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.: PACTR202301709225034 Date of Approval: 24/01/2023
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title EFFECTIVENESS OF AN EDUCATIONAL THEATRE INTERVENTION IN REDUCING SALT INTAKE OF HYPERTENSIVE PATIENTS IN BAYELSA STATE, NIGERIA
Official scientific title EFFECTIVENESS OF AN EDUCATIONAL THEATRE INTERVENTION IN REDUCING SALT INTAKE OF HYPERTENSIVE PATIENTS IN BAYELSA STATE, NIGERIA
Brief summary describing the background and objectives of the trial Hypertension is a significant global public health issue. It is the commonest and most impactful independent risk factor for cardiovascular diseases (CVDs) and premature death worldwide. It kills over seven million people yearly, representing 12.8% of annual deaths, worldwide. The single most impactful modifiable risk factor of hypertension is excessive salt intake. Daily consumption of over 5grams of salt significantly increase blood pressure. However, majority of the world’s population consumes 6 to 12grams of salt daily or 10 times of the measure the body requires physiologically. The objective of the study is to determine the effectiveness of an educational theatre intervention in reducing salt intake and improving salt-related knowledge, attitude and behaviour (KAB) of hypertensive patients in Bayelsa State, Nigeria
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Circulatory System
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Education /Training
Anticipated trial start date 24/10/2022
Actual trial start date 07/11/2022
Anticipated date of last follow up 12/12/2022
Actual Last follow-up date
Anticipated target sample size (number of participants) 94
Actual target sample size (number of participants) 94
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 by using procedures such as coin-tossing or dice-rolling 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 Salt Reduction Educational Theatre Intervention SARETI At week 1, week 6, and week 12 12 minutes of exposure to Intervention at week 1, week 6, and week 12 The intervention is an on-stage theatre drama presentation provides audio and visual information about the relationship between salt and sodium, the relationship between salt and hypertension, the recommended daily salt intake, common unhealthy salt consumption behaviours and practices that impact on sodium level, and foods with moderate to high salt content that are commonly consumed. The script of the drama was informed by professionals from the field of nutrition, Nursing, and theatre arts 47
Control Group Receive usual hospital based care No intervention 12 weeks Visit hospital on scheduled dates for case review accompanied by any needed treatment, drug refill, counselling and necessary investigations 47 Uncontrolled
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. Individuals who have been diagnosed of hypertension three months before subject recruitment and are between 25 and 65 years of age irrespective of gender. 2. Individuals who are able to speak and understand English language 3. Individuals who are able to give informed consent 4. Individuals who are resident within Yenagoa metropolis 5. Individuals who own a cell phone 1. Individuals who are on a clinician-supervised diet or a restricted diet 2. Individuals who on medications that may lead to hyponatremia or fluid retention 3. Individuals who are having medical conditions that may cause hypernatremia or hyponatraemia. Eg, kidney disease, diabetes, burns, diarrhea, severe dehydration, syndrome of inappropriate anti-diuretic hormone (SIADH), etc. 4. Individuals who are having existing or recent cardiovascular conditions such as heart attack, heart failure or stroke within the last 3 months 5. Individuals who are currently participating in another research study 6. Individuals who are planning to be away from home during the period of intervention 7. Individuals who are pregnant Middle Aged: 45 Year(s)-64 Year(s) 25 Year(s) 65 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 07/11/2022 Research Ethics Committee Federal Medical Centre Yenagoa
Ethics Committee Address
Street address City Postal code Country
Along Hospital Road Ovum Yenagoa Bayelsa State Yenagoa 569101 Nigeria
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 10/11/2022 Research Ethics Committee Dietekoki Memorial Hospital
Ethics Committee Address
Street address City Postal code Country
Opolo Yenagoa, Bayelsa State Yenagoa 569101 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Change in 24-hour urinary sodium excretion 12th week, counting from the period of first exposure to intervention
Secondary Outcome Change in dietary salt-related knowledge, attitude and behaviour KAB. 12th week, counting from first week of exposure to intervention
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Federal Medical Centre FMC Yenagoa Along Hospital Road, Ovom, Yenagoa, Bayelsa State Yenagoa Nigeria
DieteKoki Memorial Hospital Opolo Along Opolo Elebele Road, Opolo Yangao, Bayelsa State Yenagoa Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Zibima Soupriye Bidokumo Community primary school Akenfa Yenagoa, Bayelsa State Yenagoa Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Secondary Sponsor Tertiary Education Trust Fund TETFUND Nigeria No. 6Zambezi Crescent, off Aguiyi Ironsi Street, Maitama, Abuja Abuja 900271 Nigeria Funding Agency
COLLABORATORS
Name Street address City Postal code Country
Prof. Anarado Agnes Nonyem Department of Nursing Sciences University of Nigeria Enugu Campus Enugu Nigeria
Prof. Okoronkwo Ijeoma Lewechi Department of Nursing Sciences University of Nigeria Enugu Campus Enugu Nigeria
Gift Benue Zibima Bayelsa State Council for Arts and Culture Yenagoa Nigeria
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Soupriye Zibima soupriyezibima@gmail.com +2348066253102 Community Primary School Akenfa 1Yenagoa Bayelsa State
City Postal code Country Position/Affiliation
Yenagoa Nigeria PhD student
Role Name Email Phone Street address
Public Enquiries Agnes Anarado agnes.anarado@unn.edu.ng +2348068178477 Department of Nursing Sciences University of Nigeria Enugu Campus
City Postal code Country Position/Affiliation
Enugu Nigeria Supervisor
Role Name Email Phone Street address
Scientific Enquiries Soupriye Zibima soupriyezibima@gmail.com +2348066253102 Community Primary School Akenfa 1 Yenagoa Bayelsa State
City Postal code Country Position/Affiliation
Yenagoa Nigeria PhD student
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Data of individual participants will be preserved in a storage device accessible only to the primary investigator and will not be shared with third party. Results of the trial will be published in scientific journals without any traceable information to individual participants. The entire data obtained from individual participants will be used only for academic purposes. Informed Consent Form,Statistical Analysis Plan,Study Protocol one year open
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