educAR: Validation of a Double Educational Strategy to Improve Therapeutic Adherence in Rheumatoid Arthritis.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 142
- 试验地点
- 16
- 主要终点
- Number of patients with therapeutic adherence.
研究概览
简要总结
Based on recent guidelines, the investigators have developed a parallel (patient and physician) educational web-based tool. To prove its effectiveness, the investigators have designed a cluster clinical trial of a 6-month duration in which 15 centres will be randomised to receive access and instruction on the strategy or to continue standard care.
The trial endpoint is adherence at the patient level, for which each centre will recruit 15 consecutive patients and measure adherence (medication, physical activity, Mediterranean diet) and disease activity as of baseline and 6 months after.
详细描述
Treatment adherence in patients with rheumatoid arthritis (RA) is estimated to be between 50-80%. Non-adherence is a health problem with a significant economic impact. The causes of non-adherence are multiple and require individualized care that is difficult both to implement at the professional level and to prove effective.
Based on recent international recommendations and previous work from the research team, plus a qualitative study with multi-stakeholders, the investigators have designed a web-based strategy to avoid non-adherence in RA.
The primary objective is to evaluate the effectiveness of an evidence-based, consensus-based adherence intervention strategy for improving adherence in patients with RA.
Secondary objectives are to evaluate the impact on disease activity, healthy habits (diet/exercise), cardiovascular risk factors, quality of life and patient satisfaction.
The investigators have designed a cluster clinical trial of 6-month duration.
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
- Single (Participant)
盲法说明
The patients are invited to participate in an observational study of adherence, as the intervention is done at the level of the care providers.
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
- •Adults (>18 years of age)
- •RA according to diagnosis recorded in clinical records
- •< 2 years since diagnosis of rheumatoid arthritis.
- •Independent daily living.
排除标准
- •Cognitive impairment
- •Language barriers
- •Impossibility of follow-up
结局指标
主要结局
Number of patients with therapeutic adherence.
时间窗: 6 months
Score ≥ 80% both in the Compliance Questionnaire in Rheumatology (CQR) plus the in Adherence Medication Scale (RAM).
次要结局
- Adherence to physical exercise(6 months)
- Disease activity(6 months)
- Degree of satisfaction with medical care(6 months)
- Adherence to mediterranean diet(6 months)
- Health-related quality of life measured using the Short-form12 (SF-12) version 2 questionnaire, a shortened version of the SF-36(6 months)
研究者
María Ahijón
Principal investigator
Fundación de Investigación Biomédica - Hospital Universitario de La Princesa