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

Recruiting now · Not applicable

Conditions studied: Frailty, Diabetes, Lifestyle

In brief

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.

Key facts

Study ID

NCT05721599

Run by

Buddhist Tzu Chi General Hospital

People needed

100

Starts

2023-04-13

Expected to finish

2025-12-31

Last updated by the study team

2024-08-07

Who can join

Age: 65 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Buddhist Tzu Chi General Hospital — Hualien City, Taiwan (enrolling)

Full record on ClinicalTrials.gov

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