Pragmatic, Multicenter, Cluster, Cohort Randomized Controlled Treat-to-target Trial for Treatment of SIBO in SSc Pilot
试验速览
- 阶段
- 不适用
- 入组人数
- 500
- 试验地点
- 2
- 主要终点
- Determine if protocol treatment is effective
研究概览
简要总结
This is a pragmatic study in which will compare a detailed treat-to-target (T2T) treatment algorithm to standard care for SSc SIBO at multiple sites around the world. The treatment algorithm was developed from the results of a survey of SIBO treatment preferences of rheumatologists and gastroenterologists. Although the drugs in the algorithm are already used in SSc, there is no uniform way of doing this and assessing the patient response. A very standardized protocol was created with details of how to use the medications, the duration of use and the timing of different drugs. In addition, symptoms of SIBO will be dectected by having patients complete a validated screening questionnaire, the global symptomatic score (GSS), online every 3 months for the duration of the study. A score > 5 is very strongly related to bacterial overgrowth. In other studies, about 40% of unselected patients score at this level. This same questionnaire will be used in the T2T doctors' offices to decide if response is adequate and will also be used to assess outcome in the algorithm group versus standard care group.
The primary outcome is the change in symptoms based on the total GSS. Secondary outcomes will include examination of all GSS subscales. HRQoL will be assessed by the social scale of the newly developed UCLA SSc GIT 2.0 questionnaire, which has become the standard GI questionnaire in SSc trials.
RN. # 00296313
详细描述
Objectives: To determine the feasibility of the full project. This will be a trial with 3 months of recruitment and 6 months of follow up for each case.
Specific Aims:
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Determine if REBs perceive any major issues regarding the full trial.
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Determine if the sites are consenting all eligible patients.
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Determine the signing rate of consent.
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Determine patient adherence to web access for questionnaires.
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Assess the method for detecting eligible cases from web questionnaires.
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Assess whether physician notifications are being sent out quickly after detecting eligible cases.
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Assess the timeliness and completeness of physician receipt of notification of patient eligibility.
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Assess physician adherence to treatment protocol:
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how soon protocol patients are brought in to see doctor after receipt of notice.
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does doctor record what he does accurately.
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does he/she schedule return visits according to protocol.
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does he/she use in office questionnaires for treat to target.
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does he/she base decisions on these questionnaires.
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does he/she follow algorithm sequentially.
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For control sites,
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Record how soon protocol patients are brought in to see doctor after receipt of notice.
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Assess whether the doctor accurately records what he/she does.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of Scleroderma
- •Internet access
- •An email address
- •Adequate computer literacy in order to fill out the online questionnaires.
排除标准
- •Allergy to protocol drugs
- •Concomitant disease that would make it unlikely that they will survive for one year
- •Use of substances known to cause diarrhea
- •History of antibiotics in the 12 weeks prior to inclusion
- •History of intestinal pseudo-obstruction
- •Inability to complete the symptom questionnaires
- •No functional level of written & spoken languages
- •Previous C. Dificile infection
- •Previous gastrointestinal surgery
- •Prolonged QT interval
- •Pregnancy or breastfeeding
研究组 & 干预措施
Protocol Treatment
If a score on the GSS is > 5, the computer will send an automatic notice to the office of the doctor and to the doctor him/herself telling them of this.
Upon receipt of the notice, the protocol doctors will be expected to make an appointment within the timeframe outline in the protocol. Upon receipt of this notice the secretaries or clerks at the site will be asked to insert a treatment sheet in the doctor's chart. This sheet will be used to assess the timeliness of the first visit after notification, about the adherence of protocol doctors to protocol treatment.
干预措施: Treatment Protocol (Other)
Standard of Care
Standard care doctors, who will not know the details of this protocol, will decide on their own if and when to see the patient. Upon receipt of this notice the secretaries or clerks at the site will be asked to insert a treatment sheet in the doctor's chart. This sheet will be used to assess types of medications and general pattern of treatment of the standard of care doctors.
干预措施: Standard of Care (Other)
结局指标
主要结局
Determine if protocol treatment is effective
时间窗: 3 years
The primary outcome is the total Gastrointestinal Symptom Scale score. Each symptom carries a score from 0 (no symptoms) to 3 (severe). The maximum overall score is 33. An improvement in the score, ie a lower score, indicates an improvement in GI symptoms.
次要结局
未报告次要终点
研究者
Murray Baron
Dr.
Canadian Scleroderma Research Group