Integrated care with nutrition and lifestyle support for frail older patients with diabetes
Effectiveness of Integrated Care Combined Nutrition and Lifestyle Counselling in Frail Older Patients With Diabetes
This study is testing whether a new combined approach of nutrition and lifestyle support can help frail older adults with diabetes feel better and manage their condition more effectively than regular care.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 65 Years and up |
| Sex | All |
| Sponsor | Buddhist Tzu Chi General Hospital Academic / other |
| Locations | 1 site (Hualien City) |
| Trial ID | NCT05721599 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of an integrated care approach that combines nutrition and lifestyle counseling for frail elderly patients with diabetes aged 65 and older. Participants will receive 12 weeks of structured care, including specialist assessments, group health education, personalized guidance, and support through both online and face-to-face interactions. The study aims to compare this integrated care model with standard outpatient care to assess its impact on frailty, physical function, and blood sugar control.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 65 and older who are pre-frail or frail and have a history of type II diabetes.
Not a fit: Patients with type I diabetes or those with severe uncontrolled medical conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve the health and quality of life for frail older adults with diabetes.
How similar studies have performed: Other studies have shown promise in using integrated care approaches for managing chronic conditions in elderly populations, suggesting potential for success in this novel application.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Hualien City
- Buddhist Tzu Chi General Hospital — Hualien City, Taiwan (Recruiting)
Study contacts
- Principal investigator: Sheng-Lun Kao, MD.PhD. — Buddhist Tzu Chi General Hospital
- Study coordinator: Sheng-Lun Kao, MD.PhD.
- Email: stevenkao7434@gmail.com
- Phone: +886-3-8561825
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.