Implementing and Evaluating the Genie Tool in COPD

Study Overview
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Brief Summary
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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.

Detailed Description
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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

Official Title
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Implementing and Evaluating the GENIE Tool in Southampton Integrated COPD Service: A Clinical Trial to Ascertain Cost Effectiveness and Patient Benefit

Conditions
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COPD, Emphysema

Intervention / Treatment
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* Behavioral: GENIE - social networking tool


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: No clear COPD diagnosis Inability to consent

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Genie<br>This group will have the Genie social tool delivered on a one to one basis at discharge points in the study. | Behavioral: GENIE - social networking tool<br>* GENIE is a way to help people think about the links they have with others to manage a health problem (local groups, friends, acquaintances, family members, professionals) and to reflect on their involvement in health and wellness activities and their ability to live an ordinary life with a long term condition. By using GENIE and thinking or talking through the GENIE mapping tool, individuals can visualize their network and can reflect on connections that provide value and resources for managing and where there are gaps in support- this might be social, practical or emotional as well as specifically related to a health condition.<br>|
| No Intervention: Normal Care<br>This group will have the same questionaires at discharge, but will be offered normal care | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in EQ ED From Baseline to 3 Months Endpoint | 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. | Baseline and change at 3 months | 
| Changes in the Symptom Burden of Disease From Baseline to 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. | Baseline with change at 3 months | 
| Changes in Quality of Life (Mood) From Baseline to 3 Month Endpoint | 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. | Baseline and change at 3 months | 
| Changes in Quality of Life (Anxiety) From Baseline to 3 Month Endpoint | 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. | Baseline and change at 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Self-management, Supportive self-management, Normalisation process theory, Social networks