Acute Respiratory InfectionNCT03457519
Children's Automated Respiration Monitor (ChARM) for Child Pneumonia Diagnosis by Community Health Workers in Mali
A study testing Children's Automated Respiration Monitor (ChARM) in people with Acute Respiratory Infection, run by Diego Bassani at 2 sites in Mali.
Trial summary
The primary objective of this study is to estimate the impact of a self-monitoring tool (ChARM), used as a teaching/monitoring device, on the CHWs respiratory rate counting accuracy when assessing children under the age of 5 years with suspected pneumonia symptoms. Read more about this study
- Who is it for?
- Ages 15 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Acute Respiratory Infection
- What is being tested?
- Children's Automated Respiration Monitor (ChARM)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 141 participants
- Where
- 2 sitesMali
- Study dates
- 5 Mar 2018to 21 Jan 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 15 to 60 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- • Be currently providing iCCM services on a full-time basis to the populations they are serving.
- Have completed the Malian Ministry of Health basic community health care worker training provided as part of the 2016-2020 Strengthening Maternal, Newborn and Child Health project.
- Are using a device (a respiratory timer) as part of their basic MoH training package, or have a cell phone to use to count the respiratory rates of children under five with suspected symptoms of pneumonia.
- Be willing to participate in a trial to study the impact of using ChARM as a self-monitoring tool to improve the capacity to detect pneumonia.
Who cannot join
- • CHWs in conflict ridden geographical areas within the district or not, providing consistent services on a full-time basis to the populations they are serving.
- CHWs not willing to participate in the trial.
- CHWs who do not have a device (watch, respiratory timer or cell phone) to support measurement of respiratory rates and who are not routinely counting respiratory rate to diagnose suspected pneumonia.
- CHWs who did not complete the MoH basic training for CHWs provided through the 2016-2020 Strengthening Maternal, Newborn and Child Health program
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: Children's Automated Respiration Monitor (ChARM) for Child Pneumonia Diagnosis by Community Health Workers in Mali: Innovating ChARM's Role in Supervision, Training and Diagnosis, a Cluster Randomized Control Trial
The primary objective of this study is to estimate the impact of a self-monitoring tool (ChARM), used as a teaching/monitoring device, on the CHWs respiratory rate counting accuracy when assessing children under the age of 5 years with suspected pneumonia symptoms.
Read the detailed description
Methodology:
The study is designed as a community based, cluster randomized, pragmatic, intervention trial. It will be conducted within the existing 2016-2020 project structure. Specifically, the intervention will evaluate the potential of the ChARM device to improve CHWs competency in counting respiratory rate and diagnose pneumonia more accurately in children under 5 years presenting with symptoms in remote areas.
Intervention Group A - Community Health Workers (CHWs) (Basic training in CHW curriculum, ChARM training and 8-month application of the ChARM device, self-monitoring, direct observation and review of CHW routine monthly reports and drug supply sheets): 8 months, March- November 2018.
Intervention Group B - Community Health Workers (Basic training in CHW curriculum, ChARM training and 4-month application of the ChARM device, self-monitoring, direct observation and review of CHW routine monthly reports and drug supply sheets): 8 months,March- November 2018.
Control Group C - Community Health Workers (Basic training in CHW curriculum, direct observation and CHW routine monthly reports and drug supply sheets): 8 months, March- November 2018.
CHW and Field Monitor In-depth interviews - November 2018
Data analysis and report writing - December 2018-January 2019
- Conditions
- Acute Respiratory Infection
- Being tested
- Children's Automated Respiration Monitor (ChARM)
- Keywords
- ChARM, community health worker
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Children's Automated Respiration Monitor (ChARM)Device
The Philips CHARM (children's automatic respiratory monitor) is specifically designed to detect pneumonia in low resource areas. The lightweight measuring device sits on a child's or infant's chest, secured by a strap and measures respiration rate (fast breathing) through an ingenious algorithm. In this study ChARM will be used as a self monitoring and teaching aide by the CHWS.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group A | Active comparator | CHWs trained in ChARM and using ChARM as a self-monitoring tool for 8 months while counting respiratory rate of children under 5 visually using a timer.
Intervention: The Children's Respiration Monitor (also known as ChARM) device is routinely used to diagnose Pneumonia cases but in this study it will be used as a self-monitoring and teaching aide for strengthening CHWs skills. Receives: Device: Children's Automated Respiration Monitor (ChARM) |
| Intervention Group B | Active comparator | CHWs trained in ChARM and using ChARM as a self-monitoring tool for 4 months while counting respiratory rate of children under 5 visually using a time; then discontinue using ChARM and continue to monitor the respiratory rate visually using a timer only for the remaining 4 months.
Intervention: The Children's Respiration Monitor (also known as ChARM) device is routinely used to diagnose Pneumonia cases but in this study it will be used as a self-monitoring and teaching aide for strengthening CHWs skills. Receives: Device: Children's Automated Respiration Monitor (ChARM) |
| Control Group C | No intervention | CHWs who did not receive the ChARM training and will be monitoring the respiratory rate of children under 5 visually using a timer only, as per the MoH traditional training. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acute Respiratory Illness (ARI) Case fatality rate
Acute Respiratory Illness (ARI) Case fatality rate defined as number of deaths from respiratory infections among children diagnosed with respiratory infections
Measured: 8 months
Secondary outcomes (5)
Respiratory rate counting accuracy
Respiratory rate is defined as the number of breaths taken per minute
Measured: 8 months
Proportion of pneumonia cases detected and treated by CHWs
Proportion of pneumonia cases detected by the CHWs that are treated by CHWs
Measured: 8 months
Proportion of suspected severe pneumonia cases referred by CHWs to the CSCom
Proportion of all suspected severe pneumonia cases identified by the CHWs (based on presence of fever and increased respiratory rates for age) referred by CHWs to the CSCom
Measured: 8 months
Proportion of suspected pneumonia cases in the community who sought care from a CHW
Proportion of self-referenced pneumonia cases in the community (via household survey) who report seeking care from a CHW
Measured: 8 months
Accuracy in drug management and procurement requests
Percent of CHW with no stock-outs in the last 4 months
Measured: 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2018
- Study start5 Mar 2018
- Primary completion21 Jan 2019
- Study completion21 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Respiratory InfectionStudies 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Intervention Group A - Community Health Workers (CHWs) (Basic training in CHW curriculum, ChARM training and 8-month application of the ChARM device, self-monitoring, direct observation and review of CHW routine monthly reports and drug supply sheets): 8 months, March- November 2018. Intervention Group B - Community Health Workers (Basic training in CHW curriculum, ChARM training and 4-month application of the ChARM device, self-monitoring, direct observation and review of CHW routine monthly reports and drug supply sheets): March- November 2018. Control Group C - Community Health Workers (Basic training in CHW curriculum, direct observation and CHW routine monthly reports and drug supply sheets): 8 months, March- November 2018.
- Masking
- None (open label)
- Enrolment
- 141 participants (actual)
Sponsor and investigators
- Lead sponsor
- Diego Bassani
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Red Cross
- Responsible party
- Sponsor-investigator, Diego Bassani, The Hospital for Sick Children
- Investigators
- Diego G Bassani, PhD, Principal investigator, University of Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03457519
- Sponsor's protocol ID
- R-ST-POC-1707-07682
- Status last verified
- Jun 2019
- First submitted
- 14 Dec 2017
- Last updated
- 25 Jun 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Plan to share Study Protocol and Clinical Study Reports with local study partners with the purposes of future decisions on future CHW training
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Children's Automated Respiration Monitor (ChARM) for Child Pneumonia Diagnosis by Community Health Workers in Mali: Innovating ChARM's Role in Supervision, Training and Diagnosis, a Cluster Randomized Control Trial
- ClinicalTrials.gov ID
- NCT03457519
- Acronym / sponsor ID
- R-ST-POC-1707-07682
- Conditions
- Acute Respiratory Infection
- Keywords
- ChARM, community health worker
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 141 participants (actual)
- Lead sponsor
- Diego BassaniUniversity, hospital or other
- Collaborators
- Canadian Red Cross
- Study start
- 5 Mar 2018 (actual)
- Primary completion
- 21 Jan 2019 (actual)
- Study completion
- 21 Jan 2019 (actual)
- First posted
- 7 Mar 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.
The primary objective of this study is to estimate the impact of a self-monitoring tool (ChARM), used as a teaching/monitoring device, on the CHWs respiratory rate counting accuracy when assessing children under the age of 5 years with suspected pneumonia symptoms.
Detailed description
Methodology:
The study is designed as a community based, cluster randomized, pragmatic, intervention trial. It will be conducted within the existing 2016-2020 project structure. Specifically, the intervention will evaluate the potential of the ChARM device to improve CHWs competency in counting respiratory rate and diagnose pneumonia more accurately in children under 5 years presenting with symptoms in remote areas.
Intervention Group A - Community Health Workers (CHWs) (Basic training in CHW curriculum, ChARM training and 8-month application of the ChARM device, self-monitoring, direct observation and review of CHW routine monthly reports and drug supply sheets): 8 months, March- November 2018.
Intervention Group B - Community Health Workers (Basic training in CHW curriculum, ChARM training and 4-month application of the ChARM device, self-monitoring, direct observation and review of CHW routine monthly reports and drug supply sheets): 8 months,March- November 2018.
Control Group C - Community Health Workers (Basic training in CHW curriculum, direct observation and CHW routine monthly reports and drug supply sheets): 8 months, March- November 2018.
CHW and Field Monitor In-depth interviews - November 2018
Data analysis and report writing - December 2018-January 2019
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Intervention Group A - Community Health Workers (CHWs) (Basic training in CHW curriculum, ChARM training and 8-month application of the ChARM device, self-monitoring, direct observation and review of CHW routine monthly reports and drug supply sheets): 8 months, March- November 2018. Intervention Group B - Community Health Workers (Basic training in CHW curriculum, ChARM training and 4-month application of the ChARM device, self-monitoring, direct observation and review of CHW routine monthly reports and drug supply sheets): March- November 2018. Control Group C - Community Health Workers (Basic training in CHW curriculum, direct observation and CHW routine monthly reports and drug supply sheets): 8 months, March- November 2018.
| Arm | Type | Receives |
|---|---|---|
| Intervention Group A | Active comparator | Device: Children's Automated Respiration Monitor (ChARM)CHWs trained in ChARM and using ChARM as a self-monitoring tool for 8 months while counting respiratory rate of children under 5 visually using a timer. Intervention: The Children's Respiration Monitor (also known as ChARM) device is routinely used to diagnose Pneumonia cases but in this study it will be used as a self-monitoring and teaching aide for strengthening CHWs skills. |
| Intervention Group B | Active comparator | Device: Children's Automated Respiration Monitor (ChARM)CHWs trained in ChARM and using ChARM as a self-monitoring tool for 4 months while counting respiratory rate of children under 5 visually using a time; then discontinue using ChARM and continue to monitor the respiratory rate visually using a timer only for the remaining 4 months. Intervention: The Children's Respiration Monitor (also known as ChARM) device is routinely used to diagnose Pneumonia cases but in this study it will be used as a self-monitoring and teaching aide for strengthening CHWs skills. |
| Control Group C | No intervention | –CHWs who did not receive the ChARM training and will be monitoring the respiratory rate of children under 5 visually using a timer only, as per the MoH traditional training. |
Who may qualify
- Ages
- 15 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- • Be currently providing iCCM services on a full-time basis to the populations they are serving.
Key exclusion criteria (4 listed)
- • CHWs in conflict ridden geographical areas within the district or not, providing consistent services on a full-time basis to the populations they are serving.
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 |
|---|---|---|
| Children's Automated Respiration Monitor (ChARM)The Philips CHARM (children's automatic respiratory monitor) is specifically designed to detect pneumonia in low resource areas. The lightweight measuring device sits on a child's or infant's chest, secured by a strap and measures respiration rate (fast breathing) through an ingenious algorithm. In this study ChARM will be used as a self monitoring and teaching aide by the CHWS. | Device | Intervention Group A, Intervention Group B |
Primary outcome
Acute Respiratory Illness (ARI) Case fatality rate
Time frame: 8 months
Acute Respiratory Illness (ARI) Case fatality rate defined as number of deaths from respiratory infections among children diagnosed with respiratory infections
5 secondary outcomes
Respiratory rate counting accuracy
Time frame: 8 months
Proportion of pneumonia cases detected and treated by CHWs
Time frame: 8 months
Proportion of suspected severe pneumonia cases referred by CHWs to the CSCom
Time frame: 8 months
Proportion of suspected pneumonia cases in the community who sought care from a CHW
Time frame: 8 months
Accuracy in drug management and procurement requests
Time frame: 8 months
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 25 Jun 2019.
- Individual participant dataSharing planned: Yes. Plan to share Study Protocol and Clinical Study Reports with local study partners with the purposes of future decisions on future CHW training
Related trials for Acute Respiratory Infection
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
Enrolling by invitation
Personalized Ventilator Settings for Patients on ECMO
Acute Respiratory Distress Syndrome (ARDS), Extracorporeal Membrane Oxygenation
Not yet recruiting
Expanded Diagnostic Strategy in Older Adults Hospitalized With Community-Acquired Acute Respiratory Infection
Acute Respiratory Infection
Not yet recruiting
Influence of Patient Positioning During Nasal Lavage
Acute Upper Respiratory Tract Infections, Nasal Obstruction
Recruiting
Whole-body Cryotherapy in Those With Chronic Fatigue: A Feasibility Study
ME/CFS, Fibromyalgia (FM)
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.
Diego G Bassani, PhD principal investigator
University of Toronto
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Children's Automated Respiration Monitor (ChARM) in people with Acute Respiratory Infection, run by Diego Bassani at 2 sites in Mali.
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 4 inclusion and 4 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 25 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Mali. 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?
Acute Respiratory Illness (ARI) Case fatality rate (time frame: 8 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 25 Jun 2019.