Effectiveness of self care intervention guidelines on knowledge on self care, Attitude, Compliance to Anti-retroviral therapy (ART), Anxiety, Quality of life (QOL), and Practices in home care management of persons living with HIV infection (PLHIV).
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 148
- 试验地点
- 1
- 主要终点
- oImprovement in knowledge on self care, attitude, compliance to ART, quality of life,and practices in home care management of minor illnesses.
研究概览
简要总结
Objectives and aims of study
o To develop and validate self care intervention guidelines for Persons Living with HIV Infection (PLHIV) on ART.
o To assess the knowledge on self care, attitude, compliance to ART, anxiety, Quality of Life (QOL) and practices in home care management of PLHIV before and after standard care and self care intervention guidelines.
o To assess the effectiveness of self care intervention guidelines on the knowledge on self care, attitude, compliance to ART, anxiety, QOL, and practices in home care management of PLHIV.
o To determine the relationship between knowledge on self care, attitude, compliance to ART, anxiety, QOL, & practices in home care management of PLHIV
o To determine the association between the pretest scores of knowledge on self care, attitude, compliance to ART, anxiety, QOL, & practices in home care management of PLHIV with their socio-demographic and clinical variables.
Research Hypotheses
H1- There will be a significant increase in the knowledge on self care, attitude, and practices in home care management of PLHIV with Self Care Intervention Guidelines (SCIG) than the PLHIV without SCIG as measured by questionnaire, likert scale & checklist.
H2-There will be a significant reduction in anxiety, improvement in compliance to ART, & QOL of PLHIV with SCIG than the PLHIV without SCIG as measured by State Trait Anxiety Inventory (STAI) Scale, Morisky Medication Adherence Scale
( MMAS), and patient recall & pill count and World Health Organization Quality Of Life BREF (WHOQOL-BREF) scale respectively.
H3- knowledge on self care, attitude, compliance to ART, anxiety, QOL, has significant relationship with the practices in home care management of PLHIV.
H4- There will be a significant association between the pretest scores of knowledge on self care, attitude, compliance to ART, anxiety, QOL, & practices in home care management of PLHIV and their selected socio-demographic and clinical variables.
This study will be done at ART Clinic, CMC, Vellore, to develop and assess the effectiveness of Self Care Intervention Guidelines (SCIG) on knowledge on self care, attitude, anxiety, compliance to ART, QOL and practices in home care management of PLHIV who are taking ART. The targeted sample size is 148 i.e.74 in each group. Systematic random sampling technique will be used to choose the eligible subjects for the study. Block randomization will be done to allocate subjects into experimental and control group. The control group subjects will receive the standard care and SCIG will be administered as intervention to subjects in the experimental group. For subjects in both the groups, data will be collected at 3 time points i.e. pretest, post-test I at 4-6th week (2nd month) and post-test II at 12-14 weeks (4th month). Data will be analyzed using SPSS version 20.
研究设计
- 研究类型
- Interventional
- 分配方式
- Permuted block randomization, fixed
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •PLHIV who are; •able to speak and read Tamil or English •on ART •between the age of 18 and 65 irrespective of their clinical stage.
排除标准
- •PLHIV who are; •on anxiolytic drugs •having psychiatric illness.
- •(Diagnosed by the Psychiatrist) •unwilling to give written consent •with co-existing severe, chronic debilitating diseases such as COPD, cancer, renal disease.
- •â€¢with dementia.
结局指标
主要结局
oImprovement in knowledge on self care, attitude, compliance to ART, quality of life,and practices in home care management of minor illnesses.
时间窗: At 4th week and 12th week after the intervention.
oReduction in anxiety
时间窗: At 4th week and 12th week after the intervention.
次要结局
未报告次要终点