Rebif Compliance Support Program - Assessing Needs in Multiple Sclerosis (AIMS)
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | March 3, 2010 | ||||
| Last Updated Date | April 26, 2011 | ||||
| Start Date ICMJE | January 2007 | ||||
| Primary Completion Date | April 2011 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Discontinuation of Rebif treatment (yes or no) [ Time Frame: Data collection is expected to end 3 months after last subject is recruited ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01080573 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Rebif Compliance Support Program - Assessing Needs in Multiple Sclerosis | ||||
| Official Title ICMJE | A Questionnaire Based Survey to Identify Issues With Patient Compliance and to Develop Solutions to Improve Rebif Compliance and Improve Patient Outcomes | ||||
| Brief Summary | This 1-arm, open-label, multicentric, observational study aims to collect subject centric information in line with routine care. Subjects' expectations of therapy, side effect management and lifestyle may influence adherence to therapy. This survey aims to determine whether such factors and/or others affect the successful initiation and maintenance of Rebif therapy. The data collected during this study will include information on the subject's treatment including expectations, experience, training and support. The results of the study will be used to understand the impact on subjects' compliance and tailor training and support services to subject's need. It will also be made available to other healthcare organisations involved in the subjects treatment. |
||||
| Detailed Description | Multiple sclerosis (MS) is a chronic, inflammatory, demyelinating disease of the central nervous system and is one of the most common causes of neurological disability in young adults. It is characterised by multifocal, recurrent attacks of neurological symptoms and signs with variable recovery. Eventually the majority of subjects develop a progressive clinical course. It is important to carefully initiate and maintain subjects with MS on therapy. Information will be gathered in a structured way which will enable easier identification of any subgroups of subjects who may be at risk of poor compliance. These risk groups could possibly include groups with particular attributes such as poor information at the start of treatment, unrealistic expectations or a particular life style. This study will be conducted during the contact with the subject necessary to deliver the homecare service. Participants will be contacted by Bupa Home Healthcare Multiple Sclerosis subject coordinators by telephone to conduct specific questionnaires during the 4 stages of the subject's treatment i.e. pre-installation of treatment, post installation of treatment, monthly pre delivery of drug and at a subject's end treatment. OBJECTIVES
|
||||
| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Prospective |
||||
| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Non-Probability Sample | ||||
| Study Population | Subjects who have been prescribed Rebif and referred to Bupa Home Healthcare service by one of the participating referring centres. |
||||
| Condition ICMJE | Multiple Sclerosis | ||||
| Intervention ICMJE | Not Provided | ||||
| Study Group/Cohort (s) | Not Provided | ||||
| Publications * | Not Provided | ||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||
| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 1257 | ||||
| Completion Date | April 2011 | ||||
| Primary Completion Date | April 2011 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
|
||||
| Gender | Both | ||||
| Ages | Not Provided | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United Kingdom | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01080573 | ||||
| Other Study ID Numbers ICMJE | MMFM 100 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Dr Gillian Shepherd, Medical Director, Merck Serono Ltd. UK, an affiliate of Merck KGaA, Darmstadt, Germany | ||||
| Study Sponsor ICMJE | Merck KGaA | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
|
||||
| Information Provided By | Merck KGaA | ||||
| Verification Date | April 2011 | ||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|||||