The Impact of Geriatric Assessment on the Treatment Plan of Elderly Patients With T2DM
NCT Number: NCT06469437
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Type2diabetes|Frail Elderly Syndrome|Frailty|Geriatric Assessment
Interventions: BEHAVIORAL: Providing the physicians with a proposed glycated hemoglobin target
Sponsor: Hospital de Clinicas de Porto Alegre
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 220
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-07-05
Completion Date: 2028-12-31
Locations: Hospital de Clínicas de Porto Alegre, Porto Alegre, RS, 91755678, Brazil

Summary:
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.

Primary Outcome Measures: Adequacy of hyperglycemia prescription, The adequacy of treatment will be considered when:

* The treatment is intensified if the patient's HbA1C is higher by at least 0.5% than the glycemic target proposed by the geriatric assessment.
* The treatment is de-intensified if the patient's HbA1C is lower by at least 0.5% than the glycemic target proposed by the geriatric assessment.
* The treatment is maintained if the patient's HbA1C is within 0.5% above or below the glycemic target proposed by the geriatric assessment., up to 1 week
Secondary Outcome Measures: Hypoglycemia (general and severe), Hypoglycemia is defined by blood sugar levels below 70mg/dl and severe hypoglycemia requires assistance from another person. This outcome will be assessed through a questionnaire administered to the patient or family member in a telephone interview one month after the second consultation (approximately 6 months after the index consultation)., up to 6 months.|Incidence of falls, Number of falls in general and the number of falls that require emergency care. This outcome will be assessed through a questionnaire administered to the patient or family member in a telephone interview one month after the second consultation (approximately 6 months after the index consultation)., up to 6 months.|Infection, Number of infections requiring antibiotics prescription. Severe infection will be considered when hospitalization is needed. This outcome will be assessed through a questionnaire administered to the patient or family member in a telephone interview one month after the second consultation (approximately 6 months after the index consultation)., up to 6 months.|Hospitalization, Number of times the patient required hospitalization in general and due to diabetes. This outcome will be assessed through a questionnaire administered to the patient or family member in a telephone interview one month after the second consultation (approximately 6 months after the index consultation)., up to 6 months.|Death, This outcome will be assessed through a questionnaire to the patient or family member in a telephone interview one month after the second consultation (approximately 6 months after the index consultation)., up to 6 months.|Adequacy of antiplatelet prescription, Based on medical records, the investigators will measure the adequacy of antiplatelet prescription. This outcome will be assessed through a questionnaire administered to the patient or family member in a telephone interview one month after the second consultation (approximately 6 months after the index consultation)., up to 6 months.|Glycemic control, Based on medical records, the investigators will consult if the patient have new measurements of glycated hemoglobin and its adequacy., up to 6 months.