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Implementing and Evaluating the Genie Tool in COPD (GeCop)

Primary Purpose

COPD, Emphysema

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
GENIE - social networking tool
Sponsored by
University of Southampton
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for COPD focused on measuring Self-management, Supportive self-management, Normalisation process theory, Social networks

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Southampton

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Genie

Normal Care

Arm Description

This group will have the Genie social tool delivered on a one to one basis at discharge points in the study.

This group will have the same questionaires at discharge, but will be offered normal care

Outcomes

Primary Outcome Measures

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.
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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
August 25, 2016
Last Updated
January 29, 2021
Sponsor
University of Southampton
Collaborators
Solent NHS Trust
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1. Study Identification

Unique Protocol Identification Number
NCT02935452
Brief Title
Implementing and Evaluating the Genie Tool in COPD
Acronym
GeCop
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

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
June 8, 2017 (Actual)
Primary Completion Date
November 30, 2017 (Actual)
Study Completion Date
January 20, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Southampton
Collaborators
Solent NHS Trust

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COPD, Emphysema
Keywords
Self-management, Supportive self-management, Normalisation process theory, Social networks

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Genie
Arm Type
Active Comparator
Arm Description
This group will have the Genie social tool delivered on a one to one basis at discharge points in the study.
Arm Title
Normal Care
Arm Type
No Intervention
Arm Description
This group will have the same questionaires at discharge, but will be offered normal care
Intervention Type
Behavioral
Intervention Name(s)
GENIE - social networking tool
Intervention Description
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 Outcome Measure Information:
Title
Changes in EQ ED From Baseline to 3 Months Endpoint
Description
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
Title
Changes in the Symptom Burden of Disease From Baseline to 3 Months
Description
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
Title
Changes in Quality of Life (Mood) From Baseline to 3 Month Endpoint
Description
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
Title
Changes in Quality of Life (Anxiety) From Baseline to 3 Month Endpoint
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lindsay Ms Welch, Masters
Organizational Affiliation
University of Southampton
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Southampton
City
Southampton
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32513163
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.
Results Reference
result
PubMed Identifier
32042439
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.
Results Reference
result

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Implementing and Evaluating the Genie Tool in COPD

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