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.: PACTR202607724405438 Date of Registration: 16/07/2026
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Scenario-Based Simulation Training for End-Stage Kidney Disease Patients and Family Caregivers in Malawi
Official scientific title Assessing the Effectiveness of Scenario-Based Simulation Training among End-Stage Kidney Disease Patients and Family Caregivers at Kamuzu Central Hospital, Malawi
Brief summary describing the background and objectives of the trial End-stage kidney disease (ESKD) is an increasing public health challenge in Malawi and is associated with substantial morbidity, mortality, and reduced quality of life. Access to renal replacement therapy remains extremely limited, resulting in most patients relying on conservative kidney management. Successful conservative management depends largely on effective self-management; however, many patients and their family caregivers lack the knowledge, confidence, and practical skills required to manage the condition effectively, which affects their quality of life. Traditional teaching methods have been shown to be ineffective in meeting the complex care needs of these patients, hence a need for innovative teaching methods that promote practical skills. Scenario-based simulation education is an experiential learning approach that provides opportunities to practise decision-making and self-management skills in realistic, risk-free environments and has the potential to improve self-management behaviours, confidence, and health-related quality of life. This randomized controlled trial aims to evaluate the effectiveness of scenario-based simulation training, compared with standard health education, in improving self-management knowledge, confidence, self-care behaviours, and health-related quality of life among patients with end-stage kidney disease, as well as self-management knowledge, attitudes, and caregiving practices among their family caregivers.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) SBST-ESKD
Disease(s) or condition(s) being studied Kidney Disease
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Education /Training
Anticipated trial start date 27/07/2026
Actual trial start date
Anticipated date of last follow up 19/10/2026
Actual Last follow-up date
Anticipated target sample size (number of participants) 204
Actual target sample size (number of participants)
Recruitment status Not yet recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
P.06251610 COMREC
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 Sealed opaque envelopes Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Low Fidelity Simulation Participants will receive one standard health education session, after which they will be provided with a self-management educational booklet for independent reading in preparation for the simulation training. Following a one-week preparation period, participants will have three scenario-based simulation sessions covering diet management, fluid management, and symptom recognition and management. Standard health education: approximately 4 hours. Participants will be given the educational booklet one week before the simulation sessions to allow time for self-directed preparation. Each simulation session will last approximately 50–60 minutes, comprising: Pre-briefing (10–15 minutes), Video-supported simulation and role-play (10–15 minutes), Facilitated debriefing (30 minutes) Participants will receive one standard health education session followed by a self-management educational booklet for independent reading. After a one-week preparation period, participants will undergo three scenario-based simulation sessions, each delivered once and focusing on one of the following self-management domains: diet management, fluid management, and symptom recognition and management. 102
Control Group Standard Health Education One routine health education session delivered according to usual renal clinic practice. Approximately 1 hour. Participants allocated to the control group will receive the routine standard health education currently provided to patients with end-stage kidney disease and their family caregivers at Kamuzu Central Hospital Renal Clinic. The education includes information on disease management as part of routine clinical care. Participants in the control group will not receive scenario-based simulation training during the study period. 102 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Patient Participants Confirmed diagnosis of end-stage kidney disease receiving conservative management. Age 18 years and above. Medically stable Family Caregiver Participants Primary caregiver identified by the patient. Age 18 years and above. Patient medically stable. Patient Participants On renal replacement therapy Critically or acutely ill On another intervention that may impact study outcomes Family Caregiver Participants Professional/ paid caregivers Caring for critically ill patients Caring for patients enrolled in another intervention Adult: 18 Year(s)-44 Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 60 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 13/08/2025 College of Medicine Research Ethics Committee COMREC
Ethics Committee Address
Street address City Postal code Country
Ground Floor, Room 822, Postgraduate Building, Mahatma Gandhi Campus, Kamuzu University of Health Sciences Blantyre 312225 Malawi
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Self-management Knowledge, confidence/ self-efficacy and behaviours Baseline, 4 weeks and 12 weeks post-intervention
Secondary Outcome Health Related Quality of Life Baseline, 4 weeks and 12 weeks post-intervention
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Kamuzu Central Hospital Renal Unit Mzimba Street Lilongwe 207233 Malawi
FUNDING SOURCES
Name of source Street address City Postal code Country
Kamuzu University of Health Sciences Mzimba Lilongwe 207233 Malawi
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Kamuzu University of Health Sciences Mzimba Lilongwe 207233 Malawi University
COLLABORATORS
Name Street address City Postal code Country
University of Stavanger Kjell Arholms 41 Stavanger 4021 Norway
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Chisomo Mulenga cmulenga@kuhes.ac.mw +265994043502 Mzimba
City Postal code Country Position/Affiliation
Lilongwe 207233 Malawi PhD Student
Role Name Email Phone Street address
Public Enquiries Chisom Mulenga cmulenga@kuhes.ac.mw +265990043502 Mzimba
City Postal code Country Position/Affiliation
Lilongwe 207233 Malawi PhD student
Role Name Email Phone Street address
Scientific Enquiries Chisomo Mulenga cmulenga@kuhes.ac.mw +265994043502 Mzimba
City Postal code Country Position/Affiliation
Lilongwe 207233 Malawi PhD Student
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes De-identified individual participant data underlying the published results, including demographic characteristics and outcome measures, will be made available upon reasonable request to the Principal Investigator after publication of the primary study results. Study Protocol Beginning 12 months after publication of the primary study results and ending 5 years after publication. Access will be provided to qualified researchers upon reasonable request, subject to approval by the Principal Investigator and Kamuzu University of Health Sciences, and after signing a data sharing agreement. Only de-identified data will be shared for scientifically sound research purposes.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Not applicable 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 Final no of participants 09/07/2026 Populations, patient and family caregivers, 51 each, making a total of 102 in the control arm and 102 in the intervention arm 204
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Final no of participants 09/07/2026 This section remains as originally submitted. 204
Section Name Field Name Date Reason Old Value Updated Value
Intervention Intervention List 09/07/2026 Revised the intervention and control arm sizes from session group sizes to total arm sample sizes. Each arm will include 102 participants, comprising 51 patients and 51 family caregivers, to correspond with the final total sample size of 204 participants. Experimental Group, Low Fidelity Simulation, Participants will receive one standard health education session, after which they will be provided with a self-management educational booklet for independent reading in preparation for the simulation training. Following a one-week preparation period, participants will have three scenario-based simulation sessions covering diet management, fluid management, and symptom recognition and management., Standard health education: approximately 4 hours. Participants will be given the educational booklet one week before the simulation sessions to allow time for self-directed preparation. Each simulation session will last approximately 50–60 minutes, comprising: Pre-briefing (10–15 minutes), Video-supported simulation and role-play (10–15 minutes), Facilitated debriefing (30 minutes), Participants will receive one standard health education session followed by a self-management educational booklet for independent reading. After a one-week preparation period, participants will undergo three scenario-based simulation sessions, each delivered once and focusing on one of the following self-management domains: diet management, fluid management, and symptom recognition and management., 16, Experimental Group, Low Fidelity Simulation, Participants will receive one standard health education session, after which they will be provided with a self-management educational booklet for independent reading in preparation for the simulation training. Following a one-week preparation period, participants will have three scenario-based simulation sessions covering diet management, fluid management, and symptom recognition and management., Standard health education: approximately 4 hours. Participants will be given the educational booklet one week before the simulation sessions to allow time for self-directed preparation. Each simulation session will last approximately 50–60 minutes, comprising: Pre-briefing (10–15 minutes), Video-supported simulation and role-play (10–15 minutes), Facilitated debriefing (30 minutes), Participants will receive one standard health education session followed by a self-management educational booklet for independent reading. After a one-week preparation period, participants will undergo three scenario-based simulation sessions, each delivered once and focusing on one of the following self-management domains: diet management, fluid management, and symptom recognition and management., 102,
Section Name Field Name Date Reason Old Value Updated Value
Intervention Intervention List 09/07/2026 Revised the intervention and control arm sizes from session group sizes to total arm sample sizes. Each arm will include 102 participants, comprising 51 patients and 51 family caregivers, to correspond with the final total sample size of 204 participants. Control Group, Standard Health Education, One routine health education session delivered according to usual renal clinic practice., Approximately 1 hour., Participants allocated to the control group will receive the routine standard health education currently provided to patients with end-stage kidney disease and their family caregivers at Kamuzu Central Hospital Renal Clinic. The education includes information on disease management as part of routine clinical care. Participants in the control group will not receive scenario-based simulation training during the study period., 35, Active-Treatment of Control Group Control Group, Standard Health Education, One routine health education session delivered according to usual renal clinic practice., Approximately 1 hour., Participants allocated to the control group will receive the routine standard health education currently provided to patients with end-stage kidney disease and their family caregivers at Kamuzu Central Hospital Renal Clinic. The education includes information on disease management as part of routine clinical care. Participants in the control group will not receive scenario-based simulation training during the study period., 102, Active-Treatment of Control Group