COPDGeCopNCT02935452
Implementing and Evaluating the Genie Tool in COPD
A study testing GENIE - social networking tool in people with COPD and Emphysema, run by University of Southampton at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- GENIE - social networking tool
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 8 Jun 2017to 20 Jan 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- No clear COPD diagnosis
- Inability to consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Implementing and Evaluating the GENIE Tool in Southampton Integrated COPD Service: A Clinical Trial to Ascertain Cost Effectiveness and Patient Benefit
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.
Read more
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.
Read the 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
- Being tested
- GENIE - social networking tool
- Keywords
- Self-management, Supportive self-management, Normalisation process theory, Social networks
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Emphysema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GENIE - social networking toolBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Genie | Active comparator | This group will have the Genie social tool delivered on a one to one basis at discharge points in the study. Receives: Behavioral: GENIE - social networking tool |
| Normal Care | No intervention | This group will have the same questionaires at discharge, but will be offered normal care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline and change at 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2016 (estimated)
- Study start8 Jun 2017
- Primary completion30 Nov 2017
- Study completion20 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for COPDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southampton
- Sponsor type
- University, hospital or other
- Collaborators
- Solent NHS Trust
- Responsible party
- Sponsor
- Investigators
- Lindsay Ms Welch, Masters, Principal investigator, University of Southampton
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02935452
- Sponsor's protocol ID
- 19175
- Acronym
- GeCop
- Status last verified
- Jan 2021
- First submitted
- 25 Aug 2016
- Last updated
- 17 Feb 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 32513163Bloom 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.
PubMed 32042439
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementing and Evaluating the GENIE Tool in Southampton Integrated COPD Service: A Clinical Trial to Ascertain Cost Effectiveness and Patient Benefit
- ClinicalTrials.gov ID
- NCT02935452
- Acronym / sponsor ID
- GeCop / 19175
- Keywords
- Self-management, Supportive self-management, Normalisation process theory, Social networks
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of SouthamptonUniversity, hospital or other
- Collaborators
- Solent NHS Trust
- Study start
- 8 Jun 2017 (actual)
- Primary completion
- 30 Nov 2017 (actual)
- Study completion
- 20 Jan 2018 (actual)
- First posted
- 17 Oct 2016 (estimated)
- Results
- Posted 17 Feb 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Genie | Active comparator | Behavioral: GENIE - social networking toolThis group will have the Genie social tool delivered on a one to one basis at discharge points in the study. |
| Normal Care | No intervention | –This group will have the same questionaires at discharge, but will be offered normal care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- No clear COPD diagnosis
- Inability to consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GENIE - social networking toolGENIE 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. | Behavioural | Genie |
Primary outcome
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.
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.
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.
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 32513163Welch 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.
- Results publication: PubMed 32042439Bloom 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lindsay Ms Welch, Masters principal investigator
University of Southampton
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GENIE - social networking tool in people with COPD and Emphysema, run by University of Southampton at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Feb 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in EQ ED From Baseline to 3 Months Endpoint (time frame: Baseline and change at 3 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02935452, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2021; AzTrials last refreshed its copy on 28 Oct 2026.