Clinical trial NCT04522128: 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
Overall status: COMPLETED
Phase: NA
Conditions: COVID
Quality of Life
Behavior
Social Isolation
Keywords: COVID
Behaviour Change
Prevention
Quality of Life
Social Isolation
Lead sponsor: University of Manchester
Sponsor class: OTHER
First posted: 2020-08-21
Enrollment: 274
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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.

Primary outcomes:
measure: Change in World Health Organisation Quality of Life Combination
timeFrame: Change from baseline quality of life to 2 weeks post intervention
measure: Change in World Health Organisation Quality of Life Combination
timeFrame: Change from baseline quality of life to 3 months post intervention
measure: Change in World Health Organisation Quality of Life Combination
timeFrame: Change from baseline quality of life to 6 months post intervention
Secondary outcomes:
measure: Change in The Lubben Social Network Scale
timeFrame: Change from baseline social isolation to 2 weeks post intervention
measure: Change in The Lubben Social Network Scale
timeFrame: Change from baseline social isolation to 3 months post intervention
measure: Change in The Lubben Social Network Scale
timeFrame: Change from baseline social isolation to 6 months post intervention
measure: Change in 6-Item Loneliness Scale
timeFrame: Change from baseline loneliness to 2 weeks post intervention
measure: Change in 6-Item Loneliness Scale
timeFrame: Change from baseline loneliness to 3 months post intervention
measure: Change in 6-Item Loneliness Scale
timeFrame: Change from baseline loneliness to 6 months post intervention
measure: Quality of Life Importance Ratings
timeFrame: Change from baseline importance to 2 weeks post intervention
measure: Quality of Life Importance Ratings
timeFrame: Change from baseline importance to 3 months post intervention
measure: Quality of Life Importance Ratings
timeFrame: Change from baseline importance to 6 months post intervention
Other outcomes:
Locations:
city: Manchester
country: United Kingdom
facility: University of Manchester - online
state: Cheshire
Study officials:
affiliation: University of Manchester
name: Tracy Epton
role: PRINCIPAL_INVESTIGATOR
References: