Condition category
Circulatory System
Date applied
14/03/2013
Date assigned
21/03/2013
Last edited
17/11/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
The NHS Health Check programme was set up to help prevent heart disease, stroke, diabetes and kidney disease. Everyone aged 40 to 74 years is invited to have a NHS Health Check every five years. Most people have their NHS Health Check at their GP surgery. In some parts of England, people can have their NHS Health Check at a pharmacy (chemist) or can be seen by nurses who are based in the community.People who are found to be at high risk in the next 10 years of having a stroke or heart attack or being diagnosed with kidney disease or diabetes are offered medication and help to live a more healthy life (such as helping the person to stop smoking or helping the person to do more exercise).The Department of Health has worked out that NHS Health Checks could stop 2000 people from dying each year if enough people have their NHS Health Check. They have also worked out that NHS Health Checks could stop up to 9,500 heart attacks and strokes each year that would have been serious but would not have caused the person to die. However, evaluations have found that only 45% of people who live in poorer areas of England are going for their NHS Health Check.In this study we want to see whether a questionnaire sent to patients before they are invited for their NHS Health Check makes more people actually go for their NHS Health Check.

Who can participate?
Men and women who are 40 to 74 years old who are going to be invited for their NHS Health Check. People who already have heart disease, diabetes, kidney disease or who have had a stroke before are not invited for NHS Health Checks.

What does the study involve?
People who are going to be invited for a NHS Health Check will be randomly put into 1 of 3 groups. Group 1 will get a normal NHS Health Check invitation. Group 2 will be posted a questionnaire one week before they are sent a normal NHS Health Check invitation. Group 3 will be posted a questionnaire one week before they are sent a normal NHS Health Check invitation. They will be told that they will be given a £5 shopping voucher if they send the questionnaire back. The study will look at whether Group 2 or Group 3 group were more likely to go for a NHS Health Check within 6 months of being invited than Group 1.

What are the possible benefits and risks of participating?
People who take part in the study who are put into Group 3 will get a £5 shopping voucher if they return the questionnaire. There are no risks to people taking part.

Where is the study run from?
The study is run by a team at King’s College London and is being done in 2 London boroughs: Lambeth and Lewisham. People from up to 95 GP practices will take part in this study.

When is the study starting and how long is it expected to run for?
The study is starting in May 2013 and will run for 2 years and 6 months. The trial be recruiting participants for 1 year.

Who is funding the study?
National Institute for Health Research (NIHR) Health Technology Assessment (HTA) programme

Who is the main contact?
Prof. Martin Gulliford
martin.gulliford@kcl.ac.uk

Trial website

Contact information

Type

Scientific

Primary contact

Prof Martin Gulliford

ORCID ID

Contact details

Department of Primary Care and Public Health Sciences
Capital House
42 Weston Street
London
SE1 3QD
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

HTA 11/129/61

Study information

Scientific title

Enhanced invitation methods to increase uptake of NHS Health Checks: randomised controlled trial

Acronym

Study hypothesis

Participants who complete and return a question-behaviour effect questionnaire will be more likely to attend an NHS Health Check within six months of being invited.

More details can be found at: http://www.nets.nihr.ac.uk/projects/hta/1112961
Protocol can be found at: http://www.nets.nihr.ac.uk/__data/assets/pdf_file/0005/81194/PRO-11-129-61.pdf

Ethics approval

NRES Committee London -– London Bridge, 07/03/2013, ref: 13/LO/0197

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

GP practices

Trial type

Other

Patient information sheet

GP information sheet is available from the researchers on request

Condition

Vascular disease

Intervention

Three study arms: standard invitation, question-behaviour effect questionnaire, and question-behaviour effect questionnaire plus incentive

Question-behaviour effect questionnaire. A brief questionnaire sent to participants one week before they are invited for their NHS Health Check. The content of the questionnaire is informed by the Theory of Planned Behaviour as well as research showing that experiencing anticipated regret may predict behaviour over and above the constructs in the Theory of Planned Behaviour. The dominant explanation of how the question-behaviour effect works, based upon psychological laboratory studies, is that asking behavioural intention questions heightens the accessibility of the person’s attitude toward the behaviour, which in turns increases the likelihood that the behaviour will be performed.

Question-behaviour effect questionnaire plus incentive. The question-behaviour effect questionnaire is sent to participants one week before they are invited for their NHS Health Check. They are also offered a £5 retail voucher as an incentive for them to return the questionnaire. We are incentivising questionnaire return as this is known to increase questionnaire response rates. The maximum impact of the question-behaviour effect occurs in individuals who return the questionnaires. This is because it is completing the questionnaire that causes the thinking processes that increase attitude accessibility and so the likelihood of health check uptake. Therefore, offering an incentive for questionnaire return should increase the proportion of participants who complete the questionnaire, thus increasing the accessibility of their attitudes and their likelihood of acting when they receive the health check invitation letter.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

NHS Health Check attendance six months after invitation.

Secondary outcome measures

1. Whether each participant received an NHS Health Check within 91 days (3 months) of the date of the standard NHS Health Check Invitation.
2. Time elapsed between invitation distribution and health check uptake for those who had the checks will also be analysed

Overall trial start date

01/05/2013

Overall trial end date

31/10/2015

Reason abandoned

Eligibility

Participant inclusion criteria

Eligible to be invited for a NHS Health Check. NHS Health Checks are offered to all individuals aged 40 to 74 years old and who do not already have heart disease, kidney disease, diabetes or have previously had a stroke.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

21,288

Participant exclusion criteria

Ineligible for a NHS Health Check

Recruitment start date

01/05/2013

Recruitment end date

31/10/2015

Locations

Countries of recruitment

United Kingdom

Trial participating centre

King's College London
London
SE1 3QD
United Kingdom

Sponsor information

Organisation

King's College London (UK)

Sponsor details

c/o Mr Keith Brennan
Room 1.6 Hodgkin Building
Guy’s Campus
London
SE1 1UL
United Kingdom

Sponsor type

University/education

Website

http://www.kcl.ac.uk

Funders

Funder type

Government

Funder name

Health Technology Assessment Programme

Alternative name(s)

NIHR Health Technology Assessment Programme, HTA

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2014 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/25174568
2016 results in: http://www.ncbi.nlm.nih.gov/pubmed/27846927

Publication citations

  1. Protocol

    Forster AS, Burgess C, McDermott L, Wright AJ, Dodhia H, Conner M, Miller J, Rudisill C, Cornelius V, Gulliford MC, Enhanced invitation methods to increase uptake of NHS health checks: study protocol for a randomized controlled trial., Trials, 2014, 15, 342, doi: 10.1186/1745-6215-15-342.

Additional files

Editorial Notes

17/11/2016: Publication reference added.