Geriatric AssessmentFrailtyNCT07727811
Frailty Syndrome and Its Associated Factors Among Elderly Patients
An observational study of Geriatric Assessment, run by Assiut University.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Geriatric Assessment
- How many people
- 175 participants
- Where
- No sites listed yet
- Study dates
- 20 Jul 2026to 20 Jul 2027
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: elderly patients attending Assiut university hospital, including outpatients and inpatients who fulfill inclusion criteria.
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
Read more
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
- 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
Read the detailed description
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.
- Conditions
- Geriatric Assessment
- Keywords
- Frailty syndrome
- Medical subject headings
- Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| • Patient attending Assiut university hospital during the study period aged above 60 years | * 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
• Prevalence of frailty syndrome
- Prevalence of frailty syndrome among elderly patients attending Assiut university hospital, defined as FI ≥ 0.25
Measured: Baseline
Secondary outcomes (1)
Socio-demographic characteristics associated with frailty syndrome
Assessment of age, gender, education level, living arrangement, and marital status collected via a structured questionnaire
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2026
- Study start20 Jul 2026 (estimated)
- Primary completion20 Jul 2027 (estimated)
- Study completion20 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Geriatric AssessmentStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 175 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Asma Ahmed Rafat Najeeb, Assiut University
- Investigators
- Dalia Galal Mahran, professor, Study director, Professor at Public Health and community medicine Department, Head of Family medicine department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07727811
- Sponsor's protocol ID
- Frailty Syndrome
- Acronym
- Frailty
- Status last verified
- Jul 2026
- First submitted
- 2 Jul 2026
- Last updated
- 27 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Frailty Syndrome and Its Associated Factors Among Elderly Patients Attending Assiut University Hospitals
- ClinicalTrials.gov ID
- NCT07727811
- Acronym / sponsor ID
- Frailty / Frailty Syndrome
- Conditions
- Geriatric Assessment
- Keywords
- Frailty syndrome
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 175 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 20 Jul 2026 (estimated)
- Primary completion
- 20 Jul 2027 (estimated)
- Study completion
- 20 Jul 2027 (estimated)
- First posted
- 27 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- 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
Detailed description
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.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| • Patient attending Assiut university hospital during the study period aged above 60 years | – | –* 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 |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- elderly patients attending Assiut university hospital, including outpatients and inpatients who fulfill inclusion criteria.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
• Prevalence of frailty syndrome
Time frame: Baseline
• Prevalence of frailty syndrome among elderly patients attending Assiut university hospital, defined as FI ≥ 0.25
1 secondary outcome
Socio-demographic characteristics associated with frailty syndrome
Time frame: Baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Dalia Galal Mahran, professor study director
Professor at Public Health and community medicine Department, Head of Family medicine department
Questions about this trial
What is this clinical trial studying?
An observational study of Geriatric Assessment, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 27 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Asma Ahmed Rafat, specialist (+201030533071, asmaacc@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
• Prevalence of frailty syndrome (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2026.