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imProving Outcomes after STroke clinical pilot trial protocol
- Source :
- International journal of stroke : official journal of the International Stroke Society. 5(1)
- Publication Year :
- 2010
-
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 ≥8) in patients with a recent stroke. Secondary end-points include reduced anxiety (HADS anxiety subscale score ≥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.
- Subjects :
- medicine.medical_specialty
Cost-Benefit Analysis
Pilot Projects
Suicide, Attempted
Anxiety
Social Environment
Health Services Accessibility
Quality of life
Clinical Protocols
Rating scale
Activities of Daily Living
medicine
Humans
Social Behavior
Stroke
Depression (differential diagnoses)
Depressive Disorder
business.industry
medicine.disease
Clinical trial
Mood
Neurology
Research Design
Relative risk
Physical therapy
Quality of Life
medicine.symptom
business
Subjects
Details
- ISSN :
- 17474949
- Volume :
- 5
- Issue :
- 1
- Database :
- OpenAIRE
- Journal :
- International journal of stroke : official journal of the International Stroke Society
- Accession number :
- edsair.doi.dedup.....b2a171459cf43fefff0a56bc5edbd726