Ignite Creation Date:
2025-12-24 @ 12:12 PM
Ignite Modification Date:
2025-12-27 @ 10:38 PM
Study NCT ID:
NCT01584661
Status:
UNKNOWN
Last Update Posted:
2012-04-25
First Post:
2012-04-24
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Continuity of Nutritional Care Among Elderly Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2012-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-04', 'lastUpdateSubmitDate': '2012-04-24', 'studyFirstSubmitDate': '2012-04-24', 'studyFirstSubmitQcDate': '2012-04-24', 'lastUpdatePostDateStruct': {'date': '2012-04-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-04-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Primary: Compliance with nutritional recommendations'}], 'secondaryOutcomes': [{'measure': 'Health status'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Continuity of Nutritional Care', 'Health Care Use', 'Nutritional Status']}, 'descriptionModule': {'briefSummary': 'Objectives:\n\n1. To determine the level of compliance with nutritional recommendations (dietary and nutritional supplements) following discharge from hospitalization;\n2. To identify barriers for post-discharge adherence to professional nutritional recommendations;\n3. To determine the impact of adherence (high vs. low) to the nutritional treatment guidelines on functional and health indicators.\n\nWorking hypothesis:\n\nHigh adherence to nutritional care after hospitalization will be associated with better functional and health outcomes.', 'detailedDescription': 'The proposed study will follow patients who were hospitalized in the rehabilitation departments at "Bait Balev". Patients who were treated with nutritional supplements by a dietitian during hospitalization and received dietary recommendations upon discharge will be followed for their adherence with the treatment recommendations. The impact of the level of adherence to the nutritional recommendations on health will be assessed.\n\nC2. Experimental design:\n\nThis shall be a retrospective and prospective cohort study. Patients from the orthopedic and neurologic rehabilitation departments, who received nutritional intervention by nutritional supplements during hospitalization and were advised to receive nutritional enrichment at discharge, will be enrolled to the study. The main criteria for nutritional intervention during hospitalization and recommendation for supplements upon discharge include, among others, withdrawal of alternative nourishment, underweight, undernutrition, non-voluntary weight loss, low protein status and other criteria typical among this population during hospitalization. In order to assess the level of compliance with dietitian\'s recommendations upon discharge, only patients who were discharged to their homes will be followed. In order to increase the sample size, a retrospective cohort study will be conducted, in which patients from the same departments who were discharged in the last 3 months will be followed both retrospectively and prospectively.\n\nHome visits will take place 3 and 6 months after discharge, during which the dietitian shall complete a questionnaire measuring the level of patient compliance to the nutritional recommendations, and in addition the patient or their legal guardian shall provide anamnesis in order to review the effect of compliance on health, functional, nutritional and social status (it should be noted that approx. 90% of the patients in the hospital belong to the Maccabi Health Care Services group, so the follow up of discharged patients in the community will be conducted with Maccabi Health Care Services).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'maximumAge': '95 Years', 'minimumAge': '65 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Study population Patients over the age of 65 who are members of Maccabi Health Care Services will be recruited for the current study. The Inclusion criteria comprise patients who were treated nutritionally with food enrichment supplements during their hospitalization in "Bait Balev" and were discharged to their homes with dietary recommendations. Participants who are willing to participate will sign an informed consent form. For patients with cognitive impairment or dementia, as reported in their medical records, their formal primary caregiver or proxy will sign the informed consent form.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:comprise patients who were treated nutritionally with food enrichment supplements during their hospitalization in "Bait Balev" and were discharged to their homes with dietary recommendations. Participants who are willing to participate will sign an informed consent form. For patients with cognitive impairment or dementia, as reported in their medical records, their formal primary caregiver or proxy will sign the informed consent form.\n\n\\-\n\nExclusion Criteria:\n\n* 1\\. Patients who were discharged to a Retirement home; 2. Palliative patients; 3. Patients who are not members of Maccabi Health Care Services. 4. Patients with enteral nutrition (PZ / PEG / PEJ)'}, 'identificationModule': {'nctId': 'NCT01584661', 'briefTitle': 'The Continuity of Nutritional Care Among Elderly Patients', 'organization': {'class': 'OTHER', 'fullName': 'Bait Balev Hospital'}, 'officialTitle': 'The Continuity of Nutritional Care From the Hospital to the Community and Its Impact on Health and Functional Indicators Among Elderly Patients', 'orgStudyIdInfo': {'id': 'ABB-1-2012'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Compliance with nutritional care', 'description': 'The Inclusion criteria comprise patients who were treated nutritionally with food enrichment supplements during their hospitalization in "Bait Balev" and were discharged to their homes with dietary recommendations. Participants who are willing to participate will sign an informed consent form. For patients with cognitive impairment or dementia, as reported in their medical records, their formal primary caregiver or proxy will sign the informed consent form.', 'interventionNames': ['Behavioral: Dietary recommendations']}], 'interventions': [{'name': 'Dietary recommendations', 'type': 'BEHAVIORAL', 'armGroupLabels': ['Compliance with nutritional care']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Bat Yam', 'country': 'Israel', 'contacts': [{'name': 'Yulia Ginzburgh, RD', 'role': 'CONTACT', 'email': 'yulia_ginzburg@walla.com', 'phone': '972526885631'}], 'facility': 'Bait Balev', 'geoPoint': {'lat': 32.02379, 'lon': 34.75185}}, {'city': 'Bat Yam', 'country': 'Israel', 'contacts': [{'name': 'Yulia Ginzburgh, RD', 'role': 'CONTACT', 'email': 'yulia_ginzburg@walla.com', 'phone': '972526885631'}, {'name': 'Danit R Shahar, PhD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Bait Balev', 'geoPoint': {'lat': 32.02379, 'lon': 34.75185}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bait Balev Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Ben-Gurion University of the Negev', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof', 'investigatorFullName': 'Danit R Shahar', 'investigatorAffiliation': 'Ben-Gurion University of the Negev'}}}}