imProving Outcomes after STroke clinical pilot trial protocol.
BACKGROUND
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.


METHODS
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.


CONCLUSIONS
Evidence of efficacy will determine whether a multi-centre, international trial is warranted.
Hackett
M L
ML
Neurological and Mental Health Division, The George Institute for International Health, The University of Sydney and Royal Prince Alfred Hospital, Camperdown, Sydney, NSW 2050, Australia. mhackett@george.org.au
Carter
G
G
Crimmins
D
D
Clarke
T
T
Maddock
K
K
Sturm
J W
JW
D000203:Activities of Daily Living; D001007:Anxiety / Q000453:epidemiology / Q000209:etiology / Q000628:therapy; D002985:Clinical Protocols; D003362:Cost-Benefit Analysis; D003866:Depressive Disorder / Q000209:etiology / Q000523:psychology* / Q000628:therapy*; D006297:Health Services Accessibility; D006801:Humans; D010865:Pilot Projects; D011788:Quality of Life; D012107:Research Design; D012919:Social Behavior; D012931:Social Environment; D020521:Stroke / Q000150:complications / Q000523:psychology* / Q000628:therapy*; D013406:Suicide, Attempted / Q000706:statistics & numerical data