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PneumoniaNCT04493047

mHealth for Pneumonia Prevention

A study testing Mobile health (mHealth) for pneumonia in people with Pneumonia and Childhood Pneumonia, run by University of Edinburgh at 1 site in Pakistan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Any ageHealthy volunteers can take part
Conditions the study is for
Pneumonia, Childhood Pneumonia, Infectious Disease
What is being tested?
Mobile health (mHealth) for pneumonia
Could I receive a placebo?
No, everyone receives an active treatment
How many people
520 participants
Where
1 sitePakistan
Study dates
1 Apr 2018to 30 Mar 2021
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 Any age
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Pakistan1 site
  • MNCHRN

    Islamabad, Federal, 44000

Other trials in Pakistan

About this study

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.

Read the 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.
Being tested
Mobile health (mHealth) for pneumonia
Keywords
childhood Pneumonia, Acute respiratory illness, Pakistan
Medical subject headings
Pneumonia, Communicable Diseases

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.

Study groups in NCT04493047
Study groupRoleWhat they receive
Counselling on pneumonia preventionExperimentalRecruited 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.
Receives: Behavioral: Mobile health (mHealth) for pneumonia

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of caregivers with improved knowledge on under five pneumonia

    A structured questionnaire will be used to interview the caregivers

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Jul 2020
  2. Study start1 Apr 2018
  3. Primary completion1 Dec 2020
  4. Study completion30 Mar 2021

Resources

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
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)
Enrolment
520 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04493047
Sponsor's protocol ID
16/136/109
Status last verified
Jul 2020
First submitted
17 Apr 2020
Last updated
10 Jun 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Mobile health (mHealth) for pneumonia in people with Pneumonia and Childhood Pneumonia, 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 6 inclusion and 2 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 10 Jun 2024. 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?

Number of caregivers with improved knowledge on under five pneumonia (time frame: 6 months). 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 10 Jun 2024.

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