Usual Care Randomized Study Measuring the Impact of an Online Personal Health Record (Sanoia) in Rheumatoid Arthritis Patients on Reported Outcomes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 320
- 试验地点
- 26
- 主要终点
- Change from Baseline to 12 months after inclusion of Perceived efficacy by the patient of patient-physician interactions (PEPPI)
研究概览
简要总结
Recommendations of Rheumatoid Arthritis management agree on the necessity of patient self-involvement in the care. In parallel, the observation of the adoption rate of websites directed toward patients may indicate that this involvement is shared by a large number ot the population.
However, most of these sites are only informative and few of them offer patients to be engaged to generate their own data that can impact on the patient-physician relationship by easing the dialog and then leading to better mutual understanding.
As new web or mobile services allowing patients to self-report their outcomes are flourishing only a very few of them have already addressed the their impact of the patient-physician relationship.
The main objective of this study is to quantify the effect of a website (Sanoia) on the quality of patient-doctor interactions, as perceived by the patient using the french translations of the Peppi Questionnaire during the 12 months observation period.
In France, the patient protection committee (CPP) has ranked this study in "Soins Courants" (Usual Care).
详细描述
Recommendations of care in rheumatoid arthritis (RA) advocate for patient involvement and management of his/her own health.
The observation of the sole rate of use of websites specialized health patients might indicate that this involvement is occurring for a large number. Indeed, yet in 2010, more than 71% of French Netizen used the Internet to search for information related to their health according to a 2012 survey from the French National Order of Medical Doctors. Focusing on rheumatology, 68% of French patients have already used the Internet to search for information related to their arthritis as shown from a 2012 survey of the French Society of Rheumatology. In this medical field, these results reflect the fact that in France since years 2000, patients' associations and institutions, edited websites to offer patients a direct and easier access to information on diseases or treatments.
Nevertheless, it is useful to observe the type of service provided to the patient on these sites: the majority of these sites, even the most recent offer only the dissemination of information and never have been studied on this informative nature. These sites should be considered as an introductory step toward patient involvement.
Indeed, patients involvement is effective if they are really "active" and produce data, e.g. when him(her)self notes personal information online, manages a 'health book' virtual or self-assessing internet. In other words, involvement makes sense when it contributes to an "improvement" doctor-patient exchanges and when at last it leads to an increase in entropy.
Especially the latter type of use, i.e. the patient self-reported measure (patient-reported outcomes), can be a manner to both involve the patient in his care, and to feed the medical decision support with the certified rheumatologist. Moreover, it appears that the self-measurements in particular by the RA patient, are reliable.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Single (Participant)
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
- •Adult over 18 years.
- •Patient with Rheumatoid Arthritis diagnosed according to American College of Rheumatology (ACR ) / European League Against Rheumatism (EULAR) 2010 criteria.
- •Patient monitored by the recruiting physician from over a year.
- •Patient access who have access to an Internet broadband equipment other than on a mobile or a a smartphone
排除标准
- •Patient already using Sanoia at the time of inclusion.
- •Patient already participating in a therapeutic clinical trial in rheumatology
- •Patient having no computer literacy and understanding difficulties
结局指标
主要结局
Change from Baseline to 12 months after inclusion of Perceived efficacy by the patient of patient-physician interactions (PEPPI)
时间窗: Baseline and Month 12
Patients connects to the electronic Case Report Form (e-CRF) and file the French translation of the 5-item PEPPI Questionnaire
次要结局
- Rheumatoid Arthritis Impact of Disease (RAID) score(Baseline, Month 3, Month 6 and Month 12)
- Overall assessment of the patient's Health as measured by a VAS(Baseline, Month 3, Month 6 and Month 12)
- Patient-Physician communication quality, as assessed by the patient using a Numeric Rating Scale(Baseline, Month 3, Month 6 and Month 12)
- Overall perceived quality of care, as assessed by the patient via a Numeric Rating Scale(Baseline, Month 3, Month 6 and Month 12)
- Number of patient's visits to the Rheumatologist from baseline to 12 months after inclusion(Month 3, Month 6 and Month 12)
- Satisfaction of SANOIA using a Numeric Rating Scale for the PHR Group(Month 3 and Month 12)
- Unsatisfactory criteria using a pre-defined list for the PHR Group(Month 3 and Month 12)
- Spontaneous access and use of SANOIA for Non-PHR Group (usual care)(Month 12)
- Health Assessment Quality of Life Disability Index Questionnaire(Baseline)
- Co-morbidities list(Baseline)