Intensified secondary prevention intending a reduction of recurrent events in TIA and minor stroke patients (INSPiRE-TMS): a protocol for a randomised controlled trial

Abstract

BackgroundPatients with recent stroke or TIA are at high risk for new vascular events. Several evidence based strategies in secondary prevention of stroke are available but frequently underused. Support programs with multifactorial risk factor modifications after stroke or TIA have not been investigated in large-scale prospective controlled trials so far. INSPiRE-TMS is a prospective, multi-center, randomized open intervention trial for intensified secondary prevention after minor stroke and TIA.Methods/designPatients with acute TIA or minor stroke admitted to the participating stroke centers are screened and recruited during in-hospital stay. Patients are randomised in a 1:1 ratio to intervention (support program) and control (usual care) arms. Inclusion of 2.082 patients is planned. The support program includes cardiovascular risk factor measurement and feedback, monitoring of medication adherence, coaching in lifestyle modifications, and active involvement of relatives. Standardized motivational interviewing is used to assess and enhance patients’ motivation. Primary objective is a reduction of new major vascular events defined as nonfatal stroke and myocardial infarction or vascular death. Recruitment time is planned for 3.5 years, follow up time is at least 2 years for every patient resulting in a total study time of 5 years (first patient in to last patient out).DiscussionGiven the high risk for vascular re-events in acute stroke and the available effective strategies in secondary prevention, the INSPIRE-TMS support program has the potential to lead to a relevant reduction of recurrent events and a prolongation of the event-free survival time. The trial will provide the basis for the decision whether an intensified secondary prevention program after stroke should be implemented into regular care. A cost-effectiveness evaluation will be performed.Trial registrationclinicaltrials.gov: 01586702

Effectiveness of Goal-Setting Telephone Follow-Up on Health Behaviors of Patients with Ischemic Stroke: A Randomized Controlled Trial

“…2 Patients who have suffered a stroke are at high risk for stroke recurrence. 3 Recurrence risk is also higher in China; the stroke recurrence rate was 8% at 1 year in both South Carolina and South London 4,5 compared to 13.4%-18.4% in China. 6,7 Guidelines 8,9 for secondary prevention of stroke have been published.…”

“…12 Second, the separation of health systems into hospital-based and community care in China is a major barrier to optimal secondary prevention as recommendations provided in hospitals are frequently not adhered to by community physicians, a situation similar to that in Germany. 3 Third, in our experience, many stroke patients do not visit outpatient clinics for long-term secondary prevention programs. Moreover, a long-term secondary prevention program alone, consisting of regular followup visits, was not sufficient to reach guidelinerecommended treatment targets in most of our ischemic stroke patients, a situation similar to that in The Netherlands.…”

“…14 In fact, stroke knowledge is positively related to healthy behaviors. [15][16][17] Previous studies have demonstrated that many stroke patients do not follow the recommended measures over the long-term 3 and exhibit suboptimal health behaviors, including inadequate physical activity, poor diet, alcohol consumption, and smoking. [16][17][18] Additionally, one third of stroke patients discontinue medications prescribed for secondary prevention.…”

The effectiveness of a comprehensive reminder system in the secondary prevention of hypertensive ischaemic stroke: randomized controlled trial protocol

“…World‐wide patients who have experienced recent strokes are at high risk for stroke recurrence (Leistner et al . ). Recurrent stroke is a major cause of morbidity and mortality among stroke survivors (Feng et al .…”

“…Recommendations included in discharge letters generally focus on medical treatments rather than lifestyle modifications (Leistner et al . ). The separation of health systems in hospital‐based and community care as in China is a major barrier for optimal secondary prevention, as recommendations provided in hospitals are frequently not adhered to by community physicians.…”