Ignite Creation Date:
2024-06-16 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06444633
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-21
First Post:
2024-05-24
Brief Title:
The Impact of Pre-emptive Home Delivery of ORS Zinc on Treatment for Child Diarrhea
Sponsor:
RAND
Organization:
RAND
Study Overview
Official Title:
The Impact of Pre-emptive Home Delivery of ORS Zinc on Treatment for Child Diarrhea a Cluster Randomized Controlled Trial in Bauchi Nigeria
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
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 aim of this clustered randomized controlled trial is to evaluate whether free and pre-emptive distribution of Oral Rehydration Salts ORS and Zinc at home increases the use of ORS to treat diarrhea cases among children under the age of 5 in Bauchi Nigeria The primary research questions for the study are
RQ1a Does pre-emptive home delivery with free distribution of ORS and zinc coupled with information about the importance of proper treatment henceforth referred to as the intervention result in greater use of ORS to treat child diarrhea for children under the age of 5 over the 6 months following the deliveries relative to the status quo ie in the absence of such an intervention
RQ1b Does the intervention result in greater use of ORS to treat child diarrhea for children under the age of 5 over the 12 months following the deliveries relative to the status quo
RQ11 How much does the effect of the intervention on use of ORS to treat child diarrhea for children under the age of 5 change over time
All wards in Bauchi state will be randomly assigned to one of two groups
treatment where all households with at least one child under the age of 5 will receive free pre-emptive ORS and zinc co-packs - with two ORS sachets and 10 zinc tablets per child - coupled with information about the importance of proper treatment
delayed-start control with care as usual during the evaluation period and intervention delivery post evaluation groups
A total of 1732 enumeration areas EAs will be sampled across all wards for the study period Within each EA 20 eligible households will be randomly sampled for surveys during each wave of data collection baseline endline wave 1 over 1-6 months post intervention and endline wave 2 over 7-12 months post intervention The primary outcomes for the study include the use of ORS to treat child diarrhea over 6 months post-intervention over 12 months post-intervention and over each month until 12 months post-intervention
RQ1a Does pre-emptive home delivery with free distribution of ORS and zinc coupled with information about the importance of proper treatment henceforth referred to as the intervention result in greater use of ORS to treat child diarrhea for children under the age of 5 over the 6 months following the deliveries relative to the status quo ie in the absence of such an intervention
RQ1b Does the intervention result in greater use of ORS to treat child diarrhea for children under the age of 5 over the 12 months following the deliveries relative to the status quo
RQ11 How much does the effect of the intervention on use of ORS to treat child diarrhea for children under the age of 5 change over time
All wards in Bauchi state will be randomly assigned to one of two groups
treatment where all households with at least one child under the age of 5 will receive free pre-emptive ORS and zinc co-packs - with two ORS sachets and 10 zinc tablets per child - coupled with information about the importance of proper treatment
delayed-start control with care as usual during the evaluation period and intervention delivery post evaluation groups
A total of 1732 enumeration areas EAs will be sampled across all wards for the study period Within each EA 20 eligible households will be randomly sampled for surveys during each wave of data collection baseline endline wave 1 over 1-6 months post intervention and endline wave 2 over 7-12 months post intervention The primary outcomes for the study include the use of ORS to treat child diarrhea over 6 months post-intervention over 12 months post-intervention and over each month until 12 months post-intervention
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None