Does Quality of Life Decline During the COVID-19 Pandemic and Can we Change Behaviour to Improve Poor Quality of Life?

Study Overview
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Brief Summary
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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
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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.

Official Title
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Does Quality of Life Decline During the COVID-19 Pandemic and Can we Change Behaviour to Improve Poor Quality of Life?

Conditions
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COVID, Quality of Life, Behavior, Social Isolation

Intervention / Treatment
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* Behavioral: Behaviour Change Technique Intervention to Improve Quality of Life


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Feedback Intervention<br>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. | Behavioral: Behaviour Change Technique Intervention to Improve Quality of Life<br>* 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.<br>|
| Experimental: Extended Intervention<br>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. | Behavioral: Behaviour Change Technique Intervention to Improve Quality of Life<br>* 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.<br>|
| Other: Waitlist Control<br>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. | Behavioral: Behaviour Change Technique Intervention to Improve Quality of Life<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 from baseline quality of life to 2 weeks post intervention | 
| 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 from baseline quality of life to 3 months post intervention | 
| 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 from baseline quality of life to 6 months post intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 from baseline social isolation to 2 weeks post intervention | 
| 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 from baseline social isolation to 3 months post intervention | 
| 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 from baseline social isolation to 6 months post intervention | 
| Change in 6-Item Loneliness Scale | Measure of loneliness, score ranges between 0 and 50, with a higher score indicating less loneliness. | Change from baseline loneliness to 2 weeks post intervention | 
| Change in 6-Item Loneliness Scale | Measure of loneliness, score ranges between 0 and 50, with a higher score indicating less loneliness. | Change from baseline loneliness to 3 months post intervention | 
| Change in 6-Item Loneliness Scale | Measure of loneliness, score ranges between 0 and 50, with a higher score indicating less loneliness. | Change from baseline loneliness to 6 months post intervention | 
| 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. | Change from baseline importance to 2 weeks post intervention | 
| 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. | Change from baseline importance to 3 months post intervention | 
| 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. | Change from baseline importance to 6 months post intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COVID, Behaviour Change, Prevention, Quality of Life, Social Isolation