search
Back to results

Effect of the SCOT-HEART 2 Trial on Lifestyle.

Primary Purpose

Coronary Artery Disease, Primary Prevention

Status
Recruiting
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Delivery of CT scan results
Sponsored by
University of Edinburgh
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Coronary Artery Disease

Eligibility Criteria

40 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • MUST BE ENROLLED IN SCOTHEART 2 TRIAL

Exclusion Criteria:

  • MUST BE ENROLLED IN SCOTHEART 2 TRIAL

Sites / Locations

  • University of EdinburghRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Active Comparator

Active Comparator

Arm Label

ASSIGN score

CTCA - visual report

CTCA - verbal report

Arm Description

The baseline assessment will be completed on the same day as consent is gained. Every patients will complete a comprehensive assessment including questionnaires and objective assessments. Patients randomised to standard care with ASSIGN score alone (n=200) will be invited back approximately 6 months after baseline assessment. The detailed questionnaire, breath test, blood pressure monitoring, and 2-week activity monitor will be repeated. Bloods will be retaken to look at change in lipid levels and HbA1c where appropriate - no more than 30mls will be required.

Those in the CTCA group will be further randomised into review with or without CT images. The review WITH images (VISUAL REPORT N=100) group will have results delivered by the principal investigator (a trained Cardiology Registrar) to ensure a standardised approach to relaying information. These results will be preliminary and focused only on whether the patient has evidence of coronary disease or not. A full report describing the extent of coronary disease, other cardiac problems and incidental findings will follow as per the SCOT-HEART-2 protocol. Patients will be made aware that the presented findings are a focused preliminary report and that a more detailed formal report will follow.

The baseline assessment will be completed on the same day as consent is gained. Every patients will complete a comprehensive assessment including questionnaires and objective assessments. Those in the CTCA group will be further randomised into review with or without CT images. The review WITHOUT images (VERBAL REPORT N=100) group will have results delivered by the principal investigator (a trained Cardiology Registrar) to ensure a standardised approach to relaying information. These results will be preliminary and focused only on whether the patient has evidence of coronary disease or not. A full report describing the extent of coronary disease, other cardiac problems and incidental findings will follow as per the SCOT-HEART-2 protocol. Patients will be made aware that the presented findings are a focused preliminary report and that a more detailed formal report will follow.

Outcomes

Primary Outcome Measures

Proportion of patients who meet National Institute for Heath and Care Excellence (NICE) recommendations on risk factor modifications
The primary endpoint will be the proportion of patients who meet NICE recommendations on diet, smoking, weight and activity levels (%)

Secondary Outcome Measures

Smoking cessation
Proportion of patients who changed smoking habits (%)
Weight loss
Measure change in weight via body mass index and waist circumference (%)
Blood pressure control
Change in blood pressure control through lifestyle/compliance with medications (%)
Lipid levels
Change in serum lipid levels through lifestyle/compliace with medications (%)
Diabetic control
Change in glycosylated haemoglobin (HbA1c) (%)
Adherence to medications
Change in compliance with medications tracked through questionnaire
Exercise
Change in activity levels measured through activity monitoring (step count over 2 weeks) and international physical activity questionnaire
Quality of life/Anxiety and Depression
Change in quality of life measured through PHQ-9 (patient health questionnaire): anxiety and depression score (%)
ASSIGN score
Change in ASSIGN score as a result of lifestyle / risk factor modification (%)

Full Information

First Posted
November 1, 2019
Last Updated
November 7, 2022
Sponsor
University of Edinburgh
Collaborators
British Heart Foundation, NHS Lothian
search

1. Study Identification

Unique Protocol Identification Number
NCT04156061
Brief Title
Effect of the SCOT-HEART 2 Trial on Lifestyle.
Official Title
Effect of the SCOT-HEART 2 Trial on Lifestyle and Risk Factor Modification.
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 28, 2020 (Actual)
Primary Completion Date
April 30, 2023 (Anticipated)
Study Completion Date
August 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Edinburgh
Collaborators
British Heart Foundation, NHS Lothian

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This study will recruit 400 participants who are taking part in the Computed Tomography Coronary Angiography for the Prevention of Myocardial Infarction (SCOT-HEART 2) trial. The investigator will assess diet, activity and habits at the start of the study and 6 months later. This will help us understand the effects taking part in the study may have on lifestyle. In addition, for participants who have CT scans, the investigator will present the results of the heart from the CT scan. This will help us understand how best to explain the results of the CT scan to patients.
Detailed Description
This is a sub-study of the SCOT-HEART 2 trial (which aims to determine the best way to prevent heart attacks). The purpose of this sub-study is to determine the effect of getting information on heart disease risk on lifestyle. At present doctors usually use a "risk score" to identify people at risk of heart disease who may benefit from medical treatment. In the SCOT-HEART 2 study the investigator will compare this "risk score" to a specialised heart scan (a computed tomography coronary angiogram or CTCA scan). In this study the investigator would like to understand more about the effects of receiving this information about the heart on lifestyle, including effects on smoking, diet and activity. This study will recruit 400 participants who are taking part in the SCOT-HEART 2 trial. The investigator will assess lifestyle by using a detailed questionnaire which will be done at the start of the study and 6 months later. The investigator will also perform some simple investigations including a carbon monoxide breath test, blood pressure tests and measurements of activity such as step counts. This will help us understand the effects on lifestyle of getting information about a "risk score" or having a CT scan. In addition, for people who have CT scans the investigator will either provide a verbal explanation of the results, as is usual, or show pictures of the heart from the CT scan. This will help us understand how best to explain the results of the CT scan to partipants.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease, Primary Prevention

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
400 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
ASSIGN score
Arm Type
No Intervention
Arm Description
The baseline assessment will be completed on the same day as consent is gained. Every patients will complete a comprehensive assessment including questionnaires and objective assessments. Patients randomised to standard care with ASSIGN score alone (n=200) will be invited back approximately 6 months after baseline assessment. The detailed questionnaire, breath test, blood pressure monitoring, and 2-week activity monitor will be repeated. Bloods will be retaken to look at change in lipid levels and HbA1c where appropriate - no more than 30mls will be required.
Arm Title
CTCA - visual report
Arm Type
Active Comparator
Arm Description
Those in the CTCA group will be further randomised into review with or without CT images. The review WITH images (VISUAL REPORT N=100) group will have results delivered by the principal investigator (a trained Cardiology Registrar) to ensure a standardised approach to relaying information. These results will be preliminary and focused only on whether the patient has evidence of coronary disease or not. A full report describing the extent of coronary disease, other cardiac problems and incidental findings will follow as per the SCOT-HEART-2 protocol. Patients will be made aware that the presented findings are a focused preliminary report and that a more detailed formal report will follow.
Arm Title
CTCA - verbal report
Arm Type
Active Comparator
Arm Description
The baseline assessment will be completed on the same day as consent is gained. Every patients will complete a comprehensive assessment including questionnaires and objective assessments. Those in the CTCA group will be further randomised into review with or without CT images. The review WITHOUT images (VERBAL REPORT N=100) group will have results delivered by the principal investigator (a trained Cardiology Registrar) to ensure a standardised approach to relaying information. These results will be preliminary and focused only on whether the patient has evidence of coronary disease or not. A full report describing the extent of coronary disease, other cardiac problems and incidental findings will follow as per the SCOT-HEART-2 protocol. Patients will be made aware that the presented findings are a focused preliminary report and that a more detailed formal report will follow.
Intervention Type
Other
Intervention Name(s)
Delivery of CT scan results
Intervention Description
Method of results delivery - verbal or visual.
Primary Outcome Measure Information:
Title
Proportion of patients who meet National Institute for Heath and Care Excellence (NICE) recommendations on risk factor modifications
Description
The primary endpoint will be the proportion of patients who meet NICE recommendations on diet, smoking, weight and activity levels (%)
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Smoking cessation
Description
Proportion of patients who changed smoking habits (%)
Time Frame
6 months
Title
Weight loss
Description
Measure change in weight via body mass index and waist circumference (%)
Time Frame
6 months
Title
Blood pressure control
Description
Change in blood pressure control through lifestyle/compliance with medications (%)
Time Frame
6 months
Title
Lipid levels
Description
Change in serum lipid levels through lifestyle/compliace with medications (%)
Time Frame
6 months
Title
Diabetic control
Description
Change in glycosylated haemoglobin (HbA1c) (%)
Time Frame
6 months
Title
Adherence to medications
Description
Change in compliance with medications tracked through questionnaire
Time Frame
6 months
Title
Exercise
Description
Change in activity levels measured through activity monitoring (step count over 2 weeks) and international physical activity questionnaire
Time Frame
6 months
Title
Quality of life/Anxiety and Depression
Description
Change in quality of life measured through PHQ-9 (patient health questionnaire): anxiety and depression score (%)
Time Frame
6 months
Title
ASSIGN score
Description
Change in ASSIGN score as a result of lifestyle / risk factor modification (%)
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: MUST BE ENROLLED IN SCOTHEART 2 TRIAL Exclusion Criteria: MUST BE ENROLLED IN SCOTHEART 2 TRIAL
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mohammed N Meah, MB ChB
Phone
07921238123
Email
m.meah@ed.ac.uk
Facility Information:
Facility Name
University of Edinburgh
City
Edinburgh
State/Province
Midlothian
ZIP/Postal Code
EH16 4SB
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mohammed N Meah, MBChB, MRCP
Phone
07921238123
Email
m.meah@ed.ac.uk
First Name & Middle Initial & Last Name & Degree
David E Newby, BA BSc(Hons) PhD BM DM
Phone
01312426515
Email
d.e.newby@ed.ac.uk

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Anonymised participant data will be made available to other researchers
IPD Sharing Time Frame
To be determined

Learn more about this trial

Effect of the SCOT-HEART 2 Trial on Lifestyle.

We'll reach out to this number within 24 hrs