Ignite Creation Date:
2024-07-17 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06469437
Status:
RECRUITING
Last Update Posted:
2024-07-15
First Post:
2024-05-13
Brief Title:
The Impact of Geriatric Assessment on the Treatment Plan of Elderly Patients With T2DM
Sponsor:
Hospital de Clinicas de Porto Alegre
Organization:
Hospital de Clinicas de Porto Alegre
Study Overview
Official Title:
The Impact of Geriatric Assessment on the Treatment Plan of Elderly Patients With Type 2 Diabetes Mellitus a Randomized Clinical Trial
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 N220 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 70
Functionally dependent CFS 4-5 Consider higher glycemic targets by 05 compared to the general adult population Aim for short- and medium-term treatment effects Target suggested HbA1c less than 80
Frail CFS 6-8 Consider higher glycemic targets by 15 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 85
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 patients 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
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 70
Functionally dependent CFS 4-5 Consider higher glycemic targets by 05 compared to the general adult population Aim for short- and medium-term treatment effects Target suggested HbA1c less than 80
Frail CFS 6-8 Consider higher glycemic targets by 15 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 85
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 patients 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None