Contributions
Abstract: EP1572
Type: ePoster
Abstract Category: Therapy - symptomatic - Quality of life
Background: Stressful life events can worsen the disease for patients with multiple sclerosis (MS) and are claimed to provoke relapses in patients with relapsing-remitting (RR) disease (Mohr et al., 2012). Biosync Technology AB has developed a technological solution for a wearable device tailored for stress measurement in MS-patients. The biofeedback tool for stress measurement consists of a wristband with biosensors, a mobile application for data visualization and an integrated stress-management solution. The idea behind this biofeedback tool is to increase awareness and improve handling of stress.
Goal: To investigate the improvement of quality of life and clinical well-being in RRMS-patients using a wearable device with biofeedback for stress.
Methods: A randomized, multi-center, open-label, observational study with RRMS-patients in Sweden. 30 MS-patients on first-line treatment are provided with a wristband with biosensing abilities. Those 30 MS-patients are compared with 30 MS-patients on first-line treatment who do not use a wristband during the study period. Patients with an Expanded Disease Severity Score between 0 to 5.5, aged 18 to 55 years are included in the study. The effect of the wristband will be investigated as an add-on to a first-line treatment. All study subjects are followed for at least 24 weeks. Included patients should have been on first-line treatment for at least six months and a baseline MRI for the treatment according to the usual clinical procedure should have been performed prior to study entry. Last patient in to the study will be last of June 2016. Database closure is expected to be 31st of December 2016.
Results: Descriptive summary statistics and frequency counts of demographics and baseline data will be included in the final presentation. Sample size calculation require a total of 60 patients for 80% power and 5% significance level and a drop-out rate of 5%. The primary objective is to determine the effect of wristband-usage and the use of the application for stress-feedback during the study-period of 24 weeks on the patients´ quality of life, measured by MS Impact Scale.
Conclusion: Based on previous studies, we would expect an improvement in quality of life in the wristband-using group. If beneficial results can be found, this biofeedback tool could be considered as an add-on to first-line treatment monitoring stress and improving quality of life.
Disclosure: Katharina Fink: Has received an unrestricted academic research grant from Biogen and compensations for lectures from Biogen, Teva and Novartis which have been exclusively used to support research activities.
Ulf Kläppe: Nothing to disclose.
Sebastian Lindblom: Nothing to disclose.
Abstract: EP1572
Type: ePoster
Abstract Category: Therapy - symptomatic - Quality of life
Background: Stressful life events can worsen the disease for patients with multiple sclerosis (MS) and are claimed to provoke relapses in patients with relapsing-remitting (RR) disease (Mohr et al., 2012). Biosync Technology AB has developed a technological solution for a wearable device tailored for stress measurement in MS-patients. The biofeedback tool for stress measurement consists of a wristband with biosensors, a mobile application for data visualization and an integrated stress-management solution. The idea behind this biofeedback tool is to increase awareness and improve handling of stress.
Goal: To investigate the improvement of quality of life and clinical well-being in RRMS-patients using a wearable device with biofeedback for stress.
Methods: A randomized, multi-center, open-label, observational study with RRMS-patients in Sweden. 30 MS-patients on first-line treatment are provided with a wristband with biosensing abilities. Those 30 MS-patients are compared with 30 MS-patients on first-line treatment who do not use a wristband during the study period. Patients with an Expanded Disease Severity Score between 0 to 5.5, aged 18 to 55 years are included in the study. The effect of the wristband will be investigated as an add-on to a first-line treatment. All study subjects are followed for at least 24 weeks. Included patients should have been on first-line treatment for at least six months and a baseline MRI for the treatment according to the usual clinical procedure should have been performed prior to study entry. Last patient in to the study will be last of June 2016. Database closure is expected to be 31st of December 2016.
Results: Descriptive summary statistics and frequency counts of demographics and baseline data will be included in the final presentation. Sample size calculation require a total of 60 patients for 80% power and 5% significance level and a drop-out rate of 5%. The primary objective is to determine the effect of wristband-usage and the use of the application for stress-feedback during the study-period of 24 weeks on the patients´ quality of life, measured by MS Impact Scale.
Conclusion: Based on previous studies, we would expect an improvement in quality of life in the wristband-using group. If beneficial results can be found, this biofeedback tool could be considered as an add-on to first-line treatment monitoring stress and improving quality of life.
Disclosure: Katharina Fink: Has received an unrestricted academic research grant from Biogen and compensations for lectures from Biogen, Teva and Novartis which have been exclusively used to support research activities.
Ulf Kläppe: Nothing to disclose.
Sebastian Lindblom: Nothing to disclose.