Plain English Summary
Not provided at time of registration
Trial website
http://www.rdnottspct.nhs.uk/npcrp/clinical-genetics-in-primary-c
Contact information
Type
Scientific
Primary contact
Dr Nadeem Qureshi
ORCID ID
Contact details
Division of Primary Care
The University of Nottingham
Graduate Medical School
Derby City General Hospital
Uttoxeter Road
Derby
DE22 3DT
United Kingdom
+44 (0)1332 724677
nadeem.qureshi@nottingham.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
HSR/36A
Study information
Scientific title
Acronym
ADDFAM - Added Value of ADDing FAMily history to CVD risk calculations
Study hypothesis
The project will assess the clinical value and utility of a systematic approach to incorporate family history information into Coronary Heart Disease (CHD) risk assessment in primary care, from the perspective of the users of this service; the health care practitioners providing this service, and the National Health Service. Principal research questions:
1. What is the extra proportion of patients who will be defined as being at higher risk of CHD and who would benefit from intensive lifestyle advice and medications, when systematically collected family history is incorporated into CHD risk assessment?
2. Will changes in self-reported behaviour, anxiety and social/contextual experience be different in those whose CHD risk assessment is assessed using standard risk assessment complemented with systematic collection of family history compared with those whose risk is assessed using standard CHD risk assessment alone?
3. What is the cost-effectiveness of systematic family history collection as part of CHD risk assessment?
Study hypotheses:
1. The increase in the number of patients defined as being at high risk of CHD by inclusion of systematic family history collection will identify a cost-effective approach to target limited primary care CHD prevention resources.
2. Patients in whom family history is systematically collected will be more likely to change their behaviour than those who do not have this information collected.
To evaluate these hypotheses, the project will include:
1. An exploratory randomised study (including validated quantitative measures, qualitative semi-structured interviews and focus groups) to evaluate the impact of systematic family history recording on patients' and primary care professionals' experience, and
2. Develop an economic model of the costs and benefits of incorporating family history into CHD risk assessment.
Please note that as of 21/09/10 the start and end dates of this trial have been updated from 01/04/2006 and 01/12/2008 to 01/03/2007 and 02/04/2009 respectively.
Ethics approval
Ethics approval granted by Multi-centre Research Ethics Committee (MREC) for Scotland on 15/05/2006. REC reference number 06/MRE10/9
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
GP practices
Trial type
Prevention
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Coronary Heart Disease (CHD)
Intervention
A pragmatic exploratory cluster randomised controlled trial with a nested qualitative semi-structured interview and focus group study, in two centres (Nottingham and Exeter). 1400 patients will be invited to participate. Estimate 1000 will complete CHD risk assessment and 600 complete the final postal survey at 6 months, 300 in each arm of the study.
For the cluster RCT, pairs of practices will be matched according to deprivation and ethnic minority population. One practice within each pair will be randomly allocated to either the family history arm of the study or standard CHD risk assessment arm.
Participants in the intervention arm of the RCT will receive standard CHD risk assessment complemented by systematic collection of family history, whilst participants in the control arm will only receive standard CHD risk assessment (as recommended by Joint Cardiac Societies: JBS2).
All study participants receive a health heart advice leaflet with information on smoking, exercise and diet.
All study participants at "high" risk (i.e. 20% or more risk of CardioVascular Disease (CVD) over the next 10 years) have a follow-up consultation with the nominated clinician at the surgery. In the consultation, patients have their CHD risk explained and given lifestyle advice and, when clinically indicated, statins will be offered. Patients in the intervention arm will also have the impact of premature CHD family history on the CVD risk score explained.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
The increase in the proportion of patients falling in the "high" risk group resulting from the inclusion of family history in the CHD risk assessment.
Secondary outcome measures
The secondary outcome measures given below will be compared between patients recruited to the intervention (family history) and control (standard assessment) arms of the study. Quantitative data will be taken at initial visit and by postal survey at 2 weeks and 6 months from all respondents. The principal measures include:
1. Proportion of people who have stopped smoking
2. Proportion of patients in action/maintenance exercise stage
3. Fat intake score measured using Dietary Instrument for Nutrition Education (DINE) questionnaire
4. Anxiety score measured using 6-item Spielberger State-Trait Anxiety Inventory (STAI)
5. Changes in short-term health status (SF-6D)
Overall trial start date
01/03/2007
Overall trial end date
02/04/2009
Reason abandoned
Eligibility
Participant inclusion criteria
Practices: To be within either Trent Primary Care Trusts (PCTs) in East Midlands or PCTs in Central Cornwall, Plymouth and Exeter
Participants: To be registered patients at the above practices and be between 30 and 65 years of age
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
1,400
Participant exclusion criteria
General Practices outside of these defined areas will be excluded
Participants exclusion criteria:
1. Patients noted to have a previous history of atherosclerotic disease (this includes CHD, CerebroVascular Accident [CVA] and peripheral vascular disease)
2. Previous history of diabetes mellitus
3. Patients already on statin therapy or other lipid lowering medication
4. Patients considered by the General Practitioners to be inappropriate to recruit due to psychosocial reasons
Recruitment start date
01/03/2007
Recruitment end date
02/04/2009
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Division of Primary Care
Derby
DE22 3DT
United Kingdom
Sponsor information
Organisation
University of Nottingham (UK)
Sponsor details
c/o Professor Paul Cartledge
Head of Research Grants and Contracts
University Park
Nottingham
NG7 2RD
United Kingdom
+44 (0)115 951 5679
paul.cartledge@nottingham.ac.uk
Sponsor type
University/education
Website
Funders
Funder type
Government
Funder name
Department of Health, the Research into Genetics Based Health Services programme (ref: HSR/36A) (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
1. 2009 study protocol in http://www.ncbi.nlm.nih.gov/pubmed/19821989
2. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/22351711
Publication citations
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Results
Qureshi N, Armstrong S, Dhiman P, Saukko P, Middlemass J, Evans PH, Kai J, , Effect of adding systematic family history enquiry to cardiovascular disease risk assessment in primary care: a matched-pair, cluster randomized trial., Ann. Intern. Med., 2012, 156, 4, 253-262, doi: 10.7326/0003-4819-156-4-201202210-00002.
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Qureshi N, Armstrong S, Saukko P, Sach T, Middlemass J, Evans PH, Kai J, Farrimond H, Humphries SE, Realising the potential of the family history in risk assessment and primary prevention of coronary heart disease in primary care: ADDFAM study protocol., BMC Health Serv Res, 2009, 9, 184, doi: 10.1186/1472-6963-9-184.