Comprehensive Approach to Reduce Elderly Functional Decline in Diabetes: the CARED Study
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age75-110
SponsorUniversity of Cagliari
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Severe disability in basic activity of daily living (dependency in 3 or more activities),
Not being resident in the hospital catchment area; residence in long-term care;
Diagnosis of schizophrenia, other psychotic or bipolar disorder, or severe cognitive impairment (MMSE score < 21/30);
Alcohol abuse (> 14 drinks per week);
Trial design
Design model
Single group
Treatments tested in this trial
Geriatric Assessment
Other interventionThe intervention group will undergo Geriatric Assessment in addition to diabetes usual care. 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 results will be used to diagnoses or drug review; 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 professional, 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.
Treatment groups
180 Participants
are divided into 2 treatment groupsGroup A: Intervention group: CGA based individualized multimodal plan of careExperimental treatment 1 intervention
Group B: Control arm: usual care control groupNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Change in the Short Physical Performance Battery score over time
The primary outcome will be represented by the change in physical performance, assessed by the Short Physical Performance Battery (SPPB) score between baseline and of the follow-up (12 months). SPPB is a composite battery inclunding three objective performance based physical tests (4-meter usual walking speed, balance test, and repeated chair stand test). The SPPB score ranges from 0 to 12 with higher scores indicating better physical performance.
Time frame
every 6 months for at least 12 monthsSecondary outcomes
1
Change in the performance of individual items of the SPPB (balance score, walking speed, 5 repeated chair raises time)econdary outcomes
The SPPB is composed by three single objective performance based test: * balance test * 4-meter usual walking speed * repeated (5) chair stand test Each of the test has an individual score ranging from 0 to 4 with for indicating better performance. Change over time between baseline and 12-month follow-up will be assessed.
Time frame
every 6 months for at least 12 months2
Incidence of sarcopenia according to the European working group of Sarcopenia in Older People (EWGSOP2) definition during the 12-month follow-up
At baseline and during the follow-up sarcopenia will be assessed according to EWGSOP2 criteria. EWGSOP2 criteria defines sarcopenia as the presence of reduced skeletal muscle mass and strenght. Skeletal muscle mass will be analyzed using using bioimpedenziometry tecnique. Handgrip strength will assessed as indicator of skeletal muscle strength using a manual portable dynamometer.
Time frame
6- and 12-month follow-up3
Incidence of disability in Basic Activity of Daily Living (BADL)
Self-reported functional status in six Basic Activity of Daily Living (Bathing, Dressing; Personal Hygiene/Toileting; Moving/transfering; Eating; Continence, will be assessed at basiline and over the follow-up. Incidence of BADL disability will be defined as the onset of new disability in one more activities over the follow-up.
Time frame
6- and 12-month follow-up4
Change in cognitive function over time assessed using the Montreal Cognitve Assessment (MoCA) tool
Cognitve function will be assessed at baseline and over the follow-up using the MoCA. The MoCA is a widely used screening assessment for detecting cognitive impairment. It was validated in the setting of mild cognitive impairment and has subsequently been adopted in numerous other clinical settings. This test consists of 30 points and takes 10 minutes for the individual to complete (higher score indicating better function). The MoCA assesses several cognitive domains: * The short-term memory recall task (5 points) * Visuospatial abilities using a clock-drawing task (3 points) and a three-dimensional cube copy (1 point). * Multiple aspects of executive function (4 points). * Attention, concentration, and working memory (5 points). * Language using a three-item confrontation naming task with low-familiarity animals, repetition of two syntactically complex sentences, and the aforementioned fluency task (5 points). * Abstract reasoning (2 points) Orientation to time and place (6 points)
Time frame
6- and 12-month follow-upSponsors and contacts
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University of Cagliari
Lead sponsor
University of Milano Bicocca
Collaborator
Università degli Studi di Ferrara
Collaborator
Source ClinicalTrials.gov