Single-arm Feasibility Study Research Articles

Whole-Body Photobiomodulation Therapy for Fibromyalgia: A Feasibility Trial.

Effective treatment for fibromyalgia (FM) is lacking and further treatment options are needed. Photobiomodulation therapy (PBMT) represents one potential treatment option. Whilst favourable findings have been reported using localised PBMT, no investigations have established the value of whole-body PBMT for the complete set of symptom domains in FM. A single-arm feasibility study was conducted in accordance with CONSORT (Consolidated Standards of Reporting Trials) guidelines. A non-probability sampling method was used to access individuals with FM. The primary outcome measure was identified as the Revised Fibromyalgia Impact Questionnaire (FIQR). Forty-nine participants were screened and twenty-one trial participants entered the trial. Nineteen participants completed the intervention (18 whole-body PBMT sessions over approximately six weeks). Descriptive statistics and qualitative analysis was undertaken to represent feasibility outcomes. Acceptability of the trial device and processes were established. Outcome measures towards efficacy data were guided by core and peripheral OMERACT (outcomes measures in rheumatological clinical trials) domains, utilising a combination of participant-reported and performance-based outcome measures. Data for the embedded qualitative component of the trial were captured by participant-reported experience measures and audio-recorded semi-structured interviews. Positive changes were observed for FM-specific quality of life, pain, tenderness, stiffness, fatigue, sleep disturbance, anxiety, depression and cognitive impairment. Patient global assessment revealed improvements at 6 weeks, with continued effect at 24 weeks. FM-specific quality of life at 24 weeks remained improved compared with baseline scores. The findings provided evidence to support a full-scale trial and showed promise regarding potential efficacy of this novel non-invasive treatment in an FM population.

Adherence to a Web-based Exercise Programme: A Feasibility Study Among Patients with Hip or Knee Osteoarthritis.

To describe adherence to a 12-week web-based aerobic exercise programme, to compare characteristics between those who adhere or not, and to identify barriers for exercising in patients with hip or knee osteoarthritis. Single-arm feasibility study. Patients with hip or knee osteoarthritis in specialist healthcare, age 40-80 years, and not candidates for joint surgery. Adherence to a 12-week exercise programme was defined as having completed ≥ 2 exercise sessions a week for at least 8 weeks. Baseline differences between adherent and non-adherent groups in demographics, symptoms, disability, physical activity and fitness were assessed using Mann-Whitney U or χ2 tests. Reasons for not completing exercise sessions were reported in weekly diaries. Results: A total of 29 patients (median age 64 years, 72% female) were included. Median baseline pain (numerical rating scale 0-10) was 5. Fifteen patients adhered to the exercise programme, 14 did not. Non-adherent patients were less active (p = 0.032) and had lower cardiorespiratory fitness (p = 0.031). The most frequently reported barrier to exercising was sickness. Less than 10% reported pain as a barrier. Half of the patients with hip or knee osteoarthritis adhered to the digitally delivered exercise programme and the most frequently reported barrier for adherence was sickness, while less than 10% reported pain as a reason for not exercising. ClinicalTrials.gov, NCT04084834. The Regional Committee for Medical and Health Research Ethics South-East, 2018/2198.

Development and feasibility of a mHealth intervention to improve guardians' adherence to children's follow up care after treatment for acute lymphoblastic leukemia in Tanzania: An overview of the GuardiansCan project.

Cancer is a leading cause of death during childhood and in low- and middle-income countries (LMICs) survival rates can be as low as 20%. A leading reason for low childhood cancer survival rates in LMICs such as Tanzania is treatment abandonment. Contributing factors include poor communication between healthcare providers and children's guardians (guardians), insufficient cancer knowledge, and psychological distress. Our aim is to respond to Tanzanian guardians' poor adherence to children's follow-up care after treatment for acute lymphoblastic leukemia with the help of mHealth technology. Our goal is to increase guardians' adherence to children's medications and follow-up visits; and secondly to decrease their psychological distress. Following the Medical Research Council (MRC) Framework for developing and evaluating complex interventions, we will undertake the GuardiansCan project in an iterative phased approach to develop an mHealth intervention for subsequent testing. Public contribution activities will be implemented throughout via a Guardians Advisory Board consisting of guardians of children with acute lymphoblastic leukemia. We will examine the acceptability, feasibility, and perceived impact of public contribution activities via an impact log and semi-structured interviews (Study I). In Phase One (intervention development) we will explore guardians' needs and preferences for the provision of follow-up care reminders, information, and emotional support using focus group discussions and photovoice (Study II). We will then co-design the mHealth intervention with guardians, healthcare professionals, and technology experts using participatory action research (Study III). In Phase Two (feasibility) we will examine clinical, methodological, and procedural uncertainties associated with the intervention and study methods in a single-arm pre-post mixed methods pragmatic feasibility study (Study IV). Data collection for the GuardiansCan project is anticipated to take three years. We plan to commence Study I by recruiting Guardians Advisory Board members in autumn 2023. By systematically following the intervention development and feasibility phases of the MRC Framework, and working alongside an advisory board of guardians, we intend to develop an acceptable, culturally appropriate, feasible, and relevant mHealth intervention with the potential to increase guardians' adherence to children's follow-up care after treatment of acute lymphoblastic leukemia, leading to a positive impact on children's health and chances to survive and reduced suffering for guardians. n/a.

Protocol for a Single-Arm Feasibility Study of Photobiomodulation for Fatigue, Depression, and Pain in Inflammatory Bowel Disease.

There are limited treatment options for mental health comorbidities associated with Inflammatory Bowel Disease (IBD), although they have been shown to negatively affect the course of IBD and multiple important areas of functioning. Photobiomodulation (PBM) is a new therapeutic intervention using laser-generated low-powered light therapy that has shown early promise in alleviating fatigue, depression, and pain in chronic illness. This prospective, single-arm pilot study aims to assess the feasibility and efficacy of PBM in the treatment of fatigue, depression, and pain in youth with IBD. We will recruit 28 young adults with IBD who will receive PBM in addition to treatment as usual. The primary outcome will be fatigue, while secondary outcomes will include depression, pain, quality of life, inflammatory markers, alterations in microbiome composition, physical activity, and functioning. Outcome measures will be assessed at baseline, after a 10-week control period (pre-PBM), at 20 weeks (post-PBM), and at 30 weeks. Feasibility will be assessed by attendance, recruitment rates, and participants' views of PBM. Mixed-effects linear regression modelling will be used to assess the PBM effect on continuous outcomes (fatigue, depression, anxiety and stress scores, and inflammation levels). The study will provide preliminary indicators of PBM feasibility and efficacy in IBD.

Is a novel digital system for arm and hand rehabilitation suitable for stroke survivors? A qualitative process evaluation of OnTrack

Objectives and designNational guidelines emphasise the need to enhance arm and hand recovery poststroke. OnTrack is a 12-week package aiming to address this need. Feasibility was evaluated in a single-arm...

Attachment and trauma-informed programme to support forcibly displaced parents of youth in Sweden: feasibility and preliminary outcomes of the eConnect Online programme

ObjectivesTo assess the feasibility, acceptability and the impact of an online parenting programme for forcibly displaced parents of adolescents.DesignThe study was a single-arm feasibility study using pre-intervention post-intervention and follow-up...

Addressing the psychology of weight loss and maintenance: A feasibility study of the Skills for weight loss and Maintenance weight management programme.

Building on prior theory, we aimed to evaluate the feasibility and acceptability of integrating novel, weight loss maintenance strategies into existing weight management programmes. We also piloted recruitment and data collection procedures for future research. Two phases of action research nested within a single-arm feasibility study. The intervention was refined between phases using feedback from intervention fidelity analysis and qualitative exploration of patient and provider experiences. Changes in outcomes were assessed up to 18 months post-baseline. One hundred adults with a mean body mass index of 37 kg/m2 were offered the Skills for weight loss and Maintenance (SkiM) intervention. This included existing weight management programme content and additional weight loss maintenance techniques delivered fortnightly for 6 months in local community centres to groups of 11-15 people. Of the 100 participants, 65%, 58% and 56% provided data at 7, 12 and 18 months. Across both phases, the mean initial weight loss was 4.2 kg (95% CI: 2.4-5.9) and 3.1 kg at 18 months (95% CI: .8-5.5). In Phase 2, we observed better weight loss maintenance (.5 kg [13.2%] regain from 7 to 18 months, vs. 1.7 kg [36.2%] in Phase 1). Variation in outcomes, high early dropout rates and qualitative feedback indicated that, although delivery of the intervention and trial procedures was feasible and acceptable, there was scope to refine the intervention to engage a wider range of participants. Intervention fidelity was acceptable, particularly in Phase 2. The SkiM intervention seems promising, but more research is needed to improve recruitment and retention prior to further evaluation.

Assessing the feasibility of a clinical trial to evaluate an advanced practice physiotherapy model of care in chronic pain management: a feasibility study

BackgroundChronic pain management is challenging for health systems worldwide. Clinical practice guidelines recommend interprofessional chronic pain management, but chronic pain clinics often have lengthy wait-lists. Advanced practice physiotherapists (APP) in orthopedic clinics and emergency departments have provided effective care and reduced wait times. The purpose of this study is to determine the feasibility of a clinical trial to evaluate the effects of integrating an APP into a chronic pain clinic setting. The primary objectives are as follows: (1) determine the feasibility of implementing trial methods by evaluating participant recruitment rates, retention, and assessment completion; (2) determine the feasibility of implementing the APP model of care by monitoring care provided and treatment fidelity; and (3) assess contextual factors that may influence implementation of the APP model of care by exploring the perspectives of patient participants and healthcare providers related to the model of care.MethodsThis will be a single-arm feasibility study with embedded qualitative interviews to assess contextual factors influencing implementation by exploring participant and provider perspectives. Approximately 40 adults with chronic musculoskeletal pain referred for care at an interprofessional chronic pain clinic will be invited to participate in the feasibility study. Approximately 10–12 patient participants and 5–10 health professionals from the interprofessional team will be interviewed using an interpretive description approach. The APP model of care will involve participants seeing a physiotherapist as the first point of contact within the interprofessional team. The APP will complete an initial assessment and make care recommendations. Outcome measures planned for the full trial will be reported descriptively, including pain severity, pain interference, health-related quality of life, psychosocial risk factors for chronic pain, treatment satisfaction, perceived change, healthcare utilization, and healthcare costs over one year.DiscussionThis study will inform plans to implement a full-scale study to evaluate the impact of an APP model of care in an interprofessional chronic pain management program. The results of the full study are intended to inform stakeholders considering this model to improve patient-centered and health system outcomes in interprofessional pain management program settings.Trial registrationClinicalTrials.gov, NCT05336903 (Registered April 5, 2022).

Patient Experiences of a Telehealth Multidisciplinary Cancer Rehabilitation Programme: Qualitative Findings from the ReStOre@Home Feasibility Study

Purpose. Multidisciplinary rehabilitation programmes providing exercise, nutrition support, education, and peer support can effectively meet the rehabilitation needs of upper gastrointestinal (UGI) cancer survivors. This study aimed to explore the experiences of participants who engaged in a telehealth, multidisciplinary rehabilitation programme for UGI cancer survivors. Methods. This single-arm feasibility study recruited participants who completed curative treatment for UGI cancer. Participants (n = 10, male = 9) aged 58–76 years were 5–17 months postsurgery. A 12-week telehealth rehabilitation programme was delivered via video call, consisting of group resistance training, remotely monitored aerobic training, 1 : 1 dietary counselling, 1 : 1 physiotherapy support, and group education sessions. Independent researchers conducted semistructured interviews at postintervention assessments. Transcripts were analysed using reflexive thematic analysis (RTA). Results. RTA of participant transcripts generated three overarching themes: (1) ReStOre@Home impacted psychosocial and physical needs by addressing a broad and meaningful gap in services, (2) paving a pathway towards prosperity, and (3) contrasting experiences with using technology. Participants’ preferences and recommendations for future telehealth programmes were discussed. Conclusions. A telehealth multidisciplinary rehabilitation programme supported participants in physical and psychosocial recovery. Qualitative analysis identified an important ongoing need for some in-person care and provided detailed insights into participant experiences during telehealth-delivered rehabilitation.

Real World Clinical Utility of Neurophysiological Measurement Utilizing Closed-Loop Spinal Cord Stimulation in a Chronic Pain Population: The ECAP Study Protocol.

Spinal cord stimulation (SCS) is an established chronic pain treatment, but the effectiveness of traditional, open-loop paradigms has been plagued by variable sustainability in a real-world setting. A new approach, utilizing evoked compound action potential (ECAP) controlled closed-loop (CL) SCS, continuously monitors spinal cord activation and automatically adjusts the stimulation amplitude of every pulse, maintaining stimulation at the prescribed ECAP level through this continual feedback mechanism. Recent studies demonstrated the long-term safety and efficacy of ECAP-controlled CL-SCS. Here, we report the design of a prospective, multicenter, single-arm feasibility study to characterize clinical outcomes in a real-world chronic pain population utilizing ECAP-controlled CL-SCS. Objective neurophysiological measurements such as device performance and patient therapy compliance, will be analyzed against baseline biopsychosocial assessments, to explore the clinical utility of these objective physiologic biomarkers in patient phenotyping. This study will enroll up to 300 subjects with chronic, intractable trunk and/or limb pain in up to 25 United States investigation sites. Subjects meeting eligibility criteria will undergo a trial procedure and a permanent implant following a successful trial. Neurophysiological measurements (measured in-clinic and continuously during home use) and clinical outcomes including pain, quality-of-life, psychological, emotional, and functional assessments will be collected at baseline, trial end, and up to 24-months post-implantation. Associations between objective neurophysiological data, clinical evaluation and patient-reported outcomes may have important clinical and scientific implications. They may provide novel insights about the chronic pain pathophysiology, its modulation during CL-SCS, and identification of pain phenotypes and/or mechanisms associated with treatment response during SCS trials and long-term therapy. Data from the ECAP study could lead to improvements in diagnosis, assessment, patient identification and management of chronic pain. It could also provide the foundation for development of a new SCS treatment approach customized by the patient's pain phenotype, unique neurophysiology, and disease severity.

Video-telecare collaborative pain management during COVID-19: a single-arm feasibility study

BackgroundChronic pain is among the most common conditions presenting to primary care and guideline-based care faces several challenges. A novel pain management program, Video-Telecare Collaborative Pain Management (VCPM), was established to support primary care providers and meet new challenges to care presented by the COVID-19 pandemic.MethodsThe present single-arm feasibility study aimed to evaluate the feasibility and acceptability of VCPM and its components among U.S. veterans on long-term opioid therapy for chronic pain at ≥ 50 mg morphine equivalent daily dose (MEDD). VCPM consists of evidence-based interventions, including opioid reassessment and tapering, rotation to buprenorphine and monitoring, and encouraging behavioral pain and opioid-use disorder self-management.ResultsOf the 133 patients outreached for VPCM, 44 completed an initial intake (33%) and 19 attended multiple VCPM appointments (14%). Patients were generally satisfied with VCPM, virtual modalities, and provider interactions. Nearly all patients who attended multiple appointments maintained a buprenorphine switch or tapered opioids (16/19; 84%), and buprenorphine switches were generally reported as acceptable by patients. Patients completing an initial intake with VCPM had reduced morphine equivalent daily dose after three months (means = 109 mg MEDD vs 78 mg), with greater reductions among those who attended multiple appointments compared to intake only (ΔMEDD = -58.1 vs. -8.40). Finally, 29 referrals were placed for evidence-based non-pharmacologic interventions.ConclusionPre-defined feasibility and acceptability targets for VCPM and its components were broadly met, and preliminary data are encouraging. Novel strategies to improve enrollment and engagement and future directions are discussed.

Feasibility and safety of Heavy Lifting Strength Training in Head and Neck Cancer survivors post-surgical neck dissection (the LIFTING trial).

Light-to-moderate intensity strength training (LMST) improves muscular strength, physical functioning, and some side effects in head and neck cancer survivors (HNCS). Heavy lifting strength training (HLST) may further improve these outcomes; however, it has not been studied in HNCS. The primary aim of the LIFTING trial was to examine the feasibility and safety of a HLST program in HNCS ≥1-year post-surgical neck dissection. In this single-arm feasibility study, HNCS were asked to complete a twice weekly, 12-week, supervised HLST program, gradually progressing to lifting heavy loads of 80-90% of 1 repetition maximum (1RM) for barbell squat, bench press, and deadlift. The feasibility outcomes included recruitment rate, 1RM completion rate, program adherence, barriers, and motivation. The preliminary efficacy outcomes included changes in upper and lower body strength. Nine HNCS were recruited over an 8-month period during the COVID-19 pandemic. All 9 (100%) completed the 1RM tests and successfully progressed to heavy loads at approximately 5 weeks. The median attendance was 95.8% (range 71-100%), and few barriers were reported. Weight lifted increased for squat/leg press (median change: +34kg; 95% CI +25 to +47), bench press (median change: +6kg; 95% CI +2 to +10), and deadlift (median change: +12kg; 95% CI +7 to +24). No adverse events were reported and participants were motivated to continue HLST after the study. HLST appears feasible and safe for HNCS and may result in meaningful improvements in muscular strength. Future research should consider additional recruitment strategies and compare HLST to LMST in this understudied survivor population. NCT04554667.

Near-infrared (NIR) imaging with indocyanine green (ICG) may assist in intraoperative decision making and improving surgical margin in bone and soft tissue tumor surgery.

Negative surgical margins are significant in improving patient outcomes. However, surgeons can only rely on visual and tactile information to identify tumor margins intraoperatively. We hypothesized that intraoperative fluorescence imaging with indocyanine green(ICG) could serve as an assistive technology to evaluate surgical margins and guide surgery in bone and soft tissue tumor surgery. Seventy patients with bone and soft tissue tumors were enrolled in this prospective, non-randomized, single-arm feasibility study. All patients received intravenous indocyanine green (0.5 mg/kg) before surgery. Near-infrared(NIR) imaging was performed on in situ tumors, wounds, and ex vivo specimens. 60/70 tumors were fluorescent at NIR imaging. The final surgical margins were positive in 2/55 cases, including 1/40 of the sarcomas. Surgical decisions were changed in 19 cases by NIR imaging, and in 7/19 cases final pathology demonstrated margins were improved. Fluorescence analysis showed that the tumor-to-background ratio (TBR) of primary malignant tumors was higher than that of benign, borderline, metastatic, and tumors ≥5 cm in size had higher TBR than those <5 cm. ICG fluorescence imaging may be a beneficial technique to assist in surgical decision making and improving surgical margins in bone and soft tissue tumor surgery.

Aspirin deprescribing in primary prevention of cardiovascular disease: a prospective risk-benefit approach.

Current evidence and practice guidelines do not recommend aspirin for primary prevention of cardiovascular disease (CVD). Insufficient all-cause mortality benefits juxtaposed to increased gastrointestinal bleeding rates are well established. Pharmacists are well placed to assess the clinical appropriateness of aspirin in CVD and initiate deprescribing as required with medical colleagues. The aim of this study was to identify medical inpatients taking aspirin for primary prevention of CVD and initiate deprescribing utilising a risk-benefit approach. A single-arm prospective feasibility study of general medicine patients admitted to a major tertiary hospital over 5 weeks (July-August 2020) was conducted. Screened patients were categorised as either taking aspirin for primary or secondary prevention. A 5-year benefit-risk analysis of bleeding and cardiovascular risk was calculated using a validated tool from the Cardiac Society of Australia and New Zealand to guide recommendations. This study screened 277 patients, of which 71 patients were identified as taking aspirin. Ten of these patients (14%) were categorised as taking aspirin for primary prevention and thus were deemed suitable for deprescribing. The analysis showed that aspirin continuance would, on average, increase major bleeding events by 39%, whilst reducing major cardiovascular events by 13.4%. Pharmacists recommended aspirin cessation in seven of the cases identified, and deprescribing was successful in five cases. This study described an impactful pharmacist-led initiative utilising a validated aspirin-specific tool to conduct risk-benefit analysis to reduce potential major bleeding associated with inappropriate aspirin use.

MP53-01 TOXICITY OF CYTOREDUCTIVE SURGERY AND HYPERTHERMIC INTRAPERITONEAL CHEMOTHERAPY (HIPEC) IN PEDIATRIC PATIENTS WITH RHABDOMYOSARCOMA: EARLY EXPERIENCE AND RESULTS OF A PHASE 1 TRIAL

You have accessJournal of UrologyCME1 Apr 2023MP53-01 TOXICITY OF CYTOREDUCTIVE SURGERY AND HYPERTHERMIC INTRAPERITONEAL CHEMOTHERAPY (HIPEC) IN PEDIATRIC PATIENTS WITH RHABDOMYOSARCOMA: EARLY EXPERIENCE AND RESULTS OF A PHASE 1 TRIAL Andres Guillen Lozoya, Alexander Krueger, Candace Granberg, and Patricio Gargollo Andres Guillen LozoyaAndres Guillen Lozoya More articles by this author , Alexander KruegerAlexander Krueger More articles by this author , Candace GranbergCandace Granberg More articles by this author , and Patricio GargolloPatricio Gargollo More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000003301.01AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: Soft-tissue sarcomas as a group comprise the most common type of extra-cranial solid tumor type in children. Most soft-tissue sarcomas diagnosed in children are rhabdomyosarcoma (RMS). Rapid growth and aggressive metastatic spread are major factors in severely decreasing the prognosis of patients with this condition, and current therapies for recurrence of intraperitoneal malignancies have not provided an increase in survival over several decades. HIPEC has been demonstrated to improve survival in several adult peritoneal malignancies. Similarly, in children cytoreduction and HIPEC have been applied to some pediatric malignancies with promising results. We aim to evaluate toxicities of pediatric RMS patients treated with continuous perfusion of hyperthermic intraperitoneal cisplatin+doxorubicin. METHODS: This is a single-arm feasibility and safety study. Pediatric patients with resectable primary refractory or recurrent intra-abdominal RMS tumors treated with HIPEC (CIS+DOXO) from June of 2019 to June of 2022 were included in the analysis. Patients with mets not limited to peritoneum, prior HIPEC, active infection or systemic illness were excluded from the study. Clinical and demographic variables, adverse events within 30 days post-Op, recurrence free survival (RFS) and overall survival (OS) were compiled and stratified. RESULTS: A total of n=6 participants were included in the analysis. The cohort was comprised mostly of female patients (83%), Bladder was the most common primary tumor location (50%) and Embryonal was the most common subtype (83%). Median OS of the cohort was 20.4±6.6 months, non-deceased patients have had a median survival of 36±7.5 months and mean RFS of 14 months. 50% of the cohort evolve without a grade ≥3 adverse event [CTCAE v4]. Table 1 CONCLUSIONS: We conclude that the study technique is reasonably well tolerated in pediatric patients with refractory or recurrent intra-abdominal RMS tumors. The efficacy of Cytoreductive Surgery and HIPEC in pediatric RMS patients needs further evaluation with a larger cohort of patients. Source of Funding: None © 2023 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 209Issue Supplement 4April 2023Page: e712 Advertisement Copyright & Permissions© 2023 by American Urological Association Education and Research, Inc.MetricsAuthor Information Andres Guillen Lozoya More articles by this author Alexander Krueger More articles by this author Candace Granberg More articles by this author Patricio Gargollo More articles by this author Expand All Advertisement PDF downloadLoading ...

An Electronically Delivered Person-Centered Narrative Intervention for Persons Receiving Palliative Care: Protocol for a Mixed Methods Study

In the health care setting, electronic health records (EHRs) are one of the primary modes of communication about patients, but most of this information is clinician centered. There is a need to consider the patient as a person and integrate their perspectives into their health record. Incorporating a patient's narrative into the EHR provides an opportunity to communicate patients' cultural values and beliefs to the health care team and has the potential to improve patient-clinician communication. This paper describes the protocol to evaluate the integration of an adapted person-centered narrative intervention (PCNI). This adaptation builds on our previous research centered on the implementation of PCNIs. The adaptation for this study includes an all-electronic delivery of a PCNI in an outpatient clinical setting. This research protocol aims to evaluate the feasibility, usability, and effects of the all-electronic delivery of a PCNI in an outpatient setting on patient-reported outcomes. The first objective of this study is to identify the barriers and facilitators of an internet-based-delivered PCNI from the perspectives of persons living with serious illness and their clinicians. The second objective is to conduct acceptability, usability, and intervention fidelity testing to determine the essential requirements for the EHR integration of an internet-based-delivered PCNI. The third objective is to test the feasibility of the PCNI in an outpatient clinic setting. Using a mixed method design, this single-arm intervention feasibility study was delivered over approximately 3 to 4 weeks. Patient participant recruitment was conducted via screening outpatient palliative care clinic schedules weekly for upcoming new palliative care patient visits and then emailing potential patient participants to notify them about the study. The PCNI was delivered via email and Zoom app. Patient-reported outcome measures were completed by patient participants at baseline, 24 to 48 hours after PCNI, and after the initial palliative care clinic visit, approximately 1 month after baseline. Inclusion criteria included having the capacity to give consent and having an upcoming initial outpatient palliative care clinic visit. The recruitment of participants began in April 2021. A total of 189 potential patient participants were approached via email, and 20 patient participants were enrolled, with data having been collected from May 2021 to September 2022. A total of 7 clinician participants were enrolled, with a total of 3 clinician exit interviews and 1 focus group (n=5), which was conducted in October 2022. Data analysis is expected to be completed by the end of June 2023. The findings from this study, combined with those from other PCNI studies conducted in acute care settings, have the potential to influence clinical practices and policies and provide innovative avenues to integrate more person-centered care delivery. DERR1-10.2196/41787.

Online Physical Exercise and Group Sessions to Increase and Maintain Physical Activity in Individuals with Type 2 Diabetes: A Single-Arm Feasibility Study.

Current physical activity interventions for individuals with Type 2 diabetes do not accommodate the needs of the individual in terms of content, time, and location. The aim of this study was to evaluate the feasibility and acceptability of an 8-week high intensity online physical exercise intervention combined with online group meetings and supported by an activity watch in individuals with Type 2 diabetes. This study was designed as a one-armed feasibility study and the intervention was developed using a co-creation approach. A total of 19 individuals with Type 2 diabetes participated in eight weeks of 30 min online physical exercise intervention followed by 30 min online group meetings in smaller groups once a week. Outcomes included pre-defined research progression criteria, secondary measurements of health parameters, and participant feedback. Most research progression criteria reached a level of acceptance, with the exception of participant recruitment, burden of objectively measured physical activity, and adverse events, where changes are needed before continuing to an RCT. Combining online physical exercise with online group meetings supported by an activity watch is feasible and acceptable in individuals with Type 2 diabetes with a higher educational level compared to the general population with Type 2 diabetes.

Virtual Digital Psychotherapist App-Based Treatment in Patients With Methamphetamine Use Disorder (Echo-APP): Single-Arm Pilot Feasibility and Efficacy Study.

Substance use disorder is one of the severe public health problems worldwide. Inequitable resources, discrimination, and physical distances limit patients' access to medical help. Automated conversational agents have the potential to provide in-home and remote therapy. However, automatic dialogue agents mostly use text and other methods to interact, which affects the interaction experience, treatment immersion, and clinical efficacy. The aim of this paper is to describe the design and development of Echo-APP, a tablet-based app with the function of a virtual digital psychotherapist, and to conduct a pilot study to explore the feasibility and preliminary efficacy results of Echo-APP for patients with methamphetamine use disorder. Echo-APP is an assessment and rehabilitation program developed for substance use disorder (SUD) by a team of clinicians, psychotherapists, and computer experts. The program is available for Android tablets. In terms of assessment, the focus is on the core characteristics of SUD, such as mood, impulsivity, treatment motivation, and craving level. In terms of treatment, Echo-APP provides 10 treatment units, involving awareness of addiction, motivation enhancement, emotion regulation, meditation, etc. A total of 47 patients with methamphetamine dependence were eventually enrolled in the pilot study to receive a single session of the Echo-APP-based motivational enhancement treatment. The outcomes were assessed before and after the patients' treatment, including treatment motivation, craving levels, self-perception on the importance of drug abstinence, and their confidence in stopping the drug use. In the pilot study, scores on the Stages of Change Readiness and Treatment Eagerness Scale and the questionnaire on motivation for abstaining from drugs significantly increased after the Echo-APP-based treatment (P<.001, Cohen d=-0.60), while craving was reduced (P=.01, Cohen d=0.38). Patients' baseline Generalized Anxiety Disorder-7 assessment score (β=3.57; P<.001; 95% CI 0.80, 2.89) and Barratt Impulsiveness Scale (BIS)-motor impulsiveness score (β=-2.10; P=.04; 95% CI -0.94, -0.02) were predictive of changes in the patients' treatment motivation during treatment. Moreover, patients' baseline Generalized Anxiety Disorder-7 assessment score (β=-1.607; P=.03; 95% CI -3.08, -0.14), BIS-attentional impulsivity score (β=-2.43; P=.004; 95% CI -4.03, -0.83), and BIS-nonplanning impulsivity score (β=2.54; P=.002; 95% CI 0.98, 4.10) were predictive of changes in craving scores during treatment. Echo-APP is a practical, accepted, and promising virtual digital psychotherapist program for patients with methamphetamine dependence. The preliminary findings lay a good foundation for further optimization of the program and the promotion of large-scale randomized controlled clinical studies for SUD.

1354 USING REALIST PROGRAMME THEORY TO DESIGN A NEW INTERVENTION FOR IMPROVING RECOVERY AFTER DELIRIUM

Abstract Introduction People who recover poorly after delirium are likely to require an increased level of care. It is presently unknown whether interventions to improve recovery after delirium are effective and cost-effective. This research aimed to develop a programme theory to inform the design of an intervention to improve recovery after delirium. Method A rapid realist review of literature was conducted to develop an initial programme theory. Following this, a qualitative investigation of the perceived rehabilitation needs of older people who have experienced delirium during a hospital stay was conducted via semi-structured interviews with 41 key stakeholders (older people (5), carers (12), and healthcare professionals (24)). Data were analysed using a realist approach to identify what works, for whom, and in what context. This was deductively informed by the initial programme theory while also employing an inductive analysis to identify novel insights. Through an iterative, retroductive process, context-mechanism-outcome configurations (CMOCs) were coded to reflect stakeholders’ views to refine the programme theory. Results The initial programme theory highlighted the importance of cognitive and physical rehabilitation and emotional support as key domains of recovery. New CMOCs included optimisation of good medical care to manage delirium and monitoring and management of underlying medical conditions to promote recovery. Others included developing educational resources and support networks for older people and their carers to aid sense-making, and encouraging social interaction to reduce isolation and empower independent functioning. These recovery elements should be addressed in a person-centred manner that is tailored to individual needs and preferences, engages carers, integrates intervention goals into daily functioning, and ensures continuity of care. Conclusion A refined programme theory was developed and is currently being used to design a manualised intervention to improve recovery after delirium. The acceptability of the intervention will be tested in a multi-centre, single-arm feasibility study.

Use of a Person-Centered Narrative Intervention in an Outpatient Palliative Care Setting: A Feasibility Study.

Person-centered narrative interventions offer potential solutions to facilitate a connection between the person receiving care and the person delivering the care, to improve quality of care, and positively impact a patient's biopsychosocial well-being. This single-arm feasibility study investigates patient-reported outcomes and barriers/facilitators to the implementation of an all-virtually delivered person-centered narrative intervention into the person's electronic health record. Overall, electronic data collection for the patient-reported outcomes was feasible. All 15 participants felt participating in the study was "easy" and "enjoyable," and "not a burden." The facilitators of implementation included: "helpful to the clinician," "appreciated looking at me as whole person," "be seen and heard," "had a connection and trust," and "felt comfortable and relaxing." The barriers to implementation included: "completing all the paperwork," "being rushed for time to complete the PCNI," and some "emotion" during collection of narrative. The use of person-centered narrative interventions is a way to deploy dedicated tools to shift dehumanized healthcare delivery to a more humanized person-centered care that treats people as experts in their own life narratives by incorporating their beliefs, values, and preferences into their plan of care.