About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Parallel
Treatments tested in this trial
Integrated care with nutrition and lifestyle counselling
BehavioralThe 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.
Treatment groups
Trial outcomes
Primary outcomes
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
Sponsors and contacts
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