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Comprehensive Approach to Reduce Elderly Functional Decline in Diabetes: the CARED Study

RecruitingNAAges 75 Years - 110 YearsAllUniversity of Cagliari
NCT06842459 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Importance. Conventionally, treatment goals for diabetic patients primarily target glycemic levels and traditional cardiovascular risk factors (blood pressure, lipids) control to reduce macro- and micro-vascular complications. More recently, the relevance of assessing functional status in older diabetic patients has emerged. A knowledge gap exists regarding the risk of functional dependency in older diabetic patients and on the impact of Comprehensive Geriatric Assessment (CGA) on the achievement of easily calculated and objective patient-centered outcomes. Objective To investigate if a personalized plan of care base on CGA would reduce the risk of functional decline over time in older patients with diabetes as compared to usual care Design. Individual patient randomized controlled trial comparing intervention with usual care. Setting. Three hospitals in Cagliari, Ferrara, and Milano,

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📋 Eligibility rules (as published)
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.
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What it tests

  • Geriatric Assessment
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Where

2 sites
Azienda Ospedaliero-Universitaria di Cagliari
Cagliari, Italy
Azienda Ospedaliero-Universitaria
Cagliari, Italy
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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