COPD, Emphysema
Conditions
Keywords
Self-management, Supportive self-management, Normalisation process theory, Social networks
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
Interventions
BEHAVIORALGENIE - social networking tool
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.
Sponsors
Solent NHS Trust
University of Southampton
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in EQ ED From Baseline to 3 Months Endpoint | 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 | 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 | 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 | 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. |
Countries
United Kingdom
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Genie This group will have the Genie social tool delivered on a one to one basis at discharge points in the study.
GENIE - social networking tool: 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. | 30 |
| Normal Care This group will have the same questionaires at discharge, but will be offered normal care | 30 |
| Total | 60 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | work and life commintment | 3 | 1 |
Baseline characteristics
| Characteristic | Genie | Normal Care | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 30 Participants | 30 Participants | 60 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| COPD Severity using GOLD Guidelines Mild | 8 Participants | 5 Participants | 13 Participants |
| COPD Severity using GOLD Guidelines Moderate | 11 Participants | 9 Participants | 20 Participants |
| COPD Severity using GOLD Guidelines Severe | 7 Participants | 12 Participants | 19 Participants |
| COPD Severity using GOLD Guidelines Unknown | 0 Participants | 1 Participants | 1 Participants |
| COPD Severity using GOLD Guidelines Very Severe | 4 Participants | 3 Participants | 7 Participants |
| FEV1 | 0.56 litres STANDARD_DEVIATION 0.23 | 0.51 litres STANDARD_DEVIATION 0.21 | 0.53 litres STANDARD_DEVIATION 0.22 |
| Number of people who live with the participant 1 person live with | 16 Participants | 14 Participants | 30 Participants |
| Number of people who live with the participant 2 people live with | 14 Participants | 12 Participants | 26 Participants |
| Number of people who live with the participant 3 people or more live with | 0 Participants | 4 Participants | 4 Participants |
| Number of regular visitors for the participants 1 - 4 regular visitors | 17 Participants | 9 Participants | 26 Participants |
| Number of regular visitors for the participants 5-10 regular visitors | 6 Participants | 9 Participants | 15 Participants |
| Number of regular visitors for the participants more than 10 regular visitors | 2 Participants | 3 Participants | 5 Participants |
| Number of regular visitors for the participants no regular visitors | 5 Participants | 9 Participants | 14 Participants |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Sex: Female, Male Female | 15 Participants | 15 Participants | 30 Participants |
| Sex: Female, Male Male | 15 Participants | 15 Participants | 30 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 30 | 0 / 30 |
| other Total, other adverse events | 0 / 30 | 0 / 30 |
| serious Total, serious adverse events | 0 / 30 | 0 / 30 |
Outcome results
Primary
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.
Time frame: Baseline and change at 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Genie | Changes in EQ ED From Baseline to 3 Months Endpoint | 0.06 score on a scale | Standard Deviation 0.21 |
| Normal Care | Changes in EQ ED From Baseline to 3 Months Endpoint | 0.04 score on a scale | Standard Deviation 0.26 |
Primary
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.
Time frame: Baseline and change at 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Genie | Changes in Quality of Life (Anxiety) From Baseline to 3 Month Endpoint | -0.62 score on a scale | Standard Deviation 3.89 |
| Normal Care | Changes in Quality of Life (Anxiety) From Baseline to 3 Month Endpoint | 0.76 score on a scale | Standard Deviation 3.12 |
Primary
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.
Time frame: Baseline and change at 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Genie | Changes in Quality of Life (Mood) From Baseline to 3 Month Endpoint | -0.69 score on a scale | Standard Deviation 5.39 |
| Normal Care | Changes in Quality of Life (Mood) From Baseline to 3 Month Endpoint | 0.4 score on a scale | Standard Deviation 2.14 |
Primary
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.
Time frame: Baseline with change at 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Genie | Changes in the Symptom Burden of Disease From Baseline to 3 Months | -1.44 score on a scale | Standard Deviation 5.91 |
| Normal Care | Changes in the Symptom Burden of Disease From Baseline to 3 Months | -0.14 score on a scale | Standard Deviation 6.31 |