Trial Outcomes & Findings for Implementing and Evaluating the Genie Tool in COPD (NCT NCT02935452)
NCT ID: NCT02935452
Last Updated: 2021-02-17
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
60 participants
Primary outcome timeframe
Baseline and change at 3 months
Results posted on
2021-02-17
Participant Flow
Participant milestones
| Measure |
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.
|
Normal Care
This group will have the same questionaires at discharge, but will be offered normal care
|
|---|---|---|
|
Overall Study
STARTED
|
30
|
30
|
|
Overall Study
COMPLETED
|
27
|
29
|
|
Overall Study
NOT COMPLETED
|
3
|
1
|
Reasons for withdrawal
| Measure |
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.
|
Normal Care
This group will have the same questionaires at discharge, but will be offered normal care
|
|---|---|---|
|
Overall Study
work and life commintment
|
3
|
1
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Genie
n=30 Participants
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.
|
Normal Care
n=30 Participants
This group will have the same questionaires at discharge, but will be offered normal care
|
Total
n=60 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=30 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=60 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=30 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=60 Participants
|
|
Age, Categorical
>=65 years
|
30 Participants
n=30 Participants
|
30 Participants
n=30 Participants
|
60 Participants
n=60 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=30 Participants
|
15 Participants
n=30 Participants
|
30 Participants
n=60 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=30 Participants
|
15 Participants
n=30 Participants
|
30 Participants
n=60 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
FEV1
|
0.56 litres
STANDARD_DEVIATION 0.23 • n=30 Participants
|
0.51 litres
STANDARD_DEVIATION 0.21 • n=30 Participants
|
0.53 litres
STANDARD_DEVIATION 0.22 • n=60 Participants
|
|
COPD Severity using GOLD Guidelines
Mild
|
8 Participants
n=30 Participants
|
5 Participants
n=30 Participants
|
13 Participants
n=60 Participants
|
|
COPD Severity using GOLD Guidelines
Moderate
|
11 Participants
n=30 Participants
|
9 Participants
n=30 Participants
|
20 Participants
n=60 Participants
|
|
COPD Severity using GOLD Guidelines
Severe
|
7 Participants
n=30 Participants
|
12 Participants
n=30 Participants
|
19 Participants
n=60 Participants
|
|
COPD Severity using GOLD Guidelines
Very Severe
|
4 Participants
n=30 Participants
|
3 Participants
n=30 Participants
|
7 Participants
n=60 Participants
|
|
COPD Severity using GOLD Guidelines
Unknown
|
0 Participants
n=30 Participants
|
1 Participants
n=30 Participants
|
1 Participants
n=60 Participants
|
|
Number of people who live with the participant
1 person live with
|
16 Participants
n=30 Participants
|
14 Participants
n=30 Participants
|
30 Participants
n=60 Participants
|
|
Number of people who live with the participant
2 people live with
|
14 Participants
n=30 Participants
|
12 Participants
n=30 Participants
|
26 Participants
n=60 Participants
|
|
Number of people who live with the participant
3 people or more live with
|
0 Participants
n=30 Participants
|
4 Participants
n=30 Participants
|
4 Participants
n=60 Participants
|
|
Number of regular visitors for the participants
no regular visitors
|
5 Participants
n=30 Participants
|
9 Participants
n=30 Participants
|
14 Participants
n=60 Participants
|
|
Number of regular visitors for the participants
1 - 4 regular visitors
|
17 Participants
n=30 Participants
|
9 Participants
n=30 Participants
|
26 Participants
n=60 Participants
|
|
Number of regular visitors for the participants
5-10 regular visitors
|
6 Participants
n=30 Participants
|
9 Participants
n=30 Participants
|
15 Participants
n=60 Participants
|
|
Number of regular visitors for the participants
more than 10 regular visitors
|
2 Participants
n=30 Participants
|
3 Participants
n=30 Participants
|
5 Participants
n=60 Participants
|
PRIMARY outcome
Timeframe: Baseline and change at 3 monthsA 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.
Outcome measures
| Measure |
Genie
n=27 Participants
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.
|
Normal Care
n=29 Participants
This group will have the same questionaires at discharge, but will be offered normal care
|
|---|---|---|
|
Changes in EQ ED From Baseline to 3 Months Endpoint
|
0.06 score on a scale
Standard Deviation 0.21
|
0.04 score on a scale
Standard Deviation 0.26
|
PRIMARY outcome
Timeframe: Baseline with change at 3 monthsCOPD 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.
Outcome measures
| Measure |
Genie
n=27 Participants
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.
|
Normal Care
n=29 Participants
This group will have the same questionaires at discharge, but will be offered normal care
|
|---|---|---|
|
Changes in the Symptom Burden of Disease From Baseline to 3 Months
|
-1.44 score on a scale
Standard Deviation 5.91
|
-0.14 score on a scale
Standard Deviation 6.31
|
PRIMARY outcome
Timeframe: Baseline and change at 3 monthsPHQ-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.
Outcome measures
| Measure |
Genie
n=27 Participants
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.
|
Normal Care
n=29 Participants
This group will have the same questionaires at discharge, but will be offered normal care
|
|---|---|---|
|
Changes in Quality of Life (Mood) From Baseline to 3 Month Endpoint
|
-0.69 score on a scale
Standard Deviation 5.39
|
0.4 score on a scale
Standard Deviation 2.14
|
PRIMARY outcome
Timeframe: Baseline and change at 3 monthsGAD-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.
Outcome measures
| Measure |
Genie
n=27 Participants
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.
|
Normal Care
n=29 Participants
This group will have the same questionaires at discharge, but will be offered normal care
|
|---|---|---|
|
Changes in Quality of Life (Anxiety) From Baseline to 3 Month Endpoint
|
-0.62 score on a scale
Standard Deviation 3.89
|
0.76 score on a scale
Standard Deviation 3.12
|
Adverse Events
Genie
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Normal Care
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place