A STUDY TO EVALUATE THE EFFECTIVENESS OF SHVAS HEALTH APP ON PHYSIOLOGICAL AND PSYCHOLOGICAL PARAMETERS OF PATIENTS WITH COPD AT SELECTED HOSPITALS OF HARYANA.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- The primary outcome of the study will be the change in both physiological and psychological parameters among COPD patients using Shvas Health App. For the physiological domain, the main outcome will be the reduction in dyspnea assessed by MMRC dyspnea scale. For the Psychological domain, the primary outcome will be the improvement in anxiety, depression and stress.
研究概览
简要总结
Chronic Obstructive Pulmonary Disease (COPD) is a significant global health concern, affecting millions of individuals worldwide. According to the Global Burden of Disease Study, the incidence of COPD is approximately 251 million cases globally, with significant morbidity and mortality associated with the disease. The World Health Organization (WHO) estimates that COPD is the third leading cause of death globally, accounting for 3.23 million deaths in 2019.
In India, the burden of COPD is substantial, with an estimated prevalence of around 5.8% among adults aged 30 years and older. A study published in 2022 highlighted the increasing incidence rates, particularly in urban areas due to pollution and smoking. The Indian government has identified COPD as a major public health issue, particularly in the context of rising air pollution levels and changing lifestyles
PROBLEM STATEMENT
“A study to evaluate the effectiveness of Shvas Health App on Physiological and Psychological parameters of patients with COPD at selected hospitals of Haryana.’’
OBJECTIVES
1. 1. To asses and compare the Physiological and Psychological parameters of patients with COPD before administration of Shvas Health App.
2. 2. To assess and compare the Physiological and Psychological parameters of patients with COPD after administration of Shvas Health App.
-
To determine relationship between Physiological and Psychological parameters of patients with COPD.
-
To determine the association of Physiological and Psychological parameters with selected variables of patients with COPD.
5. To determine the usability of Shvas Health App among COPD patients.
6. To determine the level of satisfaction of Shvas Health App among COPD patients.
HYPOTHESES
The following hypotheses will be tested at 0.05 level of significance.
H1: There will be a significant difference in mean post test Physiological parameters score among patients with COPD in experimental group & control group.
H1.1: There will be a significant difference in mean post test dyspnea score among patients with COPD in experimental group & control group.
H1.2: There will be a significant difference in mean posttest fatigue score among patients with COPD in experimental group & control group.
H1.3: There will be a significant difference in mean posttest sleep quality score among patients with COPD in experimental group & control group.
H1.4: There will be a significant difference in mean post test respiratory symptoms score among patients with COPD in experimental group & control group.
H1.5: There will be a significant difference in mean post test FEV1 score among patients with COPD in experimental group & control group.
H1.6: There will be a significant difference in mean post test FVC score among patients with COPD in experimental group & control group.
H2: There will be a significant difference in mean post test Psychological parameters score among patients with COPD in experimental & control group.
H2.1: There will be a significant difference in mean post test anxiety score among patients with COPD in experimental group & control group
H2.2: There will be a significant difference in mean post test depression score among patients with COPD in experimental group & control group
H2.2: There will be a significant difference in mean post test stress score among patients with COPD in experimental group & control group
H3: There will be a significant relationship between Physiological and Psychological parameters of patients with COPD in experimental group & control group.
H4: There will be a significant association of Physiological and Psychological parameters with selected variables of patients in experimental group & control group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 90.00 Year(s)（—）
- 性别
- All
入选标准
- •The study included COPD patients who will be
- •18 or above 18 years of age
- •willing to participate
- •able to understand Hindi or English.
- •capable of using a smart smartphone application.
排除标准
- •The study excluded COPD patients who would be
- •Severe ill, COPD patients with any malignancy and severe cardiovascular disorder.
- •Not capable of using a smartphone application.
结局指标
主要结局
The primary outcome of the study will be the change in both physiological and psychological parameters among COPD patients using Shvas Health App. For the physiological domain, the main outcome will be the reduction in dyspnea assessed by MMRC dyspnea scale. For the Psychological domain, the primary outcome will be the improvement in anxiety, depression and stress.
时间窗: 6 months
次要结局
未报告次要终点
研究者
Shakuntala
Maharishi Markandeshwar College of Nursing, Mullana, Ambala, (Haryana)