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The SPHERE Study. Secondary prevention of heart disease in general practice: a randomised controlled trial of tailored practice and patient care plans with parallel qualitative, economic and policy analyses

The SPHERE Study. Secondary prevention of heart disease in general practice: a randomised controlled trial of tailored practice and patient care plans with parallel qualitative, economic and policy analyses

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN24081411
Enrollment
960
Registered
2005-02-28
Start date
2003-01-01
Completion date
Unknown
Last updated
2018-02-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Heart Disease (CHD) Circulatory System Chronic ischaemic heart disease

Interventions

INTERVENTION PRACTICES Level 1: Tailored practice care plans. 1. Training for practice staff. Training will be delivered independently in each of the three regional study centres. All trainers will

Sponsors

Health Research Board (Ireland)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Patients with existing cardiovascular disease (defined as: documented myocardial infarction [MI], coronary artery bypass graft [CABG] or angioplasty, or a diagnosis of angina ? confirmed by exercise stress test, isotope test or coronary angiogram)

Exclusion criteria

Exclusion criteria: Patients with significant mental or physical illness (based on the recorded judgement of practice staff), which is likely to impair capacity to change lifestyle behaviour or assimilate new information

Design outcomes

Primary

MeasureTime frame
1. Blood pressure 2. Total cholesterol 3. Physical and mental health status: measured by the SF-12 4. Hospital readmissions

Secondary

MeasureTime frame
1. Process of care: 1.1. SPHERE visits 1.2. Total number of GP visits 1.3. Total number of hospital OPD visits 1.4 Recording of risk factors in GP records 2. Body Mass Index/Waist-Hip Ratio 3. Exercise: measured by Godin Leisure-Time Exercise Questionnaire 4. Smoking status 5. Diet: measured by Dietary Instrument for Nutrition Education (DINE), including question regarding portions of fresh fruit and vegetables 6. Adherence to medication: measured by MARS-5 (Medication Adherence Report Scale)

Countries

Ireland

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Apr 2, 2026