Prevention of Functional Decline by Multimodal Intervention in Older Patients With Diabetes

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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, Italy. Participants. One-hundred and eighty diabetic patients aged ≥75 years. Intervention. Usual care for both the Control and Intervention groups will be assured by a diabetologist according to in-use guidelines. After randomization, a geriatrician will administer a thorough CGA to all participants allocated to the intervention groups. CGA will be used to identify specific treatment goals according to the functional status of the patient and to incorporate Patient-preferred outcome in the management of diabetes and comorbidities. Using the results of the CGA the geriatricians along with the attending diabetologist and additional healthcare professionals, if needed, will implement a personalized diagnostic and therapeutic plan of care. Participants in the Control group will receive no additional intervention over and above usual care. Follow-up. Follow-up visit will be scheduled at 6 and 12 months after randomization. Main outcome measures. The primary outcome will be represented by the change in physical performance, assessed by change in the Short Physical Performance Battery (SPPB) score over time. Secondary outcomes will be represented by change in cognitive function, sarcopenia, dependency, glycated hemoglobin levels, and rate of hospitalization as well as Time-at-home. Expected Results. The CGA-driven intervention applied to older diabetic patients will have significant benefits on functional outcomes as compared to usual care. Implications. Multimodal intervention in older diabetic patients will significantly impact on the ageing population and allow a novel process to be developed for interventions that produce the maximum disability-free life years lived combined with the highest quality of life for this vulnerable and often neglected group of adults.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 75
Maximum Age: 110
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Italy
Azienda Ospedaliero-Universitaria
RECRUITING
Cagliari
Azienda Ospedaliero-Universitaria di Cagliari
RECRUITING
Cagliari
Contact Information
Primary
Angelo Scuteri, MD PhD
angelo.scuteri@unica.it
+393334564136
Time Frame
Start Date: 2025-02-03
Estimated Completion Date: 2026-10
Participants
Target number of participants: 180
Treatments
Experimental: Intervention group: CGA based individualized multimodal plan of care
After randomization patients allocated to intervention arm will be treated following and individualized multimodal plan of care based on the results of the comprehensive geriatric assessment.
No_intervention: Control arm: usual care control group
After randomization patients allocated to this arm will be trated and followed by diabetologist according to current guidilenes (Usual Care)
Related Therapeutic Areas
Sponsors
Leads: University of Cagliari
Collaborators: Università degli Studi di Ferrara, University of Milano Bicocca

This content was sourced from clinicaltrials.gov