Evaluation of Home-Based Management of Fever in Urban Ugandan Children
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|ClinicalTrials.gov Identifier: NCT00115921|
Recruitment Status : Completed
First Posted : June 27, 2005
Last Update Posted : January 12, 2017
|First Submitted Date ICMJE||June 26, 2005|
|First Posted Date ICMJE||June 27, 2005|
|Last Update Posted Date||January 12, 2017|
|Study Start Date ICMJE||July 2005|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE
||The primary outcome measurement will be treatment incidence density (antimalarial treatments received per time at risk) for each study arm.|
|Original Primary Outcome Measures ICMJE||Same as current|
|Change History||Complete list of historical versions of study NCT00115921 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE
|Original Secondary Outcome Measures ICMJE||Same as current|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Evaluation of Home-Based Management of Fever in Urban Ugandan Children|
|Official Title ICMJE||Evaluation of Home-Based Management of Fever in Urban Ugandan Children|
|Brief Summary||The purpose of this study is to see if providing effective antimalarial treatment at home for parents/guardians to treat their children for malaria will lead to an improved health outcome compared to conventional healthcare.|
Population: Representative sample of Ugandan children aged 1 to 5 years from 400 households (approximately 540 children).
Clinical Site: The study will be conducted in the Mulago III parish community of Kampala, Uganda.
Study Duration: 13 months
Study Intervention: *Pilot period: After enrollment, households will participate in a one month pilot period to test the household pictorial diaries. At the end of the pilot period, households will be randomized to participation in the home-based management of fever (HBMF) arm or standard care arm for the remainder of the study (12 months). *HBMF arm: Households randomized to the HBMF group will be provided with pre-packaged coartemether to keep at home. Primary caregivers will be instructed to treat children participating in the study empirically with coartemether at home when the child develops fever. Study personnel will distribute drugs and educate the caregivers about administration of drugs, recognition of danger signs of fever/malaria, and when to seek additional care. *Standard care: Households randomized to the standard care arm will be asked to continue their current behaviour and to manage fever in their children as they would normally.
Measurements: Household diaries and monthly visits. Primary caregivers will be asked to keep a diary regarding the health of study participants for the duration of the study (13 months). Information on illnesses, treatments given, visits to health care facilities, and health care expenditures will be collected. Study personnel will visit the households monthly to collect completed diaries. At each visit, questionnaires will be administered to gather additional data on the health of the participants and treatment seeking behaviour.
Clinical and laboratory evaluations: Temperature, height, weight, mid-upper arm circumference, spleen size, haemoglobin, and thick blood smear will be assessed at enrollment, and at the beginning and end of the intervention period.
Study Objectives: 1. To measure the impact of home-based management of fever with coartemether on malaria-related morbidity compared to the current standard of care in the community.
2. To measure the impact of home-based management of fever with coartemether on economic measures compared to the current standard of care in the community.
Primary outcome: Treatment incidence density (treatments per time at risk) for each treatment arm
Secondary clinical outcomes: 1) mean days of fever; 2) incidence of febrile episodes; 3) mean haemoglobin at study end; 4) change in mean haemoglobin; 5) prevalence of splenomegaly; 6) prevalence of parasitaemia; 7) incidence of visits to health care facilities, and hospitalizations; 8) mortality rate; 9) anthropometric measurements; 10) proportion of "appropriate" treatments; 11) proportion of delayed treatments; 12) treatment incidence density of treatments given at >50% and at full dose
Economic outcomes: 1) household cost/febrile episode; 2) household costs for treatment of febrile episode/month; 3) provider cost/child for delivery of HBMF; 4) estimated provider facility cost/patient for uncomplicated fever, and for severe disease; 5) total net cost/child/year; 6) net cost/additional child appropriately treated; 7) net cost/day of fever averted
|Study Type ICMJE||Interventional|
|Study Phase||Not Applicable|
|Study Design ICMJE||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Intervention ICMJE||Behavioral: Provision of antimalarial treatment at home|
|Study Arms||Not Provided|
|Publications *||Staedke SG, Mwebaza N, Kamya MR, Clark TD, Dorsey G, Rosenthal PJ, Whitty CJ. Home management of malaria with artemether-lumefantrine compared with standard care in urban Ugandan children: a randomised controlled trial. Lancet. 2009 May 9;373(9675):1623-31. doi: 10.1016/S0140-6736(09)60328-7. Epub 2009 Apr 9.|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Completed|
|Original Enrollment ICMJE||Same as current|
|Actual Study Completion Date||April 2007|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
|Ages||1 Year to 5 Years (Child)|
|Accepts Healthy Volunteers||No|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Listed Location Countries ICMJE||Not Provided|
|Removed Location Countries||Uganda|
|NCT Number ICMJE||NCT00115921|
|Other Study ID Numbers ICMJE||ITCRVG40|
|Has Data Monitoring Committee||Yes|
|U.S. FDA-regulated Product||Not Provided|
|IPD Sharing Statement||Not Provided|
|Responsible Party||Brian Greenwood, London School of Hygiene and Tropical Medicine|
|Study Sponsor ICMJE||London School of Hygiene and Tropical Medicine|
|PRS Account||London School of Hygiene and Tropical Medicine|
|Verification Date||January 2017|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP