Digestive diseases and sciences · 2026
Feasibility, Acceptability, and Preliminary Effects of a Nurse-Delivered Self-Management Program for Individuals with Inflammatory Bowel Disease: A Pilot Randomized Controlled Trial.
СтатьяРандомизированное исследованиеНазвание и аннотация: Перевод пока не подготовлен
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Kamp Kendra, Yoo Linda, Kale Tanvi, Zhang Xiaoyu, Malloy Caeli, Kahveci Ihsan, Cordova Rachael, Hernandez Isabela, Tsai Chi Shan, Pan Tiffany D, Clark-Snustad Kindra, Lee Scott, Levy Rona L, Keefer Laurie, Heitkemper Margaret
Аннотация
PURPOSE: Individuals with inflammatory bowel disease experience persistent symptoms and disease challenges which may not be solved with medical management. Self-management interventions may support patients, but their feasibility, acceptability, and preliminary effectiveness should be evaluated prior to large-scale testing.
METHODS: We conducted a pilot randomized controlled trial with 2:1 allocation of a nurse-delivered, self-management program to usual care. Adults with a healthcare provider diagnosis of ulcerative colitis or Crohn's disease, aged 18-75 years, currently reporting at least two symptoms were recruited. The self-management program included eight online modules plus weekly phone check-ins with a registered nurse. Feasibility and acceptability were measured using surveys and interviews. Secondary outcomes included patient activation, self-regulation, self-efficacy, functional impairment, quality of life, symptoms, and fecal calprotectin. Linear mixed models estimated the differences in change scores between groups from baseline to 3- and 6-month follow-up.
RESULTS: Fifty-five participants were randomized (n = 36 self-management, n = 19 usual care). Participants were on average 39.0 years old (range: 20-73), 76.4% women, and 80% Crohn's disease. The self-management program demonstrated high satisfaction (91.1/100), feasibility (4.34/5), and acceptability (4.28/5). Compared with usual care, the self-management program produced the largest improvement in functional impairment (mean change - 15.1 [95% CI - 23.3, - 6.8], with additional improvements in patient activation (10.3 [2.8, 17.9]), self-regulation (4.1 [1.1, 7.1]), and quality of life (4.6 [0.3, 8.9]). Symptom severity and fecal calprotectin were largely unchanged. Qualitative feedback emphasized the value of regular nurse check-ins, accountability, and applicability of the program beyond disease-specific concerns.
CONCLUSIONS: A nurse-delivered self-management program was feasible, acceptable, and led to meaningful changes in key intervention targets for inflammatory bowel disease management. High engagement supports potential for future testing in a fully powered trial and eventual integration into routine care.
METHODS: We conducted a pilot randomized controlled trial with 2:1 allocation of a nurse-delivered, self-management program to usual care. Adults with a healthcare provider diagnosis of ulcerative colitis or Crohn's disease, aged 18-75 years, currently reporting at least two symptoms were recruited. The self-management program included eight online modules plus weekly phone check-ins with a registered nurse. Feasibility and acceptability were measured using surveys and interviews. Secondary outcomes included patient activation, self-regulation, self-efficacy, functional impairment, quality of life, symptoms, and fecal calprotectin. Linear mixed models estimated the differences in change scores between groups from baseline to 3- and 6-month follow-up.
RESULTS: Fifty-five participants were randomized (n = 36 self-management, n = 19 usual care). Participants were on average 39.0 years old (range: 20-73), 76.4% women, and 80% Crohn's disease. The self-management program demonstrated high satisfaction (91.1/100), feasibility (4.34/5), and acceptability (4.28/5). Compared with usual care, the self-management program produced the largest improvement in functional impairment (mean change - 15.1 [95% CI - 23.3, - 6.8], with additional improvements in patient activation (10.3 [2.8, 17.9]), self-regulation (4.1 [1.1, 7.1]), and quality of life (4.6 [0.3, 8.9]). Symptom severity and fecal calprotectin were largely unchanged. Qualitative feedback emphasized the value of regular nurse check-ins, accountability, and applicability of the program beyond disease-specific concerns.
CONCLUSIONS: A nurse-delivered self-management program was feasible, acceptable, and led to meaningful changes in key intervention targets for inflammatory bowel disease management. High engagement supports potential for future testing in a fully powered trial and eventual integration into routine care.