Implementing and Evaluating the GENIE Tool in Southampton Integrated COPD Service: A Clinical Trial to Ascertain Cost Effectiveness and Patient Benefit
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Changes in EQ ED From Baseline to 3 Months Endpoint
研究概览
简要总结
The Generating Engagement in Network Involvement (GENIE) Tool is designed to support people to find and join social activities in their own neighbourhoods.
Evidence has shown that people with more social support have increased ability to manage long term conditions and ill health.
Patients with Chronic Obstructive Lung Disease (COPD) have difficulty breathing every day; this is both tiring and makes its difficult to socialise as they did prior to having their condition. COPD can be managed with medicines, and exercise, but will never be cured, so it is considered a 'long term condition.'
This study plans to use a social mapping tool (GENIE) with COPD patients that are already part of the community service. The aim of the study is to increase opportunities to socialise and get day to day support outside of the health service.
Patients will be offered either the tool, or usual care.
If the study is successful then use of health care may reduce in the COPD patients already using the COPD service.
详细描述
The main aim here is to increase long term health care management options in Solent NHS ( National Health Service) Trust by building social capacity to support self-management. The GENIE tool will be introduced into the COPD service to improve options for social groups and exercise when leaving a pulmonary rehabilitation group, or when clinically unable to participate in exercise. The implementation of the GENIE tool aims;
- to build social networking awareness and the importance of utilising existing social resources in the professional and voluntary members of the COPD service
- to use social network mapping techniques and preference elicitation to engage COPD patients in reflecting on their support preferences and needs, help them access further resources and knowledge
- Evaluate the success of the social mapping techniques (GENIE) in the COPD patient population
- Evaluate the cost benefit to the health service of the GENIE in the COPD patient population
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
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
- •Adults over 18 with a predominant diagnosis of COPD
- •Ability to understand spoken English
- •Attending PR assessment/ enrolled in Pulmonary Rehabilitation (PR) or maintenance therapy
- •Ability and capacity to make their own decision and consent freely
排除标准
- •No clear COPD diagnosis
- •Inability to consent
结局指标
主要结局
Changes in EQ ED From Baseline to 3 Months Endpoint
时间窗: Baseline and change at 3 months
A quality of life indicator, for pre and post Genie in intervention and pre and post usual care. The scale is 0 to 4, the highest quality life is 0, which means the participant has no problem. The reduction means an improvement in life quality of life.
Changes in Quality of Life (Anxiety) From Baseline to 3 Month Endpoint
时间窗: Baseline and change at 3 months
GAD-7 (Generalised anxiety score), the scale is 0 to 21, the best score is 0, participants does not have anxiety. The reduction is an improvement in anxiety.
Changes in the Symptom Burden of Disease From Baseline to 3 Months
时间窗: Baseline with change at 3 months
COPD Assessment Tool (CAT) Score, the scale is 0 to 5, 0 is the best score, the participant has no symptoms. The reduction is improvement with the symptoms.
Changes in Quality of Life (Mood) From Baseline to 3 Month Endpoint
时间窗: Baseline and change at 3 months
PHQ-9 ( depression score), the scale is 0 to 27, the best score is 0, which means the participant does not have depression at all. The reduction of the score means an improvement in mood.
次要结局
未报告次要终点