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Quality Of LIfe Tool for IBD (QOLITI)

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ClinicalTrials.gov Identifier: NCT02707068
Recruitment Status : Completed
First Posted : March 14, 2016
Last Update Posted : March 6, 2017
Sponsor:
Collaborator:
Guy's and St Thomas' NHS Foundation Trust
Information provided by (Responsible Party):
King's College London

Brief Summary:
This study seeks to test the feasibility of a self-management manual with minimal telephone support by a healthcare professional. The study will also explore the acceptability of the intervention manual to patients.

Condition or disease Intervention/treatment Phase
Inflammatory Bowel Disease Behavioral: Quality Of LIfe Tool for IBD (QOLITI) Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 62 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Quality Of LIfe Tool for IBD (QOLITI): Pilot Testing of a Self-administered Intervention to Target Psychological Distress in Inflammatory Bowel Disease
Study Start Date : January 2016
Actual Primary Completion Date : November 2016
Actual Study Completion Date : November 2016

Arm Intervention/treatment
Experimental: QOLITI

Intervention group receives the QOLITI ("Quality Of LIfe Tool for IBD") manual immediately to work with over the course of several weeks along with 3 x 30 minutes of telephone support by a trained healthcare professional. Telephone calls will occur at two, four and six weeks post-randomisation.

Participants will be invited to discuss their experiences after the end of the actual study. These interviews are no obligatory part of the QOLITI study.

Behavioral: Quality Of LIfe Tool for IBD (QOLITI)
The cognitive-behavioural therapy (CBT)-inspired manual will contain several chapters each of which addresses a different topic with information, guidance in setting goals for behaviour change and accompanying tasks to aid implementation which will be completed at home in the participant's own time. Key themes are likely to include symptom management, dealing with social implications of the disease and interacting effectively with healthcare professionals among others. Each chapter will address a theme providing information, sign posting to appropriate organisations, step-by-step tasks and quotes from pwIBD among others, drawing on relevant therapeutic approaches for self-management including CBT and certain elements of Acceptance and Commitment Therapy.

No Intervention: Waitlist Control group (WLC)
Waitlist control group waits until after the study finishes to receive the same manual, but without telephone support sessions.



Primary Outcome Measures :
  1. Feasibility [ Time Frame: within 2 weeks of potential participants getting in touch (i.e. once at the beginning of the study) ]
    Percentage of patients eligible

  2. Acceptability [ Time Frame: within 2 weeks of potential participants getting in touch (i.e. once at the beginning of the study) ]
    Percentage of eligible patients consenting

  3. Effectiveness: Change in depression [ Time Frame: within 2 weeks of obtaining consent as well as 10 weeks post-randomisation ]
    Assessing whether depression levels have changed from pre- to post-intervention (Patient Health Questionnaire, PHQ-9)

  4. Acceptability: Change in numbers of participants throughout the trial [ Time Frame: 2 weeks of obtaining consent compared to 10 weeks post-randomisation ]
    Percentage of consenting eligible participants retained until completion

  5. Effectiveness: Change in anxiety [ Time Frame: within 2 weeks of obtaining consent as well as 10 weeks post-randomisation ]
    Assessing whether anxiety levels have changed from pre- to post-intervention (Generalised Anxiety Disorder 7-item scale, GAD-7)

  6. Effectiveness: Change in generic quality of life [ Time Frame: within 2 weeks of obtaining consent as well as 10 weeks post-randomisation ]
    Assessing whether generic quality of life levels have changed from pre- to post-intervention (EQ-5D-5L)

  7. Effectiveness: Change in Inflammatory Bowel Disease - specific quality of life [ Time Frame: within 2 weeks of obtaining consent as well as 10 weeks post-randomisation ]
    Assessing whether IBD-specific quality of life levels have changed from pre- to post-intervention (Inflammatory Bowel Disease Questionnaire, IBDQ)


Secondary Outcome Measures :
  1. Semi-structured qualitative interviews [ Time Frame: at 12 weeks post-randomisation ]
    semi-structured qualitative interviews of up to 30 minutes to obtain retrospective appraisal of the intervention (i.e. content and layout), conducted by a person independent of the research group, transcribed data will be analysed based on principles of grounded theory

  2. Change in fatigue [ Time Frame: within 2 weeks of obtaining consent as well as 10 weeks post-randomisation ]
    Assessing whether fatigue levels have changed from pre- to post-intervention (Chalder Fatigue Scale, CFS)

  3. Change in illness perception [ Time Frame: within 2 weeks of obtaining consent as well as 10 weeks post-randomisation ]
    Assessing whether illness perception has changed from pre- to post-intervention (Illness Perception Questionnaire, IPQ-R)

  4. Change in disease activity [ Time Frame: within 2 weeks of obtaining consent as well as 10 weeks post-randomisation ]
    Assessing whether subjective levels if disease activity have changed from pre- to post-intervention (patient-modified Simple Clinical Colitis Activity Index, p-SCCAI)

  5. Change in disease activity [ Time Frame: within 2 weeks of obtaining consent as well as 10 weeks post-randomisation ]
    Assessing whether subjective levels if disease activity have changed from pre- to post-intervention (Crohn's Disease Activity Index for research surveys, CDAI for research surveys)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Participants with must have a diagnosis of IBD,
  • be over 18 years of age as well as able to read and understand English fluently.
  • Informed consent must be obtained.

Exclusion Criteria:

  • Participants are not eligible for the study, if they do not fulfil the inclusion criteria.
  • Suicidal patients will be directly referred to liaison psychiatry or their GP and will not be able to access the study as the intensity of the manual intervention is within the low-moderate range and thus not suitable to address severe symptoms appropriately.

Information from the National Library of Medicine

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): NCT02707068


Locations
United Kingdom
Health Psychology Section, Psychology Dept, Institute of Psychiatry, King's College London
London, United Kingdom, SE1 9RT
Sponsors and Collaborators
King's College London
Guy's and St Thomas' NHS Foundation Trust
Investigators
Principal Investigator: Lynsady D Hughes, PhD King's College London

Publications:

Responsible Party: King's College London
ClinicalTrials.gov Identifier: NCT02707068     History of Changes
Other Study ID Numbers: RJ116/N006
First Posted: March 14, 2016    Key Record Dates
Last Update Posted: March 6, 2017
Last Verified: April 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: The investigators seek to publish the results of the study which are going to be based on group statistics only, i.e. no individual patient data will be made available.

Keywords provided by King's College London:
Quality of Life
Self-help intervention

Additional relevant MeSH terms:
Intestinal Diseases
Inflammatory Bowel Diseases
Gastrointestinal Diseases
Digestive System Diseases
Gastroenteritis