Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
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Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201901779740173 Date of Approval: 17/01/2019
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Effects of a health education intervention on hypertension-related knowledge, prevention and self-care practices in Nigerian Retirees: a quasi-experimental study
Official scientific title Effects of a health education intervention on hypertension-related knowledge, prevention and self-care practices in Nigerian Retirees: a quasi-experimental study
Brief summary describing the background and objectives of the trial Education is vital to increasing knowledge, prevention and self-care practices for hypertension in older adults. This study aimed to determine the effectiveness of a health education intervention in improving hypertension (HT) knowledge, prevention and self-care practices among retirees in Enugu State, South-east, Nigeria.
Type of trial CCT
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 04/06/2018
Actual trial start date 11/06/2018
Anticipated date of last follow up 12/11/2018
Actual Last follow-up date 15/11/2018
Anticipated target sample size (number of participants) 400
Actual target sample size (number of participants) 392
Recruitment status Completed
Publication URL https://archpublichealth.biomedcentral.com/articles/10.1186/s13690-019-0349-x
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 Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Hypertension Education Intervention or programme The intervention was implemented for about 60 minutes hour once a week 12 weeks We developed a health education programme to be culturally relevant. The health education programme on HT was developed based on the implementation research framework, the information-motivation-behavioral skills (IMB) model proposed by Fisher and Fisher. The IMB model explained the modifiable risk factors of HT such as behavior-related information and knowledge, beliefs and attitudes towards a particular health behavior and perceived social support, self-efficacy, and skills to negotiate preventive behaviors. The major topics of the intervention included the meaning of hypertension, causes and risk factors for HT, signs, and symptoms of HT, measurement of BP and its interpretation, HT treatment and BP control, HT prevention, and self-care practices. The themes of the twelve-session intervention were designed based on the major topics. We conducted the sessions on the day of the week (Tuesdays for the intervention group and Thursdays for the control group) at a time the participants had considered the most convenient. The intervention lasted for 12 weeks (July to September 2018), and each session last for about 60 minutes per week. We organized the sessions in groups of 50 retirees in both the intervention and control groups. 200
Control Group Health Talk The health talk was implemented for about 45 minutes once a week 12 weeks The control group received health talk about hypertension. Only the health educators delivered the hypertension health talk to the control group. The intervention materials for the control group included the flip charts without the videos. 200 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Participants must be a retiree at the time of recruitment in Enugu State civil service. Participants must be aged 65 years and above Participants who were ill were excluded from the study 80 and over: 80+ Year,Aged: 65+ Year(s) 60 Year(s) 90 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 22/01/2018 Enugu State Ministry of Health Ethical Committee on Research Projects
Ethics Committee Address
Street address City Postal code Country
GRA, Enugu, Enugu State Enugu 400001 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Secondary Outcome knowledge of hypertension, hypertension prevention, and self-care practices After intervention and follow-up
Primary Outcome Hypertension Knowledge, prevention and self-care practices after intervention and follow-up
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Enugu Abakpa, Enugu Enugu 400001 Nigeria
Nsukka Nsukka Nsukka 410001 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Mrs. Eyuche Ozoemena and Dr Olaoluwa Samson Agbaje 49/51 GRA Abakaliki Road, Enugu, Enugu State and 99 MCC Road Isi-Uja, Nsukka, Enugu State Nsukka and Enugu 400001 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Mrs. Eyuche Ozoemena and Dr. Olaoluwa Samson Agbaje 49/51 Abakaliki Road GRA, Enugu State and 99 Isi-uja, Nsukka, Enugu State Enugu 400001 Nigeria Individual
COLLABORATORS
Name Street address City Postal code Country
Dr. Cylia Iweama Department of Human Kinetics and Health Education, University of Nigeria, Nsukka Nsukka 410001 Nigeria
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Eyuche Ozoemena eyuche.ozoemena@unn.edu.ng +2348063278363 49/51 Abakaliki Road GRA, Enugu, Enugu State
City Postal code Country Position/Affiliation
Enugu 400001 Nigeria Lecturer University of Nigeria Nsukka
Role Name Email Phone Street address
Public Enquiries Cylia Iweama cylia.iweama@unn.edu.ng +2348095971565 Department of Human Kinetics and Health Education, University of Nigeria, Nsukka
City Postal code Country Position/Affiliation
Nsukka 410001 Nigeria Lecturer University of Nigeria Nsukka
Role Name Email Phone Street address
Scientific Enquiries Samson Agbaje agbajesam@yahoo.com +2348068091290 99 Isi-uja, Nsukka
City Postal code Country Position/Affiliation
Nsukka 410001 Nigeria Lecturer University of Nigeria Nsukka
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