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mHealth for Pneumonia Prevention

Primary Purpose

Pneumonia, Childhood Pneumonia, Infectious Disease

Status
Unknown status
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Mobile health (mHealth) for pneumonia
Sponsored by
University of Edinburgh
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pneumonia focused on measuring childhood Pneumonia, Acute respiratory illness, Pakistan

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion criteria for LHWs:

• LHWs that have been nominated by the district health officer (DHO).

Inclusion criteria for under five pneumonia caregivers

  • 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.

Exclusion criteria for LHWs:

• LHWs not assigned the catchment area households for visits.

Exclusion criteria for under five pneumonia caregivers:

• Any household with a child under five having a chronic debilitating illness.

Sites / Locations

  • MNCHRNRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Counselling on pneumonia prevention

Arm Description

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.

Outcomes

Primary Outcome Measures

Number of caregivers with improved knowledge on under five pneumonia
A structured questionnaire will be used to interview the caregivers

Secondary Outcome Measures

Full Information

First Posted
April 17, 2020
Last Updated
July 29, 2020
Sponsor
University of Edinburgh
Collaborators
Maternal, Neonatal and Child Health Research Network
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1. Study Identification

Unique Protocol Identification Number
NCT04493047
Brief Title
mHealth for Pneumonia Prevention
Official Title
mHealth for Pneumonia Prevention
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Unknown status
Study Start Date
April 1, 2018 (Actual)
Primary Completion Date
December 2020 (Anticipated)
Study Completion Date
March 30, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Edinburgh
Collaborators
Maternal, Neonatal and Child Health Research Network

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
In most of the low middle income countries, carer gender plays an important role in decisions to seek care. Although in majority of households, the primary caregivers of children under five are the mothers of those children, decisions with respect to care are often made by fathers or mothers in law which is a problem as they do not cater to the child in a timely manner either by not being there or being ignorant of basic management of the illness. Another contributing factor could be lack of time to take the child for healthcare as the mothers are usually occupied in their household chores and the fathers are busy working. And in rare cases where either the mother of a child dies at childbirth (500 per 100,000 live births) and when fathers are working away from home, it is the secondary caregiver who is responsible for care seeking of that child. Additionally, due to poverty, most caregivers cannot afford the cost of travel and secondary care for the child delaying care seeking until the child is severely ill. The inaccessibility of adequate healthcare within close proximity may delay care seeking. However a major contributing factor to this delay is impaired carer perception of the seriousness of the condition. The importance of caregivers' ability to recognize and seek appropriate care for their children is also one of the recommended key activities in the World Health Organization's (WHO)and UNICEF's Global Action Plan for the Control of Pneumonia and Diarrhea [11]. WHO and UNICEF have, therefore, emphasized the development of innovative, sustainable and cost-effective strategies/interventions to improve child health. It is important to devise a strategy whereby patients' symptoms are identified timely and immediate care given at their doorstep. Experimental studies provide the strongest evidence that illness perceptions can modify behaviors and care-seeking, and several studies have shown that interventions designed to change illness perceptions can improve health outcomes. The inaccessibility of adequate healthcare within close proximity may delay care seeking. However a major contributing factor to this delay is impaired carer perception of the seriousness of the condition. Although well-proven life-saving tools are available to stop mortality due to preventable illnesses like pneumonia and recurrent wheeze, the existing health systems in Pakistan are passive. One of the most impact strategies can be timely healthcare seeking through community health workers who have been a powerful force to promote healthy behaviors and extend the reach to the health system by acting as a bridge between the community and the system. Community-based packaged interventions delivered through CHWs have been shown to improve care seeking for childhood illnesses. In Pakistan, these CHWs are referred to as Lady Health Workers (LHWs) enrolled under the National Program for Family Planning and Primary Healthcare. On average each LHW covers 100-150 households by making monthly visits and providing basic health services and education. These LHWs could, therefore, be a useful mode as evidence has shown that health interventions integrating (CHWs) can lead to positive behavior changes and lower morbidity and mortality rates, while moving services and information closer to the communities where they are actually needed. Thus, our study will explore care-seeking for childhood pneumonia among caregivers of children under five through a qualitative approach and devise a Care Model to actively find cases through LHWs and promote appropriate care seeking behavior. Primary Objective • To determine the feasibility of using an android based mobile application by LHWs to educate caregivers of children under five on prevention of pneumonia in rural Islamabad.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pneumonia, Childhood Pneumonia, Infectious Disease, Acute Respiratory Infection
Keywords
childhood Pneumonia, Acute respiratory illness, Pakistan

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
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
Masking
None (Open Label)
Allocation
N/A
Enrollment
520 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Counselling on pneumonia prevention
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Mobile health (mHealth) for pneumonia
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of caregivers with improved knowledge on under five pneumonia
Description
A structured questionnaire will be used to interview the caregivers
Time Frame
6 months

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion criteria for LHWs: • LHWs that have been nominated by the district health officer (DHO). Inclusion criteria for under five pneumonia caregivers 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. Exclusion criteria for LHWs: • LHWs not assigned the catchment area households for visits. Exclusion criteria for under five pneumonia caregivers: • Any household with a child under five having a chronic debilitating illness.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dr Hana Mahmood, MBBS, MSHI, PhD (ongoing)
Phone
9203009775669
Email
hyahya82@yahoo.com
First Name & Middle Initial & Last Name or Official Title & Degree
Hira Kiani, MSHI
Email
hirakiyani.mnchrn@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dr Tabish Hazir, MBBS, FRCPCH
Organizational Affiliation
Maternal, Neonatal and Child Health Research Network
Official's Role
Principal Investigator
Facility Information:
Facility Name
MNCHRN
City
Islamabad
State/Province
Federal
ZIP/Postal Code
44000
Country
Pakistan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hira Kiani, MSHI
Email
hirakiyani.mnchrn@gmail.com

12. IPD Sharing Statement

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mHealth for Pneumonia Prevention

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