PneumoniaNCT03756259
Pneumonia Perception Project-Pakistan
A study testing Mobile Health (mHealth) for Pneumonia in people with Pneumonia and Perception, Self, run by University of Edinburgh at 1 site in Pakistan.
Trial summary
Pneumonia and recurrent wheeze contribute extensively to under five childhood morbidity and mortality in Pakistan. Among the avoidable causes of death due to these diseases, delayed care seeking is a major one whereby around 38% of deaths due to acute respiratory illnesses occur in households. Read more about this study
- Who is it for?
- Ages 1 minute to 5 yearsHealthy volunteers can take part
- Conditions the study is for
- Pneumonia, Perception, Self
- What is being tested?
- Mobile Health (mHealth) for Pneumonia
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 179 participants
- Where
- 1 sitePakistan
- Study dates
- 15 Dec 2018to 31 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 minute to 5 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Caregivers of children under five
- Those consenting to participate
Who cannot join
- Children with any long standing chronic illness
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Understanding the Reasons for Delay in Seeking Care for Pneumonia and Recurrent Wheeze Among Caregivers of Children Under Five in Pakistan
Pneumonia and recurrent wheeze contribute extensively to under five childhood morbidity and mortality in Pakistan. Among the avoidable causes of death due to these diseases, delayed care seeking is a major one whereby around 38% of deaths due to acute respiratory illnesses occur in households. Of these cases which die due to delayed care seeking, majority are taken for healthcare after 2 days of initiation of symptoms with around 30% been given antibiotics at home before seeking healthcare. Around 32% of these cases die at home, 48% in hospitals, 9% en route, and the 11% in clinics or health centres.This could be due to lack of time, lack of funds for healthcare, lack of decision making on the part of the mother or improper carer perception of the seriousness of the condition. Thus there are various cultural, social, personal and religious factors which affect the care seeking behaviors of caregivers for these illnesses. Understanding these aspects of delayed care seeking is critical to develop effective intervention strategies to reduce disease related mortality. We, therefore, aim to establish an understanding of perception of under-five pneumonia and recurrent wheeze among caregivers of children under five along with associated factors of delayed care seeking in selected communities in Pakistan. The results of this study will permit us to design an effectiveness study which can be used by program managers and policy makers to develop program strategies to reduce childhood deaths due to delayed care seeking for these diseases.
Read the detailed description
Background: 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. Similarly, children account for 20%-30% of the 2 million Pakistani asthma patients. 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. This delay is referred to as the time taken by the caregiver to seek healthcare later than what would have been optimal.
In most of the Low middle income countries (LMICs), 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. He/she could be an aunt/uncle or neighbour. But in such cases often the child is neglected due to other priorities of the secondary caregivers.
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. Here, healthcare providers tend to wait for patients to come to them but the later the patients with acute respiratory illness come, the more likely they are to die. World Health Organization (WHO) and United Nations International Children's Emergency Fund (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 patient's symptoms are identified timely and immediate care given at their doorstep. Experimental studies provide the strongest evidence that illness perceptions can modify behaviours and care-seeking, and several studies have shown that interventions designed to change illness perceptions can improve health outcomes. Locally adapted behaviour change communication may reduce the incidence of severe pneumonia and could be a key component in national child-health strategies.
One of the most impactful strategies can be timely healthcare seeking through community health workers who have been a powerful force to promote healthy behaviours 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 on health and wellbeing. These LHWs could, therefore, be a useful mode of active pneumonia and recurrent wheeze case finding and information sharing to counsel against development of acute respiratory infections as evidence has shown that health interventions integrating Community Health Workers (CHWs) can lead to positive behaviour changes and lower morbidity and mortality rates, while moving services and information closer to the communities where they are actually needed.
Objective: Our study will explore healthcare care-seeking for childhood pneumonia and recurrent wheeze among caregivers of children under five through a qualitative approach. Further, we aim to devise a Care Model to actively find cases through LHWs and promote appropriate care seeking behaviour among the caregivers.
- Conditions
- Pneumonia, Perception, Self
- Being tested
- Mobile Health (mHealth) for Pneumonia
- Medical subject headings
- Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mobile Health (mHealth) for PneumoniaBehavioural
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 and active pneumonia case finding by the LHWs which will be managed according to severity.
| Study group | Role | What they receive |
|---|---|---|
| Pneumonia perception arm | Other | Caregivers of children under five will be interviewed qualitatively to understand in depth on perception of pneumonia. These will be mothers, fathers and grandmothers of these children. Once the formative research is done, it will inform design of an intervention whereby the caregivers will be recruited to 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. The LHWs will also be trained on pneumonia case finding which they will manage at their end and refer if required while doing daily field visits. Receives: Behavioral: Mobile Health (mHealth) for Pneumonia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identification of perception of caregivers of children under five on pneumonia and recurrent wheeze
The qualitative approach will provide a detailed understanding of perception of pneumonia and recurrent wheeze among caregivers of children under five
Measured: 6 months
Improvement in perception of pneumonia and recurrent wheeze among caregivers of children under five
Through the mobile based intervention we plan to improve caregiver perception on pneumonia and recurrent wheeze
Measured: 6 months
Active case finding of pneumonia by lady health workers
LHWs will identify pneumonia cases and manage or refer them as the case may be
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2018
- Study start15 Dec 2018
- Primary completion30 Dec 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PneumoniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 179 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Edinburgh
- Sponsor type
- University, hospital or other
- Collaborators
- Maternal, Neonatal and Child Health Research Network
- Responsible party
- Sponsor
- Investigators
- Dr Tabish Hazir, MBBS, FRCPCH, Principal investigator, Maternal, Neonatal and Child Health Research Network
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03756259
- Sponsor's protocol ID
- AC 18109
- Status last verified
- May 2019
- First submitted
- 26 Nov 2018
- Last updated
- 14 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Understanding the Reasons for Delay in Seeking Care for Pneumonia and Recurrent Wheeze Among Caregivers of Children Under Five in Pakistan
- ClinicalTrials.gov ID
- NCT03756259
- Acronym / sponsor ID
- AC 18109
- Conditions
- Pneumonia, Perception, Self
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 179 participants (actual)
- Lead sponsor
- University of EdinburghUniversity, hospital or other
- Collaborators
- Maternal, Neonatal and Child Health Research Network
- Study start
- 15 Dec 2018 (actual)
- Primary completion
- 30 Dec 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 28 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Pneumonia and recurrent wheeze contribute extensively to under five childhood morbidity and mortality in Pakistan. Among the avoidable causes of death due to these diseases, delayed care seeking is a major one whereby around 38% of deaths due to acute respiratory illnesses occur in households. Of these cases which die due to delayed care seeking, majority are taken for healthcare after 2 days of initiation of symptoms with around 30% been given antibiotics at home before seeking healthcare. Around 32% of these cases die at home, 48% in hospitals, 9% en route, and the 11% in clinics or health centres.This could be due to lack of time, lack of funds for healthcare, lack of decision making on the part of the mother or improper carer perception of the seriousness of the condition. Thus there are various cultural, social, personal and religious factors which affect the care seeking behaviors of caregivers for these illnesses. Understanding these aspects of delayed care seeking is critical to develop effective intervention strategies to reduce disease related mortality. We, therefore, aim to establish an understanding of perception of under-five pneumonia and recurrent wheeze among caregivers of children under five along with associated factors of delayed care seeking in selected communities in Pakistan. The results of this study will permit us to design an effectiveness study which can be used by program managers and policy makers to develop program strategies to reduce childhood deaths due to delayed care seeking for these diseases.
Detailed description
Background: 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. Similarly, children account for 20%-30% of the 2 million Pakistani asthma patients. 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. This delay is referred to as the time taken by the caregiver to seek healthcare later than what would have been optimal.
In most of the Low middle income countries (LMICs), 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. He/she could be an aunt/uncle or neighbour. But in such cases often the child is neglected due to other priorities of the secondary caregivers.
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. Here, healthcare providers tend to wait for patients to come to them but the later the patients with acute respiratory illness come, the more likely they are to die. World Health Organization (WHO) and United Nations International Children's Emergency Fund (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 patient's symptoms are identified timely and immediate care given at their doorstep. Experimental studies provide the strongest evidence that illness perceptions can modify behaviours and care-seeking, and several studies have shown that interventions designed to change illness perceptions can improve health outcomes. Locally adapted behaviour change communication may reduce the incidence of severe pneumonia and could be a key component in national child-health strategies.
One of the most impactful strategies can be timely healthcare seeking through community health workers who have been a powerful force to promote healthy behaviours 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 on health and wellbeing. These LHWs could, therefore, be a useful mode of active pneumonia and recurrent wheeze case finding and information sharing to counsel against development of acute respiratory infections as evidence has shown that health interventions integrating Community Health Workers (CHWs) can lead to positive behaviour changes and lower morbidity and mortality rates, while moving services and information closer to the communities where they are actually needed.
Objective: Our study will explore healthcare care-seeking for childhood pneumonia and recurrent wheeze among caregivers of children under five through a qualitative approach. Further, we aim to devise a Care Model to actively find cases through LHWs and promote appropriate care seeking behaviour among the caregivers.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pneumonia perception arm | Other | Behavioral: Mobile Health (mHealth) for PneumoniaCaregivers of children under five will be interviewed qualitatively to understand in depth on perception of pneumonia. These will be mothers, fathers and grandmothers of these children. Once the formative research is done, it will inform design of an intervention whereby the caregivers will be recruited to 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. The LHWs will also be trained on pneumonia case finding which they will manage at their end and refer if required while doing daily field visits. |
Who may qualify
- Ages
- 1 minute to 5 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Caregivers of children under five
- Those consenting to participate
Key exclusion criteria (1 listed)
- Children with any long standing chronic illness
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mobile Health (mHealth) for PneumoniaAudiovisual 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 and active pneumonia case finding by the LHWs which will be managed according to severity. | Behavioural | Pneumonia perception arm |
Primary outcome
Identification of perception of caregivers of children under five on pneumonia and recurrent wheeze
Time frame: 6 months
The qualitative approach will provide a detailed understanding of perception of pneumonia and recurrent wheeze among caregivers of children under five
Improvement in perception of pneumonia and recurrent wheeze among caregivers of children under five
Time frame: 6 months
Through the mobile based intervention we plan to improve caregiver perception on pneumonia and recurrent wheeze
Active case finding of pneumonia by lady health workers
Time frame: 6 months
LHWs will identify pneumonia cases and manage or refer them as the case may be
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dr Tabish Hazir, MBBS, FRCPCH principal investigator
Maternal, Neonatal and Child Health Research Network
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mobile Health (mHealth) for Pneumonia in people with Pneumonia and Perception, Self, run by University of Edinburgh at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identification of perception of caregivers of children under five on pneumonia and recurrent wheeze (time frame: 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Mar 2022.