Infectious DiseasesNCT02763345
The Added Value of a Mobile Application of Community Case Management on Pediatric Referral Rates in Malawi
A study testing Supporting LIFE electronic Community Case Management in people with Infectious Diseases, run by University of Washington.
Trial summary
Community Case Management (CCM) is a clinical decision aid used by frontline Health Surveillance Assistants (HSAs) in Malawi to manage uncomplicated cases of pneumonia and malaria (amongst other conditions). Read more about this study
- Who is it for?
- Ages 2 to 59 months
- Conditions the study is for
- Infectious Diseases
- What is being tested?
- Supporting LIFE electronic Community Case Management
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6,995 participants
- Where
- No sites listed yet
- Study dates
- Oct 2016to 28 Feb 2017
- 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 2 to 59 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Parents/caregivers aged ≥18 years with spoken fluency in Chichewa, Tonga and Tumbuka
- Children aged ≥2 months to <5 years
- Able/willing to give voluntary verbal consent
Who cannot join
- Parents/caregivers aged <18 years
- Children aged <2 months or ≥5 years
- Children who are convulsing or unconscious/unresponsive at presentation
- Parents/caregivers unable/unwilling to give voluntary verbal consent
About this study
Official title: The Added Value of a Mobile Application of Community Case Management on Under-5 Referral, Re-consultation and Hospitalization Rates in Malawi: a Pragmatic Stepped-wedge Cluster Randomized Trial
Community Case Management (CCM) is a clinical decision aid used by frontline Health Surveillance Assistants (HSAs) in Malawi to manage uncomplicated cases of pneumonia and malaria (amongst other conditions). Children identified has having complicated illness are urgently referred to larger health facilities better equipped to clinically manage these more complex presentations. There is evidence to suggest HSAs are missing opportunities to refer seriously ill children, and parents/caregivers are failing to comply with urgent referral recommendations when given; reducing the overall effectiveness of the CCM strategy. Use of mobile technology for deploying CCM has been demonstrated in prior research as feasible to evaluate, acceptable to health workers and parents/caregivers and improving health worker fidelity to the guidelines, but it is unknown if this translates into increased referral and referral completion rates. This trial seeks to evaluate the added value of a purpose developed mobile solution for CCM, called Supporting LIFE electronic Community Case Management (SL eCCM App) on HSA referral and parent/caregiver health seeking behavior.
- Conditions
- Infectious Diseases
- Being tested
- Supporting LIFE electronic Community Case Management, Standard care
- Medical subject headings
- Communicable Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supporting LIFE electronic Community Case ManagementOther
Also called SL eCCM App
The SL eCCM App is smartphone application developed to run on Android operating systems 3.0 Honeycomb and above. The SL eCCM App represents an electronic format of the WHO and UNICEFs paper-based CCM clinical decision rule, currently adopted as national policy in Malawi for assessing children presenting to village clinics with acute illness.The App includes a tap-sensitive breath counter for measuring breathing rate.
Standard careOther
| Study group | Role | What they receive |
|---|---|---|
| Paper-based CCM (Standard Care) | Active comparator | Children are assessed and treated according to the WHO and UNICEFs paper-based Community Case Management decision aid for Malawi for a minimum of 2 and a maximum of 7-weeks. Clinical assessment is guided by the paper-based 'Sick Child Form' presented in English, and clinical data is recorded by Health Surveillance Assistants manually in the Village Clinic Register. Receives: Other: Standard care |
| SL eCCM App + paper CCM | Experimental | Health Surveillance Assistants use the Supporting LIFE electronic Community Case Management App (SL eCCM App) deployed on a smartphone and replicating paper-based CCM guidelines to assess and treat children in conjunction with standard care, for a minimum of 2-weeks and maximum of 7-weeks. Clinical data is recorded in both the SL eCCM App and Village Clinic Register. Receives: Other: Supporting LIFE electronic Community Case Management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Health worker initiated referral of children to higher-level health facilities
Measured: at the index visit (study enrollment)
Attendance/non-attendance of parent/caregivers given urgent referral recommendation at higher-level health facilities
Measured: 7-days post-enrollment
Secondary outcomes (3)
Barriers and facilitators to parent/caregiver compliance with referral recommendations
Measured: <2-weeks post-enrollment
Acceptability of the SL eCCM App to HSAs and parents/caregivers
Measured: <2-weeks post-enrollment
Household-level costs associated with healthcare seeking behavior
Measured: < 2-weeks post-enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2016 (estimated)
- Study startOct 2016
- Primary completion28 Feb 2017
- Study completion28 Feb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Infectious DiseasesStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- 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
- Masking
- None (open label)
- Enrolment
- 6,995 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- Imperial College London, University College Cork, Lund University, Mzuzu University, Luke International Norway
- Responsible party
- Principal investigator, Matthew Thompson, University of Washington
- Investigators
- Matthew J Thompson, DPhil, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02763345
- Sponsor's protocol ID
- 51750
- Status last verified
- Jan 2024
- First submitted
- 3 May 2016
- Last updated
- 23 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Chirambo GB, Thompson M, Hardy V, Ide N, Hwang PH, Dharmayat K, Mastellos N, Heavin C, O'Connor Y, Muula AS, Andersson B, Carlsson S, Tran T, Hsieh JC, Lee HY, Fitzpatrick A, Joseph Wu TS, O'Donoghue J. Effectiveness of Smartphone-Based Community Case Management on the Urgent Referral, Reconsultation, and Hospitalization of Children Aged Under 5 Years in Malawi: Cluster-Randomized, Stepped-Wedge Trial. J Med Internet Res. 2021 Oct 20;23(10):e25777. doi: 10.2196/25777.
PubMed 34668872Hardy V, O'Connor Y, Heavin C, Mastellos N, Tran T, O'Donoghue J, Fitzpatrick AL, Ide N, Wu TJ, Chirambo GB, Muula AS, Nyirenda M, Carlsson S, Andersson B, Thompson M. The added value of a mobile application of Community Case Management on referral, re-consultation and hospitalization rates of children aged under 5 years in two districts in Northern Malawi: study protocol for a pragmatic, stepped-wedge cluster-randomized controlled trial. Trials. 2017 Oct 11;18(1):475. doi: 10.1186/s13063-017-2213-z.
PubMed 29020976
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Added Value of a Mobile Application of Community Case Management on Under-5 Referral, Re-consultation and Hospitalization Rates in Malawi: a Pragmatic Stepped-wedge Cluster Randomized Trial
- ClinicalTrials.gov ID
- NCT02763345
- Acronym / sponsor ID
- 51750
- Conditions
- Infectious Diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6,995 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- Imperial College London, University College Cork, Lund University, Mzuzu University, Luke International Norway
- Study start
- Oct 2016
- Primary completion
- 28 Feb 2017 (actual)
- Study completion
- 28 Feb 2017 (actual)
- First posted
- 5 May 2016 (estimated)
- 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.
Community Case Management (CCM) is a clinical decision aid used by frontline Health Surveillance Assistants (HSAs) in Malawi to manage uncomplicated cases of pneumonia and malaria (amongst other conditions). Children identified has having complicated illness are urgently referred to larger health facilities better equipped to clinically manage these more complex presentations. There is evidence to suggest HSAs are missing opportunities to refer seriously ill children, and parents/caregivers are failing to comply with urgent referral recommendations when given; reducing the overall effectiveness of the CCM strategy. Use of mobile technology for deploying CCM has been demonstrated in prior research as feasible to evaluate, acceptable to health workers and parents/caregivers and improving health worker fidelity to the guidelines, but it is unknown if this translates into increased referral and referral completion rates. This trial seeks to evaluate the added value of a purpose developed mobile solution for CCM, called Supporting LIFE electronic Community Case Management (SL eCCM App) on HSA referral and parent/caregiver health seeking behavior.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Paper-based CCM (Standard Care) | Active comparator | Other: Standard careChildren are assessed and treated according to the WHO and UNICEFs paper-based Community Case Management decision aid for Malawi for a minimum of 2 and a maximum of 7-weeks. Clinical assessment is guided by the paper-based 'Sick Child Form' presented in English, and clinical data is recorded by Health Surveillance Assistants manually in the Village Clinic Register. |
| SL eCCM App + paper CCM | Experimental | Other: Supporting LIFE electronic Community Case ManagementHealth Surveillance Assistants use the Supporting LIFE electronic Community Case Management App (SL eCCM App) deployed on a smartphone and replicating paper-based CCM guidelines to assess and treat children in conjunction with standard care, for a minimum of 2-weeks and maximum of 7-weeks. Clinical data is recorded in both the SL eCCM App and Village Clinic Register. |
Who may qualify
- Ages
- 2 to 59 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Parents/caregivers aged ≥18 years with spoken fluency in Chichewa, Tonga and Tumbuka
- Children aged ≥2 months to <5 years
- Able/willing to give voluntary verbal consent
Key exclusion criteria (4 listed)
- Parents/caregivers aged <18 years
- Children aged <2 months or ≥5 years
- Children who are convulsing or unconscious/unresponsive at presentation
- Parents/caregivers unable/unwilling to give voluntary verbal consent
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 |
|---|---|---|
| Supporting LIFE electronic Community Case ManagementAlso: SL eCCM AppThe SL eCCM App is smartphone application developed to run on Android operating systems 3.0 Honeycomb and above. The SL eCCM App represents an electronic format of the WHO and UNICEFs paper-based CCM clinical decision rule, currently adopted as national policy in Malawi for assessing children presenting to village clinics with acute illness.The App includes a tap-sensitive breath counter for measuring breathing rate. | Other | SL eCCM App + paper CCM |
| Standard care | Other | Paper-based CCM (Standard Care) |
Primary outcome
Health worker initiated referral of children to higher-level health facilities
Time frame: at the index visit (study enrollment)
Attendance/non-attendance of parent/caregivers given urgent referral recommendation at higher-level health facilities
Time frame: 7-days post-enrollment
3 secondary outcomes
Barriers and facilitators to parent/caregiver compliance with referral recommendations
Time frame: <2-weeks post-enrollment
Acceptability of the SL eCCM App to HSAs and parents/caregivers
Time frame: <2-weeks post-enrollment
Household-level costs associated with healthcare seeking behavior
Time frame: < 2-weeks post-enrollment
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 23 Jan 2024.
- Derived from this study: PubMed 34668872Chirambo GB, Thompson M, Hardy V, Ide N, Hwang PH, Dharmayat K, Mastellos N, Heavin C, O'Connor Y, Muula AS, Andersson B, Carlsson S, Tran T, Hsieh JC, Lee HY, Fitzpatrick A, Joseph Wu TS, O'Donoghue J. Effectiveness of Smartphone-Based Community Case Management on the Urgent Referral, Reconsultation, and Hospitalization of Children Aged Under 5 Years in Malawi: Cluster-Randomized, Stepped-Wedge Trial. J Med Internet Res. 2021 Oct 20;23(10):e25777. doi: 10.2196/25777.
- Derived from this study: PubMed 29020976Hardy V, O'Connor Y, Heavin C, Mastellos N, Tran T, O'Donoghue J, Fitzpatrick AL, Ide N, Wu TJ, Chirambo GB, Muula AS, Nyirenda M, Carlsson S, Andersson B, Thompson M. The added value of a mobile application of Community Case Management on referral, re-consultation and hospitalization rates of children aged under 5 years in two districts in Northern Malawi: study protocol for a pragmatic, stepped-wedge cluster-randomized controlled trial. Trials. 2017 Oct 11;18(1):475. doi: 10.1186/s13063-017-2213-z.
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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.
Matthew J Thompson, DPhil principal investigator
University of Washington
Questions about this trial
What is this clinical trial studying?
A study testing Supporting LIFE electronic Community Case Management in people with Infectious Diseases, run by University of Washington.
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 3 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 23 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Health worker initiated referral of children to higher-level health facilities (time frame: at the index visit (study enrollment)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02763345, which also lists 2 linked publications.
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 23 Jan 2024.