Improving Beliefs About Medication in Patients With Rheumatoid Arthritis: Randomized Controlled Study Into the Effect of a Motivational Patient-centered Intervention for Non-adherent Patients Compared to Usual Care Controls
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Beliefs about medication, which is measured with Beliefs about Medicines Questionnaire (BMQ)
研究概览
简要总结
The purpose of this study is to determine if a short motivational patient-centered intervention for non-adherent patients is more successful in improving beliefs about medication (and adherence) compared to a usual care control group of non-adherent patients.
详细描述
Disease Modifying Anti Rheumatic Drugs (DMARDs) reduce disease activity and radiological progression and improve long term functional outcome in patients with Rheumatoid Arthritis (RA). However, adherence is a prerequisite for a drug to be effective. A previous study showed that 33% of the RA-patients using DMARDs are non-adherent. Non-adherence can not be attributed to a single cause, but is the result of a complex and individual decision process. An intervention should not only consider practical barriers, such as forgetfulness, but also cognitive and other psychological variables that might impact medication adherence. Therefore, an intervention was developed focusing primarily on the non-adherent patient's individual beliefs and barriers to adherence.
The effectiveness of this intervention will be evaluated in a randomized clinical trial. Primary outcome measure is beliefs about medication assessed with the Beliefs about Medicines Questionnaire (BMQ). Additionally, adherence and adherence-related variables will be measured with questionnaires.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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
- •RA according to the 1986 ACR criteria for at least 1 year
- •Prescription of anti-rheumatic medication (DMARDs)
- •Non-adherent patients (Compliance Questionnaire Rheumatology)
排除标准
- •Co-morbidity (physical or psychological) that unables patient to participate in the intervention
- •Illiteracy
- •Inability to communicate in Dutch
- •Participation in other studies with significant burden
结局指标
主要结局
Beliefs about medication, which is measured with Beliefs about Medicines Questionnaire (BMQ)
时间窗: 3 weeks before first intervention session (T0), 2 weeks after first intervention session (T1), 6 months after first intervention session (T3), 12 months after first intervention session (T4)
次要结局
- Satisfaction with information about medication, measured with Satisfaction with Information about Medicines Scale (SIMS)(3 weeks before first intervention session (T0), 2 weeks after first intervention session (T1), 6 months after first intervention session (T3), 12 months after first intervention session (T4))
- Self-efficacy, measured with Arthritis Self Efficacy Scale(3 weeks before first intervention session (T0), 2 weeks after first intervention session (T1), 6 months after first intervention session (T3), 12 months after first intervention session (T4))
- Physical functioning, measured with Health Assessment Questionnaire (HAQ), Rheumatoid Arthritis Disease Activity Index (RADAI) and Visual Analogue Scale Pain (VAS Pain)(3 weeks before first intervention session (T0), 2 weeks after first intervention session (T1), 6 months after first intervention session (T3), 12 months after first intervention session (T4))
- Psychological functioning, measured with Hospital Anxiety and Depression Scale (HADS) and Illness Cognition Questionnaire (ICQ)(3 weeks before first intervention session (T0), 2 weeks after first intervention session (T1), 6 months after first intervention session (T3), 12 months after first intervention session (T4))
- Adherence, measured with Compliance Questionnaire Rheumatology (CQR), Medication Adherence Report Scale (MARS) and refill rates(3 weeks before first intervention session (T0), 2 weeks after first intervention session (T1), 6 months after first intervention session (T3), 12 months after first intervention session (T4))
研究者
Joke Vriezekolk
Senior researcher
Sint Maartenskliniek