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Purpose <p>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.</p> Methods <p>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&#xa0;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.</p> Results <p>Fifty-five participants were randomized (<i>n</i> = 36 self-management, <i>n</i> = 19 usual care). Participants were on average 39.0&#xa0;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.</p> Conclusions <p>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.</p>

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Feasibility, Acceptability, and Preliminary Effects of a Nurse-Delivered Self-Management Program for Individuals with Inflammatory Bowel Disease: A Pilot Randomized Controlled Trial

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2026年7月18日

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  • Kendra Kamp,
  • Linda Yoo,
  • Tanvi Kale,
  • Xiaoyu Zhang,
  • Caeli Malloy,
  • Ihsan Kahveci,
  • Rachael Cordova,
  • Isabela Hernandez,
  • Chi Shan Tsai,
  • Tiffany D. Pan,
  • Kindra Clark-Snustad,
  • Scott Lee,
  • Rona L. Levy,
  • Laurie Keefer,
  • Margaret Heitkemper

摘要

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.