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23 May 2012
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Development of a Nutrition Assessment Tool for Stroke – NATS Study
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| ISRCTN | ISRCTN71032732 |
| ClinicalTrials.gov identifier | |
| Public title |
Development of a Nutrition Assessment Tool for Stroke – NATS Study
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| Scientific title | Identification of factors affecting poor nutrition following acute stroke and the development of a nutrition assessment tool for stroke - NATS Study |
| Acronym | NATS Study |
| Serial number at source | N/A |
| Study hypothesis | To identify which independent variables at what weighting and in what combination predict future nutrition status (dependent or outcome variable) in patients who have suffered an acute stroke, and have subsequently been transferred to a stroke rehabilitation ward. |
| Lay summary | Lay summary under review |
| Ethics approval | NRES Committee West Midlands - Solihull approved on 17th May 2010, Reference number: 10/H1206/23, (AM03/1 Modified) |
| Study design | Prospective longitudinal study |
| Countries of recruitment | United Kingdom |
| Disease/condition/study domain | Stroke |
| Participants - inclusion criteria |
1. Informed consent
2. Patient has a new acute stroke, is now medically stable, and has been admitted to Feldon Stroke Unit for inpatient rehabilitation 3. Sufficient English comprehension |
| Participants - exclusion criteria |
1. Lacks capacity to consent to participation in study
2. Under 18 years of age 3. Medically unstable 4. Patient Nil by Mouth 5. Patient has percutaneous endoscopic gastrostomy (PEG) prior to admission to Feldon Stroke Unit 6. Severe communication difficulties 7. Decline to participate |
| Anticipated start date | 21/06/2011 |
| Anticipated end date | 21/09/2013 |
| Status of trial | Ongoing |
| Patient information material | Not available in web format, please use the contact details below to request a patient information sheet |
| Target number of participants | 79 |
| Interventions |
In this study four widely accepted measures of nutritional status measures will be used:
1. Weight / weight change 2. Body mass index (BMI) 3. Triceps skinfold thickness (TST) 4. Mid upper-arm circumference (MUAC) Using these outcome measures the main research question is, which of the following independent variables, with what weight and combination predict poor nutritional status: 1. Age 2. Sex 3. Diagnosis (type of stroke) 4. Side of lesion 5. Handedness 6. Hemiplegia (paralysis right/left) 7. Affected side (dominant or non-dominant) 8. Hemianopia (visual field defect present) 9. Number of previous strokes 10. Pre-stroke weight loss 11. Smoking (current smoker i.e. when acute stroke occurred) 12. Dysphagia (swallowing difficulty) 13. Receptive dysphasia (difficulty with understanding speech) 14. Expressive dysphasia (difficulty with producing speech) 15. Oral health 16. Neglect of one side when eating meals 17. Oobserved to require verbal or physical prompts to eat 18. Perceived depression 19. Perceived anxiety 20. Perceived taste 21. Perceived smell 22. Perceived nausea 23. Perceived pain 24. Perceived fatigue 25. Perceived appetite 26. Perceived thirst 27. Reduced decisional capacity Based on the statistical analysis of this data, a second phase of the study will involve the development of a stroke specific screening tool, suitable for use in everyday clinical practice and evidence based. |
| Primary outcome measure(s) |
Weight / weight change measures are done following admission at:
Week 1-2 Week 5-6 Week 9-10 Week 38-40 |
| Secondary outcome measure(s) |
1. BMI
2. Triceps skinfold thickness 3. Mid upper-arm circumference Measures are done following admission at: Week 1-2 Week 5-6 Week 9-10 Week 38-40 |
| Sources of funding | Coventry & Warwickshire Cardiovascular Network (UK) |
| Trial website | |
| Publications | |
| Contact name | Mr Michael Church |
| Address |
Royal Leamington Spa Rehabilitation Hospital
Heathcote Lane |
| City/town | Warwick |
| Zip/Postcode | CV34 6SR |
| Country | United Kingdom |
| Tel | +44(0)192 631 7700 |
| michael.church@warkpct.nhs.uk | |
| Sponsor | NHS Warwickshire (UK) |
| Address |
c/o Dr. Mike Graveney
Westgate House 21 Market Street |
| City/town | Warwick |
| Zip/Postcode | CV34 4DE |
| Country | United Kingdom |
| Date applied | 21/09/2011 |
| Last edited | 18/11/2011 |
| Date ISRCTN assigned | 18/11/2011 |
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