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A 6 months prospective, randomized, multicenter, controlled, parallel-group, open-label study in RRMS patients to assess the impact of an individualized patient support program (PSP) on treatment satisfaction and to evaluate whether this individualized support improves satisfaction and with it adherence to medication compared to standard care.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 standard care | Other | standard care |
|
| 2 individualized PSP | Experimental | individualized patient support program |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| individualized patient support program | Other | individualized patient support with compliance supporting tools |
|
| Measure | Description | Time Frame |
|---|---|---|
| change in treatment satisfaction (TSQM-9) from baseline to month 6 | To evaluate the effect of an individualized patient support program vs. a standard patient support program on treatment satisfaction, measured by a treatment satisfaction questionnaire (TSQM-9) in Fingolimod-treated patients with relapsing-remitting multiple sclerosis over 6 months. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| change in Modified Morisky Scale score from baseline to month 6 | To evaluate the effect of an individualized patient support program vs. standard care on therapy adherence, measured by an adherence questionnaire (Modified Morisky Scale) in Fingolimod-treated patients with relapsing-remitting multiple sclerosis over 6 months. | 6 months |
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Inclusion Criteria:
Patients eligible for inclusion in this trial have to fulfill all of the following criteria:
Exclusion Criteria:
Patients fulfilling any of the following criteria are not eligible for inclusion in this study:
Patients, who have already been randomized into this trial earlier must not be included a second time.
Study personnel or first degree relatives of investigator(s) must not be included in the study.
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
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| ID | Term |
|---|---|
| D020529 | Multiple Sclerosis, Relapsing-Remitting |
| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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| Standard care | Other |
|
| quantification of therapy adherence (pill-count) over 6 months |
To evaluate the effect of an individualized patient support program vs. standard care on therapy adherence, measured by pill-count in Fingolimod-treated patients with relapsing-remitting multiple sclerosis over 6 months. |
| 6 months |
| change in mFIS score from baseline to month 6 | To evaluate the effect of an individualized patient support program vs. standard care on fatigue, measured by mFIS in Fingolimod-treated patients with relapsing-remitting multiple sclerosis over 6 months. | 6 months |
| change in BDI from baseline to month 6 | To evaluate the effect of an individualized patient support program vs. standard care on depression parameters, measured by the Beck depression inventory (BDI) in Fingolimod-treated patients with relapsing-remitting multiple sclerosis over 6 months. | 6 months |
| D003711 | Demyelinating Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |