Evaluation of Home-Based Management of Fever in Urban Ugandan Children

January 11, 2017 updated by: Brian Greenwood, London School of Hygiene and Tropical Medicine
The purpose of this study is to see if providing effective antimalarial treatment at home for parents/guardians to treat their children for malaria will lead to an improved health outcome compared to conventional healthcare.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Population: Representative sample of Ugandan children aged 1 to 5 years from 400 households (approximately 540 children).

Clinical Site: The study will be conducted in the Mulago III parish community of Kampala, Uganda.

Study Duration: 13 months

Study Intervention: *Pilot period: After enrollment, households will participate in a one month pilot period to test the household pictorial diaries. At the end of the pilot period, households will be randomized to participation in the home-based management of fever (HBMF) arm or standard care arm for the remainder of the study (12 months). *HBMF arm: Households randomized to the HBMF group will be provided with pre-packaged coartemether to keep at home. Primary caregivers will be instructed to treat children participating in the study empirically with coartemether at home when the child develops fever. Study personnel will distribute drugs and educate the caregivers about administration of drugs, recognition of danger signs of fever/malaria, and when to seek additional care. *Standard care: Households randomized to the standard care arm will be asked to continue their current behaviour and to manage fever in their children as they would normally.

Measurements: Household diaries and monthly visits. Primary caregivers will be asked to keep a diary regarding the health of study participants for the duration of the study (13 months). Information on illnesses, treatments given, visits to health care facilities, and health care expenditures will be collected. Study personnel will visit the households monthly to collect completed diaries. At each visit, questionnaires will be administered to gather additional data on the health of the participants and treatment seeking behaviour.

Clinical and laboratory evaluations: Temperature, height, weight, mid-upper arm circumference, spleen size, haemoglobin, and thick blood smear will be assessed at enrollment, and at the beginning and end of the intervention period.

Study Objectives: 1. To measure the impact of home-based management of fever with coartemether on malaria-related morbidity compared to the current standard of care in the community.

2. To measure the impact of home-based management of fever with coartemether on economic measures compared to the current standard of care in the community.

Primary outcome: Treatment incidence density (treatments per time at risk) for each treatment arm

Secondary clinical outcomes: 1) mean days of fever; 2) incidence of febrile episodes; 3) mean haemoglobin at study end; 4) change in mean haemoglobin; 5) prevalence of splenomegaly; 6) prevalence of parasitaemia; 7) incidence of visits to health care facilities, and hospitalizations; 8) mortality rate; 9) anthropometric measurements; 10) proportion of "appropriate" treatments; 11) proportion of delayed treatments; 12) treatment incidence density of treatments given at >50% and at full dose

Economic outcomes: 1) household cost/febrile episode; 2) household costs for treatment of febrile episode/month; 3) provider cost/child for delivery of HBMF; 4) estimated provider facility cost/patient for uncomplicated fever, and for severe disease; 5) total net cost/child/year; 6) net cost/additional child appropriately treated; 7) net cost/day of fever averted

Study Type

Interventional

Enrollment

540

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 5 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age 1 - 5 years
  • Agreement of parents or guardians to provide informed consent
  • Live in Mulago III Parish

Exclusion Criteria:

  • History of any known serious chronic disease requiring frequent medical care (e.g. AIDS, sickle cell disease, malignancy)
  • Intention to move from Kampala during the 13 month follow-up period
  • History of serious side effects to study medications
  • Weight < 10 kg
  • Severe malnutrition defined as a weight-for-height or height-for-age Z-score < - 3

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
The primary outcome measurement will be treatment incidence density (antimalarial treatments received per time at risk) for each study arm.

Secondary Outcome Measures

Outcome Measure
Mortality rate
Mean days of fever per participant
Incidence of febrile episodes
Mean haemoglobin at study end
Change in mean haemoglobin between the start and end of the intervention
Incidence of visits to health care facilities (drug shops, clinics, pharmacies, hospitals) and hospitalizations per participant
Economic outcomes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

London School of Hygiene and Tropical Medicine

Collaborators

University of California, San Francisco
Makerere University

Investigators

  • Principal Investigator: Sarah G Staedke, MD, University of California, San Francisco
  • Principal Investigator: Christopher JM Whitty, FRCP, London School of Hygiene and Tropical Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2005

Study Completion (Actual)

April 1, 2007

Study Registration Dates

First Submitted

June 26, 2005

First Submitted That Met QC Criteria

June 27, 2005

First Posted (Estimate)

June 27, 2005

Study Record Updates

Last Update Posted (Estimate)

January 12, 2017

Last Update Submitted That Met QC Criteria

January 11, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ITCRVG40

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.

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