NCT04179695招募中不适用
Optimizing PD Patient's Health Pathways: Favoring Global, Patient Centered Care by a New Communication Aid Tool PARKINSUN
University Hospital, Lille2 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2020年7月21日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- variation of the delta of G-MISS Questionnaire
研究概览
简要总结
PARKINSUN is a new communication aid tool, expected to favor global patient centered care for PD patients during consultation with GPs and neurologists. Two groups of patients will be randomized to use or not PARKINSUN when they consult their physicians every 3 months during 7 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult men and women with all stages of PD
- •Without severe chronic neurological or mental or psychiatric pathology
- •Absence of cognitive impairment affecting autonomy (MDS criteria of dementia and MOCA > 22)
- •able to come (alone or accompanied) to consultation
- •Affiliate or beneficiary of a social security scheme
- •Subject having signed informed consent
- •Patient willing to comply with all procedures of the study and its duration
排除标准
- •Administrative reasons: impossibility of receiving informed information, inability to participate in the whole study, absence of coverage by the social security system, refusal to sign consent.
- •Subject under tutelage or curtailer.
- •Subject not fluent in the French language to understand the instructions necessary to carry out the cognitive tests.
研究组 & 干预措施
consultation with Parkinsun
Experimental
干预措施: Consulting with PARKINSUN as communication aid-tool (Other)
consultation as usual without Parkinsun
Active Comparator
干预措施: Consulting without PARKINSUN as communication aid-tool (Other)
结局指标
主要结局
variation of the delta of G-MISS Questionnaire
时间窗: at 7 months
次要结局
- Likert Scale(at the end of each consultation (1 month and 7 months))
- G-MISS-Questionnaire at the end of each consultation (1 month, 4 months and 7 months)(at the end of each consultation (1 month and 7 months))
- Global score of PARKINSUN(at the end of each consultation ((1 month and 7 months))
- PDQ-39 scores 6. Interpersonal Reactivity Index (IRI)(at the end of each consultation ((1 month and 7 months))
- Individuals scores of PARKINSUN(at the end of each consultation ((1 month and 7 months))
- MDS-UPDRS scores(at the end of each consultation ((1 month and 7 months))
- Interpersonal Reactivity Index (IRI)(at the end of each consultation (1 month and 7 months))
研究者
研究点 (2)
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