TY - JOUR
T1 - A Novel Digital Self-management Intervention for Symptoms of Fatigue, Pain, and Urgency in Inflammatory Bowel Disease
T2 - Describing the Process of Development
AU - Sweeney, Louise
AU - Windgassen, Sula
AU - Artom, Micol
AU - Norton, Christine
AU - Fawson, Sophie
AU - Moss-Morris, Rona
N1 - Funding Information:
This paper presents independent research funded by the National Institute for Health Research (NIHR) under its Program Grants for Applied Research Program (grant reference number RP-PG-0216-20001). The views expressed are those of the authors and not necessarily those of the NIHR or the Department of Health and Social Care. It also represents independent research, with RMM and LS partly funded by the NIHR Biomedical Research Center in South London, the Maudsley National Health Service Foundation Trust, and the King’s College London.
Publisher Copyright:
©Louise Sweeney, Sula Windgassen, Micol Artom, Christine Norton, Sophie Fawson, Rona Moss-Morris.
PY - 2022/5/18
Y1 - 2022/5/18
N2 - BACKGROUND: Empirical studies and systematic reviews have demonstrated the role of biological, cognitive, behavioral, and emotional factors in fatigue, pain, and urgency in inflammatory bowel disease (IBD). Behavioral management that addresses the cognitive, behavioral, and emotional factors offered alongside medical treatment is seldom available to people with IBD. Digital interventions provide a potentially scalable and cost-effective way of providing behavioral support to patients.OBJECTIVE: This paper aimed to describe the process of developing a supported digital self-management intervention for fatigue, pain, and urgency in IBD using theory and evidence-based approaches and stakeholder input.METHODS: The Medical Research Council framework for complex health interventions and a person-based approach were used to guide intervention development, consulting with 87 patients with IBD and 60 nurses. These frameworks informed the selection and use of a theoretical model that subsequently guided cognitive behaviorally based intervention content. They also guided the design of tailored digital intervention pathways for individuals with IBD that matched the predominant symptoms.RESULTS: A transsymptomatic cognitive behavioral framework of symptom perpetuation was developed for the symptoms of fatigue, pain, and urgency in IBD. A logic model was used to define the intervention techniques. Patient feedback and qualitative interviews refined the website content and functionalities, including the use of visual aids, email reminders, and graphical tracking of symptoms. Nurse focus groups informed the volume and delivery model of the therapist facilitator support. Ratings of acceptability out of 10 following feasibility testing (31/87, 36%) demonstrated accessibility (scoring 9.43, SD 1.040), ease (scoring 8.07, SD 3.205), clarity, and the relevant tone of the intervention. The final intervention comprised 12 web-based sessions (8 core and 4 symptom-specific), with one 30-minute facilitator phone call following session 1 and subsequent on-site messaging.CONCLUSIONS: The use of theory and integration of stakeholders' views throughout informed the development of an evidence-based digital intervention for fatigue, pain, and urgency in IBD. This is the first web-based self-management intervention designed to address these multiple symptoms with the aim of improving the quality of life and reducing the symptom burden of IBD. The intervention is being tested in a large multicenter randomized controlled trial.TRIAL REGISTRATION: ISRCTN Registry ISRCTN71618461; https://www.isrctn.com/ISRCTN71618461.
AB - BACKGROUND: Empirical studies and systematic reviews have demonstrated the role of biological, cognitive, behavioral, and emotional factors in fatigue, pain, and urgency in inflammatory bowel disease (IBD). Behavioral management that addresses the cognitive, behavioral, and emotional factors offered alongside medical treatment is seldom available to people with IBD. Digital interventions provide a potentially scalable and cost-effective way of providing behavioral support to patients.OBJECTIVE: This paper aimed to describe the process of developing a supported digital self-management intervention for fatigue, pain, and urgency in IBD using theory and evidence-based approaches and stakeholder input.METHODS: The Medical Research Council framework for complex health interventions and a person-based approach were used to guide intervention development, consulting with 87 patients with IBD and 60 nurses. These frameworks informed the selection and use of a theoretical model that subsequently guided cognitive behaviorally based intervention content. They also guided the design of tailored digital intervention pathways for individuals with IBD that matched the predominant symptoms.RESULTS: A transsymptomatic cognitive behavioral framework of symptom perpetuation was developed for the symptoms of fatigue, pain, and urgency in IBD. A logic model was used to define the intervention techniques. Patient feedback and qualitative interviews refined the website content and functionalities, including the use of visual aids, email reminders, and graphical tracking of symptoms. Nurse focus groups informed the volume and delivery model of the therapist facilitator support. Ratings of acceptability out of 10 following feasibility testing (31/87, 36%) demonstrated accessibility (scoring 9.43, SD 1.040), ease (scoring 8.07, SD 3.205), clarity, and the relevant tone of the intervention. The final intervention comprised 12 web-based sessions (8 core and 4 symptom-specific), with one 30-minute facilitator phone call following session 1 and subsequent on-site messaging.CONCLUSIONS: The use of theory and integration of stakeholders' views throughout informed the development of an evidence-based digital intervention for fatigue, pain, and urgency in IBD. This is the first web-based self-management intervention designed to address these multiple symptoms with the aim of improving the quality of life and reducing the symptom burden of IBD. The intervention is being tested in a large multicenter randomized controlled trial.TRIAL REGISTRATION: ISRCTN Registry ISRCTN71618461; https://www.isrctn.com/ISRCTN71618461.
KW - Inflammatory Bowel Disease
KW - Symptoms
KW - Self-management
KW - intervention development
KW - digital health
UR - http://www.scopus.com/inward/record.url?scp=85130604575&partnerID=8YFLogxK
U2 - 10.2196/33001
DO - 10.2196/33001
M3 - Article
C2 - 35583924
SN - 2561-326X
VL - 6
SP - e33001
JO - JMIR Formative Research
JF - JMIR Formative Research
IS - 5
M1 - e33001
ER -