TY  - JOUR
PY  - 2010//
TI  - imProving Outcomes after STroke clinical pilot trial protocol
JO  - International journal of stroke
A1  - Hackett, M. L.
A1  - Carter, G.
A1  - Crimmins, D.
A1  - Clarke, T.
A1  - Maddock, K.
A1  - Sturm, J. W.
SP  - 52
EP  - 56
VL  - 5
IS  - 1
N2  - RATIONALE: One in three patients experience depression after stroke and this risk is consistent over time. A strategy to prevent depression that could be economically delivered to most stroke patients and ideally which also has a low likelihood of adverse events needs to be developed and evaluated. Aims POST aims to determine whether a simple intervention (postcards) prevents depression (Hospital Anxiety and Depression rating Scale, HADS depression subscale score > or =8) in patients with a recent stroke. Secondary end-points include reduced anxiety (HADS anxiety subscale score > or =8) and improved health-related quality of life in patients with a recent stroke.  DESIGN: A single-centre randomised, double-blind, pilot trial to prevent depression in patients with a recent (within 8 weeks) stroke presenting to hospital. Patients will be enrolled over 12 months and randomised to receive three trial-specific assessments (baseline, 3- and 6-month assessments of mood, HRQoL and social functioning), or three trial-specific assessments plus a postcard sent centrally in a sealed envelope at 1, 2, 3, 4 and 5 months after discharge from hospital. Blinded follow-up telephone assessments will be conducted for both groups. STUDY OUTCOMES AND SAMPLE SIZE: For the primary end-point the POST trial will have 80% power to detect a relative risk of 0.4 given an incidence of depression of 30%. For the secondary aims POST has 90% power to detect a difference of 3 points on the HADS depression subscale (assuming a standard deviation of 6 points) between randomised groups. This includes an inflation factor of 15% to account for patients lost to follow-up.  DISCUSSION: Evidence of efficacy will determine whether a multi-centre, international trial is warranted.<p /> <p>Language: en</p>
LA  - en
SN  - 1747-4930
UR  - http://dx.doi.org/10.1111/j.1747-4949.2009.00388.x
ID  - ref1
ER  -