Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0835 or +27 21 938 0967
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201502001029209 Date of Registration: 09/02/2015
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title SMS4Care
Official scientific title SMS4Care: community-based surveillance of diarrhea and demographic indicators
Brief summary describing the background and objectives of the trial Surveillance of a health problem helps to evaluate interventions designed to control it. Hospital-based surveillance is limited where health facilities are geographically, economically and socio-culturally inaccessible.An answer to this limitation would be to setup a community based surveillance system, by community volunteers, using mobile phones.Within the context of the fight against cholera and other diarrheal diseases, this strategy would help in early detection and management of cases and thus reduction of the burden of the disease. The objective of this project is to assess the feasibility and benefits of setting up a community-basedsurveillance system of diarrhea and demographic events using mobile phones. The study will be conducted intwophases, a pilot phase planned for four months at the Kousseri, Mada, Makary and Goulfey health districts. After validation of thesurveillance method, an extension will be done to six health districts of the region.During the pilot phase,all villages of the selected District will be randomly assigned to 2:in the first group(intervention group), community volunteers will be trained in the detection of diarrhea and other health events,administration of ORS and data transmission via SMS. The second group(control group) will not receive the intervention. Hospital and community detection rates of diarrhea will be compared in groups with data from two surveys, one before and another after the intervention.Comparison will be done using Poisson regression. These results would help to redirect national policy on epidemiological surveillance of diarrhea and other diseases under surveillance.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) SMS4Care
Disease(s) or condition(s) being studied Cholera like diarrhea, fever, cough, demographic events like deaths, births, migration, immigration,Digestive System,Infections and Infestations
Sub-Disease(s) or condition(s) being studied Cholera
Purpose of the trial Prevention
Anticipated trial start date 15/02/2015
Actual trial start date 15/02/2015
Anticipated date of last follow up 30/05/2015
Actual Last follow-up date 30/05/2015
Anticipated target sample size (number of participants) 136
Actual target sample size (number of participants)
Recruitment status Recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised villages were ranked in alphabetic order, numbered and randomised using block randomisation (block size=4 and not variable) the randomisation was done using Fisher randomisation table allocation was determined by the allocation of villages, all people belonging to a village of the intervention group will received the intervention Masking/blinding used Care giver/Provider,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Community-based surveillance 3 months community volunteers will be trained inthe detection of diarrhea and other health events,administration of ORS and notification via SMS through ODK collect preformatted form 63
Control Group Hospital-based surveillance the surveillance will be conducted according to the national surveillance system that is notification of cases that reached the health facility and transmission of a notification form 73
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
- all individual living in the selected villages that accepted to participate in the study any people taht refuses to continue the study 0 Day(s) 200 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 15/01/2015 Cameroon national ethics review committee
Ethics Committee Address
Street address City Postal code Country
Division de la Recherche opérationnelle en santé, Hygiène mobile Yaounde Cameroon
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome proportion of diarrhea and demographic events detected Post community-based survey at the end the surveillance period
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
M.A.SANTE Biyem-Assi avenue de Mvolye, Face Wisdom Academic complex Yaounde BP: 33490 Cameroon
Kousseri Regional Hospital (M.A.SANTE Laboratory) Kousseri regional Hospital Kousseri Cameroon
FUNDING SOURCES
Name of source Street address City Postal code Country
M.A.SANTE/ BAHCare (Meilleur accès aux soins de Santé/ Better access to Health Care) Yaoundé, Biyem Assi, face Wisdom Academic Complex Yaounde 33490 Cameroon
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor M.A.SANTE/ BAHCare (Meilleur accès aux soins de Santé/ Better access to Health Care) Yaoundé, Biyem Assi, face Wisdom Academic Complex Yaounde 33490 Cameroon Funding Agency
COLLABORATORS
Name Street address City Postal code Country
Yakum Martin Ndinakie Biyem-Assi avenue de Mvolye, Face Wisdom Academic complex Yaounde Cameroon
Ebile Akoh Walter Biyem-Assi avenue de Mvolye, Face Wisdom Academic complex Yaounde Cameroon
Jérôme Ateudjieu Biyem-Assi avenue de Mvolye, Face Wisdom Academic complex Yaounde Cameroon
Guenou Etienne kousseri Regional Hospital Kousseri Cameroon
Njimbia Chebe Anthony kousseri Regional Hospital Kousseri Cameroon
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Julienne Stéphanie Nouetchognou julienne.nouetchognou@masante-cm.org +237 696366281 Biyem-Assi avenue de Mvolye, Face Wisdom Academic complex
City Postal code Country Position/Affiliation
Yaounde 33490 Cameroon Reasearch Assistant _ M.A.SANTE
Role Name Email Phone Street address
Public Enquiries Julienne Stéphanie Nouetchognou julienne.nouetchognou@masante-cm.org +237 696366281 Biyem-Assi avenue de Mvolye, Face Wisdom Academic complex
City Postal code Country Position/Affiliation
Yaounde 33490 Cameroon Reasearch Assistant _ M.A.SANTE
Role Name Email Phone Street address
Scientific Enquiries Jérôme Ateudjieu jateudj@yahoo.fr +237 699701011 Yaoundé Mendong
City Postal code Country Position/Affiliation
Yaounde Cameroon Project Coordinator_M.A.SANTE
Role Name Email Phone Street address
Scientific Enquiries Jérôme Ateudjieu jateudj@yahoo.fr +237 699701011 Biyem-Assi avenue de Mvolye, Face Wisdom Academic complex
City Postal code Country Position/Affiliation
Yaounde 33490 Cameroon Project Coordinator_M.A.SANTE
REPORTING
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