Personalized care plan to prevent functional decline in elderly diabetics

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.