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.: PACTR201906616852062 Date of Approval: 20/06/2019
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title A comprehensive intervention for cardiovascular disease prevention in selected primary health care facilities in Capricorn District, South Africa: An effectiveness-implementation study
Official scientific title A comprehensive intervention for cardiovascular disease prevention in selected primary health care facilities in Capricorn District, South Africa: An effectiveness-implementation study
Brief summary describing the background and objectives of the trial South Africa, just like other developing countries, is undergoing a process of epidemiological transition from infectious to non-communicable diseases (NCDs). While the burden of infectious disease such as HIV/AIDS and TB epidemic still predominate in terms of both morbidity and mortality, there are now other emerging NCD epidemics. NCDs, mainly cardiovascular diseases (CVDs), cancers, chronic respiratory diseases and diabetes represent a leading threat to human health and development. The prevalence of these epidemics coincide with the rise in urbanization, industrialization, economic transition and health services that are not always adequately equipped to deal with the issues, more people are becoming ill and dying from the diseases. The broad aim of the project is to implement and evaluate a comprehensive CVD prevention programme in selected rural and semi-urban primary health care facilities in Capricorn District, South Africa. The study also aims to identify and document the barriers and facilitators associated with the implementation of the project.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) SPICES
Disease(s) or condition(s) being studied Cardiology
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 01/03/2019
Actual trial start date 01/05/2019
Anticipated date of last follow up 01/06/2021
Actual Last follow-up date 31/12/2021
Anticipated target sample size (number of participants) 600
Actual target sample size (number of participants) 600
Recruitment status Recruiting
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
Crossover: all participants receive all interventions in different sequence during study Randomised Permuted block randomization 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 SPICES Every four months 3 years 1. To implement behavior change counselling on CVD risk factors with nurses in a primary setting to change health behaviour for people with hypertension and those with high CVD risk (diagnosis and treatment). 2. To implement behavior change counselling on CVD risk factors with health promoters in the community to change health behaviour for people with hypertension and those with high CVD risk (self-management). 300
Control Group SPICES Every 4 months 3 years • To implement behavior change counselling on CVD risk factors with health promoters in the community to change health behaviour for people with hypertension and those with high CVD risk (self-management). 300 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. Both male and female 2. Aged 18 years and above 3. Consent to participate in the study 1. Below age of 18 2. Those not consenting to participate 3. Those not falling withing the catchment areas of the identified 11 clinics in Capricorn District, Limpopo Province, South Africa. Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 70 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 06/02/2019 Turfloop Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
University of Limpopo, C/O R71 Tzaneen Road and University Street Sovenga 0727 South Africa
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The primary outcomes are implementation science outcomes (Reach, Appropriateness, Acceptability, Self-efficacy, Adoption, Cost, Feasibility, Fidelity and Sustainability). Reach data will be number of person screened, number of green, amber and red profiled person, number of participants, number of participants with a complete follow up and quartiles for both groups (are the questionnaires fully filled up for all quantitative data in both groups), number of intervention groups participants that achieved the full, ¾ or ½ or ¼ of the training. Every four months
Secondary Outcome The impact of an enhanced comprehensive CVD prevention program on patient outcomes regarding lifestyle behavior change. To explore the barriers and facilitators of cardiovascular primary prevention (CPP) implementation approaches with participants, supervisors and screeners we will use a qualitative research framework. Each setting will collect qualitative data about perceived and actual barriers and facilitators of CPP implementation and this will then be analyzed and compared with the other settings to inform best practice both in, and between, the settings during the three-year implementation period. Every four months
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
University of Limpopo C/O R71 Tzaneen Road and University Street Sovenga 0727 South Africa
FUNDING SOURCES
Name of source Street address City Postal code Country
European Commission Horizon 2020 Charlemange Building, Rue de la Loi 170 Brussels 1040 Belgium
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor University of Limpopo C/O R71 Tzaneen Road and University Street, Mankweng Township Sovenga 0727 South Africa University
COLLABORATORS
Name Street address City Postal code Country
Hilde Bastiaens Prinsstraat 13 Antwerpen 2000 Belgium
Geofrey Musinguzi Makerere University, Main Campus Kampala 7072 Uganda
Jean Yves Reste Universitaire de Brest, 22 Camille Desmoulins Brest 29200 France
Harm van Marwijk Sussex University, Sussex House, Falmer Brighton United Kingdom
Linda Gibson Nottingham Trent University, Goldsmith Street Nottingham United Kingdom
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Tholene Sodi Tholene.Sodi@ul.ac.za 27152682318 C/O R71 Tzaneen Road and University Street, Mankweng Township
City Postal code Country Position/Affiliation
Sovenga 0727 South Africa Principal investigator
Role Name Email Phone Street address
Public Enquiries Mpsanyana Makgahlela mpsyanyana.makgahlela@ul.ac.za 27152683942 C/O R71 Tzaneen Road and University Street, Mankweng Township
City Postal code Country Position/Affiliation
Sovenga 0727 South Africa Senior Lecturer
Role Name Email Phone Street address
Scientific Enquiries Nancy Malema nancy.malema@ul.ac.za 27152684658 C/O R71 Tzaneen Road and University Streets, Mankweng Township
City Postal code Country Position/Affiliation
Sovenga 0727 South Africa Professor
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes The datasets generated during and/or analysed during the current study will be stored in a repository. All individual participant data collected during the trial will be available for sharing. Other documents such as study protocol, statistical analysis plan, informed consent forms and clinical study report will also be made available. The data will be available to anyone who wishes to have access. This will be immediately following publication, with no end date. Study Protocol Access can be requested from the PI a year after completion of the study. The project will utilize both the Green Open Access and Gold Open Access model to disseminate and publish research data. Dissemination workshops and meetings will be organized at the local, national and international platforms.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
www.ul.ac.za 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