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| Name | Class |
|---|---|
| Solent NHS Trust | OTHER_GOV |
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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.
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;
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Genie | Active Comparator | This 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 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lindsay Ms Welch, Masters | University of Southampton | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Southampton | Southampton | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32513163 | Result | 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. | |
| 32042439 | Result | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | Normal Care | This group will have the same questionaires at discharge, but will be offered normal care |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline and change at 3 months |
|
1 year
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ms Lindsay Welch | University of Southampton | 07881205106 | lw13e14@soton.ac.uk |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 26, 2017 | Nov 15, 2018 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| D004646 | Emphysema |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
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|
| BG001 | Normal Care | This group will have the same questionaires at discharge, but will be offered normal care |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| FEV1 | Mean | Standard Deviation | litres |
|
| COPD Severity using GOLD Guidelines | Count of Participants | Participants |
|
| Number of people who live with the participant | Count of Participants | Participants |
|
| Number of regular visitors for the participants | Count of Participants | Participants |
|
| OG001 | Normal Care | This group will have the same questionaires at discharge, but will be offered normal care |
|
|
| 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline with change at 3 months |
|
|
|
| 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline and change at 3 months |
|
|
|
| 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline and change at 3 months |
|
|
|
| 0 |
| 30 |
| 0 |
| 30 |
| 0 |
| 30 |
| EG001 | Normal Care | This group will have the same questionaires at discharge, but will be offered normal care | 0 | 30 | 0 | 30 | 0 | 30 |
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| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Severe |
|
| Very Severe |
|
| Unknown |
|