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OpenTrials
Completed

NCT Number: NCT04522128

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.

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Key information

Conditions

COVID Behavior Quality of Life Social Behavior Social Isolation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Manchester - online

Manchester, Cheshire, M13 9PT, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Change in World Health Organisation Quality of Life Combination

    Time frame: Change from baseline quality of life to 2 weeks post intervention

    Measure of quality of life, score ranges from 0-100 per domain, with a higher score indicating greater quality of life

  2. Change in World Health Organisation Quality of Life Combination

    Time frame: Change from baseline quality of life to 3 months post intervention

    Measure of quality of life, score ranges from 0-100 per domain, with a higher score

  3. Change in World Health Organisation Quality of Life Combination

    Time frame: Change from baseline quality of life to 6 months post intervention

    Measure of quality of life, score ranges from 0-100 per domain, with a higher score

Secondary outcomes

  1. Change in The Lubben Social Network Scale

    Time frame: Change from baseline social isolation to 2 weeks post intervention

    Measure of social isolation, score ranges between 0 and 30, with a higher score indicating more social engagement.

  2. Change in The Lubben Social Network Scale

    Time frame: Change from baseline social isolation to 3 months post intervention

    Measure of social isolation, score ranges between 0 and 30, with a higher score indicating more social engagement.

  3. Change in The Lubben Social Network Scale

    Time frame: Change from baseline social isolation to 6 months post intervention

    Measure of social isolation, score ranges between 0 and 30, with a higher score indicating more social engagement.

  4. Change in 6-Item Loneliness Scale

    Time frame: Change from baseline loneliness to 2 weeks post intervention

    Measure of loneliness, score ranges between 0 and 50, with a higher score indicating less loneliness.

  5. Change in 6-Item Loneliness Scale

    Time frame: Change from baseline loneliness to 3 months post intervention

    Measure of loneliness, score ranges between 0 and 50, with a higher score indicating less loneliness.

  6. Change in 6-Item Loneliness Scale

    Time frame: Change from baseline loneliness to 6 months post intervention

    Measure of loneliness, score ranges between 0 and 50, with a higher score indicating less loneliness.

  7. Quality of Life Importance Ratings

    Time frame: Change from baseline importance to 2 weeks post intervention

    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.

  8. Quality of Life Importance Ratings

    Time frame: Change from baseline importance to 3 months post intervention

    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.

  9. Quality of Life Importance Ratings

    Time frame: Change from baseline importance to 6 months post intervention

    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.

Sponsors and collaborators

Lead sponsor

University of Manchester

Other

Registry information

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Aug 21, 2020
Registry last updated
Sep 30, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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