Utilize este identificador para referenciar este registo: https://hdl.handle.net/1822/70125

TítuloStudy adherence in a tDCS longitudinal clinical trial with people with spinal cord injury
Autor(es)Carvalho, Sandra
Leite, Jorge
Jones, Felipe
Morse, Leslie R.
Zafonte, Ross
Fregni, Felipe
Data2018
EditoraNature Publishing Group
RevistaSpinal Cord
CitaçãoCarvalho, S., Leite, J., Jones, F. et al. Study adherence in a tDCS longitudinal clinical trial with people with spinal cord injury. Spinal Cord 56, 502–508 (2018). https://doi.org/10.1038/s41393-017-0023-5
Resumo(s)Study design Secondary analysis of a clinical trial.Objectives To analyze adherence to 1-year transcranial Direct Current Stimulation (tDCS) clinical trial in people with chronic pain due to spinal cord injury (SCI). We also explore the association between dropout and several baseline variables such as age, depression levels, pain severity, number of days with pain in the last 7 days, walking ability, sleep, work, relationship with others, and enjoyment with life.Setting Boston, USA.Methods Forty-six participants were enrolled in this trial, and 33 participants were randomized to receive either active or sham tDCS.Results Using the full intention-to-treat (ITT) criteria, only 8 participants (24%) finished the study. The median time to dropout was seven (IQR:6,19) sessions (i.e., immediately after the first follow-up), regardless of the type of stimulation that participants received (active vs. sham tDCS) (chi(2) = 0.025, p = 0.875). An exploratory analysis suggested that only the number of days with pain in the last 7 days was moderately associated with dropout, with people experiencing less pain being more prone to dropout from the study.Conclusions Despite all the measures to improve study adherence (such as providing parking, flexibility to schedule sessions, follow-up with participants by phone), it seems that long follow-up periods may increase the likelihood of dropout. Given the need to understand long-term effects of interventions, longitudinal trials need to consider alternative designs or methods of treatment (for instance home treatment or home assessment) to decrease attrition rate.
TipoArtigo
URIhttps://hdl.handle.net/1822/70125
DOI10.1038/s41393-017-0023-5
ISSN1362-4393
Versão da editorahttps://www.nature.com/articles/s41393-017-0023-5
Arbitragem científicayes
AcessoAcesso aberto
Aparece nas coleções:CIPsi - Artigos (Papers)

Ficheiros deste registo:
Ficheiro Descrição TamanhoFormato 
Carvalho et al 2018_Spinal Cord Journal .pdf536,5 kBAdobe PDFVer/Abrir

Partilhe no FacebookPartilhe no TwitterPartilhe no DeliciousPartilhe no LinkedInPartilhe no DiggAdicionar ao Google BookmarksPartilhe no MySpacePartilhe no Orkut
Exporte no formato BibTex mendeley Exporte no formato Endnote Adicione ao seu ORCID