Cholera-Hospital-Based-Intervention-for-7-days

Not Applicable

Completed

• Conditions: Diarrhea; Cholera; Stunting
• Interventions: Behavioral: CHoBI7 health facility program; Behavioral: CHoBI7 mHealth program; Behavioral: CHoBI7 home visit program

• Registration Number: NCT04008134
• Lead Sponsor: Johns Hopkins Bloomberg School of Public Health

Brief Summary

The Cholera Hospital Based Intervention for 7 Days (CHoBI7) randomized controlled trial for transition to scale aimed to: (1) Develop and evaluate scalable approaches to integrate the CHoBI7 intervention into the services provided for hospitalized diarrhea patients at health facilities in Bangladesh; and (2) Evaluate the ability of the CHoBI7 intervention to lead to a sustained uptake of the promoted hand washing with soap and water treatment behaviors and significant reductions in diarrheal disease over time.

Detailed Description

The findings from the recent randomized controlled trial of The Cholera Hospital Based Intervention for 7 Days (CHoBI7) demonstrated that this intervention was effective in significantly reducing symptomatic cholera infections in intervention households, and had significant sustained impacts on hand washing with soap behaviors and improved water quality 12 months post intervention. Next steps to transition to scale were: (1) Develop and evaluate scalable approaches to integrate the CHoBI7 intervention into the services provided for hospitalized diarrhea patients at health facilities in Bangladesh; and (2) Evaluate the ability of the CHoBI7 intervention to lead to a sustained uptake of the promoted hand washing with soap and water treatment behaviors and significant reductions in diarrheal disease over time.

Study Timeline

• Study Start: 2016-12-04
• Primary Completion: 2019-04-26
• Study Completion: 2019-04-26
• Study First Submitted: 2019-07-02
• Study First Submitted QC: 2019-07-02
• Study First Posted: 2019-07-05
• Status Verified: 2022-01
• Last Update Submitted: 2022-01-27
• Last Update Posted: 2022-02-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2626

Inclusion Criteria

Diarrhea patients will be defined as patients having acute watery diarrhea three or more loose stools over a 24-hour period in the past three days. Diarrhea patients admitted to ICDDRB Dhaka Hospital or Mugda General Hospital will be eligible for the trial if:

1. have had 3 or more loose stools over the past 24 hours
2. plan to reside in Dhaka for the next 12 months
3. have no basin for running water in their home
4. have a child under five years of age in their household (including themselves) that produced a stool sample at baseline
5. have a working mobile phone in the household.

Household members of the diarrhea patient will be eligible for the trial if:

1. they have shared the same cooking pot and resided in the same home with the diarrhea patient for the last three days
2. plan to reside in their current household with the diarrhea patient for the next 12 months

Exclusion Criteria

(1) Children in foster care will be excluded from all research study activities.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
mHealth with home visits	CHoBI7 mHealth program	Participants received the health facility delivery of CHoBI7, plus two home visits and bi-weekly mHealth (voice and text) reminders for 12 months
mHealth with no home visits	CHoBI7 health facility program	Participants received the health facility delivery of CHoBI7, plus bi-weekly mHealth (voice and text) reminders for 12 months
mHealth with no home visits	CHoBI7 mHealth program	Participants received the health facility delivery of CHoBI7, plus bi-weekly mHealth (voice and text) reminders for 12 months
mHealth with home visits	CHoBI7 health facility program	Participants received the health facility delivery of CHoBI7, plus two home visits and bi-weekly mHealth (voice and text) reminders for 12 months
mHealth with home visits	CHoBI7 home visit program	Participants received the health facility delivery of CHoBI7, plus two home visits and bi-weekly mHealth (voice and text) reminders for 12 months

Primary Outcome Measures

Name	Time	Method
Diarrhea prevalence among children under 2 years of age	12 months	Diarrhea prevalence among children under 2 years of age assessed by caregiver self report over a 12-month period
Diarrhea prevalence among all household members	12 months	Diarrhea prevalence among all household members assessed by self report over a 12-month period
Diarrhea prevalence among children under 5 years of age	12 months	Diarrhea prevalence among children under 5 years of age assessed by caregiver self report over a 12-month period

Secondary Outcome Measures

Name	Time	Method
Weight-for-age among children under 5 years of age	12 months	Height, weight and age measurements among children under 5 years of age assessed over a 12-month period were used to calculate weight-for-age z-scores according to the World Health Organization child growth standards
Weight-for-height among children under 5 years of age	12 months	Height, weight and age measurements among children under 5 years of age assessed over a 12-month period were used to calculate weight-for-height z-scores according to the World Health Organization child growth standards
Diarrhea prevalence among participants ages 10-18 years	12 months	Diarrhea prevalence among all household members ages 10-18 years assessed by self report over a 12-month period
Handwashing with soap	12 months	Household members handwashing with soap at food and stool related events assessed by 5-hour structured observation over a 12-month period
Diarrhea prevalence among participants ages 5-9 years	12 months	Diarrhea prevalence among all household members ages 5-9 years assessed by self report over a 12-month period
Weight-for-age among children under 2 years of age	12 months	Height, weight and age measurements among children under 2 years of age assessed over a 12-month period were used to calculate weight-for-age z-scores according to the World Health Organization child growth standards
Diarrhea prevalence among participants ages greater than 18 years	12 months	Diarrhea prevalence among all household members ages greater than 18 years assessed by self report over a 12-month period
Household drinking water treatment	12 months	Households with stored drinking water samples without detectable E.coli (\<1 colony forming units / 100 ml) assessed by unannounced household visits for sample collection of household stored drinking water over a 12-month period
Height-for-age among children under 2 years of age	12 months	Height, weight and age measurements among children under 2 years of age assessed over a 12-month period were used to calculate height-for-age z-scores according to the World Health Organization child growth standards
Height-for-age among children under 5 years of age	12 months	Height, weight and age measurements among children under 5 years of age assessed over a 12-month period were used to calculate height-for-age z-scores according to the World Health Organization child growth standards
Weight-for-height among children under 2 years of age	12 months	Height, weight and age measurements among children under 2 years of age assessed over a 12-month period were used to calculate weight-for-height z-scores according to the World Health Organization child growth standards