CTRI/2025/12/098283尚未招募不适用
Effectiveness of a Structured Self-Management Intervention on Health-Related Quality of Life in Patients with Chronic Obstructive Pulmonary Disease (COPD) delivered in Primary Care Settings at Ballabgarh, Haryana: A quasi-experimental pragmatic trial
未提供2 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2025年12月10日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Health-related Quality of Life measured using St George Respiratory Questionnaire
研究概览
简要总结
| This is a quasi-experimental pragmatic trial to be |
| conducted at two Primary Health Centres (Chhainsa and Dayalpur) in the |
| Ballabgarh field practice area of AIIMS, New Delhi. The study will include 80 |
| adult patients with spirometry-confirmed COPD, with 40 participants enrolled |
| at each PHC. One PHC will serve as the intervention site, where a structured |
| self-management package will be delivered in addition to routine care, while |
| the other PHC will serve as the control site, where patients will continue to |
| receive treatment as per current practices. The structured intervention will |
| be delivered through face-to-face counselling sessions at baseline by the |
| investigator and pharmacist, supported by a health diary and educational |
| flyer. Monthly reinforcement visits will then be carried out at the |
| participants’ homes by trained health workers for 9 months. The intervention |
| includes counselling on recognition of exacerbations, medication adherence, |
| correct inhaler technique, lifestyle modification (smoking cessation, nutrition, |
| physical activity), stress management (breathing techniques and yoga), |
| vaccination counselling, and reduction of air pollution exposure. Baseline assessment will include sociodemographic details, |
| spirometry (FEV1 percent predicted), and health-related quality of life |
| measured using the St. George’s Respiratory Questionnaire (SGRQ). Follow-up |
| will consist of telephonic interviews at 3 and 6 months, and an endline |
| assessment at 9 months. The primary outcome is change in SGRQ score; |
| secondary outcomes include lung function, frequency of acute exacerbations, and |
| healthcare utilization. |
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 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Adult COPD patients confirmed by spirometry as per GOLD 2025 (post-bronchodilator FEV1/FVC less than 0.70).
排除标准
- •Contraindications for spirometry (eg.
- •decompensated heart failure, active TB, malignancy, haemoptysis of unknown origin, pneumothorax, recent MI or pulmonary embolus, recent eye surgery, recent thoracic or abdominal surgery) as reported by the patients, Critically ill patients, Patients who do not have functional phone in the household.
结局指标
主要结局
Health-related Quality of Life measured using St George Respiratory Questionnaire
时间窗: Baseline and endline (9 months)
次要结局
- FEV1 % predicted via spirometry(Baseline and endline (9 months))
- Healthcare utilization(At 3,6 & 9 months)
- Frequency of acute exacerbations of COPD(At 3,6 & 9 months)
研究者
Dr Palak Choudhary
AIIMS New Delhi
研究点 (2)
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