Actively Recruiting

Phase Not Applicable
Age: 75Years - 110Years
All Genders
ID06842459

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

Led by University of Cagliari · Updated on 2025-02-24

180

Participants Needed

2

Research Sites

N/A

Total Duration

On this page

Sponsors

U

University of Cagliari

Lead Sponsor

U

University of Milano Bicocca

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are investigating whether a personalized care plan based on Comprehensive Geriatric Assessment (CGA) can reduce functional decline in older adults aged 75 and above with diabetes. Diabetes in older adults often leads to greater risks of disability, functional loss, and earlier mortality, with a need for treatment approaches that address functional outcomes important to patients. This randomized controlled trial compares the CGA-based care to usual diabetes care to better understand its impact on physical performance and other patient-centered outcomes. The study involves two groups: one receiving usual diabetes care from a diabetologist, and the other receiving an additional CGA by a geriatrician. This assessment helps create a personalized diagnostic and therapeutic plan addressing the patient's functional status and preferences. The intervention group receives this tailored plan alongside usual care, while the control group continues with usual care alone. Follow-up visits are scheduled at 6 and 12 months to monitor progress. Participants will undergo evaluations including physical performance tests using the Short Physical Performance Battery (SPPB), cognitive function tests, and assessments for sarcopenia, disability, and hospitalization rates. Data on glycated hemoglobin levels and time spent at home will also be collected. Assessments occur at baseline, 6 months, and 12 months. The study aims to provide evidence on the benefits of CGA-driven care in maintaining function and quality of life among older adults with diabetes, with total participation lasting at least 12 months.

CONDITIONS

Brief Title

Comprehensive Approach to Reduce Elderly Functional Decline in Diabetes: the CARED Study

Who Can Participate

Age: 75Years - 110Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 75 years or older
  • Diagnosis of diabetes mellitus
  • Functional limitation with a Short Physical Performance Battery (SPPB) score between 4 and 9
  • Willingness to participate in the study
Not Eligible

You will not qualify if you...

  • Severe disability in basic activities of daily living (dependency in 3 or more activities)
  • Not residing in the hospital catchment area or living in long-term care
  • Diagnosis of schizophrenia, psychotic or bipolar disorder, or severe cognitive impairment (MMSE score below 21)
  • Alcohol abuse (more than 14 drinks per week)
  • Cancer requiring treatment in the past 3 years, except certain skin cancers or early-stage breast or prostate cancer
  • Respiratory insufficiency requiring regular supplemental oxygen
  • Recent myocardial infarction (within 6 months)
  • Class IV New York Heart Association heart failure
  • Severe chronic kidney disease (stage V, dialysis)
  • Decompensated liver cirrhosis
  • Inability or unwillingness to provide informed consent

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person) for eligibility assessment including Short Physical Performance Battery (SPPB) testing

Treatment

Duration - 12 months

Participants receive usual diabetes care by a diabetologist. Those in the intervention group also undergo a Comprehensive Geriatric Assessment (CGA) to develop an individualized multimodal care plan addressing diabetes management and functional status.

Baseline visit and intervention delivered following randomization

Follow-up

Duration - 12 months

Participants are followed up at 6 and 12 months after randomization to assess physical performance, cognitive function, disability, sarcopenia, and other health outcomes.

Visits at 6 and 12 months (in-person or home visits; phone interviews if institutionalized or hospitalized)

Trial Site Locations

Total: 2 locations

1

Azienda Ospedaliero-Universitaria di Cagliari

Cagliari, Cagliari, Italy, 09124

Actively Recruiting

2

Azienda Ospedaliero-Universitaria

Cagliari, Cagliari, Italy, 09124

Actively Recruiting

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Research Team

A

Angelo Scuteri, MD PhD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

2

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Published Research Related To This Trial

Informing clinical practice guideline development and implementation: prevalence of coexisting conditions among adults with coronary heart disease.

Cynthia M Boyd, Bruce Leff, Jennifer L Wolff...

https://pubmed.ncbi.nlm.nih.gov/21568950

Management of hyperglycaemia in type 2 diabetes, 2022. A consensus report by the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD).

Melanie J Davies, Vanita R Aroda, Billy S Collins...

https://pubmed.ncbi.nlm.nih.gov/36151309