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. 2022 May 18;6(5):e33001.
doi: 10.2196/33001.

A Novel Digital Self-management Intervention for Symptoms of Fatigue, Pain, and Urgency in Inflammatory Bowel Disease: Describing the Process of Development

Louise Sweeney  1 , Sula Windgassen  1 , Micol Artom  2 , Christine Norton  1 , Sophie Fawson  1 , Rona Moss-Morris #  1
Affiliations

A Novel Digital Self-management Intervention for Symptoms of Fatigue, Pain, and Urgency in Inflammatory Bowel Disease: Describing the Process of Development

Louise Sweeney et al. JMIR Form Res. .

Abstract

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.

Keywords: digital health; inflammatory bowel disease; intervention development; self-management; symptoms.

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Conflict of interest statement

Conflicts of Interest: There is no specific conflict of interest with the product described in this paper. Outside of this submitted work, RMM is a beneficiary of a licence agreement signed between King's College London and Mahana Therapeutics for a digital cognitive behavioral therapy for an irritable bowel syndrome product. She receives personal fees from Mahana Therapeutics for scientific advisory work and from other universities and hospital trusts for cognitive behavioral therapy training in irritable bowel syndrome.

Figures

Figure 1
Figure 1
Intervention development stages as recommended by the Medical Research Council guidance (orange) and person-based approach (blue). IBD: inflammatory bowel disease.
Figure 2
Figure 2
Example of overlap and symptom-specific modifiable factors in inflammatory bowel disease identified from the evidence base (systematic reviews and empirical evidence).
Figure 3
Figure 3
BOOST web-based self-management program logic model. BIPQ: Brief Illness Perception Questionnaire; CBRQ: Cognitive and Behavioral Responses Questionnaire; EQ5D: European Quality of Life Scale 5 Dimension Scale; IBD-F: Inflammatory Bowel Disease-Fatigue; IBDQ: Inflammatory Bowel Disease Questionnaire; NHS: National Health Service; PHQ-9: Patient Health Questionnaire-9; QoL: quality of life; SEMCD6: Self-Efficacy for Managing Chronic Disease 6-item Scale; VAS: Visual Analog Scale; VIS: Vaizey Incontinence Score; VSI: Visceral Sensitivity Index.
See this image and copyright information in PMC

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