Ignite Creation Date:
2026-03-26 @ 3:15 PM
Ignite Modification Date:
2026-03-30 @ 3:55 AM
Study NCT ID:
NCT07473492
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-16
First Post:
2026-03-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Assessment of Malnutrition in Hospitalized Patients: a Quasi Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D029424', 'term': 'Pulmonary Disease, Chronic Obstructive'}], 'ancestors': [{'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015596', 'term': 'Nutrition Assessment'}, {'id': 'D000090143', 'term': 'Medication Review'}], 'ancestors': [{'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D015991', 'term': 'Epidemiologic Measurements'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}, {'id': 'D008509', 'term': 'Medication Systems'}, {'id': 'D009934', 'term': 'Organization and Administration'}, {'id': 'D006298', 'term': 'Health Services Administration'}, {'id': 'D010346', 'term': 'Patient Care Management'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}, 'targetDuration': '1 Month', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-04-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2026-09-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-11', 'studyFirstSubmitDate': '2026-03-11', 'studyFirstSubmitQcDate': '2026-03-11', 'lastUpdatePostDateStruct': {'date': '2026-03-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-08-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'oint Prevalence of Malnutrition using GLIM Criteria and NRS-2002', 'timeFrame': 'Within 48 hours of hospital admission', 'description': 'The primary goal is to determine the prevalence of malnutrition among hospitalized adult patients in Al-Basrah Teaching Hospital and Al-Fayhaa General Hospital. All participants are first screened using the Nutritional Risk Screening (NRS-2002). For those identified as "at risk" (score $\\\\ge$ 3), a definitive diagnosis is made using the Global Leadership Initiative on Malnutrition (GLIM) criteria. Diagnosis requires at least one phenotypic criterion (non-volitional weight loss, low BMI, or reduced muscle mass) and one etiologic criterion (reduced food intake/malabsorption or disease-related inflammation/chronic illness, such as COPD or critical illness in the Neurology ICU). The prevalence will be reported as the percentage of the total cohort meeting the GLIM diagnostic threshold.'}, {'measure': 'Point Prevalence of Malnutrition using GLIM Criteria , NRS2002', 'timeFrame': 'Within 48 hours of hospital admission.', 'description': 'The primary goal is to determine the prevalence of malnutrition among hospitalized adult patients in Al-Basrah Teaching Hospital and Al-Fayhaa General Hospital. All participants are first screened using the Nutritional Risk Screening (NRS-2002). For those identified as "at risk" (score $\\\\ge$ 3), a definitive diagnosis is made using the Global Leadership Initiative on Malnutrition (GLIM) criteria. Diagnosis requires at least one phenotypic criterion (non-volitional weight loss, low BMI, or reduced muscle mass) and one etiologic criterion (reduced food intake/malabsorption or disease-related inflammation/chronic illness, such as COPD or critical illness in the Neurology ICU). The prevalence will be reported as the percentage of the total cohort meeting the GLIM diagnostic threshold.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Hospital Malnutrition , Nutritional Risk Screening ,GLIM Criteria', 'Medication-Related Problems (MRPs'], 'conditions': ['COPD , Neurology , ICU', 'Alzheimer', 'Alzheimer s Disease']}, 'referencesModule': {'availIpds': [{'id': 'mawjali92@gmail.com', 'url': 'https://pharmacy.uobasrah.edu.iq/', 'type': 'Study Protocol', 'comment': '"This research is a prospective, cross-sectional observational study conducted as part of a Master\'s degree in Clinical Pharmacy.'}], 'references': [{'pmid': '38007257', 'type': 'BACKGROUND', 'citation': 'Azzolino D, Lucchi T. Malnutrition in older adults: a wider view. Lancet. 2023 Nov 25;402(10416):1976. doi: 10.1016/S0140-6736(23)01780-4. No abstract available.'}], 'seeAlsoLinks': [{'url': 'https://www.espen.org/guidelines/', 'label': 'The leading international body for clinical nutrition. This link provides the guidelines for the NRS-2002 screening tool and nutrition in the ICU, which are the foundations of the AMMRP protocol.'}]}, 'descriptionModule': {'briefSummary': 'Malnutrition among hospitalized patients is a critical, yet often overlooked, public health issue associated with increased complications, longer hospital stays, higher mortality, and greater healthcare costs. In Iraq, factors such as dietary patterns, the burden of chronic diseases, and healthcare constraints may increase the risk of hospital-acquired malnutrition. Current standard care may not include systematic nutritional screening or protocol-driven support. This trial aims to test whether implementing an individualized nutritional support program can improve clinical outcomes for at-risk medical inpatients in Iraqi hospitals, building upon evidence from international studies'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "The study population consists of hospitalized adult patients admitted to Al-Basrah Teaching Hospital and Al-Fayhaa General Hospital in Basra, Iraq. The cohort primarily includes individuals admitted to the Medical wards, Surgical wards, and the Neurology Intensive Care Unit (ICU).\n\nThis population represents a diverse clinical spectrum, with a particular focus on patients suffering from chronic inflammatory conditions and neurodegenerative disorders, specifically Chronic Obstructive Pulmonary Disease (COPD) and Alzheimer's Disease. The population is characterized by varying levels of nutritional risk and complex pharmacotherapy regimens (polypharmacy). Participants are recruited within the first 48 hours of admission to capture point-prevalence data. The demographic includes both males and females aged 18 years and older, representing the urban and suburban population served by the Basra Health Directorate.", 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age: Adult patients aged $\\\\ge$ 18 years.Setting: Patients admitted to the Medicine, Surgery, or Neurology Intensive Care Unit (ICU) wards at Al-Basrah Teaching Hospital or Al-Fayhaa General Hospital.Duration of Stay: Patients who have been hospitalized for a minimum of 48 hours (to ensure a baseline for malnutrition screening and medication review).Clinical Conditions: Patients with various primary diagnoses, including specific subgroups with Chronic Obstructive Pulmonary Disease (COPD) and Alzheimer's Disease.Informed Consent: Patients or their legal guardians (especially for those in the ICU or with cognitive impairment) who provide written or verbal informed consent.\n\nExclusion Criteria:\n\n* Maternity/Obstetrics: Pregnant or lactating women, as nutritional requirements and physiological BMI changes differ from the general adult population.\n\nTerminal Illness: Patients in end-of-life or palliative care where nutritional intervention is no longer a clinical goal.\n\nIncomplete Records: Patients with missing medical or medication charts that prevent the accurate identification of Medication-Related Problems (MRPs).\n\nShort Stay: Patients planned for discharge or transfer within less than 48 hours of admission.\n\nPsychiatric Disorders: Patients with primary psychiatric diagnoses that may interfere with the ability to conduct nutritional assessments (unless a guardian is present)."}, 'identificationModule': {'nctId': 'NCT07473492', 'acronym': 'AMMRP', 'briefTitle': 'Assessment of Malnutrition in Hospitalized Patients: a Quasi Study', 'organization': {'class': 'OTHER', 'fullName': 'AlFayhaa General Hospital'}, 'officialTitle': 'Assessment of Malnutrition in Hospitalized Patients: a Quasi Study', 'orgStudyIdInfo': {'id': 'hospitalized malnutrition'}, 'secondaryIdInfos': [{'id': 'AMMRP-2026-BASRA', 'type': 'OTHER', 'domain': 'University of Basrah , College of Pharmacy'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Hospitalized Adults in Basrah', 'description': 'This cohort consists of 200 adult patients (age \\> 18 years) admitted to the Medicine, Surgery, and Neurology ICU wards of Al-Basrah Teaching Hospital and Al-Fayhaa General Hospital.', 'interventionNames': ['Other: Nutritional Assessment and Medication Review']}], 'interventions': [{'name': 'Nutritional Assessment and Medication Review', 'type': 'OTHER', 'otherNames': ['NRS-2002 and GLIM-based Nutritional Assessment', 'Point Prevalence Malnutrition Screening'], 'description': 'Intervention Description"This observational intervention consists of a multi-disciplinary clinical assessment conducted in three distinct phases for each enrolled participant:Validated Two-Step Nutritional Evaluation: Unlike standard hospital screening, this study uses the Nutritional Risk Screening (NRS-2002) as an initial filter. Patients identified as \'at risk\' (score $\\\\ge$ 3) are immediately subjected to the Global Leadership Initiative on Malnutrition (GLIM) criteria. This provides a definitive diagnosis by combining phenotypic criteria (non-volitional weight loss, low BMI, or reduced muscle mass) with etiologic criteria (reduced food intake/malabsorption or disease-related inflammation/chronic illness).Specialized Comorbidity Analysis: The assessment specifically targets the impact of Chronic Obstructive Pulmonary Disease (COPD) and Alzheimer\'s Disease on nutritional status, evaluating how respiratory hypermetabolism and cognitive impairment act as independent drivers of malnutri', 'armGroupLabels': ['Hospitalized Adults in Basrah']}, {'name': 'Nutritional Assessment and Medication Review', 'type': 'OTHER', 'otherNames': ['NRS-2002 and GLIM-based Nutritional Assessment', 'Point Prevalence Malnutrition Screening', 'Assessment of Malnutrition and Medication-Related Problems (AMMRP)'], 'description': 'To distinguish your research from a standard hospital audit or a basic nutritional survey, your description must highlight the systematic, two-step diagnostic workflow and the integration of clinical pharmacy oversight.Use the following detailed description for your entry:Intervention Description"This observational intervention consists of a multi-dimensional clinical assessment conducted in three specific phases for each participant:Validated Two-Step Nutritional Protocol: Unlike standard care, which may lack formal screening, this intervention applies the Nutritional Risk Screening (NRS-2002) within 48 hours of admission. Participants identified as \'at risk\' (score $\\\\ge$ 3) are immediately subjected to the Global Leadership Initiative on Malnutrition (GLIM) criteria. This provides a definitive diagnosis by combining phenotypic criteria (non-volitional weight loss, low BMI, or reduced muscle mass) with etiologic criteria (reduced food intake/malabsorption or disease-related inflammati', 'armGroupLabels': ['Hospitalized Adults in Basrah']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'mawj ali Principal Investigator, College of Pharmacy, University of Bas, BPharm', 'role': 'CONTACT', 'email': 'mawjali92@gmail.com', 'phone': '+9647705746266'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': '"Individual Participant Data (IPD) will not be publicly shared to ensure the confidentiality and privacy of the patients recruited from Al-Basrah Teaching and Al-Fayhaa General Hospitals, particularly those in the Neurology ICU and those with sensitive diagnoses like Alzheimer\'s disease. Currently, there is no institutional mandate from the University of Basrah or the Basrah Health Directorate to share raw datasets. However, the aggregate results, statistical summaries, and the final thesis findings will be made available through the university library and potential journal publications. Requests for specific data for meta-analysis may be considered by the principal investigator and supervisor upon reasonable request and formal ethical approval."'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AlFayhaa General Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Basrah', 'class': 'OTHER'}, {'name': 'Ministry of Health, Iraq', 'class': 'NETWORK'}], 'responsibleParty': {'type': 'SPONSOR'}}}}