Condition category
Circulatory System
Date applied
29/01/2007
Date assigned
11/05/2007
Last edited
18/01/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Roger Harrison

ORCID ID

Contact details

Division of Epidemiology & Health Sciences
The Medical School
University of Manchester
Oxford Road
Manchester
M13 9PT
United Kingdom
+44 (0)161 275 5200
roger.harrison@manchester.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

G0501280

Study information

Scientific title

Exploring the ability of lay workers to support heart-health related behaviour change in deprived areas through Heart of Mersey

Acronym

LhtIST (Lay health trainer Intervention STudy)

Study hypothesis

To examine the feasibility of a Randomised Controlled Trial (RCT) to assess lay health worker intervention to reduce Coronary Heart Disease (CHD) risk using lifestyle/behaviour change.

Ethics approval

Ethics approval MREC ref: 07/H1002/65

Study design

Feasibility study for a two-group randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Prevention

Patient information sheet

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

Condition

Cardiovascular disease

Intervention

Lay worker support delivered in the home and links to existing community initiatives to promote heart-health diet, physical activity, sensible drinking and smoking cessation.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measures

A feasibility study for a RCT, to examine recruitment strategies, outcome measures, and delivery methods of the intervention. Aim of the main trial will be to reduce CHD risk factors.

Secondary outcome measures

Not provided at time of registration

Overall trial start date

18/09/2006

Overall trial end date

17/09/2008

Reason abandoned

Eligibility

Participant inclusion criteria

18+ years old with one or more diagnoses of:
1. Hypertension
2. Raised total cholesterol
3. Diabetes
4. Obesity
5. Smoker

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

100 for this feasibility study

Participant exclusion criteria

1. Established CHD
2. Non consenting
3. On current diet conflicting with heart-health dietary guidelines
4. Homeless/hostel/residential/nursing home residents
5. Life-expectancy <2 years
6. Physical/mental health reasons

Recruitment start date

18/09/2006

Recruitment end date

17/09/2008

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University of Manchester
Manchester
M13 9PT
United Kingdom

Sponsor information

Organisation

University of Manchester (UK)

Sponsor details

c/o Ms Karen Shaw
Research Office
2nd floor
Christie Building
University of Manchester
Manchester
M13 9PT
United Kingdom
+44 (0)161 275 1636
Karen.shaw@manchester.ac.uk

Sponsor type

University/education

Website

Funders

Funder type

Government

Funder name

The Medical Research Council (MRC): The National Prevention Research Initiative (NPRI) (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

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

Publication citations

Additional files

Editorial Notes

18/01/2016: no publications found on PubMed.