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.: PACTR201901552202539 Date of Approval: 16/01/2019
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Effectiveness of Mobile-phone Based Reminder System in Improving Patients' Adherence to Anti-TB Medication During Continuation Phase
Official scientific title Effectiveness of Mobile-phone Based Reminder System in Improving Patients' Adherence to Anti-TB Medication During Continuation Phase
Brief summary describing the background and objectives of the trial Tuberculosis (TB) is one of the critical public health threat worldwide. Patients’ failure to complete TB treatment may result in drug resistance, relapse and death. According to study findings in Ethiopia, non-adherence to anti-TB medication is more worsen in continuation phase than intensive phase. Poor patient–provider relationships, forgetfulness, poor knowledge towards TB and its treatment, distance to the health facility were some of the most commonly reported reasons for non-adherence to Anti-TB treatment. Studies revealed that m-Health systems such as, automatic text reminder system improve patient's engagement in their own medications. Evidences are scarce in low-income countries regarding impact of mobile-phone based reminder system in improving patients' adherence to anti-TB treatment support. This study aimed to assess effectiveness of mobile-phone based reminder system to improve patient's adherence towards anti-TB treatment during continuation phase.
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 Supportive care
Anticipated trial start date 25/02/2019
Actual trial start date 04/03/2019
Anticipated date of last follow up 26/08/2019
Actual Last follow-up date 02/09/2019
Anticipated target sample size (number of participants) 420
Actual target sample size (number of participants) 360
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
Parallel: different groups receive different interventions at same time during study Randomised Stratified allocation where factors such as age, gender, center, or previous treatment are used in the stratification Allocation was determined by the holder of the sequence who is situated off site Masking/blinding used Care giver/Provider,Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Mobile phone based reminder for TB medication and drug refilling Patients will receive medication reminder once per day and once per week for reminding clinic appointment to refill their drugs. for four months of continuation phase TB treatment Patients will receive a graphic reminder aimed to engage both literate and illiterate patients. Graphic reminders will be designed using American Standard Code for Information Interchange (ASCII) to ensure all cellphone devices compatible for running the graphic messages. Pills and glass of water will be graphically represented to remind daily medications and a picture of strip of pills will be represented to remind clinic appointments for drug refilling. Patients will be oriented about the pictures and tested before actual intervention. 210
Control Group Usual care Four months Usual care for TB patients during continuation phase includes: weekly drug refilling, patients take their medication at home, treatment supporter is assigned to support medication adherence of the patient. Treatment supporters could be family members, health extension workers,or neighbors based on patients' suggestions. 210 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
All adult (age >18 years) TB patients on continuation phase treatment and Those who own mobile phone will be included in the study Multi drug resistant TB cases will be excluded 80 and over: 80+ Year,Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 80 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 20/04/2018 Institutional Ethical Review Board of University of Gondar
Ethics Committee Address
Street address City Postal code Country
Gondar, Ethiopia Gondar 0196 Ethiopia
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Adherence to anti-TB treatment At the end of fourth month of treatment
Secondary Outcome Treatment outcome At the end of fourth month of treatment
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Central Gondar Zone and Gondar Town Health Facilities Central Gondar Zone and Gondar Town Gondar 0196 Ethiopia
FUNDING SOURCES
Name of source Street address City Postal code Country
University of Gondar Gondar Ethiopia Gondar 0196 Ethiopia
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor University of Gondar Gondar, Ethiopia Gondar 0196 Ethiopia University
COLLABORATORS
Name Street address City Postal code Country
Binyam Tilahun Gondar, Ethiopia Gondar 0196 Ethiopia
Kassahun Alemu Gelaye Gondar, Ethiopia Gondar 0196 Ethiopia
Richard Lester 2733 Heather Street Vancouver 604822499 Canada
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Kassahun Gashu kassahundessie@gmail.com +251912071344 Gondar, Ethiopia
City Postal code Country Position/Affiliation
Gondar Ethiopia University of Gondar
Role Name Email Phone Street address
Public Enquiries Kassahun Gelaye kassalemu@gmail.com +251911752466 Gondar, Ethiopia
City Postal code Country Position/Affiliation
Gondar Ethiopia University of Gondar
Role Name Email Phone Street address
Scientific Enquiries Binyam Tilahun binigcms@gmail.com +251913875066 Gondar, Ethiopia
City Postal code Country Position/Affiliation
Gondar Ethiopia University of Gondar
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
No
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information