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

NCT06842459 | Recruiting

• 1 other identifier: 2022T8AW85
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Diabetes; Older People

Keywords

diabetes; older people; geriatric assessment; functional outcomes

Outcome Measures

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.

  every 6 months for at least 12 months

Secondary Outcomes (9)

• Change in the performance of individual items of the SPPB (balance score, walking speed, 5 repeated chair raises time)econdary outcomes

  every 6 months for at least 12 months

• Incidence of sarcopenia according to the European working group of Sarcopenia in Older People (EWGSOP2) definition during the 12-month follow-up

  6- and 12-month follow-up

• Incidence of disability in Basic Activity of Daily Living (BADL)

  6- and 12-month follow-up

• Change in cognitive function over time assessed using the Montreal Cognitve Assessment (MoCA) tool

  6- and 12-month follow-up

• Incidence of hospitalization

  12-month

Study Arms (2)

Intervention group: CGA based individualized multimodal plan of care

EXPERIMENTAL

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.

Other: Geriatric Assessment

Control arm: usual care control group

NO INTERVENTION

After randomization patients allocated to this arm will be trated and followed by diabetologist according to current guidilenes (Usual Care)

Interventions

Geriatric Assessment OTHER

The 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.

Intervention group: CGA based individualized multimodal plan of care

Eligibility Criteria

• Age: 75 Years - 110 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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);
• Cancer requiring treatment in the past 3 years, except for non-melanoma skin cancers or cancers that have an excellent prognosis (e.g., the early stage breast or prostate cancer);
• Respiratory insufficiency requiring regular use of supplemental oxygen;
• Recent (\< 6 months) myocardial infarction;
• Class IV NYHA heart failure;
• Severe chronic kidney disease (stage V, dialysis);
• Decompensated liver cirrhosis;
• Inability or unwillingness to provide informed consent.

Sponsors & Collaborators

• University of Cagliari: lead
• University of Milano Bicocca: collaborator
• Università degli Studi di Ferrara: collaborator

Study Sites (2)

Azienda Ospedaliero-Universitaria di Cagliari

Cagliari, Cagliari, 09124, Italy

RECRUITING

Azienda Ospedaliero-Universitaria

Cagliari, Cagliari, 09124, Italy

RECRUITING

Related Publications (14)

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  PMID: 16696738 BACKGROUND

• Volpato S, Bianchi L, Lauretani F, Lauretani F, Bandinelli S, Guralnik JM, Zuliani G, Ferrucci L. Role of muscle mass and muscle quality in the association between diabetes and gait speed. Diabetes Care. 2012 Aug;35(8):1672-9. doi: 10.2337/dc11-2202. Epub 2012 May 17.

  PMID: 22596176 BACKGROUND

• Pavasini R, Guralnik J, Brown JC, di Bari M, Cesari M, Landi F, Vaes B, Legrand D, Verghese J, Wang C, Stenholm S, Ferrucci L, Lai JC, Bartes AA, Espaulella J, Ferrer M, Lim JY, Ensrud KE, Cawthon P, Turusheva A, Frolova E, Rolland Y, Lauwers V, Corsonello A, Kirk GD, Ferrari R, Volpato S, Campo G. Short Physical Performance Battery and all-cause mortality: systematic review and meta-analysis. BMC Med. 2016 Dec 22;14(1):215. doi: 10.1186/s12916-016-0763-7.

  PMID: 28003033 BACKGROUND

• Volpato S, Cavalieri M, Sioulis F, Guerra G, Maraldi C, Zuliani G, Fellin R, Guralnik JM. Predictive value of the Short Physical Performance Battery following hospitalization in older patients. J Gerontol A Biol Sci Med Sci. 2011 Jan;66(1):89-96. doi: 10.1093/gerona/glq167. Epub 2010 Sep 22.

  PMID: 20861145 BACKGROUND

• Penninx BW, Ferrucci L, Leveille SG, Rantanen T, Pahor M, Guralnik JM. Lower extremity performance in nondisabled older persons as a predictor of subsequent hospitalization. J Gerontol A Biol Sci Med Sci. 2000 Nov;55(11):M691-7. doi: 10.1093/gerona/55.11.m691.

  PMID: 11078100 BACKGROUND

• Guralnik JM, Ferrucci L, Simonsick EM, Salive ME, Wallace RB. Lower-extremity function in persons over the age of 70 years as a predictor of subsequent disability. N Engl J Med. 1995 Mar 2;332(9):556-61. doi: 10.1056/NEJM199503023320902.

  PMID: 7838189 BACKGROUND

• American Diabetes Association Professional Practice Committee. 13. Older Adults: Standards of Care in Diabetes-2024. Diabetes Care. 2024 Jan 1;47(Suppl 1):S244-S257. doi: 10.2337/dc24-S013.

  PMID: 38078580 BACKGROUND

• Boyd CM, Leff B, Wolff JL, Yu Q, Zhou J, Rand C, Weiss CO. Informing clinical practice guideline development and implementation: prevalence of coexisting conditions among adults with coronary heart disease. J Am Geriatr Soc. 2011 May;59(5):797-805. doi: 10.1111/j.1532-5415.2011.03391.x.

  PMID: 21568950 BACKGROUND

• Davies MJ, Aroda VR, Collins BS, Gabbay RA, Green J, Maruthur NM, Rosas SE, Del Prato S, Mathieu C, Mingrone G, Rossing P, Tankova T, Tsapas A, Buse JB. 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). Diabetologia. 2022 Dec;65(12):1925-1966. doi: 10.1007/s00125-022-05787-2. Epub 2022 Sep 24.

  PMID: 36151309 BACKGROUND

• Laiteerapong N, Karter AJ, Liu JY, Moffet HH, Sudore R, Schillinger D, John PM, Huang ES. Correlates of quality of life in older adults with diabetes: the diabetes & aging study. Diabetes Care. 2011 Aug;34(8):1749-53. doi: 10.2337/dc10-2424. Epub 2011 Jun 2.

  PMID: 21636795 BACKGROUND

• McClintock MK, Dale W, Laumann EO, Waite L. Empirical redefinition of comprehensive health and well-being in the older adults of the United States. Proc Natl Acad Sci U S A. 2016 May 31;113(22):E3071-80. doi: 10.1073/pnas.1514968113. Epub 2016 May 16.

  PMID: 27185911 BACKGROUND

• Barnett K, Mercer SW, Norbury M, Watt G, Wyke S, Guthrie B. Epidemiology of multimorbidity and implications for health care, research, and medical education: a cross-sectional study. Lancet. 2012 Jul 7;380(9836):37-43. doi: 10.1016/S0140-6736(12)60240-2. Epub 2012 May 10.

  PMID: 22579043 BACKGROUND

• Forman DE, Arena R, Boxer R, Dolansky MA, Eng JJ, Fleg JL, Haykowsky M, Jahangir A, Kaminsky LA, Kitzman DW, Lewis EF, Myers J, Reeves GR, Shen WK; American Heart Association Council on Clinical Cardiology; Council on Cardiovascular and Stroke Nursing; Council on Quality of Care and Outcomes Research; and Stroke Council. Prioritizing Functional Capacity as a Principal End Point for Therapies Oriented to Older Adults With Cardiovascular Disease: A Scientific Statement for Healthcare Professionals From the American Heart Association. Circulation. 2017 Apr 18;135(16):e894-e918. doi: 10.1161/CIR.0000000000000483. Epub 2017 Mar 23.

  PMID: 28336790 BACKGROUND

• Kirkman MS, Briscoe VJ, Clark N, Florez H, Haas LB, Halter JB, Huang ES, Korytkowski MT, Munshi MN, Odegard PS, Pratley RE, Swift CS. Diabetes in older adults. Diabetes Care. 2012 Dec;35(12):2650-64. doi: 10.2337/dc12-1801. Epub 2012 Oct 25. No abstract available.

  PMID: 23100048 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

Geriatric Assessment

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Status; Demography; Population Characteristics; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Epidemiologic Measurements; Public Health; Environment and Public Health

Central Study Contacts

Angelo Scuteri, MD PhD

CONTACT

+393334564136; angelo.scuteri@unica.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full Professor of Internal Medicine, University of Cagliari (Italy) - Director Internal Medicine Unit, University Hospital, Cagliari (Italy)

Study Record Dates

• First Submitted: January 29, 2025
• First Posted: February 24, 2025
• Study Start: February 3, 2025
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: February 24, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

IT (2)