Heller 1993.
Study characteristics | ||
Methods |
Study design: cluster‐randomised multicentre RCT Country: Australia Dates participants recruited: 18 September 1990 to 5 December 1991 Maximum follow‐up: 6 months |
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Participants |
Inclusion criteria: < 70 years with a suspected heart attack registered by the Newcastle collaborating centre of the WHO MONICA Project and discharged alive from hospital Exclusion criteria: renal failure or other special dietary requirements and those considered by their physicians to have 'endstage' heart disease N randomised: total: 450; intervention: 213; comparator: 237 Diagnosis (% of participants): MI: 100% Age (mean ± SD): intervention: 59 ± 8; comparator: 58 ± 8 Percentage male: 71% Ethnicity: NR |
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Interventions |
Intervention: a mail‐out programme designed to help participants reduce dietary fat, obtain regular exercise by walking and to quit smoking.
Components: exercise plus education Setting: home Exercise programme modality: walking Length of session: NR Frequency: NR Intensity: NR Resistance training included? NR Total duration: 6 months. Co‐interventions: supplementary telephone contact was also used and a letter was sent to the family doctor regarding the benefit of aspirin and β blockers for secondary prevention. Comparator: usual care Co‐interventions: none described |
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Outcomes | Total mortality, HRQL Study outcomes assessed at 6 months |
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Source of funding | National Health and Medical Research Council of Australia | |
Conflicts of interest | NR | |
Notes | Low use of preventative services (dietary, anti smoking) by both groups 10% of participants received CR ‐ mostly having had CABG | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Cluster‐randomisation by GP. "All general practices were randomly allocated to intervention or usual care within those strata." Method of randomisation not described. |
Allocation concealment (selection bias) | Unclear risk | Not reported |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Blinding not described |
Incomplete outcome data (attrition bias) All outcomes | High risk | 17% lost to follow‐up; no description of withdrawals or dropouts |
Selective reporting (reporting bias) | Low risk | All outcomes reported at all time points. |