Clinical trial NCT02935452: Implementing and Evaluating the Genie Tool in COPD
Official title: Implementing and Evaluating the GENIE Tool in Southampton Integrated COPD Service: A Clinical Trial to Ascertain Cost Effectiveness and Patient Benefit
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: COPD
Emphysema
Keywords: Self-management
Supportive self-management
Normalisation process theory
Social networks
Lead sponsor: University of Southampton
Sponsor class: OTHER
Collaborators: name: Solent NHS Trust
First posted: 2016-10-17
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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: 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

Eligibility criteria: 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

Primary outcomes:
measure: Changes in EQ ED From Baseline to 3 Months Endpoint
timeFrame: Baseline and change at 3 months
measure: Changes in the Symptom Burden of Disease From Baseline to 3 Months
timeFrame: Baseline with change at 3 months
measure: Changes in Quality of Life (Mood) From Baseline to 3 Month Endpoint
timeFrame: Baseline and change at 3 months
measure: Changes in Quality of Life (Anxiety) From Baseline to 3 Month Endpoint
timeFrame: Baseline and change at 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Southampton
country: United Kingdom
facility: University of Southampton
Study officials:
affiliation: University of Southampton
name: Lindsay Ms Welch, Masters
role: PRINCIPAL_INVESTIGATOR
References:
citation: Welch L, Orlando R, Lin SX, Vassilev I, Rogers A. Findings from a pilot randomised trial of a social network self-management intervention in COPD. BMC Pulm Med. 2020 Jun 8;20(1):162. doi: 10.1186/s12890-020-1130-1.
citation: Bloom I, Welch L, Vassilev I, Rogers A, Jameson K, Cooper C, Robinson S, Baird J. Findings from an exploration of a social network intervention to promote diet quality and health behaviours in older adults with COPD: a feasibility study. Pilot Feasibility Stud. 2020 Feb 6;6:15. doi: 10.1186/s40814-020-0553-z. eCollection 2020.