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

Sponsor
University of Manchester (Other)
Overall Status
Completed
CT.gov ID
NCT04522128
Collaborator
(none)
274
1
3
15.3
17.9

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Behaviour Change Technique Intervention to Improve Quality of Life
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
274 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Other
Official Title:
Does Quality of Life Decline During the COVID-19 Pandemic and Can we Change Behaviour to Improve Poor Quality of Life?
Actual Study Start Date :
May 22, 2020
Actual Primary Completion Date :
Sep 1, 2021
Actual Study Completion Date :
Sep 1, 2021

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Change in World Health Organisation Quality of Life Combination [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 [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 [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 Outcome Measures

  1. Change in The Lubben Social Network Scale [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 [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 [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 [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 [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 [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 [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 [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 [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Manchester - online Manchester Cheshire United Kingdom M13 9PT

Sponsors and Collaborators

  • University of Manchester

Investigators

  • Principal Investigator: Tracy Epton, University of Manchester

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Tracy Epton, Lecturer, University of Manchester
ClinicalTrials.gov Identifier:
NCT04522128
Other Study ID Numbers:
  • 2020-9463-15184
First Posted:
Aug 21, 2020
Last Update Posted:
Sep 30, 2021
Last Verified:
Sep 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Tracy Epton, Lecturer, University of Manchester
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 30, 2021