Patient-reported Experiences and Quality of Life Outcomes in the TB-PRACTECAL Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 137
- 试验地点
- 6
- 主要终点
- Changes in Short form 12 survey questionnaire (patient satisfaction and experience) from baseline to 12 months
研究概览
简要总结
PRACTECAL-PRO is a sub-study of a TB-PRACTECAL clinical trial for multidrug resistant Tuberculosis. It evaluates the effectiveness of TB-PRACTECAL interventions from the patient perspective in terms of their quality of life, shared decision making and satisfaction with services.
详细描述
Tolerability of drugs for TB is a complex and dynamic course for patients with drug resistance and can be affected by many different factors. A deeper understanding of the perspectives and experience of men and women participating in novel TB treatment trials will add to the understanding of the safety and efficacy of treatment.
TB-PRACTECAL is a multicentre, open label, phase 2-3 randomised controlled trial evaluating exclusively oral 6 months regimens containing bedaquiline, pretomanid, linezolid +/- moxifloxacin or clofazimine for the treatment of microbiologically confirmed pulmonary M/XDR-TB. It is registered with the ClinicalTrials.gov with identifier number NCT02589782. The trial aims to recruit 630 adults from two sites in Uzbekistan (Nukus and Tashkent) and one site each from Belarus and South Africa.
The TB-PRACTECAL trial assumes that even if the investigational arms would have non-inferior efficacy and safety compared to the standard of care outcomes, patients would prefer a shorter, exclusively oral regimen with a lower pill count. This study therefore aims to describe patient experiences (i.e. the quality of the treatment experience as opposed to the quantity of treatment or the amount of time spent on it).
The PRACTECAL-PRO sub-study aims to answer the question: "What are the perceptions, expectations and experiences of novel TB treatment for adult patients participating in a six-month regimen clinical trial in Uzbekistan, South Africa and Belarus?"
The objectives for the analysis are:
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
- 是
入选标准
- •Patients recruited into the TB-PRACTECAL trial in the approved sites OR
- •Local healthy-controls of a similar profile in terms of age and gender aged ≥18 years AND
- •Literate in the study questionnaire languages
- •Able to sign the sub-study informed consent form after agreeing to the additional interviews and completion of questionnaires.
排除标准
- •TB patients excluded from TB-PRACTECAL clinical trial
- •Healthy volenteers with co-morbidities
- •Healthy volenteers found to have TB
研究组 & 干预措施
Intervention arm
A total of 54 intervention arm trial patients (from TB-PRACTECAL trial) are anticipated across all three sites: South Africa, Belarus, and Karakalpakstan.
54 matched healthy controls are anticipated.
干预措施: Bedaquiline (Drug)
Intervention arm
A total of 54 intervention arm trial patients (from TB-PRACTECAL trial) are anticipated across all three sites: South Africa, Belarus, and Karakalpakstan.
54 matched healthy controls are anticipated.
干预措施: Pretomanid (Drug)
Intervention arm
A total of 54 intervention arm trial patients (from TB-PRACTECAL trial) are anticipated across all three sites: South Africa, Belarus, and Karakalpakstan.
54 matched healthy controls are anticipated.
干预措施: Moxifloxacin (Drug)
Intervention arm
A total of 54 intervention arm trial patients (from TB-PRACTECAL trial) are anticipated across all three sites: South Africa, Belarus, and Karakalpakstan.
54 matched healthy controls are anticipated.
干预措施: Linezolid (Drug)
Intervention arm
A total of 54 intervention arm trial patients (from TB-PRACTECAL trial) are anticipated across all three sites: South Africa, Belarus, and Karakalpakstan.
54 matched healthy controls are anticipated.
干预措施: Clofazimine (Drug)
Standard therapy
54 standard therapy trial patients (from TB-PRACTECAL trial) will be recruited across all three sites. Patients will complete measures at baseline, 3 months, 6 months and 12 months.
54 matched healthy controls are anticipated.
干预措施: Directly observed therapy (DOT) (Drug)
结局指标
主要结局
Changes in Short form 12 survey questionnaire (patient satisfaction and experience) from baseline to 12 months
时间窗: 12 months
Two summary scores are reported from the SF-12 - a mental component score (MCS-12) and a physical component score (PCS-12). The scores may be reported as Z-scores (difference compared to the population average, measured in standard deviations). Ultimate aim is to determine whether disease-specific patient satisfaction scores improve in investigational arm patients from baseline to successful completion of treatment.
Change in St George's respiratory questionnaire SGRQ survey questionnaire from baseline to 12 months
时间窗: 12 months
To assess the quality of life (QoL) of trial patients from baseline to 12 months: both those treated in the investigational arms and the standard of care arm. For the SGRQ, a change of 4 points is suggested to indicate a clinically significant change, although the questionnaire was developed with patients who had COPD rather than TB. In the sub-study with a relatively small sample we cannot be confident about whether a change of 4 points represents a similarly significant change, but we will be mindful to assess this possibility. Ultimate aim is to determine whether disease-specific patient quality of life scores improve in investigational arm patients from baseline to successful completion of treatment.
次要结局
未报告次要终点