The Living With a Long-Term Condition Study (LTC)

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ClinicalTrials.gov Identifier: NCT06072287

Recruitment Status : Recruiting

First Posted : October 10, 2023

Last Update Posted : October 12, 2023

See Contacts and Locations

View this study on the modernized ClinicalTrials.gov

Sponsor:

Information provided by (Responsible Party):

King's College London

Tracking Information

First Submitted Date

October 2, 2023

First Posted Date

October 10, 2023

Last Update Posted Date

October 12, 2023

Actual Study Start Date

June 28, 2023

Estimated Primary Completion Date

December 31, 2023 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures

Illness-related distress [ Time Frame: Week 0 and Week 1 ]

31 item questionnaire developed by the research team designed to assess illness-related distresss.

Original Primary Outcome Measures

Illness-related distress [ Time Frame: Week 0 and Week 1 ]

Change History

Current Secondary Outcome Measures

Depression [ Time Frame: Week 0 ]
Eight-item Patient Health Questionnaire - 8 (PHQ-8) Minimum=0, maximum=24, with higher scores indicating greater depression.
Anxiety [ Time Frame: Week 0 ]
Seven-item Generalised Anxiety Disorder Scale (GAD-7). Minimum=0, maximum=21, with higher scores indicating greater anxiety.
Functional impairment [ Time Frame: Week 0 ]
Five-item Work and Social Adjustment Scale (WSAS). Minimum=0, maximum=50, with higher scores indicating greater functional impairment.
Diabetes Related Distress Scale [ Time Frame: Week 0 ]
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.
IBD Distress Scale [ Time Frame: Week 0 ]
IBD Distress Scale, a 28 item self-report IBD related distress questionnaire. Minimum=29, maximum=145, with higher scores indicating greater distress.
Cognitive and Behavioural Responses to Symptoms [ Time Frame: Week 0 ]
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.

Original Secondary Outcome Measures

Depression [ Time Frame: Week 0 ]
Eight-item Patient Health Questionnaire - 8 (PHQ-8)
Anxiety [ Time Frame: Week 0 ]
Seven-item Generalised Anxiety Disorder Scale (GAD-7)
Functional impairment [ Time Frame: Week 0 ]
Five-item Work and Social Adjustment Scale (WSAS)
Diabetes Related Distress Scale [ Time Frame: Week 0 ]
Diabetes Related Distress Scale (DDS-17), a 17 item self-report diabetes related distress questionnaire.
IBD Distress Scale [ Time Frame: Week 0 ]
IBD Distress Scale, a 28 item self-report IBD related distress questionnaire.
Cognitive and Behavioural Responses to Symptoms [ Time Frame: Week 0 ]
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.

Current Other Pre-specified Outcome Measures

Not Provided

Original Other Pre-specified Outcome Measures

Not Provided

Descriptive Information

Brief Title

The Living With a Long-Term Condition Study

Official Title

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

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.

Study Type

Observational

Study Design

Observational Model: Cohort
Time Perspective: Prospective

Target Follow-Up Duration

Not Provided

Biospecimen

Not Provided

Sampling Method

Non-Probability Sample

Study Population

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

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

Intervention

Diagnostic Test: Living with LTC Questionnaire

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

Study Groups/Cohorts

Participants

Participants will answer two short questionnaires, 1 week apart.

Intervention: Diagnostic Test: Living with LTC Questionnaire

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status

Recruiting

Estimated Enrollment

600

Original Estimated Enrollment

Same as current

Estimated Study Completion Date

January 10, 2024

Estimated Primary Completion Date

December 31, 2023 (Final data collection date for primary outcome measure)

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

Sex/Gender

Sexes Eligible for Study:

All

Ages

18 Years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Not Provided

Contacts

Contact: Natasha Seaton, MSc	0207 188 1189	LTC-study@kcl.ac.uk
Contact: Natasha Seaton, MSc	0207 188 1189	natasha.seaton@kcl.ac.uk

Listed Location Countries

United Kingdom

Removed Location Countries

Administrative Information

NCT Number

NCT06072287

Other Study ID Numbers

HR/DP-22/23-36320

Has Data Monitoring Committee

U.S. FDA-regulated Product

Studies a U.S. FDA-regulated Drug Product:	No
Studies a U.S. FDA-regulated Device Product:	No

IPD Sharing Statement

Plan to Share IPD:

Undecided

Current Responsible Party

King's College London

Original Responsible Party

Same as current

Current Study Sponsor

King's College London

Original Study Sponsor

Same as current

Collaborators

Not Provided

Investigators

Principal Investigator:	Rona Moss-Morris, PhD	King's College London
Study Director:	Annie Jones, PhD	King's College London
Study Director:	Emma Jenkinson, MSc	King's College London
Study Director:	Natasha Seaton, MSc	King's College London

PRS Account

King's College London

Verification Date

September 2023

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