Currently submitted to: JMIR Aging
Date Submitted: Jul 30, 2026
Open Peer Review Period: Jul 30, 2026 - Sep 24, 2026
(currently open for review)
Warning: This is an author submission that is not peer-reviewed or edited. Preprints - unless they show as "accepted" - should not be relied on to guide clinical practice or health-related behavior and should not be reported in news media as established information.
Development, Usability Testing, and Pilot Randomized Controlled Trial of WeCareToFeedDysphagia: A Web-Based Tool to Reduce Burden in Caregivers of Community-Dwelling Persons with Dementia and Oropharyngeal Dysphagia
ABSTRACT
Background:
Oropharyngeal dysphagia (dysphagia) affects up to 86% of hospitalized patients with Alzheimer disease (AD) and AD-related dementias (AD/ADRD) and is a significant predictor of caregiver burden. Upon hospital discharge, caregivers face dramatic and persistent unmet dysphagia-related caregiving needs, yet no single comprehensive resource exists to address these needs.
Objective:
To develop (Aim 1), test the usability/acceptability (Aim 2), and conduct a pilot randomized controlled trial (RCT; Aim 3) of a web-based caregiver tool for feeding in dysphagia (WeCareToFeedDysphagia), designed to reduce burden in caregivers of community-dwelling persons with AD/ADRD and dysphagia.
Methods:
The study was conducted in three phases: (1) semi-structured interviews with 15 caregivers to develop website content; (2) usability/acceptability testing with 20 caregivers using the think-aloud method, discrete navigation tasks, and the System Usability Scale (SUS); and (3) a fully remote, two-arm pilot RCT (N=80) across 11 heterogeneous hospitals, randomizing caregivers to enhanced control (usual care + speech-language pathologist referral) or intervention (enhanced control + WeCareToFeedDysphagia), with assessments at baseline, 1-month, and 3-months post-hospital discharge.
Results:
Four primary qualitative themes emerged and consistent feedback was integrated: caregiver experience with dysphagia, dysphagia-related information gaps, hospital discharge deficiencies, and website content feedback. The average task success rate during usability testing was 94% and the mean SUS score was 90.8 (SD=10.29), indicating high usability. In phase 3 (pilot RCT), we met 6 of 6 go/no-go feasibility milestones (i.e., consent rate, attrition, initial and follow-up text receipt, home page access, and tool engagement). The observed effect size (Cohen's d) for the primary outcome (care-partner burden at 3 months) was 0.1. While cross-sectional and longitudinal analyses did not demonstrate statistically significant between-group differences in burden, the direction of mean burden consistently favored the intervention group, and a statistically significant difference was found on the CarerQol-VAS happiness scale at 3 months (intervention 6.1 vs. control 4.9, P=.030).
Conclusions:
WeCareToFeedDysphagia is the first stakeholder-informed, evidence-based, centralized web-based tool for caregivers of persons with AD/ADRD and dysphagia. It demonstrated high usability and acceptability. The pilot RCT demonstrated strong feasibility, meeting all pre-specified go/no-go milestones. These findings support transition to an NIH Stage IV (R33) full-scale effectiveness RCT (N=802). Clinical Trial: ClinicalTrials.gov NCT06557863; https://clinicaltrials.gov/study/NCT06557863
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