Evaluating the Feasibility, Acceptability and Pre Testing the Impact of a Self-management and Tele Monitoring Program for COPD Patients in Lebanon: Protocol for a Feasibility Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 30
- 主要终点
- Coverage
研究概览
简要总结
Chronic obstructive pulmonary disease (COPD) has a significant impact on quality of life and is costly to the health care system. It has been demonstrated that a self-management program improves quality of life, but programs are not universally available and telehealth interventions can provide home-based support, but have mixed results.
The aims of this study are to (1) assess the feasibility and acceptability of a 6 weeks' educational program related to self-management with remote monitoring for Lebanese COPD patients; (2) pre-test its impact on quality of life, emergency visits, and rate of rehospitalization, and (3) to make recommendations for a future randomized trial.
详细描述
This study aims to evaluate the feasibility, acceptability and pre-test the impact of a nursing consultation and tele-monitoring in Lebanon. It will be conducted at the Hôtel-Dieu de France (HDF) hospital, one of the largest university hospitals in Beirut, and will use quantitative and qualitative methods in pre- and post-intervention to collect data over a period of 3 months. Data will be collected by two researchers. A consent form will be signed by each participant prior to the intervention. Patients will be informed about the purpose of the study, the course of the intervention, and the freedom to withdraw from the study at any time. Their consent for the video recording will also be taken.
This study is the first to evaluate the application of telehealth to optimize COPD management in Lebanon. The results of this study will provide evidence regarding the efficacy and feasibility of this approach for Lebanese patients with moderate to severe COPD.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult,18 years of age or older
- •Male or female
- •Outpatient
- •With moderate (GOLD 2) or severe (Gold 3) COPD.
- •Cognitively capable, with an adequate health status to participate in the study according to the clinical consensus between nurses and physicians.
排除标准
- •Patients diagnosed with lung cancer
- •Patients who have cognitive problems related to memory loss or speech disorders that would not allow a constructive exchange
结局指标
主要结局
Coverage
时间窗: 2 month
Based on "levels of institutionalization". it is composed of 15 multiple-choice questions. Based on the average of the responses, the score will range from a low to high level of institutionalization.
Acceptability
时间窗: 2 month
Based on "Pre-Referral intervention team inventory" we have created our own evaluation grid composed of 9 questions. Answers ranged between strongly agree to strongly disagree.
Adoption
时间窗: 2 month
Based on "adoption of information technology innovation" we have created our own evaluation grid composed of 5 questions. Patient must choose one of the proposed answers that best suits him/her.
Adequacy
时间窗: 2 month
Based on "Parenting strategies questionnaire" we have created our own qualitative evaluation grid composed of three questions. the patient must assign a score to each question that varies between 0 and 10.
Fidelity
时间窗: 2 month
Fidelity will be assessed by comparing the protocol of the intervention with what will be done in the field.
Cost
时间窗: 2 month
Based on "Utilization and Cost Questionnaire" we have created our own qualitative evaluation grid composed of 4 questions.
次要结局
- Impact on quality of life(3 month)
- Rehospitalization rate(3 month)
- Emergency visit(3 month)
- Respiratory health status(3 month)
- Anxiety(3 month)
研究者
Rita Nohra
Principal Investigator
University of Paris 13