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

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.

Study Overview

• Status: Completed
• Conditions: Quality of Life; COVID; Behavior; Social Isolation
• Intervention / Treatment: Behavioral: Behaviour Change Technique Intervention to Improve Quality of Life

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.

• Study Type: Interventional
• Enrollment (Actual): 274
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Cheshire
    • Manchester, Cheshire, United Kingdom, M13 9PT
      • University of Manchester - online

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Feedback Intervention; 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; 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.
Experimental: Extended Intervention; 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; 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.
Other: Waitlist Control; 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; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Manchester
• Investigators: Principal Investigator: Tracy Epton, University of Manchester

Study record dates

Study Major Dates

• Study Start (Actual): May 22, 2020
• Primary Completion (Actual): September 1, 2021
• Study Completion (Actual): September 1, 2021

Study Registration Dates

• First Submitted: May 12, 2020
• First Submitted That Met QC Criteria: August 20, 2020
• First Posted (Actual): August 21, 2020

Study Record Updates

• Last Update Posted (Actual): September 30, 2021
• Last Update Submitted That Met QC Criteria: September 29, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: Quality of Life; Prevention; COVID; Social Isolation; Behaviour Change
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: 2020-9463-15184

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: WHOQOL COMBI data cannot be shared with researchers outside of the research team.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No