The Living With a Long-Term Condition Study (LTC)
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| ClinicalTrials.gov Identifier: NCT06072287 |
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Recruitment Status :
Recruiting
First Posted : October 10, 2023
Last Update Posted : October 12, 2023
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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.
| Condition or disease | Intervention/treatment |
|---|---|
| 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 | Diagnostic Test: Living with LTC Questionnaire |
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 |
| Estimated Enrollment : | 600 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Official Title: | Testing the Reliability and Validity of a New Measure for Illness-related Distress. |
| Actual Study Start Date : | June 28, 2023 |
| Estimated Primary Completion Date : | December 31, 2023 |
| Estimated Study Completion Date : | January 10, 2024 |
| Group/Cohort | Intervention/treatment |
|---|---|
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Participants
Participants will answer two short questionnaires, 1 week apart.
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Diagnostic Test: Living with LTC Questionnaire
A questionnaire that will ask about demographic information, mental wellbeing and distress related to chronic illness. |
- Illness-related distress [ Time Frame: Week 0 and Week 1 ]31 item questionnaire developed by the research team designed to assess illness-related distresss.
- 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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Sampling Method: | Non-Probability Sample |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06072287
| Contact: Natasha Seaton, MSc | 0207 188 1189 | LTC-study@kcl.ac.uk | |
| Contact: Natasha Seaton, MSc | 0207 188 1189 | natasha.seaton@kcl.ac.uk |
| United Kingdom | |
| King's College London | Recruiting |
| London, United Kingdom, SE1 9RT | |
| Contact: Natasha Seaton, MSc 0207 188 1189 natasha.seaton@kcl.ac.uk | |
| Contact LTC-Study@kcl.ac.uk | |
| Sub-Investigator: Annie Jones, PhD | |
| Sub-Investigator: Emma Jenkinson, MSc | |
| Principal Investigator: Rona Moss-Morris, PhD | |
| Sub-Investigator: Joanna Hudson, PhD | |
| Sub-Investigator: Natasha Seaton, MSc | |
| 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 |
| Responsible Party: | King's College London |
| ClinicalTrials.gov Identifier: | NCT06072287 |
| Other Study ID Numbers: |
HR/DP-22/23-36320 |
| First Posted: | October 10, 2023 Key Record Dates |
| Last Update Posted: | October 12, 2023 |
| Last Verified: | September 2023 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Undecided |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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mental health depression anxiety chronic illness |
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Multiple Sclerosis Motor Neuron Disease Amyotrophic Lateral Sclerosis Spondylitis Hidradenitis Suppurativa Arthritis Osteoporosis Fibromyalgia Cystic Fibrosis Liver Diseases Celiac Disease Parkinson Disease Nervous System Diseases Cerebrovascular Disorders Postural Orthostatic Tachycardia Syndrome |
Endometriosis Hypertension Atrial Fibrillation Heart Diseases Tachycardia Anemia, Sickle Cell Hidradenitis Vascular Diseases Cardiovascular Diseases Digestive System Diseases Joint Diseases Musculoskeletal Diseases Pathologic Processes Rheumatic Diseases Parkinsonian Disorders |