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

NCT04522128 | Completed

• 1 other identifier: 2020-9463-15184
• Study Type: interventional
• Target: 274
• Locations: 1 country
• Sites: 1

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.

Conditions

COVID; Quality of Life; Behavior; Social Isolation

Keywords

COVID; Behaviour Change; Prevention; Quality of Life; Social Isolation

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (9)

• Change in The Lubben Social Network Scale

  Change from baseline social isolation to 2 weeks post intervention

• Change in The Lubben Social Network Scale

  Change from baseline social isolation to 3 months post intervention

• Change in The Lubben Social Network Scale

  Change from baseline social isolation to 6 months post intervention

• Change in 6-Item Loneliness Scale

  Change from baseline loneliness to 2 weeks post intervention

• Change in 6-Item Loneliness Scale

  Change from baseline loneliness to 3 months post intervention

Study Arms (3)

Feedback Intervention

ACTIVE COMPARATOR

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

Extended Intervention

EXPERIMENTAL

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

Waitlist Control

OTHER

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

Interventions

Behaviour Change Technique Intervention to Improve Quality of Life BEHAVIORAL

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.

Extended Intervention; Feedback Intervention; Waitlist Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults aged 18+ years
• Living in United Kingdom during COVID-19 pandemic.

You may not qualify if:

• English language - all participants are required to be able to read and understand English to participate.

Sponsors & Collaborators

• University of Manchester: lead

Study Sites (1)

University of Manchester - online

Manchester, Cheshire, M13 9PT, United Kingdom

Location

MeSH Terms

Conditions

Behavior; Social Isolation

Condition Hierarchy (Ancestors)

Social Behavior

Study Officials

• Tracy Epton

  University of Manchester

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Study Record Dates

• First Submitted: May 12, 2020
• First Posted: August 21, 2020
• Study Start: May 22, 2020
• Primary Completion: September 1, 2021
• Study Completion: September 1, 2021
• Last Updated: September 30, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)