Implementing and Evaluating the Genie Tool in COPD

NCT02935452 | Completed Results

• 1 other identifier: 19175
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

COPD; Emphysema

Keywords

Self-management; Supportive self-management; Normalisation process theory; Social networks

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (2)

Genie

ACTIVE COMPARATOR

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

Behavioral: GENIE - social networking tool

Normal Care

NO INTERVENTION

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

Interventions

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.

Genie

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• No clear COPD diagnosis
• Inability to consent

Sponsors & Collaborators

• University of Southampton: lead
• Solent NHS Trust: collaborator

Study Sites (1)

University of Southampton

Southampton, United Kingdom

Location

Related Publications (2)

• 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.

  PMID: 32513163 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.

  PMID: 32042439 RESULT

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Emphysema

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Ms Lindsay Welch
• Organization: University of Southampton

lw13e14@soton.ac.uk

07881205106

Study Officials

• Lindsay Ms Welch, Masters

  University of Southampton

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 25, 2016
• First Posted: October 17, 2016
• Study Start: June 8, 2017
• Primary Completion: November 30, 2017
• Study Completion: January 20, 2018
• Last Updated: February 17, 2021
• Results First Posted: February 17, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)