COVIDNCT04522128

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

A study testing Behaviour Change Technique Intervention to Improve Quality of Life in people with COVID and Quality of Life, run by University of Manchester at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: COVID, Quality of Life, Behavior
What is being tested?: Behaviour Change Technique Intervention to Improve Quality of Life
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 274 participants
Where: 1 siteUnited Kingdom
Study dates: 22 May 2020to 1 Sep 2021
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

University of Manchester - online
Manchester, Cheshire, M13 9PT

Other trials in 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.

Read the detailed description

Conditions: COVID, Quality of Life, Behavior, Social Isolation
Being tested: Behaviour Change Technique Intervention to Improve Quality of Life
Keywords: COVID, Behaviour Change, Prevention, Quality of Life, Social Isolation
Medical subject headings: Behavior, Social Isolation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Behaviour Change Technique Intervention to Improve Quality of LifeBehavioural
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.

Study groups in NCT04522128
Study group	Role	What they receive
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. Receives: 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. Receives: 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. Receives: Behavioral: Behaviour Change Technique Intervention to Improve Quality of Life

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (9)

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.
Measured: Change from baseline social isolation to 2 weeks post intervention
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.
Measured: Change from baseline social isolation to 3 months post intervention
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.
Measured: Change from baseline social isolation to 6 months post intervention
Change in 6-Item Loneliness Scale
Measure of loneliness, score ranges between 0 and 50, with a higher score indicating less loneliness.
Measured: Change from baseline loneliness to 2 weeks post intervention
Change in 6-Item Loneliness Scale
Measure of loneliness, score ranges between 0 and 50, with a higher score indicating less loneliness.
Measured: Change from baseline loneliness to 3 months post intervention
Change in 6-Item Loneliness Scale
Measure of loneliness, score ranges between 0 and 50, with a higher score indicating less loneliness.
Measured: Change from baseline loneliness to 6 months post intervention
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.
Measured: Change from baseline importance to 2 weeks post intervention
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.
Measured: Change from baseline importance to 3 months post intervention
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.
Measured: Change from baseline importance to 6 months post intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

22 May 20201 Sep 2021

First posted21 Aug 2020
Study start22 May 2020
Primary completion1 Sep 2021
Study completion1 Sep 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for COVIDStudies of the same condition, open and under way.
More trials run by University of ManchesterThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 274 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04522128
Sponsor's protocol ID: 2020-9463-15184
Status last verified: Sep 2021
First submitted: 12 May 2020
Last updated: 30 Sep 2021
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: WHOQOL COMBI data cannot be shared with researchers outside of the research team.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 30 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Does Quality of Life Decline During the COVID-19 Pandemic and Can we Change Behaviour to Improve Poor Quality of Life?
ClinicalTrials.gov ID: NCT04522128
Acronym / sponsor ID: 2020-9463-15184
Conditions: COVID, Quality of Life, Behavior, Social Isolation
Keywords: COVID, Behaviour Change, Prevention, Quality of Life, Social Isolation
Study type: Interventional
Recruitment status: Completed
Enrolment: 274 participants (actual)
Lead sponsor: University of ManchesterUniversity, hospital or other
Study start: 22 May 2020 (actual)
Primary completion: 1 Sep 2021 (actual)
Study completion: 1 Sep 2021 (actual)
First posted: 21 Aug 2020 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 3

Arm	Type	Receives
Feedback Intervention	Active comparator	Behavioral: Behaviour Change Technique Intervention to Improve Quality of LifeAll 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.
Extended Intervention	Experimental	Behavioral: Behaviour Change Technique Intervention to Improve Quality of LifeAll 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.
Waitlist Control	Other	Behavioral: Behaviour Change Technique Intervention to Improve Quality of LifeAll 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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

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

Key exclusion criteria (1 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Behaviour Change Technique Intervention to Improve Quality of LifeThe 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.	Behavioural	Extended Intervention, Feedback Intervention, Waitlist Control

Primary outcome

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
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
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

9 secondary outcomes

Change in The Lubben Social Network Scale
Time frame: Change from baseline social isolation to 2 weeks post intervention
Change in The Lubben Social Network Scale
Time frame: Change from baseline social isolation to 3 months post intervention
Change in The Lubben Social Network Scale
Time frame: Change from baseline social isolation to 6 months post intervention
Change in 6-Item Loneliness Scale
Time frame: Change from baseline loneliness to 2 weeks post intervention
Change in 6-Item Loneliness Scale
Time frame: Change from baseline loneliness to 3 months post intervention
Change in 6-Item Loneliness Scale
Time frame: Change from baseline loneliness to 6 months post intervention
Quality of Life Importance Ratings
Time frame: Change from baseline importance to 2 weeks post intervention
Quality of Life Importance Ratings
Time frame: Change from baseline importance to 3 months post intervention
Quality of Life Importance Ratings
Time frame: Change from baseline importance to 6 months post intervention

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2021.
Individual participant dataSharing planned: No. WHOQOL COMBI data cannot be shared with researchers outside of the research team.

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Enrolling by invitation
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Tracy Epton principal investigator

University of Manchester

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Behaviour Change Technique Intervention to Improve Quality of Life in people with COVID and Quality of Life, run by University of Manchester at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in World Health Organisation Quality of Life Combination (time frame: Change from baseline quality of life to 2 weeks post intervention). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04522128.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2021.