Ignite Creation Date:
2024-05-05 @ 11:43 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00115921
Status:
COMPLETED
Last Update Posted:
2017-01-12
First Post:
2005-06-26
Brief Title:
Evaluation of Home-Based Management of Fever in Urban Ugandan Children
Sponsor:
London School of Hygiene and Tropical Medicine
Organization:
London School of Hygiene and Tropical Medicine
Study Overview
Official Title:
Evaluation of Home-Based Management of Fever in Urban Ugandan Children
Status:
COMPLETED
Status Verified Date:
2017-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to see if providing effective antimalarial treatment at home for parentsguardians to treat their children for malaria will lead to an improved health outcome compared to conventional healthcare
Detailed Description:
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 fevermalaria 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 costfebrile episode 2 household costs for treatment of febrile episodemonth 3 provider costchild for delivery of HBMF 4 estimated provider facility costpatient for uncomplicated fever and for severe disease 5 total net costchildyear 6 net costadditional child appropriately treated 7 net costday of fever averted
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 fevermalaria 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 costfebrile episode 2 household costs for treatment of febrile episodemonth 3 provider costchild for delivery of HBMF 4 estimated provider facility costpatient for uncomplicated fever and for severe disease 5 total net costchildyear 6 net costadditional child appropriately treated 7 net costday of fever averted
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None