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Completed

NCT Number: NCT02086981

The DETEcT Study - Delirium in Elderly paTiEnts Admitted to Trauma

Primary objectives are to define incidence and prevalence of Delirium in an elderly population admitted to the Department of Orthopedics and Traumatology and, in the postoperative phase, in the high Dependency Unit as well as to determine the presence of risk factors. Secondary objectives are to determine mean hospital stay, rates of complications as well as in-hospital mortality and at 1-3 and 12 months after discharge, functional recovery and cognitive outcomes at 1, 3 and 12 moths follow-up.

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Key information

Age range

65 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

C.T.O. Azienda Ospedaliero-Universitaria Careggi

Florence, 50134, Italy

About this study

The aging of population as well as the increased life expectancy put progressively urgent demands about the adequacy of the level of care provided in a hospital environment to ensure clinical pathways tailored on the needs of each individual patient. On the other hand, the gradual evolution of Health Care systems to care for the acute, with increasing levels of specialization often technologically driven, cannot and must not neglect these aspects of personalization of care protecting the elderly "frail" patient, because of its intrinsic characteristics. In such a context, evaluation of frailty undertakes not only the meaning of prevention and promotion of quality of life but it takes in account important issues for patient's safety and the economic weight it entails. Delirium (acute confusional state) is a complex syndrome which frequently occurs in the elderly hospitalized population. Development of Delirium is associated with negative outcomes such as a longer hospital stay, a higher rate of complications, cognitive and functional decline, loss of independence, institutionalization, and, ultimately, death. For skilled healthcare professionals, on the other hand, it represents a challenging condition because a prompt and accurate diagnosis with the introduction of all those prevention and non-pharmacological measures may reduce the incidence, severity and/or duration of Delirium and improve functional recovery. Therefore the meaning of conducting such an observational study is also to provide evidence of patients' needs and address the on-ground educational aspect for healthcare professionals in a daily practice. The purposes of the study are to determine the incidence and prevalence (before and after surgery) of Delirium in an elderly population admitted to the Department of Orthopedics and Traumatology and in the High Dependency Unit in the postoperative phase as well as to determine the risk factors for developing such a condition. Secondary objectives are mean hospital stay, rates of complications as well as in-hospital mortality and at 1, 3 and 12 months after discharge, functional recovery and cognitive outcomes at 1, 3 and 12 months follow-up.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with any medical condition with an age of 65 years and older

Exclusion criteria

  • Impossibility to give an informed consent; refusal

Treatment and study plan

Primary outcomes

  1. Prevalence of Delirium, its association with risk factors and their prognostic value

    Time frame: At hospital admission

    Patients are evaluated on admission with:

    • IqCode
    • Katz Index of Independence in Activities of Daily Living (ADL)
    • The Lawton Instrumental Activities of Daily Living (IADL) Scale
    • The Barthel Index for Mobility
    • The Confusion Assessment Method (CAM)
    • The 4AT Scale
    • Presence of Risk Factors
  2. Incidence of Delirium, its association with risk factors and their prognostic value

    Time frame: At hospital admission and for the next 48 hours

    Detection of any change in clinical condition. Patients are evaluated with:

    • The Confusion Assessment Method (CAM)
    • The 4AT Scale
  3. Incidence of Delirium, its association with risk factors and their prognostic value

    Time frame: After surgery and for the next 48 hours

    Detection of any change in clinical condition. Patients are evaluated with:

    • The Confusion Assessment Method (CAM)
    • The 4AT Scale

Secondary outcomes

  1. Mortality rates

    Time frame: In-Hospital

  2. Mortality rates

    Time frame: At 1,3 and 12 months follow-up

  3. Mean Hospital Stay

    Time frame: In-Hospital

  4. Clinical Complications

    Time frame: In-Hospital

  5. Changes in functional capabilities

    Time frame: At 1, 3 and 12 months follow-up

    Patients are evaluated with:

    • Katz Index of Independence in Activities of Daily Living (ADL)
    • The Lawton Instrumental Activities of Daily Living (IADL) Scale
    • The Barthel Index for Mobility

Other outcomes

  1. Variations of serum cystatin C as a marker of glomerular filtration rate and its association with the development of Delirium

    Time frame: At hospital admission and on the fifth day of hospitalization

Sponsors and collaborators

Lead sponsor

Azienda Ospedaliero-Universitaria Careggi

Other

Registry information

Acronym: DETEcT

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Mar 14, 2014
Registry last updated
Dec 29, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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