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 |
| Secondary identifying numbers | HSR/36A |
- 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
Scientific
Division of Primary Care
The University of Nottingham
Graduate Medical School
Derby City General Hospital
Uttoxeter Road
Derby
DE22 3DT
United Kingdom
| Phone | +44 (0)1332 724677 |
|---|---|
| nadeem.qureshi@nottingham.ac.uk |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | GP practice |
| Study type | Prevention |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | The ADDFAM study: Realising the potential of the family history in risk assessment and primary prevention of Coronary Heart Disease (CHD) in primary care |
| Study acronym | ADDFAM - Added Value of ADDing FAMily history to CVD risk calculations |
| Study objectives | 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(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) studied | 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 |
| Primary outcome measure | 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 study start date | 01/03/2007 |
| Completion date | 02/04/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 1,400 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/03/2007 |
| Date of final enrolment | 02/04/2009 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Division of Primary Care
Derby
DE22 3DT
United Kingdom
DE22 3DT
United Kingdom
Sponsor information
University of Nottingham (UK)
University/education
University/education
c/o Professor Paul Cartledge
Head of Research Grants and Contracts
University Park
Nottingham
NG7 2RD
England
United Kingdom
| Phone | +44 (0)115 951 5679 |
|---|---|
| paul.cartledge@nottingham.ac.uk | |
| Website | http://www.nottingham.ac.uk |
"ROR" |
https://ror.org/01ee9ar58 |
Funders
Funder type
Government
Department of Health, the Research into Genetics Based Health Services programme (ref: HSR/36A) (UK)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | study protocol | 12/10/2009 | Yes | No | |
| Results article | results | 21/02/2012 | Yes | No |
Editorial Notes
16/01/2018: internal review.
