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NCT07727811

Frailty Syndrome and Its Associated Factors Among Elderly Patients

Sponsor: Assiut University

View on ClinicalTrials.gov

Summary

This is a cross-sectional analytical study conducted among elderly patients attending Assiut university hospital. 2.4. 2- Study Setting:The study will be conducted in Assiut University hospital, including outpatients and inpatients who fulfill inclusion criteria. 2.4. 3- Study subjects: * a. Inclusion criteria: * Age ≥ 60 years * Patient attending Assiut university hospital during the study period, regardless primary diagnosis. * Ability to provide informed consent and agreed to participate in the study. * Ability to communicate and answer the study questionnaire. * b. Exclusion criteria: * Age \< 60 years * Patients admitted for elective surgical procedures or transferred from surgical wards * Patients with a terminal illness or those receiving palliative/end-of-life care only * Patients with incomplete medical records or inability to complete the assessment due to severe aphasia or critical hemodynamic instability * Patients with severe cognitive impairment or psychiatric disorders affecting communication. * Patients who refused to participate c. Sample Size Calculation: Based on determining the main outcome variable, the estimated minimum required sample size is 175 patients. The sample size was calculated using Epi-Info version 7 software, based on the following assumptions: Based on a previous study by Perez-Zepeda et al. (2023)(3), which reported a frailty prevalence of approximately 42% among hospitalized elderly patients using the Frailty Index with a deficit accumulation approach, Based on a confidence level of 90% and an absolute precision (confidence limit) of 5%. 2.4.4 Study tools: The study will be done by using a semi structured questionnaire that will include four sections as follows: Section I: Sociodemographic and Clinical Data Sheet: A structured interviewer-administered data collection form will be used to record baseline sociodemographic and clinical characteristics of all enrolled patients. This will include age, sex, level of education, marital status, and place of residence. Clinical data will encompass the primary diagnosis on admission, all documented comorbidities, total number of regular medications (polypharmacy defined as the concurrent use of five or more medications), smoking history, and the number of hospital admissions within the preceding 12 months. Section II: The 30-Item Frailty Index (FI): Frailty will be assessed using a 30-item Frailty Index (FI) constructed in accordance with the deficit accumulation model originally proposed by Rockwood and Mitnitski. This model conceptualizes frailty as the cumulative burden of age-related health deficits across multiple physiological domains. Each deficit is coded as 0 (absent) or 1 (present); where a deficit is gradable in severity, an intermediate score of 0.5 is assigned. The FI is calculated by the following formula: FI="Number of deficits present" /30 Participants are subsequently classified into three frailty categories according to their FI score: FI Score Frailty Category \< 0.10 Robust 0.10 - 0.24 Pre-frail ≥ 0.25 Frail Section III. Physical examination and Anthropometric Measurements: All participants will undergo a comprehensive physical examination including assessment of vital signs (blood pressure, pulse rate, respiratory rate, and body temperature), anthropometric measurements (weight, height and body mass index), and a systematic clinical examination relevant to the study objectives. * Body weight will be measured using calibrated digital scales, with the patient wearing light clothing and no shoes * Height will be measured using a wall-mounted stadiometer * BMI will be calculated accordingly Findings will be recorded in a standardized data collection sheet. Section IV. Laboratory Investigations: The following investigations will be collected from the routine admission workup or ordered as part of the study protocol: * Complete blood count (CBC) for hemoglobin and hematocrit * Serum albumin measured by colorimetric bromocresol green (BCG) method * Random blood glucose for diabetes assessment

Official title: Frailty Syndrome and Its Associated Factors Among Elderly Patients Attending Assiut University Hospitals

Key Details

Gender

All

Age Range

60 Years - Any

Study Type

OBSERVATIONAL

Enrollment

175

Start Date

2026-07-20

Completion Date

2027-07-20

Last Updated

2026-07-27

Healthy Volunteers

No