Evaluation of Therapeutic Adherence Among Patients Followed in the Department of Hereditary Metabolic Diseases at Necker Hospital
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Assessment of therapeutic adherence
研究概览
简要总结
The purpose of this study is to evaluate treatment adherence among patients followed in the Department of Inherited Metabolic Diseases at Necker Hospital, in order to assess the need for implementing a therapeutic education workshop focused on medication adherence.
详细描述
There is limited data in the literature regarding treatment adherence in children with metabolic disorders. A 2011 study on phenylketonuria highlighted a decline in dietary adherence during adolescence. Another study, dating from 1996 and focusing on urea cycle disorders, emphasized the importance of good treatment adherence for maintaining disease control. Furthermore, larger-scale research in epileptic patients has identified several barriers to treatment compliance, highlighting the crucial role of treatment adherence in improving disease control.
The purpose of this study is to evaluate treatment adherence among patients followed in the Department of Inherited Metabolic Diseases at Necker Hospital, in order to assess the need for implementing a therapeutic education workshop focused on medication adherence.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 7 Years 至 20 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients followed in the Hereditary Metabolic Diseases department of Necker Hospital during their visit to the department for their usual care and having a specific daily oral medication treatment.
- •Children aged at least 7 years and adolescents/young adults
- •Holders of parental authority and children or adolescents or adults' patients informed and consenting to participate in the study
排除标准
- •Metabolic disease without oral medication (intravenous treatments, amino acid mixtures, and dietary regimens are not evaluated).
- •Patient and parents not proficient in French.
- •Refusal by the patient's holders of parental authority or adult patient to participate in the study and/or refusal of the child/adolescent.
研究组 & 干预措施
Patients
Patients, children aged at least 7 years and adolescents/young adults followed in the pediatric department of hereditary metabolic diseases of Necker Hospital, having specific oral drug treatment.
干预措施: Questionnaire (Other)
Patients
Patients, children aged at least 7 years and adolescents/young adults followed in the pediatric department of hereditary metabolic diseases of Necker Hospital, having specific oral drug treatment.
干预措施: Calculation of the metabolic balance score (Other)
结局指标
主要结局
Assessment of therapeutic adherence
时间窗: Time 0
Therapeutic adherence score, established from the declarations of patients and their parents to the study questionnaire.
次要结局
- Assessment of medication adherence in the event of a travel(Time 0)
- Number of treatments taken each day(Time 0)
- Knowledge of the disease(Time 0)
- Knowledge of treatments(Time 0)
- Correlation between the therapeutic adherence score and the number of medications taken daily by patients(Time 0)
- Correlation between the therapeutic adherence score and the age of patients(Time 0)
- Correlation between the therapeutic adherence score and patients' and their parents' knowledge of the disease(Time 0)
- Correlation between the therapeutic adherence score and patients' and their parents' knowledge of treatments(Time 0)
- Correlation between therapeutic adherence score and metabolic balance for patients cared for urea cycle deficiency(Time 0)