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| Name | Class |
|---|---|
| University of Malawi | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard of Care | Active Comparator | 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. |
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| Counseling Intervention Package | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Counseling Intervention Package | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Malawi Developmental Assessment Tool Score | Gross motor, fine motor, language, and social development | 6 months post-discharge from hospital |
| Measure | Description | Time Frame |
|---|---|---|
| Nutritional status based on: mid-upper arm circumference (MUAC) | MUAC in millimeters | 6 months post-discharge from hospital |
| Nutritional status based on: World Health Organization (WHO) z-scores |
| Measure | Description | Time Frame |
|---|---|---|
| Self Reporting Questionnaire (SRQ-20) | Mental health of primary caregivers | 6 months post-discharge from hospital |
| Home Observation for Measurement of the Environment (HOME) Inventory | Stimulus and support for children in the household |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Robert Bandsma, PhD | The Hospital for Sick Children | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Queen Elizabeth Central Hospital | Blantyre | Malawi |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34447897 | Derived | 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. | |
| 30258650 |
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| ID | Term |
|---|---|
| D015362 | Child Nutrition Disorders |
| ID | Term |
|---|---|
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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| Standard of Care | Behavioral | 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. |
|
Weight-for-length or -height z-scores and height-for-age z-scores
| 6 months post-discharge from hospital |
| Nutritional status based on: nutritionally-induced bilateral pitting oedema | Bilateral pitting oedema | 6 months post-discharge from hospital |
| Duration of hospital stay | Number of days that hospital treatment is required | During hospitalization; up to three days before enrollment until discharge from hospital (e.g., up to 30 days) |
| Appetite | Number of days that nasogastric tube is required | During hospitalization; up to three days before enrollment until discharge from hospital (e.g., up to 30 days) |
| Clinical deterioration | Number of clinical danger signs | During hospitalization; up to three days before enrollment until discharge from hospital (e.g., up to 30 days) |
| Readmission | Requiring inpatient treatment | Within 6 months post-discharge from hospital |
| Mortality | Inpatient or post-discharge mortality | Within 6 months post-discharge from hospital |
| 6 months post-discharge from hospital |
| Primary caregiver knowledge, attitudes, and practices | 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 | 6 months post-discharge from hospital |
| Participant engagement | Attendance of participants on day one of the intervention program | Day one of the intervention during hospital stay |
| Participant adherence | Attendance of participants on all four days of the intervention program | Across the four days of the intervention during hospital stay |
| Derived |
| 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. |
| 29149905 | Derived | 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. |