Condition category
Circulatory System
Date applied
27/02/2017
Date assigned
27/02/2017
Last edited
28/02/2017
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Coronary heart disease (CHD), also known as ischemic heart disease, is one of the leading causes of death worldwide. CHD develops because of the build-up of fatty deposits (plaque) on the walls of the coronary arteries (the arteries that supply the heart with oxygen-rich blood). When arteries are blocked or narrowed, the heart does not receive enough blood to function properly, which can lead to a cardiac event such as a heart attack. After experiencing one cardiac event, the risk of experiencing one again is increased unless there is intensive management of risk factors such as physical activity, smoking, diabetes, hypertension (elevated blood pressure levels), hyperlipidaemia (elevated fat levels in the blood) and obesity. This usually involves being offered a structured education and exercise programme of cardiac rehabilitation, after which risk factor management is done by a GP. The aim of this study is to look at the effectiveness of an education programme with text messaging support for increasing physical activity, specifically walking, in individuals who have had a cardiac event in the past 12 to 36 months.

Who can participate?
Adults who have had a cardiac event 12-36 months ago.

What does the study involve?
Participants are randomly allocated to one of two groups. Those in the first group receive usual care, which involves being given general health advices in the form of a standard information leaflet and will be returned to standard care delivered by their GP. Those in the second group also receive the standard information leaflet as well as being invited to take part in two group-based structured education sessions. These education sessions are delivered by trained facilitators approximately two weeks apart. Following this, participants receive regular text messages providing support for a year. Participants in both groups have their physical activity levels assessed at the start of the study and then again after six and 12 months.

What are the possible benefits and risks of participating?
By taking part, both groups will benefit from a health assessment and physical activity advice. Individuals will also receive information on their general fitness levels. Most importantly participants will add to evidence-based lifestyle information that may improve the treatment and support for people 12 months after a cardiac event in the future. During any physical activity there is always an increased risk of a heart event or injury. The walking test is being performed before participants start the study to ensure the risks to an individuals health is very low. These risks are also lowered because the education sessions target the increase of daily physical activity levels rather than vigorous physical activity. There will also be a trained researcher undertaking all aspects of the study. If there are any contraindications individuals will not participate and their GP will be informed. All clinic measurements are carried out by qualified members of the research team. Some people experience minor discomfort and slight bruising during blood tests. A fully qualified research team member will carry out the blood test to ensure any pain is kept to a minimum. If 'abnormal' blood results are found, participant's GPs will be contacted so that they can investigate further.

Where is the study run from?
Leicester Diabetes Research Centre (UK)

When is the study starting and how long is it expected to run for?
February 2017 to January 2020

Who is funding the study?
1. East Midlands Academic Health Science Network (UK)
2. National Institute for Health Research (UK)
3. National Institutes of Health (USA)

Who is the main contact?
Dr Louisa Herring
PACES@uhl-tr.nhs.uk

Trial website

Contact information

Type

Scientific

Primary contact

Dr Louisa Herring

ORCID ID

Contact details

Leicester Diabetes Centre
Leicester General Hospital
Gwendolen Road
Leicester
LE5 4PW
United Kingdom
+44 1162 588964
PACES@uhl-tr.nhs.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

32603

Study information

Scientific title

Developing and evaluating an education programme aimed at increasing physical activity in individuals with diagnosed coronary heart disease: a randomised controlled trial

Acronym

Study hypothesis

The aim of the study is to implement an acceptable and cost-effective education programme with text message support and to test the effectiveness of this programme for increasing total daily physical activity, specifically walking activity measured using accelerometry, in individuals 12 to 36 months after diagnosis of a cardiac event.

Ethics approval

West Midlands - Solihull Research Ethics Committee

Study design

Randomised; Interventional; Design type: Treatment, Prevention, Education or Self-Management, Psychological & Behavioural, Complex Intervention

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

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

Condition

Specialty: Diabetes, Primary sub-specialty: Both; UKCRC code/ Disease: Cardiovascular/ Other forms of heart disease

Intervention

Eligible participants will be randomised, apart from those in the same household, using a block design and stratified by gender (men; women), and ethnicity (White European; other) to one of two groups.

Control group: Participants will be provided with general health advice in the form of a British Heart Foundation standard information leaflet and will be returned to standard care delivered by their general practitioner.

Intervention group: Participants will receive the British Heart Foundation standard information leaflet and will be invited to attend two group-based structured education sessions. Theses education sessions will be delivered by trained facilitators approximately two weeks apart and will receive subsequent reinforcement via text message support thereafter (section 3.2). These structured education sessions have been developed and refined in conjunction with PPI work and through the use of existing infrastructure consisting of Diabetes Education and Self-Management in on-going and Newly Diagnosed (DESMOND) groups and a network of trained facilitators. The participants will receive 82 physical activity related text messages at different weekly frequencies following the second education session to the 12 month follow-up assessment.

Participants in both groups will be followed up after 6 and 12 months.

Intervention type

Other

Phase

Drug names

Primary outcome measures

Average daily physical activity is assessed using an accelerometer (Average daily physical activity - Milligravities [mg]) worn for eight days at baseline, 6 and 12 months.

Secondary outcome measures

1. Aerobic fitness is assessed using an Incremental Shuttle walk test (metres) at baseline and 12 months
2. Anthropometric measures of height, body mass, BMI, waist circumference, hip circumference and waist to hip ratio are measured using standard techniques at baseline and 12 months
3. Blood pressure (mmHg) & resting heart rate (bpm) are measured using standard techniques at baseline and 12 months
4. Lipid profile (Cholesterol, HDL, LDL, Triglycerides) is measured via venepuncture at baseline and 12 months
5. HbA1c (mmol/mol, %) is measured via venepuncture at baseline and 12 months
6. Self-efficacy for exercise expectations is measured using the Jenkins self-efficacy for exercise expectations scale at baseline, 6 and 12 months
7. Anxiety and depression is measured using the Hospital Anxiety and Depression scale (HADS) at baseline, 6 and 12 months
8. Self-reported physical activity is measured using the Recent Physical Activity Questionnaire (RPAQ) at baseline, 6 and 12 months
9. Quality of life is measured using the EuroQoL EQ-5D-5L at baseline, 6 and 12 months
10. Chronotype is measured using the Morningness- Eveningness Questionnaire at baseline, 6 and 12 months
11. Biomarkers of inflammation, proteomics, metabolomics and novel markers of cardiovascular health are measured via venepuncture at baseline and 12 months

Overall trial start date

01/03/2016

Overall trial end date

02/01/2020

Reason abandoned

Eligibility

Participant inclusion criteria

1. Aged 18 years or older
2. 12-36 months post confirmed diagnosis of a cardiac event (myocardial infarction, angina or acute coronary syndrome)
3. Able to speak and read English to participate effectively in a group education programme
4. Willing and able to attend the education sessions and clinic visits
5. Willing and able to give informed consent
6. Access to a mobile phone in order to receive text messages
7. Willingness to allow GP notification of their participation in study and access to patient records for purpose of study
8. Able to take part in moderate physical activity as assessed using Incremental Shuttle Walk Test (ISWT) (Level three or above)

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 290; UK Sample Size: 290

Participant exclusion criteria

1. Individuals with a diagnosis of heart failure where the underlying primary cause is not myocardial disease as a result of atherosclerosis will be excluded from this study
2. Musculoskeletal limitations that would limit physical activity (e.g. musculoskeletal injury)
3. Participation in another clinical intervention study in the past 12 weeks
4. Lacks capacity to give informed consent
5. Severe life-threatening co-morbidity (e.g. malignancy)
6. Poor exercise capacity, (< level three on the ISWT [120 metres]), these individuals will be directed back into cardiac rehabilitation (good practice)
7. Housebound or immobile
8. Unstable symptoms (chest pain or breathlessness at rest; unstable stage II hypertension [160/100mmHg], not on necessary medications)
9. Individuals with no or limited understanding of written or verbal English

Recruitment start date

14/03/2017

Recruitment end date

30/09/2018

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Leicester Diabetes Research Centre
Leicester General Hospital Gwendolen Road
Leicester
LE5 4PW
United Kingdom

Sponsor information

Organisation

University of Leicester

Sponsor details

Fielding Johnson Building
University Road
Leicester
LE1 7RH
United Kingdom
+44 116 223 1660
uolsponsor@leicester.ac.uk

Sponsor type

University/education

Website

Funders

Funder type

Government

Funder name

East Midlands Academic Health Science Network

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

National Institute for Health Research

Alternative name(s)

NIHR

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

United Kingdom

Funder name

National Institutes of Health

Alternative name(s)

NIH

Funding Body Type

government organisation

Funding Body Subtype

federal/national government

Location

United States of America

Results and Publications

Publication and dissemination plan

Planned publication in peer-reviewed academic journals.

IPD Sharing plan:
The current data sharing plans for the current study are unknown and will be made available at a later date.

Intention to publish date

02/01/2021

Participant level data

To be made available at a later date

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes