<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04493047</url>
  </required_header>
  <id_info>
    <org_study_id>16/136/109</org_study_id>
    <nct_id>NCT04493047</nct_id>
  </id_info>
  <brief_title>mHealth for Pneumonia Prevention</brief_title>
  <official_title>mHealth for Pneumonia Prevention</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Edinburgh</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Maternal, Neonatal and Child Health Research Network</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Edinburgh</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      In Pakistan, pneumonia and recurrent wheeze in children under five pose significant threats&#xD;
      to children's health. Despite being preventable, more than 90,000 children die each year due&#xD;
      to pneumonia in Pakistan, making it one of the top five countries in the world, with the&#xD;
      highest pneumonia related childhood mortality. The predisposing factors which lead to these&#xD;
      illnesses include lack of hygiene, lack of immunization, overcrowding, household air&#xD;
      pollution, smoking, and poverty. Prompt recognition and timely initiation of treatment is&#xD;
      imperative in children under five with pneumonia and recurrent wheeze and failure to do so&#xD;
      can lead to complications and death. In children under five, among the causes of death due to&#xD;
      these diseases, one is delayed care seeking. It has been identified that around 38% of deaths&#xD;
      due to respiratory illnesses occur in households due to this delayed care seeking which is&#xD;
      defined as delay in care sought for an illness outside home.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In most of the low middle income countries, carer gender plays an important role in decisions&#xD;
      to seek care. Although in majority of households, the primary caregivers of children under&#xD;
      five are the mothers of those children, decisions with respect to care are often made by&#xD;
      fathers or mothers in law which is a problem as they do not cater to the child in a timely&#xD;
      manner either by not being there or being ignorant of basic management of the illness.&#xD;
      Another contributing factor could be lack of time to take the child for healthcare as the&#xD;
      mothers are usually occupied in their household chores and the fathers are busy working. And&#xD;
      in rare cases where either the mother of a child dies at childbirth (500 per 100,000 live&#xD;
      births) and when fathers are working away from home, it is the secondary caregiver who is&#xD;
      responsible for care seeking of that child. Additionally, due to poverty, most caregivers&#xD;
      cannot afford the cost of travel and secondary care for the child delaying care seeking until&#xD;
      the child is severely ill. The inaccessibility of adequate healthcare within close proximity&#xD;
      may delay care seeking. However a major contributing factor to this delay is impaired carer&#xD;
      perception of the seriousness of the condition. The importance of caregivers' ability to&#xD;
      recognize and seek appropriate care for their children is also one of the recommended key&#xD;
      activities in the World Health Organization's (WHO)and UNICEF's Global Action Plan for the&#xD;
      Control of Pneumonia and Diarrhea [11]. WHO and UNICEF have, therefore, emphasized the&#xD;
      development of innovative, sustainable and cost-effective strategies/interventions to improve&#xD;
      child health. It is important to devise a strategy whereby patients' symptoms are identified&#xD;
      timely and immediate care given at their doorstep. Experimental studies provide the strongest&#xD;
      evidence that illness perceptions can modify behaviors and care-seeking, and several studies&#xD;
      have shown that interventions designed to change illness perceptions can improve health&#xD;
      outcomes.&#xD;
&#xD;
      The inaccessibility of adequate healthcare within close proximity may delay care seeking.&#xD;
      However a major contributing factor to this delay is impaired carer perception of the&#xD;
      seriousness of the condition. Although well-proven life-saving tools are available to stop&#xD;
      mortality due to preventable illnesses like pneumonia and recurrent wheeze, the existing&#xD;
      health systems in Pakistan are passive. One of the most impact strategies can be timely&#xD;
      healthcare seeking through community health workers who have been a powerful force to promote&#xD;
      healthy behaviors and extend the reach to the health system by acting as a bridge between the&#xD;
      community and the system. Community-based packaged interventions delivered through CHWs have&#xD;
      been shown to improve care seeking for childhood illnesses. In Pakistan, these CHWs are&#xD;
      referred to as Lady Health Workers (LHWs) enrolled under the National Program for Family&#xD;
      Planning and Primary Healthcare. On average each LHW covers 100-150 households by making&#xD;
      monthly visits and providing basic health services and education. These LHWs could,&#xD;
      therefore, be a useful mode as evidence has shown that health interventions integrating&#xD;
      (CHWs) can lead to positive behavior changes and lower morbidity and mortality rates, while&#xD;
      moving services and information closer to the communities where they are actually needed.&#xD;
&#xD;
      Thus, our study will explore care-seeking for childhood pneumonia among caregivers of&#xD;
      children under five through a qualitative approach and devise a Care Model to actively find&#xD;
      cases through LHWs and promote appropriate care seeking behavior.&#xD;
&#xD;
      Primary Objective&#xD;
&#xD;
      • To determine the feasibility of using an android based mobile application by LHWs to&#xD;
      educate caregivers of children under five on prevention of pneumonia in rural Islamabad.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">April 1, 2018</start_date>
  <completion_date type="Anticipated">March 30, 2021</completion_date>
  <primary_completion_date type="Anticipated">December 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_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:&#xD;
Pre-intervention phase&#xD;
Intervention phase&#xD;
Post-intervention phase</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of caregivers with improved knowledge on under five pneumonia</measure>
    <time_frame>6 months</time_frame>
    <description>A structured questionnaire will be used to interview the caregivers</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">520</enrollment>
  <condition>Pneumonia</condition>
  <condition>Childhood Pneumonia</condition>
  <condition>Infectious Disease</condition>
  <condition>Acute Respiratory Infection</condition>
  <arm_group>
    <arm_group_label>Counselling on pneumonia prevention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Mobile health (mHealth) for pneumonia</intervention_name>
    <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.</description>
    <arm_group_label>Counselling on pneumonia prevention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion criteria for LHWs:&#xD;
&#xD;
        • LHWs that have been nominated by the district health officer (DHO).&#xD;
&#xD;
        Inclusion criteria for under five pneumonia caregivers&#xD;
&#xD;
          -  Caregivers of all children under five years.&#xD;
&#xD;
          -  Caregivers residing in the study site.&#xD;
&#xD;
          -  Caregivers who can understand Urdu.&#xD;
&#xD;
          -  Caregivers who will consent to participate.&#xD;
&#xD;
          -  Those caregivers who have mobile phones in their household.&#xD;
&#xD;
        Exclusion criteria for LHWs:&#xD;
&#xD;
        • LHWs not assigned the catchment area households for visits.&#xD;
&#xD;
        Exclusion criteria for under five pneumonia caregivers:&#xD;
&#xD;
        • Any household with a child under five having a chronic debilitating illness.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Dr Tabish Hazir, MBBS, FRCPCH</last_name>
    <role>Principal Investigator</role>
    <affiliation>Maternal, Neonatal and Child Health Research Network</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Dr Hana Mahmood, MBBS, MSHI, PhD (ongoing)</last_name>
    <phone>9203009775669</phone>
    <email>hyahya82@yahoo.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Hira Kiani, MSHI</last_name>
    <email>hirakiyani.mnchrn@gmail.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>MNCHRN</name>
      <address>
        <city>Islamabad</city>
        <state>Federal</state>
        <zip>44000</zip>
        <country>Pakistan</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Hira Kiani, MSHI</last_name>
      <email>hirakiyani.mnchrn@gmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Pakistan</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>April 17, 2020</study_first_submitted>
  <study_first_submitted_qc>July 29, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 30, 2020</study_first_posted>
  <last_update_submitted>July 29, 2020</last_update_submitted>
  <last_update_submitted_qc>July 29, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 30, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>childhood Pneumonia</keyword>
  <keyword>Acute respiratory illness</keyword>
  <keyword>Pakistan</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pneumonia</mesh_term>
    <mesh_term>Communicable Diseases</mesh_term>
    <mesh_term>Infections</mesh_term>
    <mesh_term>Respiratory Tract Infections</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04493047
org study id: 16/136/109
nct id: NCT04493047
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
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.
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.
allocation: N/A
intervention model: Single Group Assignment
intervention 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
primary purpose: Prevention
masking: None (Open Label)
measure: Number of caregivers with improved knowledge on under five pneumonia
time frame: 6 months
description: A structured questionnaire will be used to interview the caregivers
arm group label: Counselling on pneumonia prevention
arm group type: Experimental
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: Mobile health (mHealth) for pneumonia
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.
arm group label: Counselling on pneumonia prevention
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Dr Tabish Hazir, MBBS, FRCPCH
role: Principal Investigator
affiliation: Maternal, Neonatal and Child Health Research Network
last name: Dr Hana Mahmood, MBBS, MSHI, PhD (ongoing)
phone: 9203009775669
email: hyahya82@yahoo.com
last name: Hira Kiani, MSHI
email: hirakiyani.mnchrn@gmail.com
facility: 
status: Recruiting
contact: 
country: Pakistan
responsible party type: Sponsor
mesh term: Pneumonia
mesh term: Communicable Diseases
mesh term: Infections
mesh term: Respiratory Tract Infections