The Living With a Long-Term Condition Study

Recruiting

• Conditions: Hypertension; Stroke; Pain; Diabetes; Atrial Fibrillation; Cerebrovascular Disorders; Epilepsy; Obesity; Cancer; CKD
• Interventions: Diagnostic Test: Living with LTC Questionnaire

• Registration Number: NCT06072287
• Lead Sponsor: King's College London

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 Timeline

• Study Start: 2023-06-28
• Status Verified: 2023-09
• Study First Submitted: 2023-10-02
• Study First Submitted QC: 2023-10-02
• Study First Posted: 2023-10-10
• Last Update Submitted: 2023-10-10
• Last Update Posted: 2023-10-12
• Primary Completion: 2023-12-31
• Study Completion: 2024-01-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 600

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Participants	Living with LTC Questionnaire	Participants will answer two short questionnaires, 1 week apart.

Primary Outcome Measures

Name	Time	Method
Illness-related distress	Week 0 and Week 1	31 item questionnaire developed by the research team designed to assess illness-related distresss.

Secondary Outcome Measures

Name	Time	Method
Cognitive and Behavioural Responses to Symptoms	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.
Depression	Week 0	Eight-item Patient Health Questionnaire - 8 (PHQ-8) Minimum=0, maximum=24, with higher scores indicating greater depression.
Anxiety	Week 0	Seven-item Generalised Anxiety Disorder Scale (GAD-7). Minimum=0, maximum=21, with higher scores indicating greater anxiety.
Functional impairment	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	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	Week 0	IBD Distress Scale, a 28 item self-report IBD related distress questionnaire. Minimum=29, maximum=145, with higher scores indicating greater distress.

Trial Locations

Locations (1)

King's College London; 🇬🇧 London, United Kingdom