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.: PACTR202407741896902 Date of Approval: 25/07/2024
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Asthma education
Official scientific title Effect of Asthma Self-Management Education on Asthma Outcomes among Adults in Tigray, Northern Ethiopia: A Quasi-Experimental Study
Brief summary describing the background and objectives of the trial Promoting asthma education among asthma patients, and their families is vital for proper self-management, and prevention of exacerbations. By empowering individuals with knowledge and skills, we can foster a proactive approach to asthma care that improves health outcomes and reduces the burden on individuals and societies. This study's objective was to evaluate if asthma self-management education intervention improved asthma control and self-management knowledge.
Type of trial Non-Randomised
Acronym (If the trial has an acronym then please provide) Asthma self management education
Disease(s) or condition(s) being studied Respiratory
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Education /Training
Anticipated trial start date 01/04/2018
Actual trial start date 20/05/2018
Anticipated date of last follow up 01/03/2019
Actual Last follow-up date 20/09/2020
Anticipated target sample size (number of participants) 204
Actual target sample size (number of participants) 204
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 Non-randomised Allocation was determined by the holder of the sequence who is situated off site Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Asthma self management education for an hour or two at baseline, 3rd month and 6th month Asthma self-management education (ASME) intervention included basic facts about asthma, appropriate use of inhaled medications, environmental control strategies, and self-monitoring skills. Teaching methods were lectures, group discussions, and demonstrations. A leaflet was provided for each intervention study participant, which was prepared with simple words in a local language (Tigrigna) to use as a reminder. The ASME intervention started with the preparation of manuals for the education facilitators and the study participants, followed by training the education facilitators. Finally, the potential asthma education facilitators provided education intervention for the intervention group in each selected hospital. 102
Control Group No Intervention was provided Participants were contacted at baseline and end line for the administration of the questionnaire For less than 1 hour Participants in the control group did not receive asthma self-management education. This group was asked to respond to interviewer-guided ASMQ and ACT questionnaire during entry or exit from the outpatient departments or clinic during their follow-up and after finishing the education program (end line). 102 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Patients with a diagnosis of asthma Age 18 years or older Who has a follow-up in the study hospitals Patients having significant respiratory distress due to an exacerbation that required an emergency department visit or admission 80 and over: 80+ Year,Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 87 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 30/04/2018 Addis Ababa University College of Health of Health Sciences Institutional Review Board
Ethics Committee Address
Street address City Postal code Country
No Addis Ababa 1165 Ethiopia
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 30/10/2019 Mekelle University College of Health Sciences Health Research Ethics review committee
Ethics Committee Address
Street address City Postal code Country
no Mekelle 7000 Ethiopia
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Asthma control Pre and Post intervention
Secondary Outcome asthma knowledge Pre and Post intervention
Secondary Outcome Asthma-related healthcare utilization Pre and post intervention
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Axum referral hospital none Axum 7080 Ethiopia
Shire none Shire 7080 Estonia
Dansha hospital none Dansha None Ethiopia
St merry hospital none Axum 7080 Ethiopia
Adwa hospital none Adwa 7060 Ethiopia
Abi Adi hospital none Temben 7080 Ethiopia
Adigrat Hospital none Adigrat 7040 Ethiopia
Wukuro Hospital none Wukuro kilte Awlaelo none Ethiopia
Ayder referral hospital Ayder Mekelle 7000 Ethiopia
Mekelle hospital none Mekelle 7000 Ethiopia
Alamata none Alamata none Ethiopia
Lemelem karl none Maichew 7020 Ethiopia
FUNDING SOURCES
Name of source Street address City Postal code Country
Research grant Beherawi Addis Ababa 7000 Ethiopia
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Addis Ababa University Biherawi Addis Ababa 7000 Ethiopia University
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Tirhas Gebresillasie tgereaku@gmail.com 0914731626 Denver
City Postal code Country Position/Affiliation
Axum 7080 Ethiopia Aksum University College of Health Science
Role Name Email Phone Street address
Scientific Enquiries Alemayehu Worku alemayehuwy@yahoo.com 251911405652 Biherawi
City Postal code Country Position/Affiliation
Addis Ababa 7000 Ethiopia Addis Ababa University College of Health Sciences
Role Name Email Phone Street address
Public Enquiries Negussie Deyessa negdaysun@gmail.com 251911400059 Neherawi
City Postal code Country Position/Affiliation
Addis Ababa 7000 Ethiopia Addis Ababa University Colleg of Health Sciences
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes IPD will be shared and it will be coded first. Aggregate data sharing (i.e. publication) will be included in the plan description Clinical Study Report,Informed Consent Form IPD will be coded during submission. Data requests can be submitted after 12 months after article publication and the data will be made accessible for up to 24 months. Extensions will be considered on a case-by-case request. Access to trial IPD can be requested by qualified researchers engaging in independent scientific research and will be provided following publication.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Yes 08/07/2024
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result - 09/07/2024
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information