Ignite Creation Date:
2025-12-25 @ 2:40 AM
Ignite Modification Date:
2026-01-07 @ 6:31 PM
Study NCT ID:
NCT03072433
Status:
COMPLETED
Last Update Posted:
2022-12-22
First Post:
2017-02-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
An Intervention for Primary Caregivers to Improve Outcomes in Children With Severe Malnutrition
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015362', 'term': 'Child Nutrition Disorders'}], 'ancestors': [{'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D059039', 'term': 'Standard of Care'}], 'ancestors': [{'id': 'D019984', 'term': 'Quality Indicators, Health Care'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D006298', 'term': 'Health Services Administration'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 181}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-12', 'completionDateStruct': {'date': '2020-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-12-21', 'studyFirstSubmitDate': '2017-02-17', 'studyFirstSubmitQcDate': '2017-03-01', 'lastUpdatePostDateStruct': {'date': '2022-12-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-03-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Self Reporting Questionnaire (SRQ-20)', 'timeFrame': '6 months post-discharge from hospital', 'description': 'Mental health of primary caregivers'}, {'measure': 'Home Observation for Measurement of the Environment (HOME) Inventory', 'timeFrame': '6 months post-discharge from hospital', 'description': 'Stimulus and support for children in the household'}, {'measure': 'Primary caregiver knowledge, attitudes, and practices', 'timeFrame': '6 months post-discharge from hospital', 'description': 'Questionnaire with the following modules: hygiene and sanitation, nutrition and feeding with a 24-hour food recall of the child (follow-up only), and malnutrition knowledge and attitudes'}, {'measure': 'Participant engagement', 'timeFrame': 'Day one of the intervention during hospital stay', 'description': 'Attendance of participants on day one of the intervention program'}, {'measure': 'Participant adherence', 'timeFrame': 'Across the four days of the intervention during hospital stay', 'description': 'Attendance of participants on all four days of the intervention program'}], 'primaryOutcomes': [{'measure': 'Malawi Developmental Assessment Tool Score', 'timeFrame': '6 months post-discharge from hospital', 'description': 'Gross motor, fine motor, language, and social development'}], 'secondaryOutcomes': [{'measure': 'Nutritional status based on: mid-upper arm circumference (MUAC)', 'timeFrame': '6 months post-discharge from hospital', 'description': 'MUAC in millimeters'}, {'measure': 'Nutritional status based on: World Health Organization (WHO) z-scores', 'timeFrame': '6 months post-discharge from hospital', 'description': 'Weight-for-length or -height z-scores and height-for-age z-scores'}, {'measure': 'Nutritional status based on: nutritionally-induced bilateral pitting oedema', 'timeFrame': '6 months post-discharge from hospital', 'description': 'Bilateral pitting oedema'}, {'measure': 'Duration of hospital stay', 'timeFrame': 'During hospitalization; up to three days before enrollment until discharge from hospital (e.g., up to 30 days)', 'description': 'Number of days that hospital treatment is required'}, {'measure': 'Appetite', 'timeFrame': 'During hospitalization; up to three days before enrollment until discharge from hospital (e.g., up to 30 days)', 'description': 'Number of days that nasogastric tube is required'}, {'measure': 'Clinical deterioration', 'timeFrame': 'During hospitalization; up to three days before enrollment until discharge from hospital (e.g., up to 30 days)', 'description': 'Number of clinical danger signs'}, {'measure': 'Readmission', 'timeFrame': 'Within 6 months post-discharge from hospital', 'description': 'Requiring inpatient treatment'}, {'measure': 'Mortality', 'timeFrame': 'Within 6 months post-discharge from hospital', 'description': 'Inpatient or post-discharge mortality'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['child malnutrition', 'child development', 'counseling'], 'conditions': ['Child Malnutrition']}, 'referencesModule': {'references': [{'pmid': '34447897', 'type': 'DERIVED', 'citation': 'Daniel AI, Bwanali M, Tenthani JC, Gladstone M, Voskuijl W, Potani I, Ziwoya F, Chidzalo K, Mbale E, Heath A, Bourdon C, Njirammadzi J, van den Heuvel M, Bandsma RHJ. A Mixed-Methods Cluster-Randomized Controlled Trial of a Hospital-Based Psychosocial Stimulation and Counseling Program for Caregivers and Children with Severe Acute Malnutrition. Curr Dev Nutr. 2021 Jul 21;5(8):nzab100. doi: 10.1093/cdn/nzab100. eCollection 2021 Aug.'}, {'pmid': '30258650', 'type': 'DERIVED', 'citation': 'Daniel AI, van den Heuvel M, Gladstone M, Bwanali M, Voskuijl W, Bourdon C, Potani I, Fernandes S, Njirammadzi J, Bandsma RHJ. A mixed methods feasibility study of the Kusamala Program at a nutritional rehabilitation unit in Malawi. Pilot Feasibility Stud. 2018 Sep 24;4:151. doi: 10.1186/s40814-018-0347-8. eCollection 2018.'}, {'pmid': '29149905', 'type': 'DERIVED', 'citation': 'Daniel AI, van den Heuvel M, Voskuijl WP, Gladstone M, Bwanali M, Potani I, Bourdon C, Njirammadzi J, Bandsma RHJ. The Kusamala Program for primary caregivers of children 6-59 months of age hospitalized with severe acute malnutrition in Malawi: study protocol for a cluster-randomized controlled trial. Trials. 2017 Nov 17;18(1):550. doi: 10.1186/s13063-017-2299-3.'}]}, 'descriptionModule': {'briefSummary': 'This cluster-randomized controlled trial will evaluate the effectiveness of a four-day hospital-based intervention program for primary caregivers of children with severe malnutrition.', 'detailedDescription': 'Mortality rates remain high in hospitalized children with severe malnutrition and long-term impairments in child development exist in children that do survive. Hospitalized children with severe malnutrition will be allocated to an intervention or standard of care group in each one-week cycle. The intervention package consists of a counseling and support program that includes three modules: 1) psychosocial stimulation; 2) nutrition and feeding; and 3) water, sanitation and hygiene. Assessments will be done at baseline (t=0) and follow-up (t=6 months). The primary outcome is child development, which will be assessed using the Malawi Developmental Assessment Tool, a validated tool for gross and fine motor, language, and social development.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '5 Years', 'minimumAge': '6 Months', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Child 6-59 months of age with severe malnutrition\n* Child admitted to hospital because of severe malnutritionwith medical complications as defined by the current World Health Organization guidelines or has no appetite if there are no complications\n* Primary caregiver (self-identified) present at hospital.\n\nExclusion Criteria:\n\n* Primary caregiver declined to give informed consent;\n* Child with a known terminal illness (i.e. in the opinion of the treating physician the child is likely to die within six months)\n* Child requires a surgical procedure.'}, 'identificationModule': {'nctId': 'NCT03072433', 'briefTitle': 'An Intervention for Primary Caregivers to Improve Outcomes in Children With Severe Malnutrition', 'organization': {'class': 'OTHER', 'fullName': 'The Hospital for Sick Children'}, 'officialTitle': 'The Effect of an Intervention Program for Primary Caregivers on the Development of Children With Severe Malnutrition: A Cluster Randomized Controlled Clinical Trial', 'orgStudyIdInfo': {'id': '1000053078'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Standard of Care', 'description': 'Comparison group will receive the current standard of care. Nurses are instructed to tell mothers about nutrition and water, sanitation and hygiene at any point prior to discharge from hospital. In addition, nurses will tell primary caregivers to play with their children even while they are receiving treatment in a play area with toys available.', 'interventionNames': ['Behavioral: Standard of Care']}, {'type': 'EXPERIMENTAL', 'label': 'Counseling Intervention Package', 'description': 'Primary caregivers in the intervention group receive group education sessions involving psychosocial stimulation, nutrition and feeding, and water, sanitation and hygiene components during a total of four days.', 'interventionNames': ['Behavioral: Counseling Intervention Package']}], 'interventions': [{'name': 'Counseling Intervention Package', 'type': 'BEHAVIORAL', 'otherNames': ['Kusamala Program'], 'description': 'Daily 45 minutes of group teaching for primary caregivers, followed by 45 minutes of supervised play and stimulation with their children for a total of four days. Teaching modules consist of psychosocial stimulation, nutrition and feeding, and water, sanitation and hygiene practices.', 'armGroupLabels': ['Counseling Intervention Package']}, {'name': 'Standard of Care', 'type': 'BEHAVIORAL', 'description': 'Nutrition and water sanitation and hygiene counseling at any point prior to discharge from hospital as per the local nutrition rehabilitation unit standard of care. In addition, primary caregivers will be stimulated to play with their children in a play area.', 'armGroupLabels': ['Standard of Care']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Blantyre', 'country': 'Malawi', 'facility': 'Queen Elizabeth Central Hospital', 'geoPoint': {'lat': -15.78499, 'lon': 35.00854}}], 'overallOfficials': [{'name': 'Robert Bandsma, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Hospital for Sick Children'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Hospital for Sick Children', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Malawi', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Staff Gastroenterologist', 'investigatorFullName': 'Robert Bandsma', 'investigatorAffiliation': 'The Hospital for Sick Children'}}}}