The Living With a Long-Term Condition Study

Trial Title: The Living With a Long-Term Condition Study

NCT ID: NCT06072287

Condition: 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

Conditions: Official terms:
Spondylitis
Hidradenitis Suppurativa
Arthritis
Osteoporosis
Fibromyalgia
Liver Diseases
Cystic Fibrosis
Celiac Disease
Parkinson Disease
Multiple Sclerosis
Nervous System Diseases
Motor Neuron Disease
Amyotrophic Lateral Sclerosis
Cerebrovascular Disorders
Postural Orthostatic Tachycardia Syndrome
Endometriosis
Hypertension
Atrial Fibrillation
Heart Diseases
Tachycardia
Anemia, Sickle Cell
Hidradenitis

Conditions: Keywords:
mental health
depression
anxiety
chronic illness

Study type: Observational

Overall status: Recruiting

Study design:

Time perspective: Prospective

Intervention:

Intervention type: Diagnostic Test
Intervention name: Living with LTC Questionnaire
Description: A questionnaire that will ask about demographic information, mental wellbeing and distress related to chronic illness.
Arm group label: Participants

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.

Criteria for eligibility:

Study pop:
Adults in the UK with a diagnosis of a Long-Term Condition or chronic illness.

Sampling method: Non-Probability Sample
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

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Locations:

Facility:
Name: King's College London

Address:
City: London
Zip: SE1 9RT
Country: United Kingdom

Status: Recruiting

Contact:
Last name: Natasha Seaton, MSc

Phone: 0207 188 1189
Email: natasha.seaton@kcl.ac.uk

Contact backup:
Email: LTC-Study@kcl.ac.uk

Investigator:
Last name: Annie Jones, PhD
Email: Sub-Investigator

Investigator:
Last name: Emma Jenkinson, MSc
Email: Sub-Investigator

Investigator:
Last name: Rona Moss-Morris, PhD
Email: Principal Investigator

Investigator:
Last name: Joanna Hudson, PhD
Email: Sub-Investigator

Investigator:
Last name: Natasha Seaton, MSc
Email: Sub-Investigator

Start date: June 28, 2023

Completion date: January 10, 2024

Lead sponsor:
Agency: King's College London
Agency class: Other

Source: King's College London

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06072287
https://linktr.ee/ltc_study