- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07727811
Frailty Syndrome and Its Associated Factors Among Elderly Patients (Frailty)
Frailty Syndrome and Its Associated Factors Among Elderly Patients Attending Assiut University Hospitals
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
연구 개요
상태
정황
상세 설명
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
The 30 deficits are distributed across six sections as follows:
Section A: Chronic Diseases (10 items) The presence of each chronic disease is confirmed through a combination of patient interview, review of medical records, and available investigation results. The ten items are: hypertension (diagnosed and/or on antihypertensive therapy); diabetes mellitus (diagnosed and/or on antidiabetic treatment); ischemic heart disease (confirmed by electrocardiography, echocardiography, or documented medical history); heart failure (diagnosed clinically and/or by echocardiographic assessment of ejection fraction); atrial fibrillation (confirmed on 12-lead ECG or Holter monitoring); prior stroke or transient ischemic attack (documented cerebrovascular event in the medical record); chronic obstructive pulmonary disease or chronic lung disease (diagnosed by spirometry or clinical assessment); chronic kidney disease (estimated glomerular filtration rate below 60 mL/min/1.73m² for more than three months); chronic liver disease (confirmed by clinical, laboratory, or imaging findings); and active or prior malignancy (confirmed by histopathological report or documented in the clinical record).
Section B: General Symptoms (5 items):
These items are assessed through a structured patient interview. They include: unintentional weight loss, defined as a loss of more than 4.5 kg or more than 5% of body weight over the preceding year; persistent fatigue, defined as self-reported fatigue present most of the time for a duration of three or more months; chronic pain, defined as pain persisting beyond three months and requiring regular analgesia or limiting daily activity; dyspnea on exertion, graded using the Modified Medical Research Council (mMRC) Dyspnea Scale with a score of 2 or above considered positive; and poor appetite, defined as self-reported reduction in food intake over the preceding month.
Section C: Basic Activities of Daily Living - ADL (5 items):
Functional status with respect to basic self-care activities will be assessed using the Katz Activities of Daily Living (ADL) Scale. Dependency in any of the following activities will be coded as 1 (dependent) versus 0 (independent): bathing, dressing, toileting, transferring from bed to chair, and feeding. Pre-admission functional status will be recorded based on patient or caregiver recall to reflect the patient's baseline prior to the acute illness.
Section D: Instrumental Activities of Daily Living - IADL (4 items):
Higher-order functional independence will be assessed using the Lawton Instrumental Activities of Daily Living (IADL) Scale. The four items assessed are: ability to use a telephone, ability to shop, ability to prepare meals, and ability to manage medications. Each item is coded as 0 (independent) or 1 (dependent).
Section E: Cognition and Mood (3 items):
Cognitive status will be evaluated using the Mini-Mental State Examination (MMSE); a score below 24 will be coded as cognitive impairment (1). Depressive symptoms will be screened using the 15-item Geriatric Depression Scale (GDS-15); a score of 6 or above will be coded as depression (1). Subjective memory complaint, defined as self-reported difficulty with memory not fully captured by formal cognitive testing, will be recorded separately and coded as 0 (absent) or 1 (present).
Section F: Physical and Laboratory Indicators (3 items):
Three objectively measured indicators will be included. Anemia is defined according to World Health Organization (WHO) criteria as a hemoglobin level below 13 g/dL in men and below 12 g/dL in women, determined from the admission complete blood count. Hypoalbuminemia is defined as a serum albumin level below 3.5 g/dL, measured using the colorimetric bromocresol green (BCG) method on the admission blood sample. Abnormal body mass index (BMI) is defined as BMI below 18.5 kg/m² (underweight) or 30 kg/m² and above (obese); body weight will be measured using a calibrated digital scale with the patient in light clothing and without footwear, and height will be measured using a wall-mounted stadiometer.
연구 유형
등록 (추정된)
연락처 및 위치
연구 연락처
- 이름: Asma Ahmed Rafat, specialist
- 전화번호: +201030533071
- 이메일: asmaacc@yahoo.com
연구 연락처 백업
- 이름: Dalia Galal Mahran, professor
- 전화번호: +201007120821
- 이메일: Daliaym2001@yahoo.com
참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
샘플링 방법
연구 인구
설명
- 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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
|---|
|
• Patient attending Assiut university hospital during the study period aged above 60 years
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
• Prevalence of frailty syndrome
기간: Baseline
|
• Prevalence of frailty syndrome among elderly patients attending Assiut university hospital, defined as FI ≥ 0.25
|
Baseline
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Socio-demographic characteristics associated with frailty syndrome
기간: Baseline
|
Assessment of age, gender, education level, living arrangement, and marital status collected via a structured questionnaire
|
Baseline
|
공동 작업자 및 조사자
수사관
- 연구 책임자: Dalia Galal Mahran, professor, Professor at Public Health and community medicine Department, Head of Family medicine department
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
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개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
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미국 FDA 규제 기기 제품 연구
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