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

Quality of Life Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04522128
• Other study ID #: 2020-9463-15184
• Status: Completed
• Phase: N/A
• Start date: May 22, 2020
• Est. completion date: September 1, 2021

Study information

• Verified date: September 2021
• Source: University of Manchester
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 274
• Est. completion date: September 1, 2021
• Est. primary completion date: September 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Behavior
• COVID
• COVID-19
• Quality of Life
• Social Isolation

Intervention

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.

Locations

Country	Name	City	State
United Kingdom	University of Manchester - online	Manchester	Cheshire

Sponsors (1)

Lead Sponsor	Collaborator
University of Manchester

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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