Personalized care plan to prevent functional decline in elderly diabetics
Prevention of Functional Decline by Multimodal Intervention in Older Patients With Diabetes
This study tests if a personalized care plan can help older people with diabetes stay active and healthy compared to regular care.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 180 (estimated) |
| Ages | 75 Years to 110 Years |
| Sex | All |
| Sponsor | University of Cagliari Academic / other |
| Locations | 2 sites (Cagliari, Cagliari and 1 other locations) |
| Trial ID | NCT06842459 on ClinicalTrials.gov |
What this trial studies
This study investigates whether a personalized care plan based on Comprehensive Geriatric Assessment (CGA) can reduce the risk of functional decline in older patients with diabetes compared to usual care. It involves a randomized controlled trial with 180 participants aged 75 and older, focusing on their functional status and patient-centered outcomes. The study is conducted across three hospitals in Italy, aiming to address the unique challenges faced by elderly diabetic patients, including the risk of disability and functional loss.
Who should consider this trial
Good fit: Ideal candidates for this study are diabetic patients aged 75 years and older who exhibit some functional limitations.
Not a fit: Patients with severe disabilities in daily living activities or those with significant cognitive impairments may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve the quality of life and functional independence for elderly patients with diabetes.
How similar studies have performed: Other studies have shown promise in using comprehensive geriatric assessments to improve outcomes in older populations, suggesting this approach may be beneficial.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion criteria: * Age ≥75 years; * Diagnosis of diabetes mellitus; * Functional limitation defined as a Short Physical Performance Battery (SPPB) score between 4 (included) and 9 (included), and * Willingness to participate in the study. Exclusion criteria: * Severe disability in basic activity of daily living (dependency in 3 or more activities), * Not being resident in the hospital catchment area; residence in long-term care; * Diagnosis of schizophrenia, other psychotic or bipolar disorder, or severe cognitive impairment (MMSE score \< 21/30); * Alcohol abuse (\> 14 drinks per week); * Cancer requiring treatment in the past 3 years, except for non-melanoma skin cancers or cancers that have an excellent prognosis (e.g., the early stage breast or prostate cancer); * Respiratory insufficiency requiring regular use of supplemental oxygen; * Recent (\< 6 months) myocardial infarction; * Class IV NYHA heart failure; * Severe chronic kidney disease (stage V, dialysis); * Decompensated liver cirrhosis; * Inability or unwillingness to provide informed consent.
Where this trial is running
Cagliari, Cagliari and 1 other locations
- Azienda Ospedaliero-Universitaria di Cagliari — Cagliari, Cagliari, Italy (Recruiting)
- Azienda Ospedaliero-Universitaria — Cagliari, Cagliari, Italy (Recruiting)
Study contacts
- Study coordinator: Angelo Scuteri, MD PhD
- Email: angelo.scuteri@unica.it
- Phone: +393334564136
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.