The ADDFAM study: Realising the potential of the family history in risk assessment and primary prevention of Coronary Heart Disease (CHD) in primary care

ISRCTN ISRCTN17943542
DOI https://doi.org/10.1186/ISRCTN17943542
Protocol serial number HSR/36A
Sponsor University of Nottingham (UK)
Funder Department of Health, the “Research into Genetics Based Health Services” programme (ref: HSR/36A) (UK)
Submission date
21/08/2007
Registration date
08/10/2007
Last edited
16/01/2018
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Nadeem Qureshi
Scientific

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

Study information

Primary study designInterventional
Study designRandomised controlled trial
Secondary study designRandomised controlled trial
Study type Participant information sheet
Scientific titleThe ADDFAM study: Realising the potential of the family history in risk assessment and primary prevention of Coronary Heart Disease (CHD) in primary care
Study acronymADDFAM - Added Value of ADDing FAMily history to CVD risk calculations
Study objectivesThe 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(s)Ethics approval granted by Multi-centre Research Ethics Committee (MREC) for Scotland on 15/05/2006. REC reference number 06/MRE10/9
Health condition(s) or problem(s) studiedCoronary Heart Disease (CHD)
InterventionA 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 typeOther
Primary outcome measure(s)

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.

Key secondary outcome measure(s)

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)

Completion date02/04/2009

Eligibility

Participant type(s)Patient
Age groupAdult
SexAll
Target sample size at registration1400
Key inclusion criteriaPractices: 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
Key exclusion criteriaGeneral 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
Date of first enrolment01/03/2007
Date of final enrolment02/04/2009

Locations

Countries of recruitment

  • United Kingdom
  • England

Study participating centre

Division of Primary Care
Derby
DE22 3DT
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 21/02/2012 Yes No
Protocol article study protocol 12/10/2009 Yes No
Participant information sheet Participant information sheet 11/11/2025 11/11/2025 No Yes
Study website Study website 11/11/2025 11/11/2025 No Yes

Editorial Notes

16/01/2018: internal review.

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