Impact of Nursing Interventions on Adherence to Treatment With Anti-tuberculosis Drugs in Children and Adolescents
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 359
- 主要终点
- Adherence to treatment
研究概览
简要总结
This study evaluates the efficacy of nursing interventions on adherence to antituberculosis medication in a paediatric cohort (aged 0-18 years) and identifies the risk factors for non-compliance.
There are two phases in the study; Phase 1: retrospective descriptive analysis in children and young people receiving antituberculosis treatment (non-intervention group); and Phase 2: quasi-experimental, longitudinal, prospective study (intervention group). The results of the two phases will be compared.
详细描述
The study was carried out in the outpatient tuberculosis (TB) Unit of a tertiary-care pediatric center in Catalonia (Northeast Spain), which is a referral center for pediatric TB (Hospital Sant Joan de Déu) in the Southern Barcelona Health Care Region (Regió Sanitària Barcelona Sud) (1,346,000 inhabitants, 16.5% of whom are under 18 years of age).The TB incidence rate in Catalonia has decreased from 21.6 per 100,000 population in 2004 to 14.4 in 2015 (7.3 cases per 100,000 population of pediatric age)(Rodés, Espinilla, & García, 2016).
In both phases, all children and adolescents (aged <18 years) starting anti-tuberculosis (anti-TB) treatment due to close contact with a TB patient (primary chemoprophylaxis), Latent Tuberculosis Infection (LTBI) or TB disease were eligible to participate in the study. Directly Observed Treatment (DOT) is not routinely available in Spain, and its use is restricted to individual cases, as per physician decision.
The number of children and adolescents required to participate in the study was calculated using a unilateral chi-square proportion comparison test for independent samples, with a level of significance of 5% and a power of 80%, a 2/1 ratio in Phase 1/Phase 2 group sizes and assuming a significant increase of 15% in the adherence rate after the nurse-led interventions (60% in Phase 1 and 75% in Phase 2). Thus, it was calculated that 182 and 91 children and adolescents would be needed in the Phase 1 and Phase 2 groups, respectively.
Procedure and interventions:
As per national guidelines, primary chemoprophylaxis after TB contact consists of isoniazid in monotherapy until TB infection screening is repeated 10-12 weeks later. Treatment of LTBI includes either 3 months of isoniazid and rifampicin or 6-9 months of isoniazid in monotherapy, and treatment of TB disease consists of a 2-month induction phase with 4 drugs (isoniazid, rifampicin, pyrazinamide and ethambutol), followed by isoniazid and rifampicin for a minimum of 4 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- — 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •In both phases, all children and adolescents (aged <18 years) starting anti-TB treatment due to close contact with a TB patient (primary chemoprophylaxis), Latent Tuberculosis Infectious (LTBI) or Tuberculosis (TB) disease were eligible to participate in the study.
排除标准
- •Referral from another center after anti-TB treatment had already begun
- •Patients with other chronic diseases requiring hospital follow-up and/or other chronic therapies
- •Known poor previous adherence to anti-TB treatment (if treatment was repeated or restarted)
- •A significant language barrier that prevented the child or his/her relatives from properly understanding the nature of the study.
结局指标
主要结局
Adherence to treatment
时间窗: Through the study completion, an average of 3 months for those patients starting anti-TB treatment due to close contact with a TB patient (primary chemoprophylaxis) or LTBI and 6-9 months for those with TB disease.
Non-adherence was defined as the presence of any of the following situations: 1. At the follow-up visits, it was calculated and/or the children or relatives stated that they had failed to take \>20% of the previously prescribed anti-TB treatment. 2. The child failed to attend two or more of the scheduled visits without justification. 3. DOT was indicated for any reason. 4. The child or relatives intentionally stopped the previously prescribed anti-TB treatment. 5. The Eidus-Hamilton urine test was negative on one or more follow-up visits. 6. The written questionnaire showed that compliance was below 80% of the prescribed anti-TB treatment.
次要结局
- Risk Factors(Through the study completion, an average of 3 months for those patients starting anti-TB treatment due to close contact with a TB patient (primary chemoprophylaxis) or LTBI and 6-9 months for those with TB disease.)