Heart health without a doctor: an implementation study of CVD prevention and behaviour change interventions in community settings
| ISRCTN | ISRCTN68334579 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN68334579 |
| Secondary identifying numbers | SPICESUK1 |
- Submission date
- 29/05/2019
- Registration date
- 09/08/2019
- Last edited
- 16/01/2023
- Recruitment status
- Suspended
- Overall study status
- Completed
- Condition category
- Circulatory System
Plain English summary of protocol
Background and study aims
SPICES is an EU Horizon 2020 project working simultaneously in six settings across five countries (Limpopo, South Africa; Kampala, Uganda; Brest, France; Antwerp, Belgium; Brighton and Nottingham, United Kingdom). This two-year study is exploring the effectiveness of community-based heart disease prevention interventions against Primary Care based risk profiling, advice and support.
Who can participate?
All adults (over 18 years old)
What does the study involve?
Participants are randomly allocated to receive either:
1. In-person, community-based, Behaviour Change Support (individual and group work) delivered by trained volunteers using techniques of risk profiling, national guidelines on healthy behaviours, goal setting, action planning, problem solving, and motivational interviewing. Interventions are repeated up to 11 times over 24 months starting weekly and then less frequently.
2. Risk profiling and national guidelines on healthy behaviours.
What are the possible benefits and risks of participating?
Benefits are expected to include greater awareness of behavioural risks and remedies for a healthy heart; better informed decision making within participating families around diet, exercise and smoking; and intensive and academically informed support for participants in the intervention group through a series of intervention workshops sustained over 2 years. Risks include potential emotional distress and anxiety on being made aware of a high risk category score.
Where is the study run from?
1. Nottingham Trent University (UK)
2. Brighton and Sussex Medical School (UK)
When is the study starting and how long is it expected to run for?
March 2019 to March 2021
Who is funding the study?
Horizon 2020
Who is the main contact?
Prof. Harm Van Marwijk
H.VanMarwijk@bsms.ac.uk
Contact information
Scientific
Bsms Teaching Building
University Of Sussex
Brighton
BN19PX
United Kingdom
| Phone | +44 (0)1273644774 |
|---|---|
| H.VanMarwijk@bsms.ac.uk |
Study information
| Study design | Mixed methods incorporating stepped wedge, cluster-randomised, controlled intervention trial with qualitative investigation of barriers and facilitators to individual and organisational change |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Cluster randomised trial |
| Study setting(s) | Community |
| Study type | Prevention |
| Participant information sheet | http://j.mp/2XcRvEB |
| Scientific title | Scaling up Packages of Interventions for the prevention of Cardiovascular disease in selected European and sub-Saharan countries (an implementation research project) |
| Study acronym | SPICES |
| Study objectives | Engaging with target populations outside of formal healthcare facilities will be more effective in increasing knowledge of CVD risk factors, scaling up CVD risk-profiling, and supporting personal and community behaviour change than Primary Care situated interventions. |
| Ethics approval(s) | Approved 15/03/2019, Research Office, Nottingham Trent University (Arkwright B113, 50 Shakespeare Street, Nottingham, NG1 4FQ; Tel: +44 (0)115 848 8117; Email: anton.muszansky@ntu.ac.uk), ref: 2018/286 |
| Health condition(s) or problem(s) studied | Cardiovascular disease |
| Intervention | Participants are randomised according to postcode and partner community organisations from which participants have been recruited: 1. In-person, community-based, Behaviour Change Support (individual and group work) delivered by trained volunteers using techniques of Risk Profiling, National Guidelines on Healthy Behaviours, Goal Setting, Action Planning, Problem Solving, and Motivational Interviewing. Interventions will be repeated up to 11 times over 24 months starting weekly and then less frequently. 2. Control group provided only with Risk Profiling and National Guidelines on Healthy Behaviours. |
| Intervention type | Behavioural |
| Primary outcome measure | 1. Predicted cardiovascular risk profile score measured using survey incorporating the non-clinical INTERHEART risk profiling instrument at baseline, 6, 12, 18 and 24 months 2. Perception of CVD risk score measured using survey (ABCD questionnaire) incorporated into baseline survey at baseline, 6, 12, 18 and 24 months 3. Adherence to Dietary Approaches to Stop Hypertension (DASH) dietary advice measured through administration of adapted ‘DASH-Q’ survey instrument with Intervention Group 9 times during 18-24 month period 4. Adherence to national (UK) guidelines on recommended levels of Physical Activity measured through administration of International Physical Activity Questionnaire (IPAQ) with Intervention Group 9 times during 18-24 month period |
| Secondary outcome measures | 1. Qualitative data on barriers and facilitators to healthy behaviour change collected through individual interviews with Intervention Group 9 times during 18-24 month period 2. Qualitative data on impact of social determinants on behaviour change intentions gathered through focus groups and individual case studies with selected Intervention Group participants |
| Overall study start date | 01/03/2019 |
| Completion date | 30/09/2021 |
Eligibility
| Participant type(s) | All |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 800 |
| Key inclusion criteria | All eligible adults (over 18 years old) |
| Key exclusion criteria | 1. Under 18 (non-adult) 2. Pregnant 3. Previously diagnosed with heart condition |
| Date of first enrolment | 01/04/2019 |
| Date of final enrolment | 30/06/2021 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centres
Nottingham
NG1 4FQ
United Kingdom
University Of Sussex
Brighton
BN1 9PX
United Kingdom
Sponsor information
Other
EU HQ
Rue de la Loi 175
Brussels
1000
Belgium
| Phone | +32 (0)2 281 59 20 |
|---|---|
| erc-uk@bbsrc.ac.uk | |
| Website | https://ec.europa.eu/programmes/horizon2020/en |
"ROR" |
https://ror.org/00k4n6c32 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- EU Framework Programme for Research and Innovation, Horizon 2020 - Research and Innovation Framework Programme, European Union Framework Programme for Research and Innovation
Results and Publications
| Intention to publish date | 01/10/2021 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Stored in repository |
| Publication and dissemination plan | 1. A joint protocol for publication by Nottingham Trent University and Brighton and Sussex Medical School is being drafted. A copy can be provided as soon as this has been approved by partners. 2. Implementation Science paper 3. Public Health & Community Engagement paper |
| IPD sharing plan | All survey data (baseline survey and intervention survey) are uploaded to the secure research data server at the University of Antwerp using the ‘RedCap’ application. RedCap has extensive security measures (see https://projectredcap.org/about/faq/). If you require assistance or have any questions about REDCap, please contactREDCap Administrator (swabra.nakato@uantwerpen.be/+3232658862). Participant data will only be available to third parties in aggregate and anonymised form as and when results are published in due course. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Interim results article | Validation of ABCD Risk Questionnaire with additional smoking behaviur questions | 16/01/2023 | Yes | No | |
| Protocol article | Protocol for UK study | 12/03/2020 | 16/01/2023 | Yes | No |
Editorial Notes
16/01/2023: Publication references added.
21/04/2020: The following changes have been made:
1. The overall trial end date has been changed from 30/03/2021 to 30/09/2021.
2. The intention to publish date has been changed from 01/04/2021 to 01/10/2021.
20/04/2020: Due to current public health guidance, recruitment for this study has been paused.
20/04/2020: The recruitment end date has been changed from 31/12/2020 to 30/06/2021.
04/06/2019: Trial's existence confirmed by research ethics committee.
