Obstacles and Levers of the Therapeutic Adherence of Multiple Sclerosis Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 153
- 试验地点
- 4
- 主要终点
- Therapeutic adherence evaluated by a Likert scale
研究概览
简要总结
The goal of this study is to assess the role of sociocognitive and interpersonal factors in the therapeutic adherence of multiple sclerosis patients. This study will provide a better understanding of the socio-psychological issues associated with different types of non-adherence to treatment, and identify the risk factors and vulnerability of each patient.
详细描述
Multiple sclerosis is a chronic and progressive disease that affects young adults (between 20 and 40 years old), impacting significantly the patients quality of life.
The adherence to therapy affects the long-term functional clinical course (lower risk of relapses, reduction in disability progression and quality of life). The non-adherence rate to therapy in multiple sclerosis is estimated at 40%. The main identified causes of non-adherence are: forgetting to take treatment and adverse effects of drugs.
Sociocognitive models as the Theory of Planned Behaviour (TPB) have been developed to help to understand and predict health-related behaviours. This model postulates that the intention to adopt a behaviour is one of the major determinants in the context of health. This intention comes from three independent elements :
- Personal positive or negative attitudes towards the behaviour,
- Social expectations or entourage perception (subjective norms),
- Difficulty in accomplishing this behaviour (perceived control)
Multiple sclerosis adherence to therapy studies have mainly focused on somatic variables (physical disability, illness duration, type of treatment) and some clinical variables (cognitive impairment, fatigue, depression). The few studies that have examined the multiple sclerosis therapeutic adherence determinants have mainly taken a one-dimensional perspective, such as perceived control.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
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
- •Multiple sclerosis defined according to McDonald criteria;
- •Already undergone or beginning substantive treatment (self-managed, excluding treatment administered in hospital)
- •Aged ≥ 18 years;
- •Given the informed consent form.
排除标准
- •Severe cognitive impairment (score below the 5th percentile);
- •Any associated neurological pathology or serious or chronic somatic disease (cancer);
- •Being under a legal protection measure.
结局指标
主要结局
Therapeutic adherence evaluated by a Likert scale
时间窗: 6 months
This 19-item self-questionnaire provides 5 sub-scores corresponding to each of the sub-dimensions (Attitudes, Subjective norms, Perception of control, Behavioural intention and Behaviour) and an overall score (sum of the 5 sub-scores).
次要结局
- Handicap will be evaluated by the Expanded Disability Status Scale (EDSS)(3 weeks)
- Relapses number(3 weeks)
- Personality traits measured by the Big Five Inventory-FR questionnaire (BFI-FR)(3 weeks)
- Cognitive disorders through the SDMT (Symbol Digit Modalities Test)(3 weeks)
- Perceived interpersonal relationships quality measure by the perceived social support questionnaire (QSSP)(6 months)
- Anxiety-depressive symptoms measured by the Hospital Anxiety and Depression Scale (HADS)(3 weeks)
- Perceived threat measured with a self-assessment form(3 weeks)
- Perceived interpersonal relationships quality measure by the 4-Point ordinal Alliance Scale (11-items 4-PAS)(6 months)
- Illness duration in days(3 weeks)
- Fatigue perceived through the FSS (Fatigue Severity Scale)(3 weeks)