NCT04493047

Brief Summary

In Pakistan, pneumonia and recurrent wheeze in children under five pose significant threats to children's health. Despite being preventable, more than 90,000 children die each year due to pneumonia in Pakistan, making it one of the top five countries in the world, with the highest pneumonia related childhood mortality. The predisposing factors which lead to these illnesses include lack of hygiene, lack of immunization, overcrowding, household air pollution, smoking, and poverty. Prompt recognition and timely initiation of treatment is imperative in children under five with pneumonia and recurrent wheeze and failure to do so can lead to complications and death. In children under five, among the causes of death due to these diseases, one is delayed care seeking. It has been identified that around 38% of deaths due to respiratory illnesses occur in households due to this delayed care seeking which is defined as delay in care sought for an illness outside home.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
520

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2018

Typical duration for not_applicable

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2018

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

April 17, 2020

Completed
3 months until next milestone

First Posted

Study publicly available on registry

July 30, 2020

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2021

Completed
Last Updated

June 10, 2024

Status Verified

July 1, 2020

Enrollment Period

2.7 years

First QC Date

April 17, 2020

Last Update Submit

June 7, 2024

Conditions

Keywords

childhood PneumoniaAcute respiratory illnessPakistan

Outcome Measures

Primary Outcomes (1)

  • Number of caregivers with improved knowledge on under five pneumonia

    A structured questionnaire will be used to interview the caregivers

    6 months

Study Arms (1)

Counselling on pneumonia prevention

EXPERIMENTAL

Recruited caregivers will be counselled by Lady health workers on pneumonia and its prevention via an audiovisual user friendly android based mobile application. Additionally, one text and one voice message will also be sent to the caregivers cell phones on the same subject.

Behavioral: Mobile health (mHealth) for pneumonia

Interventions

Audiovisual mobile based application will be used to counsel caregivers of children under five on pneumonia and its prevention. This will be coupled with text and voice message dissemination to the cell phones of caregivers.

Counselling on pneumonia prevention

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • LHWs that have been nominated by the district health officer (DHO).
  • Caregivers of all children under five years.
  • Caregivers residing in the study site.
  • Caregivers who can understand Urdu.
  • Caregivers who will consent to participate.
  • Those caregivers who have mobile phones in their household.

You may not qualify if:

  • LHWs not assigned the catchment area households for visits.
  • Any household with a child under five having a chronic debilitating illness.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

MNCHRN

Islamabad, Federal, 44000, Pakistan

Location

MeSH Terms

Conditions

PneumoniaCommunicable Diseases

Interventions

Telemedicine

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsLung DiseasesRespiratory Tract DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Delivery of Health CarePatient Care ManagementHealth Services Administration

Study Officials

  • Dr Tabish Hazir, MBBS, FRCPCH

    Maternal, Neonatal and Child Health Research Network

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Model Details: The design of model will be based on the Replicating Effective Program (REP) framework of implementation. The first phase of REP is comprised of a systematic review (SR) on best mobile health based approaches for LHWs on management of childhood illness followed by formative research (FR). The study consists of the following three stages: * Pre-intervention phase * Intervention phase * Post-intervention phase
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 17, 2020

First Posted

July 30, 2020

Study Start

April 1, 2018

Primary Completion

December 1, 2020

Study Completion

March 30, 2021

Last Updated

June 10, 2024

Record last verified: 2020-07

Locations