Condition category
Circulatory System
Date applied
03/10/2017
Date assigned
24/10/2017
Last edited
17/10/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Cardiovascular disease (CVD) (heart disease) is the leading cause of death, accounting for 27% of all UK deaths. NHS Health Check is a national CVD risk assessment programme for adults in England aged 40-74 without a chronic disease. Typically, general practice records are used to identify those eligible and invite them for a Health Check, where the practitioner assesses their risk of CVD in the next 10 years. This forms the basis of discussions around how to manage and reduce this risk. Nationally, uptake of Health Checks remains around 50%, as just half of those invited for a Health Check attend. This is way below the 75% needed for the programme to be cost-effective. There is some evidence that how people are invited for a Health Check is a strong predictor of whether or not they will attend (i.e., a predictor of uptake). Telephone invitations seem to increase the likelihood that patients will attend their Health Check. Yet, most general practices use standard letters to invite patients as making calls takes more time and is therefore more expensive. Changes to the standard letter could make it more relevant to patients to increase the likelihood that they will attend. This study aims to design and test a NHS Health Check invitation letter personalised to the patient’s level of CVD risk, and to compare the likelihood of patients attending when invited with the personalised letter compared with the standard letter and telephone invitation.

Who can participate?
Patients aged 40-74 who are eligible for and due to have a NHS Health Check at 10 general practices in North Staffordshire

What does the study involve?
Participants are randomly allocated to be invited to attend a Health Check using one of the three methods: standard letter, telephone call, or personalised letter. Participants are invited up to three times before being classified as a non-responder (or if they responded and declined the invitations). The study explores whether the way in which patients are invited predicts whether or not they attend the Health Check, taking other factors such as age and gender into account.

What are the possible benefits and risks of participating?
Patients may benefit from an increased likelihood of attending the Health Check. The potential risks include patients in the personalised letter group finding the risk-tailored messages distressing or difficult to understand. However, considerable development work and public consultation was undertaken to mitigate this risk.

Where is the study run from?
Staffordshire University (UK)

When is the study starting and how long is it expected to run for?
July 2015 to December 2017

Who is funding the study?
Stoke-on-Trent City Council, Public Health (UK)

Who is the main contact?
Dr Christopher Gidlow
c.gidlow@staffs.ac.uk

Trial website

Contact information

Type

Scientific

Primary contact

Dr Christopher Gidlow

ORCID ID

http://orcid.org/0000-0003-4990-4572

Contact details

Brindley Building
Staffordshire University
Stoke on Trent
ST4 2DF
United Kingdom
+44 (0)1782 294330
c.gidlow@staffs.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

4

Study information

Scientific title

HEalth Check TRial (HECTR): randomised controlled trial comparing uptake of NHS Health Check in response to standard letters, CVD risk-personalised letters and telephone invitations

Acronym

HECTR

Study hypothesis

To test the reach and uptake of Health Checks using standard letter versus telephone invitation versus letter that is personalised based on individual % cardiovascular disease (CVD) risk.

Ethics approval

NHS National Research Ethics Service Committee East of England – Cambridge, 25/08/2015, ref 15/EE/0340

Study design

Three-arm randomised controlled trial; single-centred; 12-month data collection period

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

GP practices

Trial type

Screening

Patient information sheet

Not available in web format, please use the contact details to request a patient information sheet

Condition

Cardiovascular disease

Intervention

The three trial arms are the different methods of invitation to attend a NHS Health Check (with attendance/non-attendance as the outcome):
1. Standard letter (control) - patients receive a letter with the same content (the most recent national letter template), with accompanying Health Check information leaflet.
2. Telephone - patients are invited by telephone, usually by the reception staff (a guide was provided to practices to standardise the type of information relayed to patient.
3. Personalised letter - risk-personalised letter templates developed to include messages appropriate to different levels of CVD risk based on the QRISK 10-year score (templates for 3 risk categories - High ≥20%; Medium 10-19.9%; low <10%).

Random allocation of individual patients within practices was completed within EMIS using bespoke searches: an eligible cohort search was run using the existing search based on the national NHS Health Check criteria; search was run to randomly select 33.3% of the cohort and allocate them to Arm 1; search was run to randomly select 50% of the remaining cohort and allocate them to Arm 2; the remaining 33.3% of the cohort were allocated to Arm 3. For each arm, patients are invited up to three times before being recorded as a non-responder (and non-attender).

Intervention type

Other

Phase

Drug names

Primary outcome measure

Uptake of NHS Health Check, measured at 12 months from baseline or earlier if the practice had invited the entire cohort before 12 months

Secondary outcome measures

Response to NHS Health Check invitation, measured at 12 months from baseline or earlier if the practice had invited the entire cohort before 12 months

Overall trial start date

01/07/2015

Overall trial end date

31/12/2017

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

Patients will be included if they are:
1. Registered at one of the participating practices
2. Aged 40-74 years
3. Are eligible and due for a NHS Health based on the national programme criteria (see exclusion criteria)

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

2500

Participant exclusion criteria

National NHS Health Check eligibility criteria will exclude patients from receiving an invitation if any of the following apply:
1. Coronary heart disease
2. Chronic kidney disease (CKD) which has been classified as stage 3, 4 or 5 within the meaning of the National Institute for Health and Care Excellence (NICE) clinical guideline 182 on Chronic Kidney Disease
3. Diabetes
4. Hypertension
5. Atrial fibrillation
6. Transient ischaemic attack
7. Hypercholesterolemia
8. Heart failure
9. Peripheral arterial disease
10. Stroke
11. Prescribed statins
12. People who have previously had an NHS Health Check, or any other check undertaken through the health service in England, and found to have a 20% or higher risk of developing cardiovascular disease over the next ten years

Recruitment start date

14/10/2015

Recruitment end date

28/02/2017

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Staffordshire University
School of Life Sciences and Education Brindley Building Leek Road
Stoke-on-Trent
ST4 2DF
United Kingdom

Sponsor information

Organisation

Staffordshire University

Sponsor details

Brindley Building
Leek Road
Stoke-on-Trent
ST4 2DF
United Kingdom

Sponsor type

University/education

Website

Funders

Funder type

Government

Funder name

Stoke-on-Trent City Council, Public Health

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Staffordshire County Council, Public Health

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Public Health England

Alternative name(s)

PHE

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

United Kingdom

Results and Publications

Publication and dissemination plan

The study protocol has not been published, but can be requested from the study team. The main result paper should be submitted by December 2017. The trialists hope to present findings at conferences in 2018 (e.g., Annual NHS Health Check conference in February 2018, if accepted to present).

IPD sharing statement
The datasets generated during and/or analysed during the current study are not expected to be made available because the third party data sharing agreement between Staffordshire University and general practices did not include statements regarding further sharing of data. The data will remain stored at Staffordshire University.

Intention to publish date

01/12/2017

Participant level data

Not expected to be available

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes