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The Living With a Long-Term Condition Study

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 Unknown
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Observational
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT06072287
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 King's College London
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Rona Moss-Morris, PhDAnnie Jones, PhDEmma Jenkinson, MScNatasha Seaton, MSc
Principal Investigator Affiliation King's College LondonKing's College LondonKing's College LondonKing's College London
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Other
Overall Status Recruiting
Countries United Kingdom
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 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
Study Website: View Trial Website
Additional Details

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.

Arms & Interventions

Arms

: Participants

Participants will answer two short questionnaires, 1 week apart.

Interventions

Diagnostic Test: - Living with LTC Questionnaire

A questionnaire that will ask about demographic information, mental wellbeing and distress related to chronic illness.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

King's College London, London, United Kingdom

Status

Recruiting

Address

King's College London

London, , SE1 9RT

Site Contact

Natasha Seaton, MSc

natasha.seaton@kcl.ac.uk

0207 188 1189

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