Tools for the Integrated Management of Childhood Illness (TIMCI): Evaluation of Pulse Oximetry & Clinical Decision Support Algorithms in Primary Care

NCT04910750 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 167517

Last updated 2023-10-31

No results posted yet for this study

Summary

By introducing pulse oximetry, with or without clinical decision support algorithms, to primary care facilities in India, Kenya, Senegal and Tanzania, the Tools for Integrated Management of Childhood Illness (TIMCI) project aims to contribute to reducing morbidity and mortality for sick children under-five while supporting the rational and efficient use of diagnostics and medicines by healthcare providers.

The multi-country, multi-method evaluation aims to generate evidence on the health and quality of care impact, operational priorities, cost and cost-effectiveness of introducing these tools to facilitate national and international decision-making on scale-up.

Conditions

  • Pneumonia
  • Primary Health Care
  • Child Health
  • Hypoxia
  • Referral and Consultation
  • Decision Support Systems, Clinical
  • Oxymetry

Interventions

DEVICE

Pulse oximetry

Pulse oximeters are a non-invasive, accurate and easy to use method of evaluating blood oxygen saturation

DEVICE

Clinical Decision Support Algorithm

Tablet-based clinical decision support algorithms, based on guidelines for the assessment and management of sick children under 5 years of age at primary care

Sponsors & Collaborators

  • Ifakara Health Institute

    collaborator OTHER
  • King George's Medical University

    collaborator OTHER
  • University of Waterloo

    collaborator OTHER
  • PATH

    collaborator OTHER
  • Swiss Tropical & Public Health Institute

    lead OTHER

Principal Investigators

  • Kaspar Wyss, Prof, PhD · Swiss Tropical & Public Health Institute

  • Valérie D'Acremont, MD, PhD · Swiss Tropical & Public Health Institute

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
1 Day
Max Age
5 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-07-05
Primary Completion
2023-04-21
Completion
2023-04-21
FDA Device
Yes

Countries

  • Tanzania

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04910750 on ClinicalTrials.gov