See the published version of this preprint at Trials.
This is a preprint, a preliminary version of a manuscript that has not completed peer review at a journal. Research Square does not conduct peer review prior to posting preprints. The posting of a preprint on this server should not be interpreted as an endorsement of its validity or suitability for dissemination as established information or for guiding clinical practice.
Learn more about In Review
A new preprint design is coming!
We have improved readability, clarity, accessibility, and opportunities for engagement.
Study protocol
Christine Norton
King\'s College London
Corresponding Author
ORCiD: https://orcid.org/0000-0003-2259-0948
License:
This work is licensed under a CC BY 4.0 License. Read Full License
Background
Despite being in clinical remission, many people with Inflammatory Bowel Disease (IBD) live with fatigue, chronic abdominal pain and bowel urgency or incontinence that limit their quality of life. We aim to test the effectiveness of an online self-management programme (BOOST), developed using cognitive behavioural principles and a theoretically informed logic model, and delivered with facilitator support.
Primary research question
In people with IBD who report symptoms of fatigue, pain or urgency and express a desire for intervention, does a facilitator-supported tailored (to patient needs) online self-management programme for fatigue, pain and faecal urgency/incontinence improve IBD-related quality of life (measured using the UK-IBDQ) and global rating of symptom relief (0-10 scale) compared with care as usual?
Methods
A pragmatic two-arm, parallel group Randomised Controlled Trial (RCT), of a 12-session facilitator-supported online cognitive-behavioural self-management programme versus care as usual to manage symptoms of fatigue, pain, and faecal urgency/incontinence in IBD. Patients will be recruited through a previous large-scale survey of unselected people with inflammatory bowel disease. The UK Inflammatory Bowel Disease Questionnaire and global rating of symptom relief at 6 months are the co-primary outcomes, with multiple secondary outcomes measured also at 6 and 12 months post randomisation to assess maintenance. The RCT has an embedded pilot study, health economics evaluation and process evaluation.
We will randomise 680 patients, 340 in each group. Demographic characteristics and outcome measures will be presented for both study groups at baseline. The UK-IBDQ and global rating of symptom relief at 6 and 12 months post randomisation will be compared between the study groups.
Discussion
The BOOST online self-management programme for people with IBD-related symptoms of fatigue, pain and urgency has been designed to be easily scalable and implemented. If it is shown to improve patients’ quality of life, this trial will enable clinicians and patients to make informed management decisions. This is the first trial, to our knowledge, focused on multiple symptoms prioritised by both people with IBD and health professionals.
Trial registration
registered at ISRCTN, ID: ISRCTN71618461. Registered 09/09/2019. Available at: http://www.isrctn.com/ISRCTN71618461
Protocol version 3: 28.04.2020
Keywords
RCT, Inflammatory Bowel Disease, Crohn’s disease, ulcerative colitis, fatigue, pain, faecal incontinence, online self-management
Figure 1
This is a list of supplementary files associated with this preprint. Click to download.
Loading...
Badges
Prescreen
This manuscript passed our Prescreen assessment
Complete author information
Appropriate declaration statements
Potential risks to human health
Prescreen
Peer Review Timeline
CURRENT STATUS: Published
View the published article at Trials.
Version 1
Posted 07 Jun, 2021
No community comments so far
Editorial decision: Accept
On 15 Jul, 2021
Review #1 received
Received 10 Jul, 2021
Reviews received
Received 08 Jul, 2021
Reviewer #1 agreed
On 07 Jul, 2021
Reviewers invited
Invitations sent on 06 Jul, 2021
Editor assigned
On 23 May, 2021
Submission checks complete
On 23 May, 2021
First submitted
On 13 Nov, 2020
Metrics
Comments: 0
PDF Downloads: ...
HTML Views: ...
Learn more about our company.
A new preprint design is coming!
We have improved readability, clarity, accessibility, and opportunities for engagement.
See the published version of this preprint at Trials.
This is a preprint, a preliminary version of a manuscript that has not completed peer review at a journal. Research Square does not conduct peer review prior to posting preprints. The posting of a preprint on this server should not be interpreted as an endorsement of its validity or suitability for dissemination as established information or for guiding clinical practice.
Learn more about In Review
Study protocol
Christine Norton
King\'s College London
Corresponding Author
ORCiD: https://orcid.org/0000-0003-2259-0948
Badges
Prescreen
This manuscript passed our Prescreen assessment
Complete author information
Appropriate declaration statements
Potential risks to human health
Prescreen
Peer Review Timeline
CURRENT STATUS: Published
View the published article at Trials.
Version 1
Posted 07 Jun, 2021
No community comments so far
Editorial decision: Accept
On 15 Jul, 2021
Review #1 received
Received 10 Jul, 2021
Reviews received
Received 08 Jul, 2021
Reviewer #1 agreed
On 07 Jul, 2021
Reviewers invited
Invitations sent on 06 Jul, 2021
Editor assigned
On 23 May, 2021
Submission checks complete
On 23 May, 2021
First submitted
On 13 Nov, 2020
Metrics
Comments: 0
PDF Downloads: ...
HTML Views: ...
License:
This work is licensed under a CC BY 4.0 License. Read Full License
View the published article at Trials.
Background
Despite being in clinical remission, many people with Inflammatory Bowel Disease (IBD) live with fatigue, chronic abdominal pain and bowel urgency or incontinence that limit their quality of life. We aim to test the effectiveness of an online self-management programme (BOOST), developed using cognitive behavioural principles and a theoretically informed logic model, and delivered with facilitator support.
Primary research question
In people with IBD who report symptoms of fatigue, pain or urgency and express a desire for intervention, does a facilitator-supported tailored (to patient needs) online self-management programme for fatigue, pain and faecal urgency/incontinence improve IBD-related quality of life (measured using the UK-IBDQ) and global rating of symptom relief (0-10 scale) compared with care as usual?
Methods
A pragmatic two-arm, parallel group Randomised Controlled Trial (RCT), of a 12-session facilitator-supported online cognitive-behavioural self-management programme versus care as usual to manage symptoms of fatigue, pain, and faecal urgency/incontinence in IBD. Patients will be recruited through a previous large-scale survey of unselected people with inflammatory bowel disease. The UK Inflammatory Bowel Disease Questionnaire and global rating of symptom relief at 6 months are the co-primary outcomes, with multiple secondary outcomes measured also at 6 and 12 months post randomisation to assess maintenance. The RCT has an embedded pilot study, health economics evaluation and process evaluation.
We will randomise 680 patients, 340 in each group. Demographic characteristics and outcome measures will be presented for both study groups at baseline. The UK-IBDQ and global rating of symptom relief at 6 and 12 months post randomisation will be compared between the study groups.
Discussion
The BOOST online self-management programme for people with IBD-related symptoms of fatigue, pain and urgency has been designed to be easily scalable and implemented. If it is shown to improve patients’ quality of life, this trial will enable clinicians and patients to make informed management decisions. This is the first trial, to our knowledge, focused on multiple symptoms prioritised by both people with IBD and health professionals.
Trial registration
registered at ISRCTN, ID: ISRCTN71618461. Registered 09/09/2019. Available at: http://www.isrctn.com/ISRCTN71618461
Protocol version 3: 28.04.2020
Figure 1
This is a list of supplementary files associated with this preprint. Click to download.
Loading...