Contributions
Abstract: P826
Type: Poster
Abstract Category: Therapy - symptomatic - 34 Quality of life
Introduction: RebiQoL is a phase IV multicenter randomized study to assess the impact of a telemedicine patient support program (Min Support Plus, MSP) on health-related quality of life (HRQoL) through intervention of life style factors (e.g. stress management and physical activity) in patients with relapsing-remitting MS (RRMS) being administered with Rebif® with the RebiSmart device.
Objectives: The primary endpoint was to assess the impact of MSP compared to patients only receiving technical support for RebiSmart on HRQoL at 12 months, using the psychological scale of Multiple Sclerosis Impact Scale (MSIS-29), in patients administered with Rebif.
The secondary endpoints were to assess the impact of MSP on HRQoL, (MSIS-29, EuroQoL-5 Dimension Questionnaire (EQ5D)), fatigue (Fatigue severity scale (FSS)), Modified Fatigue Impact Scale (MFIS), depression and anxiety (Hospital Anxiety and Depression Scale (HADS)), at 6 and 12 months. Impact regarding adverse events, patient satisfaction and lifestyle goals were assessed, at 12 months and the adherence was measured at 6 and 12 months.
The potential impact of gender, education and disability level as measured by Expanded Disability Status Scale (EDSS) > 4.0 vs. < 4.0 and HRQoL at baseline, were also evaluated.
Methods and patients: The telemedicine intervention consisted of 13 calls related to MSP including lifestyle interventions. A total of 97 patients diagnosed with RRMS were screened for participation in the study of which 3 patients did not fulfill the eligibility criteria and 1 patient withdrew consent. Of the 93 randomized patients, 46 were randomized to MSP and 47 to Technical support only.
Results: The demographic characteristics of the patients were well-balanced in the two arms. There were no statistical differences (linear mixed model) in any of the primary (p=0.91) or secondary outcomes.
Although the study was slightly underpowered, there was a trend towards better adherence in the MSP group. (p=0,08). No unexpected adverse events occurred.
Conclusion: This study did not show a statistical significant effect of teleintervention on HRQoL as compared to traditional hospital based health care.
Disclosure: AM Landtblom has received honoraria fromTeva, Biogen, Sanofi Genzyme, and the present study for Merck.
Sten Fredrikson has received honoraria from Bayer, Biogen, Genzyme, Merck, Novartis, Sanofi and Teva.
Claes Martin has received honoraria from Bayer, Biogen, Genzyme, Merck, Novartis, Sanofi and Teva.
Stefan Hau has received honoraria from Merck.
Dimitri Guala is working at Merck.
Lillemor Jansson has no disclosures.
Abstract: P826
Type: Poster
Abstract Category: Therapy - symptomatic - 34 Quality of life
Introduction: RebiQoL is a phase IV multicenter randomized study to assess the impact of a telemedicine patient support program (Min Support Plus, MSP) on health-related quality of life (HRQoL) through intervention of life style factors (e.g. stress management and physical activity) in patients with relapsing-remitting MS (RRMS) being administered with Rebif® with the RebiSmart device.
Objectives: The primary endpoint was to assess the impact of MSP compared to patients only receiving technical support for RebiSmart on HRQoL at 12 months, using the psychological scale of Multiple Sclerosis Impact Scale (MSIS-29), in patients administered with Rebif.
The secondary endpoints were to assess the impact of MSP on HRQoL, (MSIS-29, EuroQoL-5 Dimension Questionnaire (EQ5D)), fatigue (Fatigue severity scale (FSS)), Modified Fatigue Impact Scale (MFIS), depression and anxiety (Hospital Anxiety and Depression Scale (HADS)), at 6 and 12 months. Impact regarding adverse events, patient satisfaction and lifestyle goals were assessed, at 12 months and the adherence was measured at 6 and 12 months.
The potential impact of gender, education and disability level as measured by Expanded Disability Status Scale (EDSS) > 4.0 vs. < 4.0 and HRQoL at baseline, were also evaluated.
Methods and patients: The telemedicine intervention consisted of 13 calls related to MSP including lifestyle interventions. A total of 97 patients diagnosed with RRMS were screened for participation in the study of which 3 patients did not fulfill the eligibility criteria and 1 patient withdrew consent. Of the 93 randomized patients, 46 were randomized to MSP and 47 to Technical support only.
Results: The demographic characteristics of the patients were well-balanced in the two arms. There were no statistical differences (linear mixed model) in any of the primary (p=0.91) or secondary outcomes.
Although the study was slightly underpowered, there was a trend towards better adherence in the MSP group. (p=0,08). No unexpected adverse events occurred.
Conclusion: This study did not show a statistical significant effect of teleintervention on HRQoL as compared to traditional hospital based health care.
Disclosure: AM Landtblom has received honoraria fromTeva, Biogen, Sanofi Genzyme, and the present study for Merck.
Sten Fredrikson has received honoraria from Bayer, Biogen, Genzyme, Merck, Novartis, Sanofi and Teva.
Claes Martin has received honoraria from Bayer, Biogen, Genzyme, Merck, Novartis, Sanofi and Teva.
Stefan Hau has received honoraria from Merck.
Dimitri Guala is working at Merck.
Lillemor Jansson has no disclosures.