Please use this identifier to cite or link to this item: https://hdl.handle.net/1/1303
Title: imProving Outcomes after STroke clinical pilot trial protocol
Authors: Sturm, Jonathan ;Crimmins, Denis ;Hackett, M.L.;Carter, G.;Clarke, T.;Maddock, K.
Issue Date: Feb-2010
Source: Volume 5, Issue 1, pp. 52 - 56
Journal title: International Journal of Stroke
Abstract: 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.
URI: https://elibrary.cclhd.health.nsw.gov.au/cclhdjspui/handle/1/1303
DOI: 10.1111/j.1747-4949.2009.00388.x
Pubmed: https://www.ncbi.nlm.nih.gov/pubmed/20088995
ISSN: 1747-4949
Publicaton type: Journal Article
Keywords: Neurology
Stroke
Study or Trial: Randomized Controlled Clinical Trial/Controlled Clinical Trial
Appears in Collections:Neurology

Show full item record

Page view(s)

12
checked on Feb 1, 2023

Google ScholarTM

Check

Altmetric


Items in DSpace are protected by copyright, with all rights reserved, unless otherwise indicated.