Effectiveness of Family Support Health Education Intervention to improve Health -Related Quality of Life among Drug Sensitive Pulmonary Tuberculosis patients in Puducherry-Randomized Control Trial
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 136
- 试验地点
- 1
- 主要终点
- Modified FASTEN will improve health related Quality of Life among newly diagnosed drug sensitive Pulmonary tuberculosis
研究概览
简要总结
Topic: Effectiveness of Family Support Health Education Intervention to improve Health Related Quality of Life among Drug Sensitive Pulmonary Tuberculosis patients in Puducherry- Randomized control trial.
Supervisor name: Dr. K. Kannan
Professor
Abstract
Introduction: Tuberculosis (TB) is a major killer and cause of human suffering worldwide and imposes a substantial reduction in patients Health- Related Quality of Life .
Health- Related Quality of Life indicates the consciousness of patients regarding their physical and mental health.
Its is, therefore, very relevant in comprehending and measuring the exact impact of the disease state.
Aim: To study the impact of modified Family Support Health Education (FASTEN) in Health Related Quality of Life among newly diagnosed Drug Sensitive Pulmonary Tuberculosis patients.
Objectives:
Primary Objective
To determine the effectiveness of a modified Family Support Health Education (FASTEN) intervention in improving the Health Related Quality of Life among newly diagnosed drug sensitive adult Pulmonary Tuberculosis patients in Puducherry.
Secondary Objective
To compare the treatment outcome between the intervention and control group.
Materials and Methods:
Project design:A single-blinded, Randomized controlled field trial.
Project Setting:Field practice area of selected Primary Health Centres in Puducherry.
Target population:Newly diagnosed drug sensitive adult pulmonary Tuberculosis cases registered under National Tuberculosis Elimination Programme Puducherry district in year of 2024.
Sample size: 136
Data collection: Section-A: Socio-Demographic / economic factors questionnaireThis form collects basic details of patients such as age, sex, race, religion, residence, occupation, education level, total family members, family income, marital status, smoking status and alcohol status.
Section-B: SF 36 Questionnaire to assess Health Related Quality of Life.This part consists of eight Health Related Quality of Life domains
i. Physical Functioning ,
ii. Role limitation due to Physical condition ,
iii. Bodily Pain ,
iv. General Health ,
v. Vitality ,
vi. Social Functioning ,
vii. Role limitation due to personal Emotional problem ,
viii. General Mental Health .
Data analysis: Data will be entered in MS excel sheet. Analysis will be done using SPSS software version 16.Student T test/ Mann -Whitney test will be applied based on the distribution of the data. p value<0.05 will be taken as statistically significant.
Expected outcome: 1. Modified FASTEN will improve health related Quality of Life among newly diagnosed drug sensitive Pulmonary tuberculosis.
- Modified FASTEN intervention will also have positive impact on treatment outcome
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 19.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •All newly diagnosed drug sensitive adult Pulmonary TB cases in the year of 2024 registered under NTEP, Puducherry irrespective of gender, receiving treatment from the selected PHCs
- •Patients of age more than 18 years.
- •Participants staying with family members (spouse, children, siblings, parents).
排除标准
- •Patients too ill to participate, and the cases of retreatment Pulmonary Tuberculosis.
- •Participants with other comorbid illness including HIV infection, diabetes and other chronic diseases.
- •Family member of the Pulmonary Tuberculosis who has been already recruited into this study.
结局指标
主要结局
Modified FASTEN will improve health related Quality of Life among newly diagnosed drug sensitive Pulmonary tuberculosis
时间窗: Baseline 2 months to 6 months
次要结局
- Modified FASTEN intervention will also have positive impact on treatment outcome(6 months to 1 year)
研究者
Dr. Anithadevi K
SRI LAKSHMI NARAYANA INSTITUTE OF MEDICAL SCIENCES