Actively Recruiting

Phase Not Applicable
Age: 65Years +
All Genders
NCT05721599

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

Led by Buddhist Tzu Chi General Hospital · Updated on 2024-08-07

100

Participants Needed

1

Research Sites

141 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 65Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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 who can understand the research process, meet the research requirements, and can sign informed consent and participate in follow-up.
Not Eligible

You will not qualify if you...

  • People unable to cooperate with or accept intervention or follow-up.
  • People with a history of type I diabetes.
  • People who use insulin injections or pumps.
  • People with severe or poorly controlled conditions as judged by the PI, including acute diseases, severe infections, abnormal lab tests, or serious medical conditions affecting cardiovascular, pulmonary, hepatic, nervous, mental, metabolic, renal, musculoskeletal, gastrointestinal systems.
  • People with severe visual or hearing impairment preventing assessment and testing.
  • People with malignant tumors recently diagnosed, undergoing treatment, or at risk of recurrence.
  • People who have received hormone therapy within three months before the trial or expect to receive it during the trial.
  • People currently or expected to join other physical training or nutrition plans during the trial.
  • Others judged by the PI to potentially affect safety, study progress, or outcome evaluation.

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

Buddhist Tzu Chi General Hospital

Hualien City, Taiwan, 97071

Actively Recruiting

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Research Team

S

Sheng-Lun Kao, MD.PhD.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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