NCT01345695

Brief Summary

This study will conduct an evaluation of the World Health Partners (WHP) private provider project to see if the social franchising and telemedicine project has an impact on health outcomes in treatment vs. control areas. The evaluation will also estimate specific parameters of the WHP program that can be used to maximize financial sustainability and replicability/scalability of the program.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
106,380

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2011

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 25, 2011

Completed
6 days until next milestone

Study Start

First participant enrolled

May 1, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 2, 2011

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
Last Updated

December 16, 2015

Status Verified

December 1, 2015

Enrollment Period

3.6 years

First QC Date

April 25, 2011

Last Update Submit

December 14, 2015

Conditions

Diarrhea, InfantileChildhood Pneumonia

Keywords

Childhood diarrheachildhood pneumoniatelemedicineclustertreatment-control trial

Outcome Measures

Primary Outcomes (1)

  • Improvements in population based health outcomes

    Improvements in population based health outcomes in the treatment vs. the control areas

    Baseline; 3 years

Secondary Outcomes (3)

  • Improvements in population based health outcomes for childhood diarrhea

    Baseline; 3 years

  • Improvements in population based health outcomes for childhood pneumonia

    Baseline; 3 years

  • Cost-effectiveness of the service model

    Baseline; 3 years

Study Arms (2)

Treatment

Data collected on persons living in the catchment area for a WHP telemedicine center

Control

Data collected on persons living in the catchment area where there is not a WHP telemedicine center

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Randomly selected residents of 12 districts in Bihar State, India.

You may qualify if:

  • Households with children age \< 60 months
  • Persons with tuberculosis or visceral leishmaniasis
  • Rural private sector medical providers

You may not qualify if:

  • Households without children
  • Households with children aged \> 60 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

BEST

Patna, Bihar, India

Location

MeSH Terms

Conditions

Diarrhea, Infantile

Condition Hierarchy (Ancestors)

DiarrheaSigns and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Manoj Mohanan, PhD, MPH

    Duke University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 25, 2011

First Posted

May 2, 2011

Study Start

May 1, 2011

Primary Completion

December 1, 2014

Study Completion

October 1, 2015

Last Updated

December 16, 2015

Record last verified: 2015-12

Locations

IN(1)