Hypothesis / aims of study
Fecal incontinence (FI), referred to in this study as accidental bowel leakage (ABL), is a life-altering chronic condition associated with great stigma and emotional distress, which interferes with daily life activities and lowers quality of life. FI requires ongoing self-management, optimally guided by a plan of care from a healthcare provider. There are few resources to assist patients with FI self-management and reporting progress to their healthcare provider. Interest in a mobile application (app) to support FI self-management [1] led to the development of an initial, first-of-its-kind HIPAA-compliant app named I’M ABLe (for I can Manage Accidental Bowel Leakage). The aim of this pilot study was to examine the feasibility to recruit, randomize, and retain participants and collect data on outcomes of interest (FI severity, self-management activation, and satisfaction) and assess adherence to study activities and FI self-management plans.
Study design, materials and methods
The study used a randomized controlled design.
The I’M ABLe app had 3 sections: 1) Home – containing the app user guide, 23 short, educational “articles” about FI and self-management that were available to all users, and a list and instructions for 13 initial conservative interventions for FI. Each intervention had an associated diary or journal (hence referred to as journals) for recording self-management activities. Interventions and journals specific to a participant’s FI self-management plan were activated at enrollment, providing participants access only to information appropriate for them. 2) Me – listing the FI interventions and journals to be completed daily with links. 3) Settings – providing graphs or tables illustrating trends in progress on key outcomes reported on a journal and a place to record goals, barriers and facilitators for FI self-management. A participant’s healthcare provider could review information entered in real time.
Recruitment occurred at a university-affiliated urogynecology clinic aiming to enroll 20 patients. Participants with FI were randomized in a 1:1 ratio to the app group (AppGroup) or the usual care control group (ControlGroup).
Study activities were: Completion of a demographics questionnaire at baseline and 7 other questionnaires/tools about FI and self-management at baseline and at 5 weeks (end of the study) using REDCap; a follow-up telephone call about self-management progress with the participant’s provider; and an interview with a study team member at 5 weeks after study completion.
All participants had a patient-centered plan for managing FI developed with their healthcare provider. For 5 weeks, AppGroup participants used the I’M ABLe app to support FI self-management while ControlGroup participants performed self-management per usual care. In usual care, ControlGroup participants received written instructions about their FI interventions and had three hard-copy journals available to them (bowel diary, diet journal, and pelvic floor muscle training (PFMT) journals). Depending on their FI management plan, AppGroup participants were requested to complete 1 or more of 6 journals in the app (bowel diary and journals for diet intake, PFMT, fiber supplementation, medications, and bowel training to reduce urgency), and ControlGroup participants were requested to complete 1 or more of 3 hard-copy journals listed above. Recording on a bowel diary or diet journal was to be for 7 consecutive days at one or two time periods. Other journals were to be kept daily. Data about participant’s use of the app were recorded and saved on the app’s log. The main outcome for adherence to FI self-management was recording/submitting information on a journal that was requested by a participant’s FI management plan (either in the app or by mailing hard copies to their provider). All analyses were descriptive due to the study’s pilot nature that was not designed or powered to detect statistically significant differences.
Results
Recruitment and Attrition: Within three months, 48/118 (55%) patients responded to letters and 17 to social media posts or in-clinic contacts. Of 65 patients screened, 20 gave informed consent and were randomized, 11 were not interested, 16 were ineligible, and 18 could not be reached. The attrition rate was 15% (3/20): 1 participant in the ControlGroup and 2 in the AppGroup withdrew.
Description of Participants’ Characteristics: See Table 1 for participants’ background.
Description of Participants’ FI Severity and other Tool Scores (mean (sd)):
Fecal Incontinence Severity Index: ControlGroup=35.4 (11.56) at baseline and 35.1 (9.75) at 5 weeks; AppGroup=28.7 (12.21) at baseline and 25.8 (7.48) at 5 weeks.
Patient Activation Measure: ControlGroup=65.8 (15.53) at baseline and 65.4 (10.37) at 5 weeks; AppGroup=66.0 (18.48) at baseline and 64.9 (17.13) at 5 weeks.
Self-Efficacy for Managing Chronic Disease: ControlGroup=7.4 (1.67) at baseline and 7.2 (1.38) at 5 weeks; AppGroup=7.7 (2.12) at baseline and 8.5 (1.26) at 5 weeks.
Adherence
FI self-management plans of the AppGroup contained 4 (1.2) (mean (sd)) interventions and requested reporting on 4 (1.3) journals. FI self-management plans of the ControlGroup had 4 (2.0) (mean (sd)) interventions and requested reporting on 2 (0.5) journals.
See Table 2 for adherence to study activities and FI self-management plans.
The median (range) days reported by those recording on a bowel diary was 10.5 (7-37) in the ControlGroup (n=4) and 23 (4-46) for the AppGroup (n=10) and on the diet journal, it was 5.5 (4-7) for the ControlGroup (n=2) and 23 (2-40) for the AppGroup (n=7).
Satisfaction ratings of the app by the AppGroup (n=8) at 5 weeks (n (%) participants) were Dissatisfied=1 (12.5%), Neither dissatisfied nor satisfied=3 (37.5%), Satisfied=2 (25.0%), and Very Satisfied=2 (25.0%).
Interview comments about app: The AppGroup said they liked the I’M ABLe app because it was convenient, accessible on their mobile phone, easy and simple to use, and provided reminders to do self-management activities. The app was considered helpful because it gave a “realistic view” of what the AppGroup was doing for their FI self-management plan, kept them accountable/on track for their plan, and they “learned a lot”. Some things about the app that were disliked included needing to log in every time and being afraid of mistyping information.
Interpretation of results
Both groups had moderate FI severity, self-management activation, and self-efficacy for managing a chronic condition. Feasibility of conducting a study investigating the app was very good: Recruitment rate was high, participants were willing to be randomized, adherence to study procedures was good, and attrition was typical for intervention trials of FI. The app promoted submission of journals reporting progress in FI self-management from more participants in the AppGroup than the ControlGroup and for more days.