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Completed

NCT Number: NCT02935452

Implementing and Evaluating the Genie Tool in COPD

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.

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Key information

Conditions

COPD Chronic Disease Disease Attributes Emphysema Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Southampton

Southampton, United Kingdom

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

GENIE - social networking tool

Behavioral

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.

Primary outcomes

  1. Changes in EQ ED From Baseline to 3 Months Endpoint

    Time frame: 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.

  2. Changes in the Symptom Burden of Disease From Baseline to 3 Months

    Time frame: 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.

  3. Changes in Quality of Life (Mood) From Baseline to 3 Month Endpoint

    Time frame: 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.

  4. Changes in Quality of Life (Anxiety) From Baseline to 3 Month Endpoint

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Southampton

Other

Collaborators

  • Solent NHS Trust

Registry information

Official study title

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

Acronym: GeCop

Important dates

Study start
2017
Primary completion
2017
Study completion
2018
First posted
Oct 17, 2016
Registry last updated
Feb 17, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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