Jeannette M Gelauff1, Judith G M Rosmalen1, Alan Carson1, Joke M Dijk1, Martijn Ekkel1, Glenn Nielsen1, Jon Stone1, Marina A J Tijssen2. 1. From the Departments of Neurology (J.M.G., M.E., M.A.J.T.), Psychiatry (J.G.M.R.), and Internal Medicine (J.G.M.R.), University Medical Center Groningen, University of Groningen, the Netherlands; Centre for Clinical Brain Sciences (A.C., J.S.), University of Edinburgh, UK; Department of Neurology (J.M.D.), University of Amsterdam, Amsterdam University Medical Center, the Netherlands; and Neurosciences Research Centre (G.N.), Molecular and Clinical Sciences Research Institute, St George's University of London, UK. 2. From the Departments of Neurology (J.M.G., M.E., M.A.J.T.), Psychiatry (J.G.M.R.), and Internal Medicine (J.G.M.R.), University Medical Center Groningen, University of Groningen, the Netherlands; Centre for Clinical Brain Sciences (A.C., J.S.), University of Edinburgh, UK; Department of Neurology (J.M.D.), University of Amsterdam, Amsterdam University Medical Center, the Netherlands; and Neurosciences Research Centre (G.N.), Molecular and Clinical Sciences Research Institute, St George's University of London, UK. m.a.j.de.koning-tijssen@umcg.nl.
Abstract
OBJECTIVE: To determine whether self-rated health of patients with motor functional neurologic disorder (FND) can be improved by unguided Internet-based self-help and education. METHODS: In this nonblinded randomized controlled trial, patients were allocated 1:1 unbiased to an unguided education and self-help website in addition to usual care or usual care only. Patients over 17 years of age with a functional motor symptom that caused distress or disability were included. The primary outcome was self-rated health on the Clinical Global Improvement scale at 3 and 6 months. Secondary outcomes were severity of motor symptoms, other physical and psychiatric symptoms, physical functioning, quality of life, work and social adjustment, illness beliefs, and satisfaction with care. RESULTS:A total of 186 patients were randomized, with a follow-up rate of 87% at 6 months. There was no difference in improvement of self-rated health at 3 months (44% vs 40%, p = 0.899) or 6 months (42% vs 43%, p = 0.435). Secondary outcomes did not differ between groups, with a threshold of p < 0.01. Satisfaction was high, with 86% of patients recommending the website to other patients. CONCLUSION: We found no significant effect of the intervention added to usual care on self-rated health or secondary outcome measures, despite high patient satisfaction with the intervention. These results suggest that online education and nonguided self-help could be valuable additions to stepped care for motor FND, but are not effective treatments as interventions in their own right. CLINICALTRIALSGOV IDENTIFIER: NCT02589886. CLASSIFICATION OF EVIDENCE: This study provides Class III evidence that for patients with motor FND, online education and self-help intervention does not significantly improve self-rated health.
RCT Entities:
OBJECTIVE: To determine whether self-rated health of patients with motor functional neurologic disorder (FND) can be improved by unguided Internet-based self-help and education. METHODS: In this nonblinded randomized controlled trial, patients were allocated 1:1 unbiased to an unguided education and self-help website in addition to usual care or usual care only. Patients over 17 years of age with a functional motor symptom that caused distress or disability were included. The primary outcome was self-rated health on the Clinical Global Improvement scale at 3 and 6 months. Secondary outcomes were severity of motor symptoms, other physical and psychiatric symptoms, physical functioning, quality of life, work and social adjustment, illness beliefs, and satisfaction with care. RESULTS: A total of 186 patients were randomized, with a follow-up rate of 87% at 6 months. There was no difference in improvement of self-rated health at 3 months (44% vs 40%, p = 0.899) or 6 months (42% vs 43%, p = 0.435). Secondary outcomes did not differ between groups, with a threshold of p < 0.01. Satisfaction was high, with 86% of patients recommending the website to other patients. CONCLUSION: We found no significant effect of the intervention added to usual care on self-rated health or secondary outcome measures, despite high patient satisfaction with the intervention. These results suggest that online education and nonguided self-help could be valuable additions to stepped care for motor FND, but are not effective treatments as interventions in their own right. CLINICALTRIALSGOV IDENTIFIER: NCT02589886. CLASSIFICATION OF EVIDENCE: This study provides Class III evidence that for patients with motor FND, online education and self-help intervention does not significantly improve self-rated health.
Authors: Karina Bennett; Clare Diamond; Ingrid Hoeritzauer; Paula Gardiner; Laura McWhirter; Alan Carson; Jon Stone Journal: Clin Med (Lond) Date: 2021-01 Impact factor: 2.659
Authors: Mark Hallett; Selma Aybek; Barbara A Dworetzky; Laura McWhirter; Jeffrey P Staab; Jon Stone Journal: Lancet Neurol Date: 2022-04-14 Impact factor: 59.935