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.: PACTR202607627175210 Date of Registration: 10/07/2026
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title A study to find out whether nurse-led self-care education helps adults with asthma improve self-care, quality of life, and reduce hospital admissions
Official scientific title Effect of Nurse-Led Self-Care Education on Self-Care Practices, Quality of Life, and Hospital Admissions among Adult Asthmatic Patients: A Cluster-Randomized Controlled Trial
Brief summary describing the background and objectives of the trial Poor self-care practices, reduced quality of life, and frequent hospitalizations among people with asthma remain major public health concerns worldwide, including in Ethiopia. These challenges contribute to increased asthma exacerbations, greater healthcare utilization, and poorer health outcomes. They also impose substantial economic and psychosocial burdens on patients and their families through caregiver strain, financial hardship, and emotional distress. Evidence from previous studies suggests that nurse-led self-care education can improve self-care practices and health outcomes among people with asthma. However, its effectiveness has not been evaluated in the Ethiopian context. The primary objective of this trial is to evaluate the effectiveness of nurse-led self-care education on self-care practices among people with asthma. The secondary objectives are to evaluate the effectiveness of nurse-led self-care education on the quality of life of people with asthma and to determine its effectiveness in reducing hospital admissions among people with asthma.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
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 01/06/2025
Actual trial start date 01/06/2025
Anticipated date of last follow up 30/05/2026
Actual Last follow-up date
Anticipated target sample size (number of participants) 166
Actual target sample size (number of participants) 152
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 Simple randomization using a randomization table created by a computer software program Allocation was determined by the holder of the sequence who is situated off site Masking/blinding used Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Nurse led self care education 9 months At the intervention hospital, randomly selected adults with asthma received a structured asthma self-care education program in addition to routine care. The educational manual was developed by an interdisciplinary team comprising nurses, pharmacologists, and mental health professionals. Education was delivered in groups of up to nine participants. The intervention consisted of four consecutive daily educational sessions, each lasting approximately 2 hours. During the first session, participants were introduced to the concept of asthma self-care and received education on the definition, causes, risk factors, symptoms, and potential complications of asthma. The second session focused on asthma self-monitoring using the Asthma Control Test (ACT) and symptom diaries, types of asthma medications, the importance of medication adherence, identification and avoidance of individual asthma triggers, and stress management techniques. The third session covered recognition of early warning signs of worsening asthma, appropriate management of asthma attacks, correct use of rescue inhalers, indications for seeking emergency medical care, and development of a personalized asthma action plan outlining daily management and emergency response strategies. The fourth session included training on deep breathing exercises, controlled coughing techniques, correct use of metered-dose inhalers and nebulizers, and the importance of routine follow-up with healthcare providers for ongoing asthma management. Following the initial four-session program, participants received reinforcement education sessions lasting approximately 30 minutes every four months, resulting in a total of six educational sessions over the 12-month study period. 74
Control Group usual care 9 months Participants in the control group received the standard routine care provided to patients with asthma by healthcare professionals during their follow-up visits. 78 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
People with asthma aged 18 and above People with asthma who are severely ill and unable to communicate People with asthma who have been enrolled in another intervention Adult: 18 Year(s)-44 Year(s),Aged: 65 Year(s)-79 Year(s),Middle Aged: 45 Year(s)-64 Year(s) 20 Year(s) 78 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 23/04/2025 Institutional Research Ethics Review Committee
Ethics Committee Address
Street address City Postal code Country
Debre Markos Debre Markos 269 Ethiopia
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Self-care practice At base line, mid term and endline
Secondary Outcome Quality of life At base line, mid term and endline
Secondary Outcome Hospital admission rates At base line, mid term and endline
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Debre Markos and Tibebe Ghion Specialized Hospitals Debre Markos and Bahir Dar Debre Markos and Bahir Dar 1019, 79 Ethiopia
FUNDING SOURCES
Name of source Street address City Postal code Country
Debre Markos University Debre Markos Debre Markos 269 Ethiopia
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Debre Markos University Debre Markos Debre Markos 269 Ethiopia University
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Menberu Gete menberugete444@gmail.com +251915867618 Debre Markos
City Postal code Country Position/Affiliation
Debre Markos 1019 Ethiopia Lecturer
Role Name Email Phone Street address
Public Enquiries Tesfahun Tirunhe Beyene tesfatiruneh001@gmail.com +251953232165 Debre Markos
City Postal code Country Position/Affiliation
Debre Markos 1019 Ethiopia Nurse Practitioner
Role Name Email Phone Street address
Scientific Enquiries Mulat Belay Simegn mulatbelay560@gmail.com +251941680315 Debre Markos
City Postal code Country Position/Affiliation
Debre Markos Ethiopia Lecturer
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures and appendices). Informed Consent Form,Study Protocol Immediately following publication. No end date Individual participant data that support the findings of this study will be available upon reasonable request, subject to institutional approval and applicable ethical and legal requirements.
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
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Actual trial start date 10/07/2026 PACTR Admin 01 Jun 2025