Background Despite promising developments in eHealth, a critical gap remains in understanding how to design and implement digital self-management interventions that effectively align with users’ needs and the complex context of recovery after treatment in the intensive care unit (ICU). Objective This study aimed to develop and iteratively refine a digital self-management intervention for post–intensive care recovery and to explore related user experiences and usability among individuals with lived ICU experience. Methods A multimethod participatory development process was used including individuals with lived ICU experience (both survivors and family members) and health care professionals involved in ICU recovery. Between April 2022 and July 2026, guided by the Center for eHealth Research and Disease Management Roadmap consisting of 5 phases, data were collected through inspiration sessions and feedback rounds, individual interviews, usability testing, and pilot use, with qualitative data analyzed thematically and quantitative data analyzed descriptively. Findings from each phase informed the subsequent development steps and were revisited when necessary. The study focused on the specification and iterative refinement of the intervention’s core components based on identified values and contextual requirements, complemented by preliminary indicators of usability and descriptive usage metrics. Results Through stakeholder engagement, key functionalities were defined, including structured recovery information, easy 24-7 access, and guidance in navigating care. Two digital self-management modules, the ICU-RecoveryPointer for ICU survivors and the ICU-FamilyCoach for family members, were developed comprising (1) structured information aligned with the different phases of ICU recovery, (2) concise information tiles with layered content for more in-depth background information, (3) patient-reported e-monitoring features, (4) tailored suggestions addressing recovery challenges and emotional processing, (5) an e-diary with a timeline summary function, and (6) a comprehensive content library. During the pilot phase, the ICU-RecoveryPointer reached 33 linked accounts, with 27 users logging in at least once, whereas the ICU-FamilyCoach reached 66 accounts, with 90 monthly unique-user observations. Usage was primarily concentrated on the information tiles, suggesting that users mainly accessed the informational content within the modules. Conclusions Two digital self-management modules were designed through a participatory and iterative development process, supporting individuals with lived ICU experience during the recovery trajectory. Preliminary user experiences and usage data provided initial insights into usability and engagement, while also highlighting the need for further evaluation before broader implementation.
Background The integration of patient-reported outcomes (PROs) into routine clinical practice remains limited despite their well-documented benefits in facilitating clinical communication and research. Systematic digital PRO collection can enable real-time symptom monitoring, timely clinical interventions, and greater patient empowerment. The Health Outcomes Observatory (H2O) initiative was developed to enable systematic digital patient-reported outcome measures (PROMs) collection and integration with clinical data to support value-based, patient-centered care across health care systems. Objective This study aimed to evaluate the feasibility, usability, acceptability, clinical utility, and implementation of the H2O digital infrastructure from patient and health care professional perspectives across multiple health care settings and medical conditions. Methods A noninterventional, multicenter, convergent mixed methods feasibility study was conducted in Spain, Austria, the Netherlands, and Germany across multiple medical conditions. Locally implemented smartphone, tablet, and web-based solutions captured and displayed PROs. Surveys and interviews assessed usability, acceptability, perceived clinical utility, and implementation conditions among patients and health care professionals. Results Of 241 participants assessed initially, 115 (47.7%) contributed follow-up data. Although 83% (44/53) of the respondents indicated willingness to recommend H2O, the mean System Usability Scale (SUS) score was 44.65/100 (SD 9.78), indicating poor usability. Among 50 participants with paired Patient Satisfaction Questionnaire Short Form assessments, satisfaction with technical quality declined (t49=2.20; P=.03). Interviews identified perceived value alongside login difficulties, technical instability, weak integration with clinical systems, and inconsistent use of PRO data during consultations. Conclusions The H2O infrastructure could be deployed across heterogeneous settings, and participants perceived value in digital PRO collection; however, poor usability, substantial attrition, technical friction, and limited workflow integration qualify conclusions about feasibility and acceptability. More reliable technology, stronger interoperability, and evaluation in larger and more complete samples are needed before broader implementation.
Background Physical and psychological distress symptoms can adversely affect daily functioning and quality of life, highlighting the need for accessible self-management support. Although mobile health (mHealth) interventions show promise in supporting physical symptom management, evidence regarding their feasibility and potential effects on psychological distress remains limited. Objective This pilot study aimed to evaluate the feasibility, acceptability, and preliminary efficacy of the health app for postacute pandemic years (HAPPY) for managing physical and psychological distress symptoms. Methods A 2-arm, single-blind, quasi-experimental trial was conducted from July 2023 to January 2024. Thirty-eight participants experiencing distress symptoms related to COVID-19 were assigned to the experimental group or a waitlist control group. The experimental group received a 24-week mHealth intervention through the HAPPY app, which included an 8-week supervised phase with weekly face-to-face sessions and a 16-week self-management phase. The control group received no active treatment. Feasibility was assessed through recruitment, adherence, and adverse event monitoring, whereas preliminary efficacy was evaluated at 8 weeks (T1) and 24 weeks (T2) and compared with baseline (T0) using quantitative measures of distress, fatigue, sleep quality, pain, emotional regulation, and posttraumatic stress disorder (PTSD). Results The study demonstrated the feasibility of the HAPPY app, with a recruitment rate of 88.37% (38/43), a dropout rate of 10.5% (4/38), and an adherence rate of 93.33% (14/15) for the supervised sessions. No adverse events were reported. Significant within-group improvements were observed for distress (Kessler Psychological Distress Scale [K10]; P<.001), fatigue (Brief Fatigue Inventory–Chinese [BFI-C]; P<.001), sleep quality (Chinese Pittsburgh Sleep Quality Index [CPSQI]; P=.009), and PTSD symptoms (Chinese Impact of Event Scale–Revised [CIES-R]; P=.02). However, between-group differences were limited. Conclusions The study demonstrated the HAPPY app’s feasibility, acceptability, and potential efficacy for managing physical and psychological distress symptoms. High recruitment, retention, and adherence rates, along with measurable improvements in distress, fatigue, sleep quality, and pain, suggest the app’s promise as a scalable intervention. Trial Registration ClinicalTrials.gov NCT05459896; https://clinicaltrials.gov/study/NCT05459896
Abstract Background Conversational AI systems are increasingly used for web-based mental health support, yet evidence on sustained engagement, therapeutic alliance, and longitudinal outcomes remains limited. Baseline data from 527 self-referred users of the large language model–enabled chatbot Clare indicated high psychological distress and early development of a subjective working alliance. Objective This exploratory study examined the feasibility and descriptive outcome patterns associated with the use of the multimodal conversational agent Clare over 4 and 8 weeks in a real-world setting, focusing on engagement, perceived working alliance, and mental health measures. Methods We conducted a naturalistic, single-arm, repeated-measures observational study of self-referred, English-speaking adults recruited online via social media and search advertisements. Participants interacted with Clare over 8 weeks. Two analytic samples were defined by engagement and assessment completion: a 4-week sample (active engagement plus completed 4-week assessment) and an 8-week sample (additionally requiring continued engagement and completed 8-week assessment). Outcomes were assessed at baseline, 4, and 8 weeks: engagement metrics (calls, messages, and call duration), alliance measures (Working Alliance Inventory–Short Revised and Mobile Agnew Relationship Measure), and mental health measures (Patient Health Questionnaire–4, Patient Health Questionnaire–Distress, Mini–Social Phobia Inventory, UCLA Loneliness Scale, and Satisfaction With Life Scale). Changes were evaluated using 2-tailed paired-samples t tests with effect sizes; given substantial attrition and reliance on complete-case analyses, linear mixed-effects models were run as sensitivity analyses, and findings warrant cautious interpretation. Results Of 527 baseline participants, 369 enrolled and 348 actively engaged with Clare; 53 out of 348 (15.2%) met the 4-week criteria and 21 out of 348 (6.0%) met the 8-week criteria. Engagement peaked in week 1 (calls: mean 1.77, SD 1.52; messages: mean 10.02, SD 16.68) and declined thereafter. Among T1-T2 complete pairs (n=52), mean Patient Health Questionnaire–Distress scores decreased by 1.13 (95% CI 0.25 to 2.02) points, Patient Health Questionnaire–4 scores decreased by 0.69 (95% CI −0.01 to 1.40) points, Mini–Social Phobia Inventory scores decreased by 1.73 (95% CI 0.88 to 2.58) points, Satisfaction With Life Scale scores increased by 6.23 (95% CI 4.70 to 7.76) points, and UCLA scores increased by 0.48 (95% CI 0.00 to 0.96) points. Among participants with Working Alliance Inventory–Short Revised data (n=53), total scores increased by 0.20 points from T1b to T2 (95% CI −0.01 to 0.42); among the 8-week retained subgroup (n=21), Mobile Agnew Relationship Measure scores increased by 0.22 points from T2 to T3 (95% CI 0.03 to 0.42). Conclusions Sustained engagement was limited, and outcome estimates were obtained from small, highly selected follow-up samples. The observed changes cannot be attributed to Clare because the study had no control group and substantial, nonrandom attrition.
