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

Primary Purpose

Pneumonia, Primary Health Care, Child Health

Status
Recruiting
Phase
Not Applicable
Locations
Tanzania
Study Type
Interventional
Intervention
Pulse oximetry
Clinical Decision Support Algorithm
Sponsored by
Swiss Tropical & Public Health Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Pneumonia

Eligibility Criteria

1 Day - 5 Years (Child)All SexesDoes not accept healthy volunteers

Individual child inclusion:

  • Children 0 - 59 months for whom caregivers provide consent
  • Consulting for an illness, or reported to be unwell when attending for a routine visit (e.g. vaccination, growth or chronic disease monitoring)

Individual child exclusion:

  • Children in the immediate post-natal period or first day of life
  • Attending for a consultation related to trauma only (including new and follow-up presentations for burns, injuries, wounds)
  • Admitted within an inpatient part of the facility (including neonates delivered at the facility admitted with their mother)
  • Enrolled in the study within the preceding 28 days at any study facility

Sites / Locations

  • BukembaRecruiting
  • Igombe 60Recruiting
  • ImalamihayoRecruiting
  • KazarohoRecruiting
  • SeleliRecruiting
  • UlyankuluRecruiting
  • UyowaRecruiting
  • IgalagaliloRecruiting
  • KagungaRecruiting
  • KamangaRecruiting
  • KasungamileRecruiting
  • MulagaRecruiting
  • MwabaluhiRecruiting
  • NyamazugoRecruiting
  • Sengerema SecondaryRecruiting
  • SengeremaRecruiting
  • DugaRecruiting
  • KangeRecruiting
  • KisosoraRecruiting
  • KwanjekanyotaRecruiting
  • MachuiRecruiting
  • MafurikoRecruiting
  • MagaoniRecruiting
  • MpiraniRecruiting
  • MwakidilaRecruiting
  • NgamianiRecruiting
  • NguvumaliRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

No Intervention

Arm Label

Intervention Arm 1 - Pulse oximetry and Clinical Decision Support Algorithm

Intervention Arm 2 - Pulse oximetry alone

Control Arm - Routine Primary Health Care

Arm Description

Facilities in intervention arm 1 will be provided with handheld pulse oximeters and tablet-based clinical decision support algorithms, with pulse oximetry, CDSA and IMCI refresher training

Facilities in intervention arm 2 will be provided with handheld pulse oximeters and paper-based guidance (pulse oximetry job aid and IMCI chart booklet integrating pulse oximetry), with pulse oximetry and IMCI refresher training

Facilities in the control arm will be provided with IMCI refresher training

Outcomes

Primary Outcome Measures

Proportion of children with a severe complication (death or secondary hospitalisation) by Day 7
Secondary hospitalisation refers to any delayed hospitalisation (occurring at any point greater than 24 hours after Day 0 consultation) and any hospitalisation occurring without referral. The denominator is all enrolled children.
Proportion of children admitted to hospital within 24 hours of the Day 0 primary care consultation and as a result of a referral
This is used as a proxy for 'appropriate referral' of children, as those with severe disease should generally be admitted to hospital. The denominator for this outcomes is all children enrolled in the study, rather than only referred children. This is because the proportion of referred children that are admitted may be high in routine care, in the context of an inappropriately low referral rate. The aim of the intervention is therefore to increase the overall referral rate of children with severe disease. Hospital admission is chosen as the proxy of severe disease rather than using primary care classification of severe disease, as there are inadequacies in the classification of severe disease in routine practice. A child will be considered admitted to hospital 24hrs of Day0 consultation if the date of hospitalization is the same as Day0 date or is one day after Day0 date.

Secondary Outcome Measures

Proportion of children with severe complication (death or secondary hospitalisation) by Day 28
Secondary hospitalisation refers to any delayed hospitalisation (occurring at any point greater than 24 hours after Day 0 consultation) and any hospitalisation occurring without referral. The denominator is all enrolled children.
Proportion of children cured (defined as caregiver reported recovery from illness) by Day 7
The denominator will be all children recruited. A window of +3 days from Day 7 is considered.
Proportion of children referred by a primary care healthcare provider to a higher level of care (either to a hospital or to an inpatient part of a larger primary healthcare facility) at Day 0 consultation
The denominator will be all children recruited. Only urgent referrals will be considered.
Proportion of children who completed referral, as reported at day 7 follow-up
Only urgent referrals will be considered. A referral will be considered completed if a child attended a hospital, whether was admitted or not. A window of +3 days from Day 7 is considered.
Proportion of children with non-severe disease referred to a higher level of care on Day 0
Only urgent referrals will be considered. Only urgent referrals will be considered.
Average length of stay (in days) of children admitted to hospital
If a child is hospitalised twice, the first hospitalization will be used and second hospitalizations will be reported separately. The denominator will be all hospitalised children. This is not a time-to-event measure, as it will be analysed as a continuous variable.
Proportion of children prescribed an antibiotic at Day 0
Only antibacterials for systemic use will be taken into account for the definition of antibiotics. All children recruited will be counted in the denominator.
Proportion of children prescribed a diagnosis-appropriate antibiotic
Appropriateness of antibiotic prescription in relation to diagnosis will be evaluated as: diagnosis for which a systemic antibiotic was indicated and a systemic antibiotic was prescribed diagnosis for which a systemic antibiotic was not indicated and systemic antibiotic was prescribed first-line (or second-line) antibiotics were prescribed according to recommendations for IMCI diagnoses for which specific antibiotic(s)are indicated Diagnoses will be classified according to whether systemic antibiotics are indicated, based on IMCI and other relevant national guidelines as used for the CDSA.
Proportion of febrile children tested for malaria at Day 0
A child will be considered to be febrile if history of fever was reported by the caregiver before the consultation or temperature was recorded to be above or equal 37.5 C°. Only febrile children will be counted in the denominator.
Proportion of malaria positive children prescribed an antimalarial
Only children with a positive malaria test result will be counted in the denominator.
Proportion of malaria negative children prescribed an antimalarial
Only children with a negative malaria test result will be counted in the denominator.
Proportion of untested children prescribed an antimalarial
Only children untested for malaria will be counted in the denominator.
Proportion of children with severe, moderate and mild hypoxaemia, adjusted for sites at high altitude
The following SpO2 values ranges will be used: SpO2 < 90%, 90% ≤ SpO2 < 92% and 92% ≤ SpO2 < 94%. All children recruited will be in the denominator.
Proportion of children with hypoxaemia (according to differing cut-offs) with severe complication
The following SpO2 values ranges will be used: SpO2 < 90%, 90% ≤ SpO2 < 92% and 92% ≤ SpO2 < 94%, spurious values and missing values. Each SpO2 group will be the denominator of each proportion.
Proportion of children with severe hypoxaemia not meeting any other clinical criteria for severe disease
Country's specific cut-off for severe hypoxaemia will be used. All children recruited will be in the denominator.
Proportion of children referred with hypoxaemia who receive oxygen at hospital
All children recruited will be in the denominator. Referral and hypoxaemia are assessed at Day0 consultation. Oxygen use at hospital is only available for hospitalised children from hospital records. At the time of enrolment hypoxaemia is measured and referral advise might be issued. Whether the child received oxygen or not at hospital is evaluated based on hospital registry and it refers to oxygen given at arrival to hospital. The specified time frame takes into account that the outcome is evaluated considering information recorded at different time points.
Proportion of children attending scheduled follow-up at the same facility by Day 7
All children recruited will be in the denominator.
Proportion of children presenting for unscheduled follow-up to any health facility by Day 7
All children recruited will be in the denominator.

Full Information

First Posted
May 27, 2021
Last Updated
June 14, 2023
Sponsor
Swiss Tropical & Public Health Institute
Collaborators
Ifakara Health Institute, King George's Medical University, University of Waterloo, PATH
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1. Study Identification

Unique Protocol Identification Number
NCT04910750
Brief Title
Tools for the Integrated Management of Childhood Illness (TIMCI): Evaluation of Pulse Oximetry & Clinical Decision Support Algorithms in Primary Care
Acronym
TIMCI
Official Title
Tools for the Integrated Management of Childhood Illness: Evaluation of Pulse Oximetry & Clinical Decision Support Algorithms in Primary Care - Pragmatic Cluster Randomised Controlled Trial, With Embedded Mixed Methods, Cost & Cost-effectiveness Studies in India and Tanzania
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 5, 2021 (Actual)
Primary Completion Date
June 2023 (Anticipated)
Study Completion Date
September 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Swiss Tropical & Public Health Institute
Collaborators
Ifakara Health Institute, King George's Medical University, University of Waterloo, PATH

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
Detailed Description
This registry entry describes the pragmatic cluster randomised controlled trials (RCTs) conducted in India and Tanzania. In Kenya and Senegal, quasi-experimental pre-post studies are conducted (NCT05065320). These studies evaluating health, clinical and quality of care impact are complemented by embedded multi-method studies in all countries, including modified Service Provision Assessments, facility-based process mapping and time-flow studies, in-depth interviews (IDIs) with caregivers and healthcare providers, online key stakeholder surveys, routine data review, and an economic evaluation. We enrol sick children 0 to 59 months of age attending government primary care facilities a pragmatic parallel group, superiority cluster randomised controlled trial (RCT). Primary care facilities randomly are allocated (1:1) in India to pulse oximetry or control, and (1:1:1) in Tanzania to pulse oximetry plus CDSA, pulse oximetry, or control. Interventions are implemented with a package of training on the use of devices and refresher IMCI, supportive supervision, operational support and community engagement. IMCI refresher training is provided to all arms. Providers at intervention facilities are provided with handheld, UNICEF-approved, pulse oximeters along with guidance and training in line with government-approved criteria. In Tanzania, healthcare providers are advised to measure oxygen saturation (SpO2) on all children under 2 months of age, all children 2 to 59 months of age with cough or difficulty breathing or with signs of moderate or severe disease based on Integrated Management of Childhood Illness (IMCI); in India, healthcare providers are advised to measure oxygen saturation for all sick children. Providers are advised to urgently refer children with SpO2 <90%. The tablet-based CDSA provides step-by-step support to healthcare providers through consultations, providing national guideline-based recommendations on assessment, diagnosis and treatment based tailored to the individual child based on information entered by the provider. Following training, providers are advised to use CDSA for all consultations with sick children under 5 years of age. Sociodemographic and clinical data are collected from caregivers and records of enrolled sick children at study facilities, with phone follow-up on Day 7 and Day 28. Two primary outcomes are assessed for the RCT: severe complications by Day 7 (mortality and 'secondary hospitalisations' i.e. delayed ≥24 hours from the Day 0 consultation, or without referral); and 'primary' hospitalisations (within 24hrs the Day 0 consultation and with referral). Secondary outcomes for the RCT, relating to hypoxaemia, referral, antimicrobial prescription, follow-up, health status, are further detailed in the attached full protocol and statistical analysis plan available. The RCT sample size was estimated based on planned enrolment over 12 months and ability to detect a ≥30% decrease in severe complications (from 1.1%22) and ≥30% increase in primary hospitalisations (from 1.5%, based on facility estimates) for each arm compared to control with 80% power, 0.05 alpha per arm, and intra-cluster correlation coefficient (ICC) of 0.00147. Anticipated feasible enrolment rates were based on DHIS2 and facility data. In Tanzania, 22 clusters per arm, each recruiting an average of 1680 children, were estimated to be needed (total 110,880). In India, 40 clusters per arm, each recruiting an average of 510 children, were estimated to be needed (total 40,800). Study approval has been granted by all relevant institutional review boards, national and WHO ethical review committees. Findings will be shared with communities, healthcare providers, Ministries of Health and other local, national and international stakeholders to facilitate evidence-based decision-making on scale-up.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pneumonia, Primary Health Care, Child Health, Hypoxia, Referral and Consultation, Decision Support Systems, Clinical, Oxymetry

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
172080 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention Arm 1 - Pulse oximetry and Clinical Decision Support Algorithm
Arm Type
Active Comparator
Arm Description
Facilities in intervention arm 1 will be provided with handheld pulse oximeters and tablet-based clinical decision support algorithms, with pulse oximetry, CDSA and IMCI refresher training
Arm Title
Intervention Arm 2 - Pulse oximetry alone
Arm Type
Active Comparator
Arm Description
Facilities in intervention arm 2 will be provided with handheld pulse oximeters and paper-based guidance (pulse oximetry job aid and IMCI chart booklet integrating pulse oximetry), with pulse oximetry and IMCI refresher training
Arm Title
Control Arm - Routine Primary Health Care
Arm Type
No Intervention
Arm Description
Facilities in the control arm will be provided with IMCI refresher training
Intervention Type
Device
Intervention Name(s)
Pulse oximetry
Intervention Description
Pulse oximeters are a non-invasive, accurate and easy to use method of evaluating blood oxygen saturation
Intervention Type
Device
Intervention Name(s)
Clinical Decision Support Algorithm
Intervention Description
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
Primary Outcome Measure Information:
Title
Proportion of children with a severe complication (death or secondary hospitalisation) by Day 7
Description
Secondary hospitalisation refers to any delayed hospitalisation (occurring at any point greater than 24 hours after Day 0 consultation) and any hospitalisation occurring without referral. The denominator is all enrolled children.
Time Frame
From enrolment up to 7 days after
Title
Proportion of children admitted to hospital within 24 hours of the Day 0 primary care consultation and as a result of a referral
Description
This is used as a proxy for 'appropriate referral' of children, as those with severe disease should generally be admitted to hospital. The denominator for this outcomes is all children enrolled in the study, rather than only referred children. This is because the proportion of referred children that are admitted may be high in routine care, in the context of an inappropriately low referral rate. The aim of the intervention is therefore to increase the overall referral rate of children with severe disease. Hospital admission is chosen as the proxy of severe disease rather than using primary care classification of severe disease, as there are inadequacies in the classification of severe disease in routine practice. A child will be considered admitted to hospital 24hrs of Day0 consultation if the date of hospitalization is the same as Day0 date or is one day after Day0 date.
Time Frame
From enrolment up to 1 day after
Secondary Outcome Measure Information:
Title
Proportion of children with severe complication (death or secondary hospitalisation) by Day 28
Description
Secondary hospitalisation refers to any delayed hospitalisation (occurring at any point greater than 24 hours after Day 0 consultation) and any hospitalisation occurring without referral. The denominator is all enrolled children.
Time Frame
From enrolment up to 28 days after
Title
Proportion of children cured (defined as caregiver reported recovery from illness) by Day 7
Description
The denominator will be all children recruited. A window of +3 days from Day 7 is considered.
Time Frame
From enrolment up to 10 days after
Title
Proportion of children referred by a primary care healthcare provider to a higher level of care (either to a hospital or to an inpatient part of a larger primary healthcare facility) at Day 0 consultation
Description
The denominator will be all children recruited. Only urgent referrals will be considered.
Time Frame
At time of enrolment
Title
Proportion of children who completed referral, as reported at day 7 follow-up
Description
Only urgent referrals will be considered. A referral will be considered completed if a child attended a hospital, whether was admitted or not. A window of +3 days from Day 7 is considered.
Time Frame
From enrolment up to 10 days after
Title
Proportion of children with non-severe disease referred to a higher level of care on Day 0
Description
Only urgent referrals will be considered. Only urgent referrals will be considered.
Time Frame
At time of enrolment
Title
Average length of stay (in days) of children admitted to hospital
Description
If a child is hospitalised twice, the first hospitalization will be used and second hospitalizations will be reported separately. The denominator will be all hospitalised children. This is not a time-to-event measure, as it will be analysed as a continuous variable.
Time Frame
From hospital admission to discharge
Title
Proportion of children prescribed an antibiotic at Day 0
Description
Only antibacterials for systemic use will be taken into account for the definition of antibiotics. All children recruited will be counted in the denominator.
Time Frame
At time of enrolment
Title
Proportion of children prescribed a diagnosis-appropriate antibiotic
Description
Appropriateness of antibiotic prescription in relation to diagnosis will be evaluated as: diagnosis for which a systemic antibiotic was indicated and a systemic antibiotic was prescribed diagnosis for which a systemic antibiotic was not indicated and systemic antibiotic was prescribed first-line (or second-line) antibiotics were prescribed according to recommendations for IMCI diagnoses for which specific antibiotic(s)are indicated Diagnoses will be classified according to whether systemic antibiotics are indicated, based on IMCI and other relevant national guidelines as used for the CDSA.
Time Frame
At time of enrolment
Title
Proportion of febrile children tested for malaria at Day 0
Description
A child will be considered to be febrile if history of fever was reported by the caregiver before the consultation or temperature was recorded to be above or equal 37.5 C°. Only febrile children will be counted in the denominator.
Time Frame
At time of enrolment
Title
Proportion of malaria positive children prescribed an antimalarial
Description
Only children with a positive malaria test result will be counted in the denominator.
Time Frame
At time of enrolment
Title
Proportion of malaria negative children prescribed an antimalarial
Description
Only children with a negative malaria test result will be counted in the denominator.
Time Frame
At time of enrolment
Title
Proportion of untested children prescribed an antimalarial
Description
Only children untested for malaria will be counted in the denominator.
Time Frame
At time of enrolment
Title
Proportion of children with severe, moderate and mild hypoxaemia, adjusted for sites at high altitude
Description
The following SpO2 values ranges will be used: SpO2 < 90%, 90% ≤ SpO2 < 92% and 92% ≤ SpO2 < 94%. All children recruited will be in the denominator.
Time Frame
At time of enrolment
Title
Proportion of children with hypoxaemia (according to differing cut-offs) with severe complication
Description
The following SpO2 values ranges will be used: SpO2 < 90%, 90% ≤ SpO2 < 92% and 92% ≤ SpO2 < 94%, spurious values and missing values. Each SpO2 group will be the denominator of each proportion.
Time Frame
At time of enrolment
Title
Proportion of children with severe hypoxaemia not meeting any other clinical criteria for severe disease
Description
Country's specific cut-off for severe hypoxaemia will be used. All children recruited will be in the denominator.
Time Frame
At time of enrolment
Title
Proportion of children referred with hypoxaemia who receive oxygen at hospital
Description
All children recruited will be in the denominator. Referral and hypoxaemia are assessed at Day0 consultation. Oxygen use at hospital is only available for hospitalised children from hospital records. At the time of enrolment hypoxaemia is measured and referral advise might be issued. Whether the child received oxygen or not at hospital is evaluated based on hospital registry and it refers to oxygen given at arrival to hospital. The specified time frame takes into account that the outcome is evaluated considering information recorded at different time points.
Time Frame
At time of enrolment and at time of hospitalization
Title
Proportion of children attending scheduled follow-up at the same facility by Day 7
Description
All children recruited will be in the denominator.
Time Frame
From enrolment up to 7 days after
Title
Proportion of children presenting for unscheduled follow-up to any health facility by Day 7
Description
All children recruited will be in the denominator.
Time Frame
From enrolment up to 7 days after

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Day
Maximum Age & Unit of Time
5 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Individual child inclusion: Children 0 - 59 months for whom caregivers provide consent Consulting for an illness, or reported to be unwell when attending for a routine visit (e.g. vaccination, growth or chronic disease monitoring) Individual child exclusion: Children in the immediate post-natal period or first day of life Attending for a consultation related to trauma only (including new and follow-up presentations for burns, injuries, wounds) Admitted within an inpatient part of the facility (including neonates delivered at the facility admitted with their mother) Enrolled in the study within the preceding 28 days at any study facility
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Fabian Schaer, PhD
Phone
+41612848813
Email
fabian.schaer@swisstph.ch
First Name & Middle Initial & Last Name or Official Title & Degree
Fenella Beynon, MD
Phone
+41612848772
Email
fenella.beynon@swisstph.ch
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kaspar Wyss, Prof, PhD
Organizational Affiliation
Swiss Tropical & Public Health Institute
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Valérie D'Acremont, MD, PhD
Organizational Affiliation
Swiss Tropical & Public Health Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bukemba
City
Kaliua
Country
Tanzania
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Grace Mhalu
Facility Name
Igombe 60
City
Kaliua
Country
Tanzania
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Grace Mhalu
Facility Name
Imalamihayo
City
Kaliua
Country
Tanzania
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Grace Mhalu
Facility Name
Kazaroho
City
Kaliua
Country
Tanzania
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Grace Mhalu
Facility Name
Seleli
City
Kaliua
Country
Tanzania
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Grace Mhalu
Facility Name
Ulyankulu
City
Kaliua
Country
Tanzania
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Grace Mhalu
Facility Name
Uyowa
City
Kaliua
Country
Tanzania
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Grace Mhalu
Facility Name
Igalagalilo
City
Sengerema
Country
Tanzania
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Grace Mhalu
Facility Name
Kagunga
City
Sengerema
Country
Tanzania
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Grace Mhalu
Facility Name
Kamanga
City
Sengerema
Country
Tanzania
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Grace Mhalu
Facility Name
Kasungamile
City
Sengerema
Country
Tanzania
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Grace Mhalu
Facility Name
Mulaga
City
Sengerema
Country
Tanzania
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Grace Mhalu
Facility Name
Mwabaluhi
City
Sengerema
Country
Tanzania
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Grace Mhalu
Facility Name
Nyamazugo
City
Sengerema
Country
Tanzania
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Grace Mhalu
Facility Name
Sengerema Secondary
City
Sengerema
Country
Tanzania
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Grace Mhalu
Facility Name
Sengerema
City
Sengerema
Country
Tanzania
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Grace Mhalu
Facility Name
Duga
City
Tanga
Country
Tanzania
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Grace Mhalu
Facility Name
Kange
City
Tanga
Country
Tanzania
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Grace Mhalu
Facility Name
Kisosora
City
Tanga
Country
Tanzania
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Grace Mhalu
Facility Name
Kwanjekanyota
City
Tanga
Country
Tanzania
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Grace Mhalu
Facility Name
Machui
City
Tanga
Country
Tanzania
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Grace Mhalu
Facility Name
Mafuriko
City
Tanga
Country
Tanzania
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Grace Mhalu
Facility Name
Magaoni
City
Tanga
Country
Tanzania
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Grace Mhalu
Facility Name
Mpirani
City
Tanga
Country
Tanzania
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Grace Mhalu
Facility Name
Mwakidila
City
Tanga
Country
Tanzania
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Grace Mhalu
Facility Name
Ngamiani
City
Tanga
Country
Tanzania
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Grace Mhalu
Facility Name
Nguvumali
City
Tanga
Country
Tanzania
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Grace Mhalu

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Individual participant data will be shared that underlie the RCT outcomes as described in the study protocol, after anonymisation.
IPD Sharing Time Frame
Individual participant data will be available immediately following the cross-country publication of the RCT study outcomes. No end date.
IPD Sharing Access Criteria
Anyone who wishes to access the data. Data will be available indefinitely on the TIMCI project space on Zenodo
IPD Sharing URL
http://zenodo.org/communities/timci

Learn more about this trial

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

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