Coronary Heart Disease (CHD) Circulatory System Heart Disease
Conditions
Interventions
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 inv
Sponsors
University of Nottingham (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
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;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
Exclusion criteria
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;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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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.;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
| Measure | Time frame |
|---|---|
| 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);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) | — |
Countries
United Kingdom
Contacts
Public Contact; ;
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Outcome results
None listed