Assessment of Delirium in Hospitalized Patients
Objective Assessment of Delirium in Hospitalized Patients
調査の概要
状態
条件
詳細な説明
After obtaining written informed consent and Protected Health Information (PHI) consent, CAM-ICU (Confusion Assessment Method for the ICU) will be measured routinely by unit nurses each shift. Results will be available in the medical record. We will then measure physical activity and physiological measures (e.g. ECG, heart rate, respiration rate, and body temperature) using an unobtrusive body worn sensor. This sensor will be attached to the 5th intercostal space using a specifically designed patch (BioPatchTM) to allow quantification of physical activity such as walking, standing, sitting, lying, as well as measurement of other physiological parameters. These measurements will only be available to the research team and will not be available to the nurses on the inpatient study unit. Medical history (from clinic chart) and demographic information will be obtained, such as age, gender, weight, and height as well as details (e.g. injuries, fall score and number of falls) which happened during hospital stay. The research tests consist of one core measurements and one ancillary measurements (as required) as listed below (Note - ancillary measurement may not be required for everyone).
Core measurements Assessment of physical activity and physiological measures: Patients will be asked to wear the Zephyr BioModule for a period of 24 hours to maximum stay in the hospital. The Zephyr BioModule will be attached to the patients to the 5th intercostal space using a specifically designed patch (BioPatchTM).
Ancillary Measurements Upper Extremity Test: A validated body worn sensors (LEGSys™, Biosensics LLC) will be used to evaluate upper extremity kinematics (angular velocities). This is a simple test where the patient flexes and extends their arm for 20 seconds on each arm.
Analysis plan:
To predict the risk of delirium using physical activity and physiological data, each patient participating in the study will be categorized as to presence of delirium based on CAM-ICU questionnaire. Logistic regression analysis will be used to examine the relation between each physical activity variable (e.g. lying time) and physiological measures (e.g. heart rate) with delirium risk. Firstly, univariate logistic regression, using presence of delirium as the dependent variable, will be employed to investigate the relationship of the test variables. The Odd Ratios (OR) and coefficient of determination (R2) will be calculated for each explanatory variable. Then multivariate logistic regression using stepwise-automated methods will be performed to investigate the independent effects of the physical activity variables and physiological measures in predicting delirium. Sensitivities, specificities, positive and negative predictive values of different cut-off values will be calculated for any non-categorical variable shown to have an independent effect on predicting delirium. A two-sided P-value ≤0.05 will be considered to be statistically significant. Statistical analysis will be performed using SPSS (Statistical Package for the Social Sciences) statistics 22.0 (IBM, Armonk (name of town), NY (New York), USA).
研究の種類
入学 (予想される)
連絡先と場所
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
説明
Inclusion Criteria: At least one of the following:
- Cognitive impairment,
- UTI (urinary tract infection)
- Pneumonia,
Status post hip fracture or trauma,
->5 medications,
- Previous hospitalization in past 6 months
Exclusion Criteria:
- Refusal to participate
- Terminally ill
- On ventilator
- Delirium based on CAM-ICU
研究計画
研究はどのように設計されていますか?
デザインの詳細
この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
---|---|---|
Objective Assessment of Delirium in Hospitalized Patients
時間枠:3 years
|
To identify biodata (physiological measurement) patterns indicative of the 3 subtypes of delirium (hypoactive, hyperactive and mixed).
To build an algorithm sensitive and specific to the diagnosis of each of the three subtypes of delirium for future integration into a delirium monitoring system capable of objective delirium diagnosis, concentrating on those patterns indicative of early identification.
|
3 years
|
協力者と研究者
スポンサー
捜査官
- 主任研究者:Jane Mohler, PhD、University of Arizona
出版物と役立つリンク
一般刊行物
- Cole MG. Delirium in elderly patients. Am J Geriatr Psychiatry. 2004 Jan-Feb;12(1):7-21.
- Leslie DL, Zhang Y, Holford TR, Bogardus ST, Leo-Summers LS, Inouye SK. Premature death associated with delirium at 1-year follow-up. Arch Intern Med. 2005 Jul 25;165(14):1657-62. doi: 10.1001/archinte.165.14.1657.
- McCusker J, Cole M, Dendukuri N, Belzile E, Primeau F. Delirium in older medical inpatients and subsequent cognitive and functional status: a prospective study. CMAJ. 2001 Sep 4;165(5):575-83.
- Gleason OC. Delirium. Am Fam Physician. 2003 Mar 1;67(5):1027-34.
- Foreman MD, Wakefield B, Culp K, Milisen K. Delirium in elderly patients: an overview of the state of the science. J Gerontol Nurs. 2001 Apr;27(4):12-20. doi: 10.3928/0098-9134-20010401-06.
- Inouye SK. The dilemma of delirium: clinical and research controversies regarding diagnosis and evaluation of delirium in hospitalized elderly medical patients. Am J Med. 1994 Sep;97(3):278-88. doi: 10.1016/0002-9343(94)90011-6.
- Francis J. Delirium in older patients. J Am Geriatr Soc. 1992 Aug;40(8):829-38. doi: 10.1111/j.1532-5415.1992.tb01859.x. No abstract available.
- Albert MS, Levkoff SE, Reilly C, Liptzin B, Pilgrim D, Cleary PD, Evans D, Rowe JW. The delirium symptom interview: an interview for the detection of delirium symptoms in hospitalized patients. J Geriatr Psychiatry Neurol. 1992 Jan-Mar;5(1):14-21. doi: 10.1177/002383099200500103.
- Trzepacz PT, Baker RW, Greenhouse J. A symptom rating scale for delirium. Psychiatry Res. 1988 Jan;23(1):89-97. doi: 10.1016/0165-1781(88)90037-6.
- O'Keeffe S, Lavan J. The prognostic significance of delirium in older hospital patients. J Am Geriatr Soc. 1997 Feb;45(2):174-8. doi: 10.1111/j.1532-5415.1997.tb04503.x.
研究記録日
主要日程の研究
研究開始
一次修了 (予想される)
研究の完了 (予想される)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
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