跳至主要内容
临床试验/CTRI/2024/05/066847
CTRI/2024/05/066847尚未招募2 期

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

Indian Council of Medical Research2 个研究点 分布在 1 个国家目标入组 547 人开始时间: 2024年5月15日最近更新:

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   â€œenable 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

申办方类型
Research institution
责任方
Principal Investigator
主要研究者

Karikalan Nagarajan

ICMR-ICMR- National Institute for Research in Tuberculosis

研究点 (2)

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