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

Sponsor

Buddhist Tzu Chi General Hospital (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05721599

Collaborator

(none)

100

Enrollment

Location

Arms

Anticipated Duration (Months)

4.8

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Frailty Diabetes Lifestyle	Behavioral: Integrated care with nutrition and lifestyle counselling	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

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

Anticipated Study Start Date :

Apr 1, 2023

Anticipated Primary Completion Date :

Jun 30, 2024

Anticipated Study Completion Date :

Dec 31, 2024

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Changes from baseline frailty [baseline, 4 weeks, 8 weeks, 12 weeks, 24 weeks]
measured by Clinical Frailty Scale
Changes from baseline frail status [baseline, 4 weeks, 8 weeks, 12 weeks, 24 weeks]
measured by Fatigue, Resistance, Ambulation, Illnesses, & Loss of Weight scale
Changes from baseline activities of daily living [baseline, 4 weeks, 8 weeks, 12 weeks, 24 weeks]
measured by Barthel Index
Changes from instrumental activities of daily living [baseline, 4 weeks, 8 weeks, 12 weeks, 24 weeks]
measured by Instrumental Activities of Daily Living
Changes from baseline cognition [baseline, 4 weeks, 8 weeks, 12 weeks, 24 weeks]
measured by Mini-Mental Status Examination
Changes from baseline depression [baseline, 4 weeks, 8 weeks, 12 weeks, 24 weeks]
measured by Geriatric Depression Scale
Changes from baseline nutritional status [baseline, 4 weeks, 8 weeks, 12 weeks, 24 weeks]
measured by Mini-Nutritional Assessment-Short Form
Changes from baseline fall risk assessment [baseline, 4 weeks, 8 weeks, 12 weeks, 24 weeks]
measured by fall risk assessment
Changes from baseline risk of sarcopenia [baseline, 4 weeks, 8 weeks, 12 weeks, 24 weeks]
measured by SARC-CalF
Changes from baseline physical activity [baseline, 4 weeks, 8 weeks, 12 weeks, 24 weeks]
measured by International Physical Activity Questionnaire
Changes from baseline quality of life [baseline, 4 weeks, 8 weeks, 12 weeks, 24 weeks]
measured by Likert 7-point
Changes from baseline muscle strength measure by hand grip strength [baseline, 4 weeks, 8 weeks, 12 weeks, 24 weeks]
measured by hand grip strength
Changes from baseline walking speed [baseline, 4 weeks, 8 weeks, 12 weeks, 24 weeks]
measured by six-meter walking speed
Changes from baseline physical performance [baseline, 4 weeks, 8 weeks, 12 weeks, 24 weeks]
measured by Short Physical Performance Battery
Change from baseline percentage of glycated hemoglobin (HbA1c) [baseline, 12 weeks, 24 weeks]
Change from baseline percentage of glycated hemoglobin (HbA1c)
Change from baseline concentration of low-density lipoprotein cholesterol (LDL-C) [baseline, 12 weeks, 24 weeks]
Change from baseline concentration of low-density lipoprotein cholesterol (LDL-C)
Change from baseline concentration of triglycerides [baseline, 12 weeks, 24 weeks]
Change from baseline concentration of triglycerides
Change from baseline concentration of high-density lipoprotein cholesterol (HDL-C) [baseline, 12 weeks, 24 weeks]
Change from baseline concentration of high-density lipoprotein cholesterol (HDL-C)
Change from baseline concentration of total cholesterol [baseline, 12 weeks, 24 weeks]
Change from baseline concentration of total cholesterol
Change from baseline body weight [baseline, 12 weeks, 24 weeks]
Change from baseline body weight
Change from baseline fat mass [baseline, 12 weeks, 24 weeks]
Change from baseline fat mass
Change from baseline muscle mass [baseline, 12 weeks, 24 weeks]
Change from baseline muscle mass
Change from baseline abdominal circumference [baseline, 12 weeks, 24 weeks]
Change from baseline abdominal circumference
Change from baseline calf circumference [baseline, 12 weeks, 24 weeks]
Change from baseline calf circumference

Eligibility Criteria

Criteria

Ages Eligible for Study:

65 Years and Older

Sexes Eligible for Study:

All

Accepts 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.