Randomized Controlled Trial on Uptake of NHS Health Checks

• Sponsor: Public Health England (Other)
• Overall Status: Completed
• CT.gov ID: NCT03524131
• Collaborator: (none)
• Enrollment: 12,000
• Location: 1
• Arms: 3
• Actual Duration (Months): 8.1
• Patients Per Site Per Month: 1484.8

Study Details

Study Description

Brief 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%. 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.

Condition or Disease	Intervention/Treatment	Phase
Cardiovascular Diseases	Other: risk-framed leaflet; Other: benefits-framed leaflet; Other: current national leaflet	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 12000 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• 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
• Actual Study Start Date: Mar 29, 2018
• Actual Primary Completion Date: Nov 30, 2018
• Actual Study Completion Date: Nov 30, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: risk-framed leaflet Patients sent 2-sided risk-framed leaflet with NHS Health Check invitation	Other: risk-framed leaflet; 2-sided leaflet, emphasizing health risks of not going to the NHS Health Check
Experimental: benefits-framed leaflet Patients sent 2-sided benefits-framed leaflet with NHS Health Check invitation	Other: benefits-framed leaflet; 2-sided leaflet, emphasizing benefits of attending an NHS Health Check
Active Comparator: control Patients sent 4-sided current national leaflet with NHS Health Check invitation	Other: current national leaflet; 4-sided leaflet

Outcome Measures

Primary Outcome Measures

1. attendance at NHS Health Check [up to 6 months from time of invitation]

   whether or not the patient attended their NHS Health Check

Eligibility Criteria

Criteria

• Ages Eligible for Study: 40 Years to 74 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• due to be invited for an NHS Health Check

• aged 40-74

Exclusion Criteria:

• have an existing Cardio-Vascular Disease-related medical condition

• have had an NHS Health Check in the last five years

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Public Health England	London		United Kingdom	SE1

Sponsors and Collaborators

• Public Health England

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Public Health England
• ClinicalTrials.gov Identifier: NCT03524131
• Other Study ID Numbers: NHSHC2017
• First Posted: May 14, 2018
• Last Update Posted: Mar 3, 2020
• Last Verified: Apr 1, 2018

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Cardiovascular Diseases

Study Results

No Results Posted as of Mar 3, 2020