The Impact of Geriatric Assessment on the Treatment Plan of Elderly Patients With T2DM
Recruiting · NCT06469437 · Interventional (participants receive a specific treatment) · Lead sponsor: Hospital de Clinicas de Porto Alegre
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
Introduction: With the aging of the world population and the increasing incidence of type 2 diabetes mellitus (T2DM) with age, the number of elderly individuals living with diabetes has been considerably rising. It is known that uncontrolled T2DM negatively impacts various health outcomes, including geriatric outcomes such as sarcopenia, frailty, immobility, incontinence, and infections. Current medical literature fails to establish appropriate glycemic targets for different elderly profiles. Although guidelines emphasize the need to individualize targets, there is no concise tool to identify which individuals benefit from each therapeutic approach. Data suggest that frailty is the best predictor of negative outcomes in elderly patients living with T2DM. The Clinical Frailty Scale (CFS) and the 10-minute Targeted Geriatric Assessment (TaGA-10) are validated tools for prognosis in elderly patients and for identifying frail elderly individuals. Methods: Randomized controlled trial. Elderly individuals diagnosed with T2DM at a tertiary care outpatient clinic will be included. All enrolled patients will undergo geriatric assessment using CFS, TaGA-10, and Charlson Comorbidity Index. Patients will be randomized into usual care and intervention groups, and the intervention involves providing the geriatric assessment to the care team to support their decisions. The adequacy of the therapeutic approach will be measured in one week by reviewing the consult record or interviewing the physician. The clinical impact on the frequency of hypoglycemia, falls, infections, hospitalizations, and mortality will be evaluated at 3 and 6 months by telephone interviews. Discussion: Current guidelines recommend using age, comorbidities, cognitive, and functional status to individualize therapeutic targets in elderly patients with T2DM; however, it is possible that these variables alone may not be sufficient to classify all elderly individuals in their complexity adequately. A tool with such power and easy to use in clinical practice is necessary.
Who can take part
Inclusion criteria
- Age 60 years or older
- Diagnostic of type 2 diabetes mellitus according to American Diabetes Association criteria
- Patients under follow-up in a specialized endocrinology outpatient clinic
- Patients who have a glycated hemoglobin measurement of up to three months
Exclusion criteria
- Lack of consent for research participation from the patient or the physician
- Patients classified as Clinical Frailty Scale 9.
Where it is running
1 location listed.
- Hospital de Clínicas de Porto Alegre - Porto Alegre, Rio Grande do Sul, Brazil