MortalityMTVNCT00465777
Improved Management and in-Hospital Mortality
A study testing Guideline adherence and financial incentive in people with Mortality and Malaria, run by Bandim Health Project at 1 site in Guinea-Bissau.
Trial summary
The study intend to evaluate whether the use of standardised malaria case management protocol plus financial incentives added to the availability of free drugs reduce the case-fatality at the paediatric ward. Read more about this study
- Who is it for?
- Ages 3 months to 5 years
- What is being tested?
- Guideline adherence and financial incentive
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 950 participants
- Where
- 1 siteGuinea-Bissau
- Study dates
- Dec 2004to Feb 2006
- 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 3 months to 5 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Hospitalization due to malaria
- Non per os
Who cannot join
- Consent from parent/caretaker declined
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Reduced in-Hospital Mortality After Improved Management of Patients Hospitalised With Malaria. A Randomised Trial
The study intend to evaluate whether the use of standardised malaria case management protocol plus financial incentives added to the availability of free drugs reduce the case-fatality at the paediatric ward.
Read the detailed description
Mortality at the national paediatric ward in Guinea-Bissau is very high. During a civil war in 1998/1999 the hospital case fatality (CF) decreased by more than 40%, increasing again after the the war. This was attributed to the available free drugs from the humanitarian aid and food incentives to the personnel. Free emergency kits for treatment of severe malaria was introduced, however the CF did not decline. Therefore, the ward was split into two groups of rooms: intervention and control. All the staff of the ward was trained in the use of a standardised guideline for treatment of severe malaria and randomly assigned to one of the groups. All children hospitalised for malaria received the drug emergency kits. The only difference in the intervention group were the small financial incentives and supervision for strict adherence to the guidelines procedures.
- Being tested
- Guideline adherence and financial incentive
- Keywords
- malaria, mortality, hospital, incentive, personnel, paediatric
- Medical subject headings
- Malaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Guideline adherence and financial incentiveBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
In-hospital case-fatality
Secondary outcomes (1)
Cumulative post-discharge mortality on day 28 and length of hospitalisation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2007 (estimated)
- Study startDec 2004
- Study completionFeb 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MortalityStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 950 participants
Sponsor and investigators
- Lead sponsor
- Bandim Health Project
- Sponsor type
- University, hospital or other
- Collaborators
- Statens Serum Institut, World Health Organization
- Investigators
- Peter Aaby, DMSc, Study chair, Bandim Health Project
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00465777
- Sponsor's protocol ID
- PED-MTV-2004
- Acronym
- MTV
- Status last verified
- Apr 2007
- First submitted
- 23 Apr 2007
- Last updated
- 25 Apr 2007
- Results posted
- No
- Data monitoring committee
- No
Publications
Biai S, Rodrigues A, Gomes M, Ribeiro I, Sodemann M, Alves F, Aaby P. Reduced in-hospital mortality after improved management of children under 5 years admitted to hospital with malaria: randomised trial. BMJ. 2007 Oct 27;335(7625):862. doi: 10.1136/bmj.39345.467813.80. Epub 2007 Oct 22.
PubMed 17954513
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reduced in-Hospital Mortality After Improved Management of Patients Hospitalised With Malaria. A Randomised Trial
- ClinicalTrials.gov ID
- NCT00465777
- Acronym / sponsor ID
- MTV / PED-MTV-2004
- Keywords
- malaria, mortality, hospital, incentive, personnel, paediatric
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 950 participants
- Lead sponsor
- Bandim Health ProjectUniversity, hospital or other
- Collaborators
- Statens Serum Institut, World Health Organization
- Study start
- Dec 2004
- Study completion
- Feb 2006 (actual)
- First posted
- 25 Apr 2007 (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.
The study intend to evaluate whether the use of standardised malaria case management protocol plus financial incentives added to the availability of free drugs reduce the case-fatality at the paediatric ward.
Detailed description
Mortality at the national paediatric ward in Guinea-Bissau is very high. During a civil war in 1998/1999 the hospital case fatality (CF) decreased by more than 40%, increasing again after the the war. This was attributed to the available free drugs from the humanitarian aid and food incentives to the personnel. Free emergency kits for treatment of severe malaria was introduced, however the CF did not decline. Therefore, the ward was split into two groups of rooms: intervention and control. All the staff of the ward was trained in the use of a standardised guideline for treatment of severe malaria and randomly assigned to one of the groups. All children hospitalised for malaria received the drug emergency kits. The only difference in the intervention group were the small financial incentives and supervision for strict adherence to the guidelines procedures.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 3 months to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Hospitalization due to malaria
- Non per os
Key exclusion criteria (1 listed)
- Consent from parent/caretaker declined
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 |
|---|---|---|
| Guideline adherence and financial incentive | Behavioural | – |
Primary outcome
In-hospital case-fatality
1 secondary outcome
Cumulative post-discharge mortality on day 28 and length of hospitalisation
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 Apr 2007.
- Derived from this study: PubMed 17954513Biai S, Rodrigues A, Gomes M, Ribeiro I, Sodemann M, Alves F, Aaby P. Reduced in-hospital mortality after improved management of children under 5 years admitted to hospital with malaria: randomised trial. BMJ. 2007 Oct 27;335(7625):862. doi: 10.1136/bmj.39345.467813.80. Epub 2007 Oct 22.
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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.
Peter Aaby, DMSc study chair
Bandim Health Project
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Guideline adherence and financial incentive in people with Mortality and Malaria, run by Bandim Health Project at 1 site in Guinea-Bissau.
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 2 inclusion and 1 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 Apr 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Guinea-Bissau. 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?
In-hospital case-fatality. 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 NCT00465777, which also lists 1 linked publication.
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 Apr 2007.