Back to resultsDoes Quality of Life Decline During the COVID-19 Pandemic and Can we Change Behaviour to Improve Poor Quality of Life?
Primary Purpose
COVID, Quality of Life, Behavior
Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Behaviour Change Technique Intervention to Improve Quality of Life
Sponsored by
About this trial
This is an interventional other trial for COVID focused on measuring COVID, Behaviour Change, Prevention, Quality of Life, Social Isolation
Eligibility Criteria
Inclusion Criteria:
- Adults aged 18+ years
- Living in United Kingdom during COVID-19 pandemic.
Exclusion Criteria:
- English language - all participants are required to be able to read and understand English to participate.
Sites / Locations
- University of Manchester - online
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Experimental
Other
Arm Label
Feedback Intervention
Extended Intervention
Waitlist Control
Arm Description
All participants will complete an online questionnaire. This will include demographic information, social distancing/isolation history, The Lubben Social Network Scale, The 6-item Loneliness Scale, Ten-Item Personality Scale, Spontaneous Self-affirmation Scale, Brief Illness Perception Questionnaire and the WHOQoL COMBI plus importance of QOL facet questions. Participants randomly allocated to the feedback intervention will then be provided with graphs showing WHOQOL COMBI facet scores and their perceived importance ratings. The graphs will highlight where quality of life might be poor but important to the participant. Participants will be asked three questions (i.e. how could your QoL in this domain be improved, what resources would you need to make this change, what practical actions are needed to address the discrepancies in your QoL?) to help them plan how they might be able to improve quality of life currently rated as poor but important.
All participants will complete an online questionnaire (as described above). Participants randomly allocated to the extended intervention will then be provided with graphs to highlight differences between their actual WHOQoL COMBI scores and their perceived importance ratings. The graphs will highlight where quality of life might be poor but important to the participant. Participants will be asked three questions (i.e. how could your QoL in this domain be improved, what resources would you need to make this change, what practical actions are needed to address the discrepancies in your QoL?) to help them plan how they might be able to improve quality of life currently rated as poor but important. Participants will then receive an online intervention that will provide them with behaviour change techniques to help them address the discrepancies in the relevant quality of life domains.
All participants will complete an online questionnaire. This will include demographic information, social distancing/isolation history, The Lubben Social Network Scale, The 6-item Loneliness Scale, Ten-Item Personality Scale, Spontaneous Self-affirmation Scale, Brief Illness Perception Questionnaire and the WHOQoL COMBI plus importance of QOL facet questions. Participants randomly allocated to the waitlist control group will then receive their WHOQoL COMBI scores only, with no information about differences between quality of life and importance or intervention materials.
Outcomes
Primary Outcome Measures
Change in World Health Organisation Quality of Life Combination
Measure of quality of life, score ranges from 0-100 per domain, with a higher score indicating greater quality of life
Change in World Health Organisation Quality of Life Combination
Measure of quality of life, score ranges from 0-100 per domain, with a higher score
Change in World Health Organisation Quality of Life Combination
Measure of quality of life, score ranges from 0-100 per domain, with a higher score
Secondary Outcome Measures
Change in The Lubben Social Network Scale
Measure of social isolation, score ranges between 0 and 30, with a higher score indicating more social engagement.
Change in The Lubben Social Network Scale
Measure of social isolation, score ranges between 0 and 30, with a higher score indicating more social engagement.
Change in The Lubben Social Network Scale
Measure of social isolation, score ranges between 0 and 30, with a higher score indicating more social engagement.
Change in 6-Item Loneliness Scale
Measure of loneliness, score ranges between 0 and 50, with a higher score indicating less loneliness.
Change in 6-Item Loneliness Scale
Measure of loneliness, score ranges between 0 and 50, with a higher score indicating less loneliness.
Change in 6-Item Loneliness Scale
Measure of loneliness, score ranges between 0 and 50, with a higher score indicating less loneliness.
Quality of Life Importance Ratings
Measure of importance of different facets of quality of life, score ranges 0-200, with a higher score indicating greater importance of quality of life.
Quality of Life Importance Ratings
Measure of importance of different facets of quality of life, score ranges 0-200, with a higher score indicating greater importance of quality of life.
Quality of Life Importance Ratings
Measure of importance of different facets of quality of life, score ranges 0-200, with a higher score indicating greater importance of quality of life.
Full Information
NCT ID
NCT04522128
First Posted
May 12, 2020
Last Updated
September 29, 2021
Sponsor
University of Manchester
1. Study Identification
Unique Protocol Identification Number
NCT04522128
Brief Title
Does Quality of Life Decline During the COVID-19 Pandemic and Can we Change Behaviour to Improve Poor Quality of Life?
Official Title
Does Quality of Life Decline During the COVID-19 Pandemic and Can we Change Behaviour to Improve Poor Quality of Life?
Study Type
Interventional
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
May 22, 2020 (Actual)
Primary Completion Date
September 1, 2021 (Actual)
Study Completion Date
September 1, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Manchester
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 response to COVID-19 means social isolation/distancing for the majority of the UK. This has the potential to negatively affect all domains of quality of life (QoL). QoL can be improved by giving feedback on gaps between someone's perceived QoL in a domain and how important it is to them (plus prompting reflective questions). However, interventions that are designed to improve QoL may increase the effectiveness of this as optimised behaviour change techniques can be used. This study aims to develop and test a quality of life intervention during social isolation/distancing.
Detailed Description
The response to COVID-19 means social isolation/distancing for the majority of the UK. This has the potential to negatively affect all domains of quality of life (QoL). QoL can be improved by giving feedback on gaps between someone's perceived QoL in a domain and how important it is to them (plus prompting reflective questions). However, interventions that are designed to improve QoL may increase the effectiveness of this as optimised behaviour change techniques can be used. This study aims to develop and test a quality of life intervention during social isolation/distancing.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID, Quality of Life, Behavior, Social Isolation
Keywords
COVID, Behaviour Change, Prevention, Quality of Life, Social Isolation
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
274 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Feedback Intervention
Arm Type
Active Comparator
Arm Description
All participants will complete an online questionnaire. This will include demographic information, social distancing/isolation history, The Lubben Social Network Scale, The 6-item Loneliness Scale, Ten-Item Personality Scale, Spontaneous Self-affirmation Scale, Brief Illness Perception Questionnaire and the WHOQoL COMBI plus importance of QOL facet questions.
Participants randomly allocated to the feedback intervention will then be provided with graphs showing WHOQOL COMBI facet scores and their perceived importance ratings. The graphs will highlight where quality of life might be poor but important to the participant. Participants will be asked three questions (i.e. how could your QoL in this domain be improved, what resources would you need to make this change, what practical actions are needed to address the discrepancies in your QoL?) to help them plan how they might be able to improve quality of life currently rated as poor but important.
Arm Title
Extended Intervention
Arm Type
Experimental
Arm Description
All participants will complete an online questionnaire (as described above).
Participants randomly allocated to the extended intervention will then be provided with graphs to highlight differences between their actual WHOQoL COMBI scores and their perceived importance ratings. The graphs will highlight where quality of life might be poor but important to the participant. Participants will be asked three questions (i.e. how could your QoL in this domain be improved, what resources would you need to make this change, what practical actions are needed to address the discrepancies in your QoL?) to help them plan how they might be able to improve quality of life currently rated as poor but important.
Participants will then receive an online intervention that will provide them with behaviour change techniques to help them address the discrepancies in the relevant quality of life domains.
Arm Title
Waitlist Control
Arm Type
Other
Arm Description
All participants will complete an online questionnaire. This will include demographic information, social distancing/isolation history, The Lubben Social Network Scale, The 6-item Loneliness Scale, Ten-Item Personality Scale, Spontaneous Self-affirmation Scale, Brief Illness Perception Questionnaire and the WHOQoL COMBI plus importance of QOL facet questions.
Participants randomly allocated to the waitlist control group will then receive their WHOQoL COMBI scores only, with no information about differences between quality of life and importance or intervention materials.
Intervention Type
Behavioral
Intervention Name(s)
Behaviour Change Technique Intervention to Improve Quality of Life
Intervention Description
The intervention targets each facet of the five domains of WHOQOL COMBI. The intervention is based on the COM-B Framework (Michie et al., 2012) and utilises behaviour change techniques to help participants change their behaviour to improve their quality of life.
The intervention will be compared to an active comparator 'feedback intervention' and a waitlist control group.
Primary Outcome Measure Information:
Title
Change in World Health Organisation Quality of Life Combination
Description
Measure of quality of life, score ranges from 0-100 per domain, with a higher score indicating greater quality of life
Time Frame
Change from baseline quality of life to 2 weeks post intervention
Title
Change in World Health Organisation Quality of Life Combination
Description
Measure of quality of life, score ranges from 0-100 per domain, with a higher score
Time Frame
Change from baseline quality of life to 3 months post intervention
Title
Change in World Health Organisation Quality of Life Combination
Description
Measure of quality of life, score ranges from 0-100 per domain, with a higher score
Time Frame
Change from baseline quality of life to 6 months post intervention
Secondary Outcome Measure Information:
Title
Change in The Lubben Social Network Scale
Description
Measure of social isolation, score ranges between 0 and 30, with a higher score indicating more social engagement.
Time Frame
Change from baseline social isolation to 2 weeks post intervention
Title
Change in The Lubben Social Network Scale
Description
Measure of social isolation, score ranges between 0 and 30, with a higher score indicating more social engagement.
Time Frame
Change from baseline social isolation to 3 months post intervention
Title
Change in The Lubben Social Network Scale
Description
Measure of social isolation, score ranges between 0 and 30, with a higher score indicating more social engagement.
Time Frame
Change from baseline social isolation to 6 months post intervention
Title
Change in 6-Item Loneliness Scale
Description
Measure of loneliness, score ranges between 0 and 50, with a higher score indicating less loneliness.
Time Frame
Change from baseline loneliness to 2 weeks post intervention
Title
Change in 6-Item Loneliness Scale
Description
Measure of loneliness, score ranges between 0 and 50, with a higher score indicating less loneliness.
Time Frame
Change from baseline loneliness to 3 months post intervention
Title
Change in 6-Item Loneliness Scale
Description
Measure of loneliness, score ranges between 0 and 50, with a higher score indicating less loneliness.
Time Frame
Change from baseline loneliness to 6 months post intervention
Title
Quality of Life Importance Ratings
Description
Measure of importance of different facets of quality of life, score ranges 0-200, with a higher score indicating greater importance of quality of life.
Time Frame
Change from baseline importance to 2 weeks post intervention
Title
Quality of Life Importance Ratings
Description
Measure of importance of different facets of quality of life, score ranges 0-200, with a higher score indicating greater importance of quality of life.
Time Frame
Change from baseline importance to 3 months post intervention
Title
Quality of Life Importance Ratings
Description
Measure of importance of different facets of quality of life, score ranges 0-200, with a higher score indicating greater importance of quality of life.
Time Frame
Change from baseline importance to 6 months post intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Adults aged 18+ years
Living in United Kingdom during COVID-19 pandemic.
Exclusion Criteria:
English language - all participants are required to be able to read and understand English to participate.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tracy Epton
Organizational Affiliation
University of Manchester
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Manchester - online
City
Manchester
State/Province
Cheshire
ZIP/Postal Code
M13 9PT
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
WHOQOL COMBI data cannot be shared with researchers outside of the research team.
Learn more about this trial
Does Quality of Life Decline During the COVID-19 Pandemic and Can we Change Behaviour to Improve Poor Quality of Life?
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