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 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201504001098231 Date of Approval: 08/04/2015
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Effectiveness of an Instructional Video for diagnostic sputum production and Tuberculosis case detection
Official scientific title Effectiveness of an Instructional Video for diagnostic sputum production and Tuberculosis case detection
Brief summary describing the background and objectives of the trial Despite recent advances in molecular methods to diagnose TB sputum smear microscopy remains the cornerstone of diagnostic algorithms in national TB control programs (NTPs) in low-income settings. Instructions on how to produce a good sputum sample are also often included in the manuals of NTPs, but to formulate this comprehensibly proves exceedingly difficult. Sputum smear microscopy is the least expensive and most ubiquitously available diagnostic technique. For TB diagnosis, presumptive TB cases with coughing for more than two weeks are asked to spontaneously produce sputum from the lower respiratory tract. However, patients often give only saliva from the mouth, decreasing test sensitivity, resulting in missed diagnoses. A randomized controlled trial in Pakistan showed that provision of simple sputum submission guidance by health workers at TB clinics can significantly improve TB case detection by increasing the bacillary count in specimens and thus the likelihood of sputum smear microscopy positivity.Objective:To examine the effect of an instructional video about the production of diagnostic sputum on case detection of tuberculosis (TB)
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Infections and Infestations
Sub-Disease(s) or condition(s) being studied Tuberculosis
Purpose of the trial Education /Training
Anticipated trial start date 17/04/2014
Actual trial start date 12/05/2014
Anticipated date of last follow up 27/06/2014
Actual Last follow-up date 30/06/2014
Anticipated target sample size (number of participants) 215
Actual target sample size (number of participants) 200
Recruitment status Completed
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
Parallel: different groups receive different interventions at same time during study Randomised Allocation concealment procedure was done using cards with ¿A¿ and ¿B¿ that were folded and placed in an opaque bag. Patients were instructed to pick a folded card from the bag. Patients who picked card ¿A¿ were assigned to the control group, and those who picked card ¿B¿ were assigned to the intervention group. Cards written A and B were placed in opaque bags Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group B 1 time. 4 Minutes Patients on the Intervention group watched the video of sputum production before given sputum containers to produce sputum. 100 Active-Treatment of Control Group
Control Group A 1 time 3 minutes Patients in the control group were provided with standard of care instructions on how to produce sputum and thereafter were provided with sputum containers for sputum production. 100
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Patients who are 18 years old and above Presumptive Tb diagnosis (defined as coughing for more than two weeks, fever, night sweats or weight loss.) Ability to see and hear well. Blind patients,with eyes problems and cannot see well. Deaf patients and those who could not hear well. Patients with Mental disorders 18 Year(s) 70 Year(s) Male
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 23/04/2014 Muhimbili University Ethical Commitee
Ethics Committee Address
Street address City Postal code Country
Upanga Dar Es Salaam P.O.BOX 65015 Tanzania
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Case detection as defined by a positive sputum microscopy result. Increase in Tuberculosis case detection
Secondary Outcome level of quantitative grading of sputum microscopy, sputum volume, sputum quality Increase in sputum quality and volume.
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Mwananyamala Hospital Dar es Salaam Tanzania Mwanayamala Dar es Salaam Tanzania
FUNDING SOURCES
Name of source Street address City Postal code Country
Muhimbili University of Healt and Allied Sciences and Center for Disease Control Upanga Dar es Salaam P.O.BOX 65015 Tanzania
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Muhimbili University of Healt and Allied Sciences Upanga Dar es Salaam P.O.BOX 65015 Tanzania University
COLLABORATORS
Name Street address City Postal code Country
Lukas Fenner Socinstrasse 57,4002 Basel Switzerland
Jerry Helle Bagamoayo Dar es Salaam P.O.BOX 74 Bagamoyo Tanzania
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Grace Mhalu gmhalu@ihi.or.tz +255 655 888 891 Magomeni
City Postal code Country Position/Affiliation
Dar es Salaam P.O.BOX 74 Bagamoyo Tanzania Reasearch Officer
Role Name Email Phone Street address
Public Enquiries Grace Mhalu gmhalu@ihi.or.tz +255 655 888 891 Magomeni
City Postal code Country Position/Affiliation
Dar es Salaam P.O.BOX 74 Bagamoyo Tanzania Research Officer
Role Name Email Phone Street address
Scientific Enquiries Lukas Fenner lukas.fenner@unibas.ch +41792422066 Socinstrasse 57,4002
City Postal code Country Position/Affiliation
Basel Switzerland Scientist
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
URL Results Available Results Summary Result Posting Date First Journal Publication Date
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Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information