The Living With a Long-Term Condition Study

Obesity Clinical Trial

— LTC  

Official title:

Testing the Reliability and Validity of a New Measure for Illness-related Distress.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06072287
• Other study ID #: HR/DP-22/23-36320
• Status: Recruiting
• Start date: June 28, 2023
• Est. completion date: January 10, 2024

Study information

• Verified date: September 2023
• Source: King's College London
• Contact: Natasha Seaton, MSc
• Phone: 0207 188 1189
• Email: LTC-study[@]kcl.ac.uk
• Is FDA regulated: No
• Study type: Observational

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: January 10, 2024
• Est. primary completion date: December 31, 2023
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• AIDS
• Amyotrophic Lateral Sclerosis
• Anemia, Sickle Cell
• Arthritis
• Asthma
• Atrial Fibrillation
• Cancer
• Celiac Disease
• Cerebrovascular Disorders
• CKD
• Copd
• Cystic Fibrosis
• Dementia
• Diabetes
• Eczema
• Endometriosis
• Epilepsy
• Fibromyalgia
• Heart Diseases
• Heart Failure
• Hepatitis
• Hidradenitis
• Hidradenitis Suppurativa
• High Blood Pressure
• Hiv
• Hypertension
• IBD
• IBS
• Liver Diseases
• Long COVID
• Lupus Erythematosus
• ME/CFS
• Migraine
• MND (Motor Neurone DIsease)
• Motor Neuron Disease
• Multiple Sclerosis
• Nervous System Diseases
• Neurological Disorder
• Obesity
• Osteoarthritis
• Osteoporosis
• Pain
• Parkinson Disease
• PCOS
• Postural Orthostatic Tachycardia Syndrome
• Rheumatoid Arthritis
• Sickle Cell Disease
• Spondylitis
• Stroke
• Tachycardia

Intervention

Diagnostic Test:
• Living with LTC Questionnaire
A questionnaire that will ask about demographic information, mental wellbeing and distress related to chronic illness.

Locations

Country	Name	City	State
United Kingdom	King's College London	London

Sponsors (1)

Lead Sponsor	Collaborator
King's College London

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Illness-related distress	31 item questionnaire developed by the research team designed to assess illness-related distresss.	Week 0 and Week 1
Secondary	Depression	Eight-item Patient Health Questionnaire - 8 (PHQ-8) Minimum=0, maximum=24, with higher scores indicating greater depression.	Week 0
Secondary	Anxiety	Seven-item Generalised Anxiety Disorder Scale (GAD-7). Minimum=0, maximum=21, with higher scores indicating greater anxiety.	Week 0
Secondary	Functional impairment	Five-item Work and Social Adjustment Scale (WSAS). Minimum=0, maximum=50, with higher scores indicating greater functional impairment.	Week 0
Secondary	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.	Week 0
Secondary	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.	Week 0
Secondary	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.	Week 0

External Links

•   Study information and sign up