Supported online self-management versus care as usual for symptoms of fatigue, pain and urgency/incontinence in adults with inflammatory bowel disease (IBD-BOOST): study protocol for a randomised controlled trial
Abstract 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), de...
Ausführliche Beschreibung
Autor*in: |
Christine Norton [verfasserIn] Jonathan Syred [verfasserIn] Sally Kerry [verfasserIn] Micol Artom [verfasserIn] Louise Sweeney [verfasserIn] Ailsa Hart [verfasserIn] Wladyslawa Czuber-Dochan [verfasserIn] Stephanie J. C. Taylor [verfasserIn] Borislava Mihaylova [verfasserIn] Chris Roukas [verfasserIn] Qasim Aziz [verfasserIn] Laura Miller [verfasserIn] Richard Pollok [verfasserIn] Sonia Saxena [verfasserIn] Imogen Stagg [verfasserIn] Helen Terry [verfasserIn] Zohra Zenasni [verfasserIn] Lesley Dibley [verfasserIn] Rona Moss-Morris [verfasserIn] |
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E-Artikel |
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Englisch |
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2021 |
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In: Trials - BMC, 2006, 22(2021), 1, Seite 18 |
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volume:22 ; year:2021 ; number:1 ; pages:18 |
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DOI / URN: |
10.1186/s13063-021-05466-4 |
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Katalog-ID: |
DOAJ049432346 |
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520 | |a Abstract 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 ISRCTN71618461 . Registered on 9 September 2019. | ||
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10.1186/s13063-021-05466-4 doi (DE-627)DOAJ049432346 (DE-599)DOAJ9a1b22eb331c40eebc16485552e1c93f DE-627 ger DE-627 rakwb eng R5-920 Christine Norton verfasserin aut Supported online self-management versus care as usual for symptoms of fatigue, pain and urgency/incontinence in adults with inflammatory bowel disease (IBD-BOOST): study protocol for a randomised controlled trial 2021 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Abstract 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 ISRCTN71618461 . Registered on 9 September 2019. RCT Inflammatory bowel disease Crohn’s disease Ulcerative colitis Fatigue Pain Medicine (General) Jonathan Syred verfasserin aut Sally Kerry verfasserin aut Micol Artom verfasserin aut Louise Sweeney verfasserin aut Ailsa Hart verfasserin aut Wladyslawa Czuber-Dochan verfasserin aut Stephanie J. C. Taylor verfasserin aut Borislava Mihaylova verfasserin aut Chris Roukas verfasserin aut Qasim Aziz verfasserin aut Laura Miller verfasserin aut Richard Pollok verfasserin aut Sonia Saxena verfasserin aut Imogen Stagg verfasserin aut Helen Terry verfasserin aut Zohra Zenasni verfasserin aut Lesley Dibley verfasserin aut Rona Moss-Morris verfasserin aut In Trials BMC, 2006 22(2021), 1, Seite 18 (DE-627)326173552 (DE-600)2040523-6 17456215 nnns volume:22 year:2021 number:1 pages:18 https://doi.org/10.1186/s13063-021-05466-4 kostenfrei https://doaj.org/article/9a1b22eb331c40eebc16485552e1c93f kostenfrei https://doi.org/10.1186/s13063-021-05466-4 kostenfrei https://doaj.org/toc/1745-6215 Journal toc kostenfrei GBV_USEFLAG_A SYSFLAG_A GBV_DOAJ SSG-OLC-PHA GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2003 GBV_ILN_2005 GBV_ILN_2009 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2055 GBV_ILN_2111 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 22 2021 1 18 |
spelling |
10.1186/s13063-021-05466-4 doi (DE-627)DOAJ049432346 (DE-599)DOAJ9a1b22eb331c40eebc16485552e1c93f DE-627 ger DE-627 rakwb eng R5-920 Christine Norton verfasserin aut Supported online self-management versus care as usual for symptoms of fatigue, pain and urgency/incontinence in adults with inflammatory bowel disease (IBD-BOOST): study protocol for a randomised controlled trial 2021 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Abstract 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 ISRCTN71618461 . Registered on 9 September 2019. RCT Inflammatory bowel disease Crohn’s disease Ulcerative colitis Fatigue Pain Medicine (General) Jonathan Syred verfasserin aut Sally Kerry verfasserin aut Micol Artom verfasserin aut Louise Sweeney verfasserin aut Ailsa Hart verfasserin aut Wladyslawa Czuber-Dochan verfasserin aut Stephanie J. C. Taylor verfasserin aut Borislava Mihaylova verfasserin aut Chris Roukas verfasserin aut Qasim Aziz verfasserin aut Laura Miller verfasserin aut Richard Pollok verfasserin aut Sonia Saxena verfasserin aut Imogen Stagg verfasserin aut Helen Terry verfasserin aut Zohra Zenasni verfasserin aut Lesley Dibley verfasserin aut Rona Moss-Morris verfasserin aut In Trials BMC, 2006 22(2021), 1, Seite 18 (DE-627)326173552 (DE-600)2040523-6 17456215 nnns volume:22 year:2021 number:1 pages:18 https://doi.org/10.1186/s13063-021-05466-4 kostenfrei https://doaj.org/article/9a1b22eb331c40eebc16485552e1c93f kostenfrei https://doi.org/10.1186/s13063-021-05466-4 kostenfrei https://doaj.org/toc/1745-6215 Journal toc kostenfrei GBV_USEFLAG_A SYSFLAG_A GBV_DOAJ SSG-OLC-PHA GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2003 GBV_ILN_2005 GBV_ILN_2009 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2055 GBV_ILN_2111 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 22 2021 1 18 |
allfields_unstemmed |
10.1186/s13063-021-05466-4 doi (DE-627)DOAJ049432346 (DE-599)DOAJ9a1b22eb331c40eebc16485552e1c93f DE-627 ger DE-627 rakwb eng R5-920 Christine Norton verfasserin aut Supported online self-management versus care as usual for symptoms of fatigue, pain and urgency/incontinence in adults with inflammatory bowel disease (IBD-BOOST): study protocol for a randomised controlled trial 2021 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Abstract 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 ISRCTN71618461 . Registered on 9 September 2019. RCT Inflammatory bowel disease Crohn’s disease Ulcerative colitis Fatigue Pain Medicine (General) Jonathan Syred verfasserin aut Sally Kerry verfasserin aut Micol Artom verfasserin aut Louise Sweeney verfasserin aut Ailsa Hart verfasserin aut Wladyslawa Czuber-Dochan verfasserin aut Stephanie J. C. Taylor verfasserin aut Borislava Mihaylova verfasserin aut Chris Roukas verfasserin aut Qasim Aziz verfasserin aut Laura Miller verfasserin aut Richard Pollok verfasserin aut Sonia Saxena verfasserin aut Imogen Stagg verfasserin aut Helen Terry verfasserin aut Zohra Zenasni verfasserin aut Lesley Dibley verfasserin aut Rona Moss-Morris verfasserin aut In Trials BMC, 2006 22(2021), 1, Seite 18 (DE-627)326173552 (DE-600)2040523-6 17456215 nnns volume:22 year:2021 number:1 pages:18 https://doi.org/10.1186/s13063-021-05466-4 kostenfrei https://doaj.org/article/9a1b22eb331c40eebc16485552e1c93f kostenfrei https://doi.org/10.1186/s13063-021-05466-4 kostenfrei https://doaj.org/toc/1745-6215 Journal toc kostenfrei GBV_USEFLAG_A SYSFLAG_A GBV_DOAJ SSG-OLC-PHA GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2003 GBV_ILN_2005 GBV_ILN_2009 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2055 GBV_ILN_2111 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 22 2021 1 18 |
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10.1186/s13063-021-05466-4 doi (DE-627)DOAJ049432346 (DE-599)DOAJ9a1b22eb331c40eebc16485552e1c93f DE-627 ger DE-627 rakwb eng R5-920 Christine Norton verfasserin aut Supported online self-management versus care as usual for symptoms of fatigue, pain and urgency/incontinence in adults with inflammatory bowel disease (IBD-BOOST): study protocol for a randomised controlled trial 2021 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Abstract 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 ISRCTN71618461 . Registered on 9 September 2019. RCT Inflammatory bowel disease Crohn’s disease Ulcerative colitis Fatigue Pain Medicine (General) Jonathan Syred verfasserin aut Sally Kerry verfasserin aut Micol Artom verfasserin aut Louise Sweeney verfasserin aut Ailsa Hart verfasserin aut Wladyslawa Czuber-Dochan verfasserin aut Stephanie J. C. Taylor verfasserin aut Borislava Mihaylova verfasserin aut Chris Roukas verfasserin aut Qasim Aziz verfasserin aut Laura Miller verfasserin aut Richard Pollok verfasserin aut Sonia Saxena verfasserin aut Imogen Stagg verfasserin aut Helen Terry verfasserin aut Zohra Zenasni verfasserin aut Lesley Dibley verfasserin aut Rona Moss-Morris verfasserin aut In Trials BMC, 2006 22(2021), 1, Seite 18 (DE-627)326173552 (DE-600)2040523-6 17456215 nnns volume:22 year:2021 number:1 pages:18 https://doi.org/10.1186/s13063-021-05466-4 kostenfrei https://doaj.org/article/9a1b22eb331c40eebc16485552e1c93f kostenfrei https://doi.org/10.1186/s13063-021-05466-4 kostenfrei https://doaj.org/toc/1745-6215 Journal toc kostenfrei GBV_USEFLAG_A SYSFLAG_A GBV_DOAJ SSG-OLC-PHA GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2003 GBV_ILN_2005 GBV_ILN_2009 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2055 GBV_ILN_2111 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 22 2021 1 18 |
allfieldsSound |
10.1186/s13063-021-05466-4 doi (DE-627)DOAJ049432346 (DE-599)DOAJ9a1b22eb331c40eebc16485552e1c93f DE-627 ger DE-627 rakwb eng R5-920 Christine Norton verfasserin aut Supported online self-management versus care as usual for symptoms of fatigue, pain and urgency/incontinence in adults with inflammatory bowel disease (IBD-BOOST): study protocol for a randomised controlled trial 2021 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Abstract 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 ISRCTN71618461 . Registered on 9 September 2019. RCT Inflammatory bowel disease Crohn’s disease Ulcerative colitis Fatigue Pain Medicine (General) Jonathan Syred verfasserin aut Sally Kerry verfasserin aut Micol Artom verfasserin aut Louise Sweeney verfasserin aut Ailsa Hart verfasserin aut Wladyslawa Czuber-Dochan verfasserin aut Stephanie J. C. Taylor verfasserin aut Borislava Mihaylova verfasserin aut Chris Roukas verfasserin aut Qasim Aziz verfasserin aut Laura Miller verfasserin aut Richard Pollok verfasserin aut Sonia Saxena verfasserin aut Imogen Stagg verfasserin aut Helen Terry verfasserin aut Zohra Zenasni verfasserin aut Lesley Dibley verfasserin aut Rona Moss-Morris verfasserin aut In Trials BMC, 2006 22(2021), 1, Seite 18 (DE-627)326173552 (DE-600)2040523-6 17456215 nnns volume:22 year:2021 number:1 pages:18 https://doi.org/10.1186/s13063-021-05466-4 kostenfrei https://doaj.org/article/9a1b22eb331c40eebc16485552e1c93f kostenfrei https://doi.org/10.1186/s13063-021-05466-4 kostenfrei https://doaj.org/toc/1745-6215 Journal toc kostenfrei GBV_USEFLAG_A SYSFLAG_A GBV_DOAJ SSG-OLC-PHA GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2003 GBV_ILN_2005 GBV_ILN_2009 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2055 GBV_ILN_2111 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 22 2021 1 18 |
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Christine Norton @@aut@@ Jonathan Syred @@aut@@ Sally Kerry @@aut@@ Micol Artom @@aut@@ Louise Sweeney @@aut@@ Ailsa Hart @@aut@@ Wladyslawa Czuber-Dochan @@aut@@ Stephanie J. C. Taylor @@aut@@ Borislava Mihaylova @@aut@@ Chris Roukas @@aut@@ Qasim Aziz @@aut@@ Laura Miller @@aut@@ Richard Pollok @@aut@@ Sonia Saxena @@aut@@ Imogen Stagg @@aut@@ Helen Terry @@aut@@ Zohra Zenasni @@aut@@ Lesley Dibley @@aut@@ Rona Moss-Morris @@aut@@ |
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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. 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R5-920 Supported online self-management versus care as usual for symptoms of fatigue, pain and urgency/incontinence in adults with inflammatory bowel disease (IBD-BOOST): study protocol for a randomised controlled trial RCT Inflammatory bowel disease Crohn’s disease Ulcerative colitis Fatigue Pain |
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Christine Norton Jonathan Syred Sally Kerry Micol Artom Louise Sweeney Ailsa Hart Wladyslawa Czuber-Dochan Stephanie J. C. Taylor Borislava Mihaylova Chris Roukas Qasim Aziz Laura Miller Richard Pollok Sonia Saxena Imogen Stagg Helen Terry Zohra Zenasni Lesley Dibley Rona Moss-Morris |
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supported online self-management versus care as usual for symptoms of fatigue, pain and urgency/incontinence in adults with inflammatory bowel disease (ibd-boost): study protocol for a randomised controlled trial |
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Supported online self-management versus care as usual for symptoms of fatigue, pain and urgency/incontinence in adults with inflammatory bowel disease (IBD-BOOST): study protocol for a randomised controlled trial |
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Abstract 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 ISRCTN71618461 . Registered on 9 September 2019. |
abstractGer |
Abstract 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 ISRCTN71618461 . Registered on 9 September 2019. |
abstract_unstemmed |
Abstract 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 ISRCTN71618461 . Registered on 9 September 2019. |
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Supported online self-management versus care as usual for symptoms of fatigue, pain and urgency/incontinence in adults with inflammatory bowel disease (IBD-BOOST): study protocol for a randomised controlled trial |
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