- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04493047
mHealth for Pneumonia Prevention
Study Overview
Status
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Federal
-
Islamabad, Federal, Pakistan, 44000
- MNCHRN
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Counselling on pneumonia prevention
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of caregivers with improved knowledge on under five pneumonia
Time Frame: 6 months
|
A structured questionnaire will be used to interview the caregivers
|
6 months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Dr Tabish Hazir, MBBS, FRCPCH, Maternal, Neonatal and Child Health Research Network
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 16/136/109
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Pneumonia
-
King Edward Memorial HospitalCompletedNosocomial Pneumonia | Healthcare-Associated Pneumonia | Aspiration Pneumonia | Ventilator-Associated PneumoniaIndia
-
Melinta Therapeutics, Inc.WithdrawnHospital-Acquired Bacterial Pneumonia | Ventilator-Associated Bacterial Pneumonia | Hospital-Acquired Pneumonia | Ventilator-Associated Pneumonia
-
Venatorx Pharmaceuticals, Inc.Biomedical Advanced Research and Development AuthorityWithdrawnHospital-acquired Pneumonia | Ventilator-associated Pneumonia
-
Universidad de la SabanaClínica Universidad de La Sabana; Universidad de La Sabana, ColombiaCompletedPneumococcal Pneumonia | Community Acquired Pneumonia (CAP)Colombia
-
Hannover Medical SchoolCharite University, Berlin, Germany; University of LeipzigUnknownCOVID-19 | Bacterial Pneumonia | Viral Pneumonia | Pneumonia Due to Streptococcus Pneumoniae | Pneumonia Due to H. Influenzae | Pneumonia, Organism Unspecified | Pneumonia in Diseases Classified Elsewhere | Pneumonia Due to Other Specified Infectious OrganismsGermany
-
Nantes University HospitalSociété Française d'Anesthésie et de RéanimationCompletedPneumonia | Sepsis | Ventilator-Associated Pneumonia | Hospital Acquired PneumoniaFrance
-
University Medical Centre LjubljanaUniversity of Ljubljana, Faculty of MedicineUnknownCommunity Acquired Pneumonia | Ventilator Associated Pneumonia | Hospital Acquired PneumoniaSlovenia
-
PfizerCompletedVentilator-associated Pneumonia (VAP) | Nosocomial Pneumonia (NP)Bulgaria, France, Italy, Korea, Republic of, Mexico, Peru, Poland, Russian Federation, Spain, Turkey, United Kingdom, Vietnam, Philippines, China, Ukraine, Argentina, Brazil, Hungary, Romania, India, Japan, Taiwan, Latvia, Czechia, Slov... and more
-
Arpida AGTerminatedHospital-Acquired Pneumonia | Ventilator-Associated Pneumonia | Health-Care-Associated Pneumonia
-
ShionogiCompletedHospital Acquired Pneumonia (HAP) | Healthcare-associated Pneumonia (HCAP) | Ventilator Associated Pneumonia (VAP)Israel, Spain, United States, Belgium, Canada, Czechia, Estonia, France, Georgia, Germany, Hungary, Japan, Latvia, Philippines, Puerto Rico, Russian Federation, Serbia, Taiwan, Ukraine
Clinical Trials on Mobile health (mHealth) for pneumonia
-
University of EdinburghMaternal, Neonatal and Child Health Research NetworkCompleted
-
University of California, DavisBoston University; McKesson FoundationCompleted
-
Boston UniversityEunice Kennedy Shriver National Institute of Child Health and Human Development... and other collaboratorsCompletedBreastfeeding | SUID | SIDSUnited States
-
University of MichiganMahidol University; Fogarty International Center of the National Institute...CompletedType 2 Diabetes MellitusThailand
-
Centro Cardiologico MonzinoFondazione Policlinico Universitario Agostino Gemelli IRCCS; IRCCS Policlinico... and other collaboratorsActive, not recruiting
-
Duke UniversityCompleted
-
University of Wisconsin, MadisonNational Institute of Mental Health (NIMH)Completed
-
UConn HealthNational Institute of Mental Health (NIMH)CompletedDepressionUnited States
-
The University of Texas Health Science Center at...The University of Texas at San AntonioCompleted
-
Stanford UniversitySuspended