Cardiovascular DiseasesNCT03524131
Randomized Controlled Trial on Uptake of NHS Health Checks
A study testing risk-framed leaflet, benefits-framed leaflet and current national leaflet in people with Cardiovascular Diseases, run by Public Health England at 1 site in United Kingdom.
Trial summary
The National Health Service (NHS) Health Check is a significant part of the strategy to tackle premature mortality and promote healthy lifestyles. Public Health England aspires to an uptake rate of 75% but national uptake is less than 50%. Read more about this study
- Who is it for?
- Ages 40 to 74 years
- Conditions the study is for
- Cardiovascular Diseases
- What is being tested?
- risk-framed leaflet, benefits-framed leaflet and current national leaflet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12,000 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 29 Mar 2018to 30 Nov 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- due to be invited for an NHS Health Check
- aged 40-74
Who cannot join
- have an existing Cardio-Vascular Disease-related medical condition
- have had an NHS Health Check in the last five years
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Controlled Trial to Compare the Effect of Two New Behaviourally Enhanced NHS Health Check Leaflets and the Current Nationally Recommended Leaflet on Uptake of NHS Health Checks
The National Health Service (NHS) Health Check is a significant part of the strategy to tackle premature mortality and promote healthy lifestyles. Public Health England aspires to an uptake rate of 75% but national uptake is less than 50%. This study aims to assess the impact of two new behaviourally informed NHS Health Check leaflets on the uptake of NHS Health Checks, by randomizing patients in Lewisham and North East Lincolnshire to the different leaflets and comparing patient-level uptake data. The study will test whether a shorter risk-framed leaflet or a shorter benefits-framed leaflet will be more effective than the current national leaflet at encouraging uptake of the NHS Health Check.
- Conditions
- Cardiovascular Diseases
- Being tested
- risk-framed leaflet, benefits-framed leaflet, current national leaflet
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
risk-framed leafletOther
2-sided leaflet, emphasizing health risks of not going to the NHS Health Check
benefits-framed leafletOther
2-sided leaflet, emphasizing benefits of attending an NHS Health Check
current national leafletOther
4-sided leaflet
| Study group | Role | What they receive |
|---|---|---|
| risk-framed leaflet | Experimental | Patients sent 2-sided risk-framed leaflet with NHS Health Check invitation Receives: Other: risk-framed leaflet |
| benefits-framed leaflet | Experimental | Patients sent 2-sided benefits-framed leaflet with NHS Health Check invitation Receives: Other: benefits-framed leaflet |
| control | Active comparator | Patients sent 4-sided current national leaflet with NHS Health Check invitation Receives: Other: current national leaflet |
What is being measured
The primary outcome is the main question the study is designed to answer.
attendance at NHS Health Check
whether or not the patient attended their NHS Health Check
Measured: up to 6 months from time of invitation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2018
- Study start29 Mar 2018
- Primary completion30 Nov 2018
- Study completion30 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 12,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Public Health England
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03524131
- Sponsor's protocol ID
- NHSHC2017
- Status last verified
- Apr 2018
- First submitted
- 26 Apr 2018
- Last updated
- 3 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gold N, Durlik C, Sanders JG, Thompson K, Chadborn T. Applying behavioural science to increase uptake of the NHS Health Check: a randomised controlled trial of gain- and loss-framed messaging in the national patient information leaflet. BMC Public Health. 2019 Nov 14;19(1):1519. doi: 10.1186/s12889-019-7754-5.
PubMed 31727030
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial to Compare the Effect of Two New Behaviourally Enhanced NHS Health Check Leaflets and the Current Nationally Recommended Leaflet on Uptake of NHS Health Checks
- ClinicalTrials.gov ID
- NCT03524131
- Acronym / sponsor ID
- NHSHC2017
- Conditions
- Cardiovascular Diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12,000 participants (actual)
- Lead sponsor
- Public Health EnglandOther government
- Study start
- 29 Mar 2018 (actual)
- Primary completion
- 30 Nov 2018 (actual)
- Study completion
- 30 Nov 2018 (actual)
- First posted
- 14 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The National Health Service (NHS) Health Check is a significant part of the strategy to tackle premature mortality and promote healthy lifestyles. Public Health England aspires to an uptake rate of 75% but national uptake is less than 50%. This study aims to assess the impact of two new behaviourally informed NHS Health Check leaflets on the uptake of NHS Health Checks, by randomizing patients in Lewisham and North East Lincolnshire to the different leaflets and comparing patient-level uptake data. The study will test whether a shorter risk-framed leaflet or a shorter benefits-framed leaflet will be more effective than the current national leaflet at encouraging uptake of the NHS Health Check.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| risk-framed leaflet | Experimental | Other: risk-framed leafletPatients sent 2-sided risk-framed leaflet with NHS Health Check invitation |
| benefits-framed leaflet | Experimental | Other: benefits-framed leafletPatients sent 2-sided benefits-framed leaflet with NHS Health Check invitation |
| control | Active comparator | Other: current national leafletPatients sent 4-sided current national leaflet with NHS Health Check invitation |
Who may qualify
- Ages
- 40 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- due to be invited for an NHS Health Check
- aged 40-74
Key exclusion criteria (2 listed)
- have an existing Cardio-Vascular Disease-related medical condition
- have had an NHS Health Check in the last five years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| risk-framed leaflet2-sided leaflet, emphasizing health risks of not going to the NHS Health Check | Other | risk-framed leaflet |
| benefits-framed leaflet2-sided leaflet, emphasizing benefits of attending an NHS Health Check | Other | benefits-framed leaflet |
| current national leaflet4-sided leaflet | Other | control |
Primary outcome
attendance at NHS Health Check
Time frame: up to 6 months from time of invitation
whether or not the patient attended their NHS Health Check
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2020.
- Derived from this study: PubMed 31727030Gold N, Durlik C, Sanders JG, Thompson K, Chadborn T. Applying behavioural science to increase uptake of the NHS Health Check: a randomised controlled trial of gain- and loss-framed messaging in the national patient information leaflet. BMC Public Health. 2019 Nov 14;19(1):1519. doi: 10.1186/s12889-019-7754-5.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing risk-framed leaflet, benefits-framed leaflet and current national leaflet in people with Cardiovascular Diseases, run by Public Health England at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
attendance at NHS Health Check (time frame: up to 6 months from time of invitation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03524131, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2020.