An integrated psycho-social intervention to improve self- efficacy towards treatment uptake and infection prevention among patients and family caregivers. A multi- centric implementation research study
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 547
- 试验地点
- 2
- 主要终点
- We will use patients self efficacy score and will estimate an adjusting for timing of assessment, with self-efficacy driven intervention arm as the exposure of interest.
研究概览
简要总结
Rationale/ gaps in existing knowledge,
TB elimination goals to achieve 92% treatment success rate by 2025 requires improvement in the treatment uptake self-efficacy of patients to a substantial level. Psycho -social interventions to improve the treatment self-efficacy and self-management skills to address the multi -dimensional challenges faced by TB patients are needed to be integrated in the present TB care system
Objectives
To adapt a self- efficacy driven intervention for improving the treatment self-efficacy of TB patients and family care givers under NTEP program and to evaluate its efficacy in comparison to the standard of care on primary outcomes: i. improved TB treatment self-efficacy and secondary outcomes i. improved medication adherence ii decreased TB stigma & iii. improved infection controls self-management practices
Novelty
The proposed intervention is based on self-efficacy constructs in which the patients and caregivers are intervened to “enable them to execute their own courses of actions, behaviors and self-management skills to effectively deal with challenges and needs of TB disease and treatment. The elements of the proposed intervention is derived from the insights of positively deviant TB patients and their caregivers who had coped up with TB in the best possible way and have exhibited maximum self-efficacy. Thus the acceptance and adaptation of proposed intervention is hypothesized as more beneficial as compared to the health care provider driven vertical interventions
Methods
A multi centric hybrid mixed method implementation design to adapt and evaluate implementation feasibility and efficacy of delivering a self- efficacy driven intervention using an implementation research approach.
Expected outcome.
The proposed self-efficacy driven intervention of proven efficacious will be the first integrated, theory-driven and evidence-based psycho-social intervention for TB patient that may positively impact self-efficacy and also acceptance and uptake of treatment, self-care and underlying psycho-social issues in a holistic way. Evidences of efficacy from this study will lead to scaling up of self-efficacy interventions in a pragmatic way under NTEP program which could improve treatment services and outcomes for TB patients in India.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)(—)
- 性别
- All
入选标准
- •Adult drug sensitive TB patients ( 18 years of age and above) who are initiated treatment for TB Patients with low treatment self-efficacy Adult DR-TB & MDR-TB patients on shorter regimen Caregivers of the adult DS TB and DR TB shorter regimen patients with low self-efficacy &.
排除标准
- •Patients undergoing longer MDR-regimen Younger than 18 years of age.
结局指标
主要结局
We will use patients self efficacy score and will estimate an adjusting for timing of assessment, with self-efficacy driven intervention arm as the exposure of interest.
时间窗: Baseline Midline & Endline
次要结局
- For secondary outcome we will use & patient’s adherence, loss to follow up rate & treatment outcome as reported by NTEP as a binary outcome(Baseline, 8th Week, 26th week.)
研究者
Karikalan Nagarajan
ICMR-ICMR- National Institute for Research in Tuberculosis
