The Impact of Geriatric Assessment on the Treatment Plan of Elderly Patients With T2DM

NCT ID: NCT06469437

Last Updated: 2025-09-19

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 220 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-07-05
• Study Completion Date: 2028-12-31

Brief 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.

Detailed Description

All patients included in the research (both intervention and control groups, totaling a sample size of N=220 participants) will undergo geriatric assessment using the CFS and TaGA-10 tools. Using the CFS, the investigators will classify patients with scores of 1 to 3 as "functionally independent," 4 to 5 as "functionally dependent," and scores 6 to 8 as "frail." Patients will be randomized by random permuted block randomization, with block sizes of 2 and 4, stratified by frailty status ("functionally independent", "functionally dependent", or "frail").

Patients allocated to the control group will receive usual treatment without any additional procedures.

For the intervention group, before making decisions in the case discussion, the investigators will provide the physician a short note containing a suggested care plan as follows:

• Functionally independent (CFS 1-3): Glycemic targets should be equal to the general population, disregarding age. Consider seeking long-term treatment effects. Target suggested HbA1c around 7.0%.
• Functionally dependent (CFS 4-5): Consider higher glycemic targets by 0.5% compared to the general adult population. Aim for short- and medium-term treatment effects. Target suggested HbA1c less than 8.0%.
• Frail (CFS 6-8): Consider higher glycemic targets by 1.5% compared to the general adult population. Aim to reduce treatment complications. Do not expect medium- and long-term treatment effects. Target suggested HbA1c less than 8.5%.

These care plans are based on the Diabetes Canada Clinical Practice Guidelines Expert Committee guideline recommendations. Patients with a CFS of 9 will be excluded due to the recommendation of not measuring HbA1c to this group.

The investigators will initially approach the physicians at the outpatient clinic to apply the informed consent process and request possible eligible patients from the physician. Each physician will sign a consent form to participate in the entire study. Afterward, the investigators will check the patient's eligibility and apply the informed consent. If any of the participants (physician or patient) disagree with participating in the research, the pair will not be included. Physicians and patients wishing to withdraw consent to participate in the research can do so at any time; in this case, the pair will be treated as lost to follow-up.

The application of the Clinical Frailty Scale, with an estimated duration of 1 minute, will be conducted immediately after obtaining informed consent from the patient. The physician will attend to the patient, and during the discussion with the preceptor, the investigators will apply the TaGA-10 scale in the office. At this time, the patient will also be randomized with the assistance of the RedCap program. For the intervention group, the investigators will provide the physician with a geriatric assessment proposing a glycated hemoglobin target.

Information not requiring in-person assessment will be collected from medical records or during a telephone interview. The adequacy of the therapeutic approach (main outcome) will be measured in one week by reviewing the consult record or interviewing the physician.

The second and third evaluations will be conducted by telephone contact 3 and 6 months after the first visit. During this contact, the incidence of falls, infections, hypoglycemia, hospitalizations, and death will be queried, as long as the consult of new measurements of HbA1c on medical records. The data will be stored using the institutional computer in the institutional Google Drive and will be processed and analyzed using the RedCap program. The data will be anonymized for the analysis.

Conditions

Type2diabetes; Frail Elderly Syndrome; Frailty; Geriatric Assessment

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Control

This group will be submitted to geriatric assessment through CFS and TaGA-10 tools only.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Intervention

This group will be submitted to geriatric assessment through CFS and TaGA-10 tools, and the investigators will provide the physician with a short note with the proposed glycated hemoglobin target.

Group Type: EXPERIMENTAL

Providing the physicians with a proposed glycated hemoglobin target

Intervention Type: BEHAVIORAL

Through the geriatric assessment, the investigators will categorize the groups proposed by the Diabetes Canada Clinical Practice Guidelines Expert Committee guideline recommendations into "functionally independent", "functionally dependent" and "frail". The investigators will provide the physician with the glycated hemoglobin target proposed by the guideline.

Interventions

Providing the physicians with a proposed glycated hemoglobin target

Through the geriatric assessment, the investigators will categorize the groups proposed by the Diabetes Canada Clinical Practice Guidelines Expert Committee guideline recommendations into "functionally independent", "functionally dependent" and "frail". The investigators will provide the physician with the glycated hemoglobin target proposed by the guideline.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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 one month

Exclusion Criteria

• Lack of consent for research participation from the patient or the physician
• Patients classified as Clinical Frailty Scale 9.

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospital de Clinicas de Porto Alegre

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Renato GB Mello, Professor

Role: PRINCIPAL_INVESTIGATOR

Federal University of Rio Grande do Sul

Dimitris RV Rados, Professor

Role: STUDY_DIRECTOR

Federal University of Rio Grande do Sul

Locations

Hospital de Clínicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, Brazil

Site Status: RECRUITING

Countries

Brazil

Central Contacts

Gabriela P Rezende, Physician

Role: CONTACT

gabrielapetitot@gmail.com

5551989504774

Dimitris V Rados, Professor

Role: CONTACT

drados@hcpa.edu.br

Facility Contacts

Gabriela P Rezende

Role: primary

gabrielapetitot@gmail.com

5551989504774

Role: backup

gabrielapetitot@gmail.com

References

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Other Identifiers

2023-0456

Identifier Type: -

Identifier Source: org_study_id