AsthmaLTCNCT06072287
The Living With a Long-Term Condition Study
An observational study of Asthma and Atrial Fibrillation, run by King's College London at 1 site in United Kingdom.
Trial summary
Psychological distress (anxiety and depression) is common in and experienced differently by people living with long-term health conditions (LTCs). Being able to measure whether psychological distress is related to living with a LTC would allow researchers and clinicians to provide interventions specifically tailored… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Asthma, Atrial Fibrillation, Cancer
- What is being tested?
- Living with LTC Questionnaire
- How many people
- 600 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 28 Jun 2023to 10 Jan 2024
- Phase
- Observational
- 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
- Adult, Older adult
Study population: Adults in the UK with a diagnosis of a Long-Term Condition or chronic illness.
Who may be able to join
- Over the age of 18
- Self-reported diagnosis of a Long-Term Condition
- UK resident
- Possession of an email address to enable all study procedures
- Sufficient command of written and spoken English to understand study procedures
Who cannot join
- Under the age of 18
- Not living in the UK
- No self-reported diagnosis of an LTC
- Inability to complete questionnaires in English
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
King's College London
London, SE1 9RT
Natasha Seaton, MSc, 0207 188 1189, natasha.seaton@kcl.ac.uk
LTC-Study@kcl.ac.uk
About this study
Official title: Testing the Reliability and Validity of a New Measure for Illness-related Distress.
Psychological distress (anxiety and depression) is common in and experienced differently by people living with long-term health conditions (LTCs). Being able to measure whether psychological distress is related to living with a LTC would allow researchers and clinicians to provide interventions specifically tailored to the challenges of living with a LTC and therefore provide the most appropriate support for these patients. Such a measure would also be useful in research to identify the presence of illness-related distress in different patient groups. This project will therefore create a new measure of illness-related distress that has applications for both research and clinical practice. This will involve the psychometric validation of the new illness-related distress measure to test how valid and reliable the measure is.
The aim of the project is to provide initial validation of the Illness Related Distress Scale in a community sample, recruited through online platforms. The objective of the study is to gather initial validity and reliability data for the scale.
Read the detailed description
Background: see brief summary
Project information:
This study will be conducted online with participants from the UK. A series of standardised questionnaires will be used alongside the new questionnaire.
Participants will be those who self-select to complete our survey by responding to advertisements. The invitation will include a link to the Qualtrics survey which includes the Participant Information Sheet, Eligibility Screening, Consent Form and Baseline Questionnaire.
After completing eligibility screening and consent, participants will complete the baseline questionnaire which will include brief demographics (highest education level, long-term condition diagnoses, ethnicity age and gender), the new measure we are testing (the Illness Related Distress Scale), as well as the Patient Health Questionnaire (PHQ-8), Generalised Anxiety Disorder Scale (GAD-7), the Work and Social Adjustment Scale (WSAS). The baseline questionnaire will only include the Inflammatory Bowel Disease Distress Scale (IBD-DS) and Diabetes Distress Scale (DDS) if participants indicate that they have a diagnosis of the relevant condition.
At 1 week follow-up, participants will be sent a Qualtrics link to complete our 1-week follow-up questionnaire which will include the new Illness-Related Distress Scale only.
Participants:
We are aiming to recruit 600-700 participants for the study.
- Conditions
- Asthma, Atrial Fibrillation, Cancer, Cerebrovascular Disorders, Stroke, CKD
- Being tested
- Living with LTC Questionnaire
- Keywords
- mental health, depression, anxiety, chronic illness
- Medical subject headings
- Asthma, Atrial Fibrillation, Neoplasms, Cerebrovascular Disorders, Stroke, Pulmonary Disease, Chronic Obstructive, Fibromyalgia, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Living with LTC QuestionnaireDiagnostic test
A questionnaire that will ask about demographic information, mental wellbeing and distress related to chronic illness.
| Study group | Role | What they receive |
|---|---|---|
| Participants | Participants will answer two short questionnaires, 1 week apart. Receives: Diagnostic Test: Living with LTC Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Illness-related distress
31 item questionnaire developed by the research team designed to assess illness-related distresss.
Measured: Week 0 and Week 1
Secondary outcomes (6)
Depression
Eight-item Patient Health Questionnaire - 8 (PHQ-8) Minimum=0, maximum=24, with higher scores indicating greater depression.
Measured: Week 0
Anxiety
Seven-item Generalised Anxiety Disorder Scale (GAD-7). Minimum=0, maximum=21, with higher scores indicating greater anxiety.
Measured: Week 0
Functional impairment
Five-item Work and Social Adjustment Scale (WSAS). Minimum=0, maximum=50, with higher scores indicating greater functional impairment.
Measured: Week 0
Diabetes Related Distress Scale
Diabetes Related Distress Scale (DDS-17), a 17 item self-report diabetes related distress questionnaire. Minimum=17, maximum=102, with higher scores indicating greater distress.
Measured: Week 0
IBD Distress Scale
IBD Distress Scale, a 28 item self-report IBD related distress questionnaire. Minimum=29, maximum=145, with higher scores indicating greater distress.
Measured: Week 0
Cognitive and Behavioural Responses to Symptoms
Cognitive Behavioural Responses to Symptoms Questionnaire, 40 item self-report questionnaire consisting of seven subscales with items scored on a 5 point scale. Higher scores correspond with stronger presence of the specific cognitive/behavioural response. The seven subscales refer to 1) fear avoidance, 2) catastrophising, 3) damage beliefs, 4) embarassment avoidance 5) symptom focussing 6) all-or-nothing behaviour and 7) avoidance/resting behaviour.
Measured: Week 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2023
- Study start28 Jun 2023
- Primary completion31 Dec 2023 (estimated)
- Study completion10 Jan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- King's College London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rona Moss-Morris, PhD, Principal investigator, King's College LondonAnnie Jones, PhD, Study director, King's College LondonEmma Jenkinson, MSc, Study director, King's College LondonNatasha Seaton, MSc, Study director, King's College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06072287
- Sponsor's protocol ID
- HR/DP-22/23-36320
- Acronym
- LTC
- Status last verified
- Sep 2023
- First submitted
- 2 Oct 2023
- Last updated
- 12 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testing the Reliability and Validity of a New Measure for Illness-related Distress.
- ClinicalTrials.gov ID
- NCT06072287
- Acronym / sponsor ID
- LTC / HR/DP-22/23-36320
- Conditions
- Asthma, Atrial Fibrillation, Cancer, Cerebrovascular Disorders, Stroke, CKD
- Keywords
- mental health, depression, anxiety, chronic illness
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- King's College LondonUniversity, hospital or other
- Study start
- 28 Jun 2023 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 10 Jan 2024 (estimated)
- First posted
- 10 Oct 2023 (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.
Psychological distress (anxiety and depression) is common in and experienced differently by people living with long-term health conditions (LTCs). Being able to measure whether psychological distress is related to living with a LTC would allow researchers and clinicians to provide interventions specifically tailored to the challenges of living with a LTC and therefore provide the most appropriate support for these patients. Such a measure would also be useful in research to identify the presence of illness-related distress in different patient groups. This project will therefore create a new measure of illness-related distress that has applications for both research and clinical practice. This will involve the psychometric validation of the new illness-related distress measure to test how valid and reliable the measure is.
The aim of the project is to provide initial validation of the Illness Related Distress Scale in a community sample, recruited through online platforms. The objective of the study is to gather initial validity and reliability data for the scale.
Detailed description
Background: see brief summary
Project information:
This study will be conducted online with participants from the UK. A series of standardised questionnaires will be used alongside the new questionnaire.
Participants will be those who self-select to complete our survey by responding to advertisements. The invitation will include a link to the Qualtrics survey which includes the Participant Information Sheet, Eligibility Screening, Consent Form and Baseline Questionnaire.
After completing eligibility screening and consent, participants will complete the baseline questionnaire which will include brief demographics (highest education level, long-term condition diagnoses, ethnicity age and gender), the new measure we are testing (the Illness Related Distress Scale), as well as the Patient Health Questionnaire (PHQ-8), Generalised Anxiety Disorder Scale (GAD-7), the Work and Social Adjustment Scale (WSAS). The baseline questionnaire will only include the Inflammatory Bowel Disease Distress Scale (IBD-DS) and Diabetes Distress Scale (DDS) if participants indicate that they have a diagnosis of the relevant condition.
At 1 week follow-up, participants will be sent a Qualtrics link to complete our 1-week follow-up questionnaire which will include the new Illness-Related Distress Scale only.
Participants:
We are aiming to recruit 600-700 participants for the study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants | – | Diagnostic Test: Living with LTC QuestionnaireParticipants will answer two short questionnaires, 1 week apart. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Adults in the UK with a diagnosis of a Long-Term Condition or chronic illness.
Key inclusion criteria (5 listed)
- Over the age of 18
- Self-reported diagnosis of a Long-Term Condition
- UK resident
- Possession of an email address to enable all study procedures
- Sufficient command of written and spoken English to understand study procedures
Key exclusion criteria (4 listed)
- Under the age of 18
- Not living in the UK
- No self-reported diagnosis of an LTC
- Inability to complete questionnaires in English
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 |
|---|---|---|
| Living with LTC QuestionnaireA questionnaire that will ask about demographic information, mental wellbeing and distress related to chronic illness. | Diagnostic test | Participants |
Primary outcome
Illness-related distress
Time frame: Week 0 and Week 1
31 item questionnaire developed by the research team designed to assess illness-related distresss.
6 secondary outcomes
Depression
Time frame: Week 0
Anxiety
Time frame: Week 0
Functional impairment
Time frame: Week 0
Diabetes Related Distress Scale
Time frame: Week 0
IBD Distress Scale
Time frame: Week 0
Cognitive and Behavioural Responses to Symptoms
Time frame: Week 0
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2023.
- Study information and sign upLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
Related trials for Asthma
Enrolling by invitationObservational study
Allergy, Asthma, and Atopic Eczema in Finland
Asthma, Asthma in Children
RecruitingPhase 2
Rademikibart IV for Acute Asthma and COPD Exacerbation
Asthma Acute, COPD Exacerbation Acute
Active, not recruiting
Community Health Equity Accelerator (CHEA) Pediatric Asthma Intervention
Asthma in Children
Enrolling by invitationObservational study
Firefighter's Longitudinal Airway and Respiratory Exposome/Multiome Study (FLARES)
Anosmia, Chronic Obstructive Pulmonary Disease
RecruitingObservational study
NHALES (Natural History of Asthma With Longitudinal Environmental Sampling)
Asthma
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.
Rona Moss-Morris, PhD principal investigator
King's College London
Annie Jones, PhD study director
King's College London
Emma Jenkinson, MSc study director
King's College London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Asthma and Atrial Fibrillation, run by King's College London 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 5 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 12 Oct 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Natasha Seaton, MSc (0207 188 1189, LTC-study@kcl.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Illness-related distress (time frame: Week 0 and Week 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Oct 2023.