Clinical trial NCT06072287: The Living With a Long-Term Condition Study
Official title: Testing the Reliability and Validity of a New Measure for Illness-related Distress.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Asthma
Atrial Fibrillation
Cancer
Cerebrovascular Disorders
Stroke
CKD
Copd
Fibromyalgia
Pain
Heart Diseases
Heart Disease Chronic
Dementia
Diabetes
Epilepsy
Heart Failure
High Blood Pressure
Hypertension
Hiv
AIDS
IBD
IBS
Liver Diseases
Long COVID
Lupus Erythematosus
Multiple Sclerosis
Obesity
Osteoarthritis
Arthritis
Rheumatoid Arthritis
Osteoporosis
Parkinson Disease
Sickle Cell Disease
Hepatitis
Endometriosis
PCOS
Neurological Disorder
POTS - Postural Orthostatic Tachycardia Syndrome
MND (Motor Neurone DIsease)
Cystic Fibrosis
Migraine
Spondylitis
Celiac Disease
Hidradenitis Suppurativa
Eczema
ME/CFS
Keywords: mental health
depression
anxiety
chronic illness
Lead sponsor: King's College London
Sponsor class: OTHER
First posted: 2023-10-10
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults in the UK with a diagnosis of a Long-Term Condition or chronic illness.

Brief 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 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* Under the age of 18
* Not living in the UK
* No self-reported diagnosis of an LTC
* Inability to complete questionnaires in English

Primary outcomes:
measure: Illness-related distress
timeFrame: Week 0 and Week 1
Secondary outcomes:
measure: Depression
timeFrame: Week 0
measure: Anxiety
timeFrame: Week 0
measure: Functional impairment
timeFrame: Week 0
measure: Diabetes Related Distress Scale
timeFrame: Week 0
measure: IBD Distress Scale
timeFrame: Week 0
measure: Cognitive and Behavioural Responses to Symptoms
timeFrame: Week 0
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: King's College London
Study officials:
affiliation: King's College London
name: Rona Moss-Morris, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: King's College London
name: Annie Jones, PhD
role: STUDY_DIRECTOR
affiliation: King's College London
name: Emma Jenkinson, MSc
role: STUDY_DIRECTOR
affiliation: King's College London
name: Natasha Seaton, MSc
role: STUDY_DIRECTOR
References: