The Added Value of a Mobile Application of Community Case Management on Pediatric Referral Rates in Malawi

NCT ID: NCT02763345

Last Updated: 2024-01-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 6995 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-10-31
• Study Completion Date: 2017-02-28

Brief 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). 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Paper-based CCM (Standard Care)

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.

Group Type: ACTIVE_COMPARATOR

Standard care

Intervention Type: OTHER

SL eCCM App + paper CCM

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.

Group Type: EXPERIMENTAL

Supporting LIFE electronic Community Case Management

Intervention Type: OTHER

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.

Interventions

Supporting LIFE electronic Community Case Management

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.

Intervention Type: OTHER

Standard care

Intervention Type: OTHER

Other Intervention Names

SL eCCM App

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 2 Months
• Maximum Eligible Age: 59 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Imperial College London

OTHER

Sponsor Role: collaborator

University College Cork

OTHER

Sponsor Role: collaborator

Lund University

OTHER

Sponsor Role: collaborator

Mzuzu University

UNKNOWN

Sponsor Role: collaborator

Luke International Norway

UNKNOWN

Sponsor Role: collaborator

University of Washington

OTHER

Sponsor Role: lead

Responsible Party

Matthew Thompson

Professor, Department of Family Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Matthew J Thompson, DPhil

Role: PRINCIPAL_INVESTIGATOR

University of Washington

References

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.

Reference Type: DERIVED

PMID: 34668872 (View on PubMed)

Hardy 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.

Reference Type: DERIVED

PMID: 29020976 (View on PubMed)

Other Identifiers

51750

Identifier Type: -

Identifier Source: org_study_id