General HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention group

Control group

Arm Description

Structured integrated care model

General outpatient care

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
February 1, 2023
Last Updated
August 20, 2023
Sponsor
Buddhist Tzu Chi General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05721599
Brief Title
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

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 13, 2023 (Actual)
Primary Completion Date
June 30, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Buddhist Tzu Chi General Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Frailty, Diabetes, Lifestyle
Keywords
Frailty, Diabetes, Older adult, Integrated care, Nutrition, Lifestyle

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention group
Arm Type
Experimental
Arm Description
Structured integrated care model
Arm Title
Control group
Arm Type
No Intervention
Arm Description
General outpatient care
Intervention Type
Behavioral
Intervention Name(s)
Integrated care with nutrition and lifestyle counselling
Intervention Description
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.
Primary Outcome Measure Information:
Title
Changes from baseline frailty
Description
measured by Clinical Frailty Scale, max: 9, min: 1; higher score means worse outcome
Time Frame
baseline, 4 weeks, 8 weeks, 12 weeks, 24 weeks
Title
Changes from baseline frail status
Description
measured by Fatigue, Resistance, Ambulation, Illnesses, & Loss of Weight scale; max: 5, min: 0; higher score means worse outcome
Time Frame
baseline, 4 weeks, 8 weeks, 12 weeks, 24 weeks
Title
Changes from baseline activities of daily living
Description
measured by Barthel Index, max: 100, min: 0; higher score means better outcome
Time Frame
baseline, 4 weeks, 8 weeks, 12 weeks, 24 weeks
Title
Changes from instrumental activities of daily living
Description
measured by Instrumental Activities of Daily Living, max: 8, min: 0; higher score means better outcome
Time Frame
baseline, 4 weeks, 8 weeks, 12 weeks, 24 weeks
Title
Changes from baseline cognition
Description
measured by Mini-Mental Status Examination, max: 30, min: 0; higher score means better outcome
Time Frame
baseline, 4 weeks, 8 weeks, 12 weeks, 24 weeks
Title
Changes from baseline depression
Description
measured by Geriatric Depression Scale, max: 15, min 0; higher score means worse outcome
Time Frame
baseline, 4 weeks, 8 weeks, 12 weeks, 24 weeks
Title
Changes from baseline nutritional status
Description
measured by Mini-Nutritional Assessment-Short Form, max: 14, min: 0; higher score means better outcome
Time Frame
baseline, 4 weeks, 8 weeks, 12 weeks, 24 weeks
Title
Changes from baseline fall risk assessment
Description
measured by fall risk assessment
Time Frame
baseline, 4 weeks, 8 weeks, 12 weeks, 24 weeks
Title
Changes from baseline risk of sarcopenia
Description
measured by SARC-CalF, max: 20, min: 0; higher score means worse outcome
Time Frame
baseline, 4 weeks, 8 weeks, 12 weeks, 24 weeks
Title
Changes from baseline physical activity
Description
measured by International Physical Activity Questionnaire
Time Frame
baseline, 4 weeks, 8 weeks, 12 weeks, 24 weeks
Title
Changes from baseline quality of life
Description
measured by Likert 7-point
Time Frame
baseline, 4 weeks, 8 weeks, 12 weeks, 24 weeks
Title
Changes from baseline muscle strength measure by hand grip strength
Description
measured by hand grip strength
Time Frame
baseline, 4 weeks, 8 weeks, 12 weeks, 24 weeks
Title
Changes from baseline walking speed
Description
measured by six-meter walking speed
Time Frame
baseline, 4 weeks, 8 weeks, 12 weeks, 24 weeks
Title
Changes from baseline physical performance
Description
measured by Short Physical Performance Battery
Time Frame
baseline, 4 weeks, 8 weeks, 12 weeks, 24 weeks
Title
Change from baseline percentage of glycated hemoglobin (HbA1c)
Description
Change from baseline percentage of glycated hemoglobin (HbA1c)
Time Frame
baseline, 12 weeks, 24 weeks
Title
Change from baseline concentration of low-density lipoprotein cholesterol (LDL-C)
Description
Change from baseline concentration of low-density lipoprotein cholesterol (LDL-C)
Time Frame
baseline, 12 weeks, 24 weeks
Title
Change from baseline concentration of triglycerides
Description
Change from baseline concentration of triglycerides
Time Frame
baseline, 12 weeks, 24 weeks
Title
Change from baseline concentration of high-density lipoprotein cholesterol (HDL-C)
Description
Change from baseline concentration of high-density lipoprotein cholesterol (HDL-C)
Time Frame
baseline, 12 weeks, 24 weeks
Title
Change from baseline concentration of total cholesterol
Description
Change from baseline concentration of total cholesterol
Time Frame
baseline, 12 weeks, 24 weeks
Title
Change from baseline body weight
Description
Change from baseline body weight
Time Frame
baseline, 12 weeks, 24 weeks
Title
Change from baseline fat mass
Description
Change from baseline fat mass
Time Frame
baseline, 12 weeks, 24 weeks
Title
Change from baseline muscle mass
Description
Change from baseline muscle mass
Time Frame
baseline, 12 weeks, 24 weeks
Title
Change from baseline abdominal circumference
Description
Change from baseline abdominal circumference
Time Frame
baseline, 12 weeks, 24 weeks
Title
Change from baseline calf circumference
Description
Change from baseline calf circumference
Time Frame
baseline, 12 weeks, 24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sheng-Lun Kao, MD.PhD.
Phone
+886-3-8561825
Ext
15599
Email
stevenkao7434@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sheng-Lun Kao, MD.PhD.
Organizational Affiliation
Buddhist Tzu Chi General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Buddhist Tzu Chi General Hospital
City
Hualien City
ZIP/Postal Code
97071
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sheng-Lun Kao, MD.PhD.
Phone
+886-3-8561825
Ext
15599
Email
stevenkao7434@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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