Development and Evaluation of an Interactive Web-based Programme on Relapse Management for People With Multiple Sclerosis - a Randomized Controlled Trial With Mixed Methods Process Evaluation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 160
- 试验地点
- 2
- 主要终点
- Assessment of change in relapse treatment (relapses not treated or treated with oral steroids).
研究概览
简要总结
This randomized controlled trial will evaluate a web-based relapse management programme, which is easily accessible for people with multiple sclerosis. The trial is accompanied by a mixed-methods process evaluation and a health economic evaluation.
It is expected that the programme will positively change patients' relapse management and strengthen their autonomy and participation.
详细描述
Multiple sclerosis (MS) is a chronic inflammatory, degenerative disease of the central nervous system manifesting at first with relapses in about 85% of the cases. In Germany, intravenous mostly inpatient therapy with high-dose corticosteroids is the treatment standard of acute relapses. The treatment leads to short-term faster reduction of symptoms in about 25 of 100 treated patients (absolute risk reduction), but has no long-term benefits over placebo treatment. Also intravenous treatment is not superior to oral treatment. Therefore, informed decisions on relapse management are required. An earlier randomized controlled trial (RCT) showed that evidence-based patient information (EBPI) and education on relapse management leads to significantly more informed decisions and more relapses not treated or treated with oral steroids. POWER@MS2 builds on that evidence by transferring the content to a web-platform and making the intervention easily accessible and implementable.
The intervention will be evaluated in a pragmatic double-blind (PwMS and outcome assessors) RCT. Participants will be randomized to an interactive web-based programme (intervention group) or a web-based programme with standard information on relapse management based on the contents of the German Multiple Sclerosis Society (DMSG).
POWER@MS2 aims to demonstrate fewer glucocorticoid relapse therapies, and, in case of treated relapses, less intravenous and more orally administered therapies (primary endpoint: proportion of relapses not treated or treated with oral steroids). PwMS will be recruited via all participating centres (private neurology practices and MS outpatient departments (academic and community hospitals)) in Germany. In the federal state of Schleswig-Holstein all neurologists will be contacted. Interested and eligible PwMS will be provided with a study information sheet by the participating MS centres. Informed consent will be obtained by a physician in the MS centre. After giving their informed consent, contact data (address, email, telephone) will be forwarded to the study centre (UKE) via a secure communication platform or phone. After this, baseline data will be collected and group assignment will be performed by a block randomization procedure within the database secuTrial®. After successful randomization, PwMS will receive access (login) details to the intervention or control platform within 4-6 weeks.
Participants will be monitored for at least 12 up to 36 months (on average 24 months). Every three months, measures are recorded by a standardized phone interview executed by the coordinating study centre. Recruitment will be completed after approximately nine months. The trial will end as soon as the last participant has reached 12 months of follow-up. All participants, who have not reached 36 month of follow-up, will be called for a final phone interview.
We consider the specific risks for participating PwMS to be very low. No negative effects on the quality of life of PwMS as well as disability or other undesired events due to omitted or oral steroid administration are to be expected as previous studies showed. It is more likely that there will be positive effects for trained PwMS in terms of more autonomous decision-making and differentiated use of steroids. Participants will be educated on potentially dangerous side effects of steroid therapies and their early detection by an information sheet. To assist the physician in assessing whether oral medication is acceptable, participants will be issued a certificate with documented decision-making knowledge. As part of this study, all study participants will be contacted by phone every three months. This will also allow individual risk identification and the initiation of appropriate measures if required.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
The study will be conducted as an investigator blinded trial and participating physicians as well as MS centres in general will not be provided with any information about group assignment. Randomization will take place only after baseline documentation. Blinding of the trial participants is pursued, but only possible to a limited extent. Furthermore, it cannot be prevented that patients discuss the intervention contents with their physician. Thus participants and neurologists might realize their group assignment. While blinding in complex educational interventions including a webinar is virtually not possible, the only strategy to increase similarity of groups is to have an active control group, which we aim for with the optimized standard care group. Furthermore, the outcome assessors are blinded.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •signed informed consent
- •clinically isolated syndrom, suspected or diagnosed relapsing remitting MS
- •at least 1 relapse in the last year and/or at least 2 relapses in the last 2 years
- •access to the internet and ability to use websites
排除标准
- •primary progressive MS
- •secondary progressive MS
- •acute relapse
- •severe visual impairment
- •severe psychiatric disorder (judged based on clinical impression)
- •allergic hypersensitivity to corticosteroids
- •participation in the EBSIMS training programme (the relapse management training programme was offered in Hamburg and Bad Segeberg)
结局指标
主要结局
Assessment of change in relapse treatment (relapses not treated or treated with oral steroids).
时间窗: Telephone interview at month 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36 after patient inclusion and after final patient reaches month 12
Standardized questionnaire to assess change of relapses and their treatment. The questionnaire will be applied during 3-monthly phone interviews.
次要结局
- Planned Behaviour in MS Scale (PBMS relapse)(Month 3 and 12 after patient inclusion)
- EQ-5D(Baseline, month 3, 12, 24, 30, 36 after patient inclusion and after the final patient reaches month 12)
- Hospital Anxiety and Depression Scale (HADS)(Baseline and month 12 after patient inclusion)
- Health Economic Evaluation(Telephone interview at Baseline, month 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36 after patient inclusion and after the final patient reaches month 12)
- Annual relapse rate(Telephone interview at month 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36 after patient inclusion and after final patient reaches month 12)
- Relapse Risk Knowledge(Month 3 and 12 after patient inclusion)
- Impairment in the Expanded Disability Status Scale (EDSS)(Baseline and month 12 after patient inclusion)
- Control Preference Scale relapse (CPS relapse)(Month 3 after patient inclusion)
- Patient Activation Measure (PAM)(Baseline, month 3, 12, 24, 30, 36 after patient inclusion and after final patient reaches month 12)
- United Kingdom Neurological Disability Scale (UNDS)(Telephone interview at Baseline, month 12, 15, 18, 21, 24, 27, 30, 33, 36 after patient inclusion and after the final patient reaches month 12)
- Hamburg Quality of life in MS Scale (HAQUAMS)(Baseline and month 12 after patient inclusion)