Single-arm Feasibility Study Research Articles

Feasibility of a novel wrist-worn thermal device for management of vasomotor symptoms in patients with prostate cancer.

5067 Background: Vasomotor symptoms (VMS), or hot flashes, are a common side effect of androgen deprivation therapy (ADT) for prostate cancer (PCa). VMS negatively impact sleep, fatigue, and quality of life (QOL) in PCa survivors. There are few nonpharmacological treatments for VMS. The Embr Wave is a wearable thermal device that applies cooling to thermoreceptors on the inside of the wrist and has been associated with patient reported decreases in hot flash interference in women. We performed a single-arm feasibility study evaluating the Embr Wave for management of VMS in PCa survivors. Methods: 57 PCa survivors reporting bothersome hot flashes were enrolled and instructed to use the device as needed for VMS during the 4-week study. The primary outcome was device usage recorded by the device (minutes and sessions). Additional outcomes included the change in patient reported Hot Flash Related Daily Interference Scale (HFRDIS, range 0-10) and Patient Reported Outcomes Measurement Information System Sleep Disturbance 4a (PROMIS SD, range 0-100) and Sleep Related Impairment 8a (PROMIS SRI, range 0-100). Study procedures were conducted remotely using a virtual clinical trial management platform. Results: The study was conducted from May to Dec 2021 in the US. 44 men completed the study; 39 had retrievable usage data. Median age was 66 (range 57-78) years and median 3 (1-23) years since PCa diagnosis. The most common hormonal treatments were leuprolide (n=22), abiraterone (n=13), and enzalutamide (n=6). Baseline scores indicated moderate hot flash interference and mild sleep disturbance (Table). Mean±SD (median) usage of the Embr device was 3.2±2.5 (2.3) hours and 7.6±3.6 (7.5) sessions per day. 26 (67%) participants reported using the device 7 days/nights each week. Improvements were observed in HFRDIS, PROMIS SD, and PROMIS SRI scores (Table). There were also improvements in subjective ratings of hot flash frequency, duration, interference with daily life/sleep, bothersomeness and control (all p<0.01). The majority (69%) of participants reported that the device was effective at helping them manage hot flashes. No adverse events were reported. Conclusions: Results of this study support the feasibility of use of the thermal device for management of bothersome hot flashes in PCa survivors. Future randomized controlled studies are warranted to evaluate patient reported outcomes related to frequency and severity of VMS, sleep quality, fatigue, and overall QOL, in addition to defining the potential utility of the Embr thermal device in PCa survivors experiencing VMS. Clinical trial information: NCT04892914. [Table: see text]

Telehealth Delivery of a Multi-Disciplinary Rehabilitation Programme for Upper Gastro-Intestinal Cancer: ReStOre@Home Feasibility Study.

Simple SummaryThroughout the COVID-19 pandemic, many cancer care services have safely been delivered via telehealth. Multi-disciplinary rehabilitation programmes can help address the complex physical, nutritional and quality of life needs of upper gastrointestinal (UGI) cancer survivors, but it is unknown how well these multi-component programmes translate to a telehealth model of delivery. Therefore, we assessed the feasibility of running a 12-week exercise and nutrition rehabilitation programme for UGI cancer via telehealth. Participants found the telehealth model safe, convenient and highly satisfactory. Lower levels of technology skills were a barrier to recruitment, and some participants needed help with using the technology. Some adaptations to how the exercise programme was delivered were required. Participants recommended that future versions of the programme would have some element of in-person contact. Cancer survivors should receive all possible supports to enable their participation in telehealth programmes.Background: Telehealth has enabled access to rehabilitation throughout the pandemic. We assessed the feasibility of delivering a multi-disciplinary, multi-component rehabilitation programme (ReStOre@Home) to cancer survivors via telehealth. Methods: This single-arm mixed methods feasibility study recruited participants who had completed curative treatment for oesophago-gastric cancer for a 12-week telehealth rehabilitation programme, involving group resistance training, remotely monitored aerobic training, one-to-one dietetic counselling, one-to-one support calls and group education. The primary outcome was feasibility, measured by recruitment rates, attendance, retention, incidents, acceptability, Telehealth Usability Questionnaire (TUQ) and analysis of semi-structured interviews. Results: Characteristics of the twelve participants were: 65.42 ± 7.24 years; 11 male; 10.8 ± 3.9 months post-op; BMI 25.61 ± 4.37; received neoadjuvant chemotherapy 7/12; received adjuvant chemotherapy 4/12; hospital length of stay 16 days (median). Recruitment rate was 32.4%, and retention rate was 75%. Mean attendance was: education 90%; dietetics 90%; support calls 84%; resistance training 78%. Mean TUQ score was 4.69/5. Adaptations to the planned resistance training programme were required. Participants reported that ReStOre@Home enhanced physical and psychological wellbeing, and online delivery was convenient. Some reported a preference for in-person contact but felt that the online group sessions provided adequate peer support. Conclusion: Telehealth delivery of ReStOre@Home was most feasible in individuals with moderate to high levels of digital skills. Low level of digitals skills was a barrier to recruitment and retention. Participants reported high levels of programme adherence and participant satisfaction. Adaptations to future programmes, including introducing elements of in-person contact, are required.

Stepped-care cognitive behaviour therapy program for treating cancer-related fatigue: protocol for a feasibility study

BackgroundCancer-related fatigue (CRF) is a commonly experienced and often debilitating side effect of cancer treatment that can persist for years after treatment completion. The benefits of cognitive behaviour therapy (CBT) for CRF are well established; however, these interventions are typically not included in standard clinical care. Traditional CBT is resource-intensive, limiting implementation in hospital settings. Stepped-care approaches can offer benefits to more people, using the same personnel as traditional models.Method/designThis is a single-arm feasibility study. Fifty people with a cancer diagnosis, at least 12 weeks post-treatment or on long-term maintenance treatment, with persistent CRF that is affecting daily activities, will enrol in a stepped-care CBT program. Intervention: The stepped-care program involves two steps. Step 1: All participants begin with a 5-week supported self-management CBT progam targeting fatigue. Step 2: If fatigue remains severe or has changed less than the minimal clinically important difference on the fatigue measure after step 1, participants will be offered four sessions of therapist-directed group CBT. Measures: Participants will complete questionnaires at baseline and 6 and 10 weeks. The primary outcome is feasibility of the REFRESH program. The implementation evaluation comprises acceptability, satisfaction, appropriateness, and feasibility of the study intervention, along with administrative data including cost, processes, procedures and implementation. Secondary outcomes are changes in fatigue, quality of life and self-efficacy.ConclusionThe REFRESH program will be the first stepped-care CBT intervention for persistent CRF in Australia. Assessing feasibility of REFRESH is an important first step to establishing future implementation and efficacy.

Abstract No. 45 Treatment of painful lumbar degenerative disc disease: a feasibility study with hydrogel

Low back pain is the most common musculoskeletal problem worldwide, resulting in large medical and disability costs. Degenerative disc disease (DDD) represents the most common single cause of chronic low back pain (CLBP). This is a prospective single-arm early feasibility study that is a first in human trial to evaluate an injectable hydrogel and to assess its safety and performance.

Time-Restricted Eating to Reduce Cardiovascular Risk Among Older Breast Cancer Survivors: A Single-Arm Feasibility Study

Time-Restricted Eating to Reduce Cardiovascular Risk Among Older Breast Cancer Survivors: A Single-Arm Feasibility Study

Home Delivery of Water for Caries Prevention in Latinx Children (“Sediento por una Sonrisa,” Thirsty for a Smile): Protocol for a Single-Arm Feasibility Study

BackgroundDental caries has significant public health implications afflicting young children. In addition to low social economic status, the most prominent risk factor for early childhood caries is sugar in the diet, particularly sugar-sweetened beverages. Dental treatment for caries in young children is commonly performed under general anesthesia and a significant proportion of children require repeated treatment. Interventions to reduce sugar-sweetened beverage consumption could lead to reduced rates of retreatment for dental caries in young children.ObjectiveThis protocol describes the rationale, design, and methods of the “Thirsty for a Smile” feasibility study. The aim of the study is to assess the feasibility, acceptability, and appropriateness of a dietary intervention promoting water consumption in lieu of sugar-sweetened beverages among young patients, mostly from Latino heritage.MethodsThis protocol describes a single-arm feasibility study. Twenty-one dyads of children and their caregivers will be recruited. Children between 2 and 9 years old who recently had treatment under general anesthesia for early childhood dental caries will be eligible to participate. The intervention has two components: (1) environmental, in which bottled water is delivered to participants’ homes; and (2) behavioral, in which caregivers will receive patient-centered counseling to increase children’s water intake and reduce sugar-sweetened beverages consumption. Dental caries and anthropometric data will be collected at examination during baseline and final visits. The primary outcome is feasibility and secondary outcomes are acceptability and appropriateness of the intervention.ResultsFunding has been obtained from the National Institute of Dental and Craniofacial Research and the University of Washington approved the study. The feasibility study was conducted from March to November 2019.ConclusionsThis feasibility study will test the study processes prior to a two-arm randomized controlled trial to determine feasibility and acceptability of the intervention and study procedures. This study may provide useful information for other researchers attempting to test similar interventions.International Registered Report Identifier (IRRID)RR1-10.2196/37200

Evaluation of Safety and Effectiveness of the Paragonix™ SherpaPak Cardiac Transport System in Donation After Circulatory Death Heart Transplantation (clinicaltrials.gov Identifier: Nct05038943)

Purpose To evaluate the safety and effectiveness of The Paragonix SherpaPak™ Cardiac Transport System (CTS) in the transportation of cardiac allografts recovered from donors after circulatory death (DCD) with thoracoabdominal normothermic regional perfusion (TA-NRP). Methods Institutional Review Board (IRB#0478-21-FB) approved this single center pilot study for a total number of 5 heart transplants. The study is designed as a single arm feasibility study. The study opened for enrollment on September 15th 2021, the anticipated duration is one year. All patients included in DCD NRP study (NCT04615182) will be consented to participate in DCD NRP Paragonix study (NCT05038943). Inclusion and exclusion criteria are summarized in Table 1. Donor organs will be procured after no more than 30 minutes of warm ischemia (defined as a time period commencing from systolic blood pressure < 50 mmHg to the start of reperfusion) and resuscitated in-situ with TA-NRP in accordance with the approved institutional protocol. Criteria for donor acceptance for transplantation are depicted in Table 2. Allografts will be transported from a donor site to recipient center with the SherpaPak™ CTS. All implantation procedures will be performed at our institution. Recipients will receive standardized immunosuppression and infection prophylaxis and will undergo rejection surveillance with serial endomyocardial biopsies. Endpoints Primary outcome is primary graft dysfunction (PGD) at 24, 48, and 72 hours (using ISHLT definition). Secondary outcomes are: need for cardioversion or pacing to restart transplanted heart; vasoactive-inotropic score at 24, 48, and 72 hours (dopamine dose (µg/kg/min) + dobutamine dose (µg/kg/min) + 100 x epinephrine dose (µg/kg/min) + 100 x norepinephrine dose (µg/kg/min); intensive care unit and hospital length of stay; and 30-day, 90-day, 1-year survival. To evaluate the safety and effectiveness of The Paragonix SherpaPak™ Cardiac Transport System (CTS) in the transportation of cardiac allografts recovered from donors after circulatory death (DCD) with thoracoabdominal normothermic regional perfusion (TA-NRP). Institutional Review Board (IRB#0478-21-FB) approved this single center pilot study for a total number of 5 heart transplants. The study is designed as a single arm feasibility study. The study opened for enrollment on September 15th 2021, the anticipated duration is one year. All patients included in DCD NRP study (NCT04615182) will be consented to participate in DCD NRP Paragonix study (NCT05038943). Inclusion and exclusion criteria are summarized in Table 1. Donor organs will be procured after no more than 30 minutes of warm ischemia (defined as a time period commencing from systolic blood pressure < 50 mmHg to the start of reperfusion) and resuscitated in-situ with TA-NRP in accordance with the approved institutional protocol. Criteria for donor acceptance for transplantation are depicted in Table 2. Allografts will be transported from a donor site to recipient center with the SherpaPak™ CTS. All implantation procedures will be performed at our institution. Recipients will receive standardized immunosuppression and infection prophylaxis and will undergo rejection surveillance with serial endomyocardial biopsies. Primary outcome is primary graft dysfunction (PGD) at 24, 48, and 72 hours (using ISHLT definition). Secondary outcomes are: need for cardioversion or pacing to restart transplanted heart; vasoactive-inotropic score at 24, 48, and 72 hours (dopamine dose (µg/kg/min) + dobutamine dose (µg/kg/min) + 100 x epinephrine dose (µg/kg/min) + 100 x norepinephrine dose (µg/kg/min); intensive care unit and hospital length of stay; and 30-day, 90-day, 1-year survival.

Study protocol for the online adaptation and evaluation of the \u2018Reboot\u2019 (Recovery-boosting) coaching programme, to prepare critical care nurses for, and aid recovery after, stressful clinical events

BackgroundCritical care nurses (CCNs) are routinely exposed to highly stressful events, exacerbated during the COVID-19 pandemic. Supporting resilience and wellbeing of CCNs is therefore crucial to prevent burnout. One approach for delivering this support is by preparing critical care nurses for situations they may encounter, drawing on evidence-based techniques to strengthen relevant psychological coping strategies. As such, the current study seeks to tailor a Resilience-boosting psychological coaching programme [Reboot] for CCNs, based on cognitive behavioural therapy (CBT) principles and the Bi-Dimensional Resilience Framework (BDF), and (1) to assess the feasibility of delivering Reboot via online, remote delivery to CCNs, and (2) to provide a preliminary assessment of whether Reboot could increase resilience and confidence in coping with adverse events.MethodsEighty CCNs (n=80) will be recruited to the 8-week Reboot programme, comprised of two group workshops and two individual coaching calls. The study uses a single-arm before-after feasibility study design and will be evaluated with a mixed-methods approach, using online questionnaires (all participants) and telephone interviews (25% of participants). Primary outcomes will be confidence in coping with adverse events (the Confidence scale) and resilience (the Brief Resilience Scale) measured at four time points.DiscussionResults will determine whether it is feasible to deliver and evaluate a remote version of the Reboot coaching programme to CCNs, and will indicate whether participating in the programme is associated with increases in confidence in coping with adverse events, resilience and wellbeing (as indicated by levels of depression).

Use of a Continuous Glucose Monitoring System in High-Risk Hospitalized Noncritically Ill Patients With Diabetes After Cardiac Surgery and During Their Transition of Care From the Intensive Care Unit During COVID-19: A Pilot Study

ObjectiveContinuous glucose monitoring (CGM) has demonstrated benefits in managing inpatient diabetes. We initiated this single-arm pilot feasibility study during the COVID-19 pandemic in 11 patients with diabetes to determine the feasibility and accuracy of real-time CGM in patients who underwent cardiac surgery and whose care was being transitioned from the intensive care unit. MethodsA Clarke error grid analysis was used to compare CGM and point-of-care measurements. The mean absolute relative difference (MARD) of the paired measurements was calculated to assess the accuracy of CGM for glucose measurements during the first 24 hours on CGM, the remaining time on CGM, and for different chronic kidney disease (CKD) strata. ResultsOverall MARD between point-of-care and CGM measurements was 14.80%. MARD for patients without CKD IV and V with an estimated glomerular filtration rate (eGFR) of ≥20 mL/min/1.73 m2 was 12.13%. Overall, 97% of the CGM values were within the no-risk zone of the Clarke error grid analysis. For the first 24 hours, a sensitivity analysis of the overall MARD for all patients and those with an eGFR of ≥20 mL/min/1.73 m2 was 15.42% ± 14.44% and 12.80% ± 7.85%, respectively. Beyond the first 24 hours, overall MARD for all patients and those with an eGFR of ≥20 mL/min/1.73 m2 was 14.54% ± 13.21% and 11.86% ± 7.64%, respectively. ConclusionCGM has shown great promise in optimizing inpatient diabetes management in the noncritical care setting and after the transition of care from the intensive care unit with high clinical reliability and accuracy. More studies are needed to further assess CGM in patients with advanced CKD.

Feasibility of the SINERGIAPS (“Sinergias entre profesionales y pacientes para una Atención Primaria Segura”) intervention for improving patient safety in primary care

The primary aim was to examine the feasibility of intervention delivery and of trial procedures. Secondary aims were to study the intervention uptake; its acceptability and perceived utility; and its potential to improve safety culture and avoidable hospital admissions. We conducted a 3-month, single-arm feasibility study in 10 primary care (PC) centres in Spain. Centres received information regarding patients' experiences of safety (through the Patient Reported Experiences and Outcomes of Safety in Primary Care [PREOS-PC] questionnaire), and were instructed to plan safety improvements based on that feedback. We used a bespoke online tool to recruit PC professionals, collect patient feedback, and deliver it to the centres, and to collect outcome data (patient safety culture [Medical Office Survey on Patient Safety Culture, MOSPSC questionnaire]). We measured recruitment and follow-up rates and intervention uptake (based on the number of safety improvement plans registered). We conducted semistructured interviews with 9 professionals to explore the intervention acceptability and perceived utility. Of 256 professionals invited, 120 (47%) agreed to participate, and 97 completed baseline and postintervention measures. Of 780 patients invited, 585 (75%) completed the PREOS-PC questionnaire. Five of 10 centres (50%) designed an improvement plan, providing 27 plans in total (range per centre, 1-14). The intervention was perceived as a novel strategy for improving safety, although the healthcare professionals identified several factors limiting its acceptability and utility: lack of feedback at the individual professional level; potentially unrepresentative sample of patients providing feedback; and number of educational materials deemed overwhelming. It is feasible to deliver the proposed intervention so long as the identified limitations are addressed.

Anterior Segment Optical Coherence Tomography Angiography Following Trabecular Bypass Minimally Invasive Glaucoma Surgery.

ObjectiveTo assess anterior segment optical coherence tomography angiography (AS-OCTA) imaging of the episcleral vessels before and after trabecular bypass minimally invasive glaucoma surgery (MIGS).DesignA prospective, clinical, single-centre, single-arm pilot feasibility study conducted at National University Hospital, Singapore.SubjectsPatients with primary glaucomatous optic neuropathy undergoing Hydrus Microstent (Ivantis Inc., Irvine, CA, USA) implantation, who require at least one intra-ocular pressure-lowering medication. One or two eyes per patient may be enrolled.MethodsWe performed AS-OCTA (Nidek RS-3000 Advance 2, Gamagori, Japan) pre- and up to 6 months post-MIGS implantation using a standard protocol in all cornealimbal quadrants, to derive episcleral vessel densities (VD) using a previously described technique.Main Outcome MeasuresEpiscleral VD pre- and post-surgery, in sectors with and without the implant.ResultsWe obtained serial AS-OCTA images in 25 eyes undergoing MIGS implantation (23 subjects, mean age 70.3 ± 1.5, 61% female) with mean preoperative intraocular pressure (IOP) of 15.5 mmHg ± 4.0. We observed reductions in postoperative episcleral VD compared to preoperative VD at month 1 (mean difference −3.2, p = 0.001), month 3 (mean difference −2.94, p = 0.004) and month 6 (mean difference −2.19, p = 0.039) in sectors with implants (overall 6 month follow-up, p = 0.011). No significant changes were detected in episcleral VD in the sectors without implants (p = 0.910).ConclusionIn our pilot study, AS-OCTA was able to detect changes in the episcleral VD following trabecular bypass MIGS, which may be a useful modality to evaluate surgical outcomes if validated in future studies.

Feasibility of a pharmacist-led symptom monitoring and management intervention to improve breast cancer endocrine therapy adherence

BackgroundAdjuvant endocrine therapy (AET) for breast cancer reduces mortality, but one-third to one-half of patients discontinue it early or are nonadherent. ObjectiveWe developed a pilot single-site study of patients with evidence of early nonadherence to AET to assess the feasibility of a novel, clinical pharmacist-led intervention targeting symptom and medication management. MethodsPatients with prescription fill records showing nonadherence were enrolled in a single-arm feasibility study. Automated reminders were sent by e-mail or text with a link to symptom monitoring assessments weekly for 1 month and monthly until 6 months. Clinical oncology pharmacists used guideline-based symptom management and other medication management tools to support adherence and ameliorate symptoms reported on the assessments. Patient-reported outcome assessments included physical, mental, and social health domains and self-efficacy to manage symptoms and medications. Feasibility outcomes included completion of symptom reports and pharmacist recommendations. ResultsOf 19 participants who were nonadherent who enrolled and completed initial assessments, 18 completed all final study procedures, with 14 completing all assessments and no patient missing more than 3 assessments. All 18 participants reported at least one of 3 symptom types, and the majority reported attempting pharmacist recommendations. Patient-reported measures of physical, mental, and social health and self-efficacy improved, and 44% of the patients became adherent. ConclusionAn intervention using pharmacists in an oncology practice to systematically monitor and manage symptoms shows promise to reduce symptoms, enhance support and self-efficacy, and improve adherence to AET.

Training for Awareness, Resilience and Action (TARA) for medical students: a single-arm mixed methods feasibility study to evaluate TARA as an indicated intervention to prevent mental disorders and stress-related symptoms

BackgroundMedical students have a higher risk for depression, anxiety, stress-related symptoms, burnout, and suicide, and more rarely seek professional help or treatment than the general population. Appeals are being made to address the mental health and resilience of physicians-to-be. The novel program Training for Awareness, Resilience, and Action (TARA) was originally developed to treat depressed adolescents, targeting specific neuroscientific findings in this population. TARA has shown feasibility and preliminary efficacy in clinically depressed adolescents and corresponding brain-changes in mixed community adolescent samples. The present study investigated the feasibility and acceptability of TARA as a potential indicated prevention program for symptoms of depression, anxiety, stress and burnout in Swedish medical students.MethodsWe conducted a single-arm trial with 23 self-selected students in their early semesters of medical school (mean age 25.38 years, 5 males and 18 females), with or without mental disorders. All participants received TARA. Self-reported symptoms of depression, anxiety, perceived stress and psychological inflexibility were collected before (T0) and after the intervention (T1). Qualitative data on the participants’ experiences of TARA were collected in focus-group interviews conducted halfway through the program and upon completion of the program. Individual interviews were also conducted 2 years later. Qualitative content analysis was performed.ResultsThe mean attendance rate was 61.22% and the dropout rate was 17.40%. The Child Session Rating Scale administered after every session reflected an overall acceptable content, mean total score 34.99 out of 40.00. Trends towards improvement were seen across all outcome measures, including the Hospital Anxiety and Depression Scale Anxiety (t = 1.13, p = 0.29) and Depression (t = 1.71, p = 0.11) subscales, Perceived Stress Scale (t = 0.67, p = 0.51) and Avoidance and Fusion Questionnaire for youth (t = 1.64, p = 0.10). None of the participants deteriorated markedly during the intervention. Qualitative content analysis resulted in a main theme labeled: “An uncommon meeting-ground for personal empowerment”, with 4 themes; “Acknowledging unmet needs”, “Entering a free zone”, “Feeling connected to oneself and others” and “Expanding self-efficacy”.ConclusionTARA is feasible and acceptable in a mixed sample of Swedish medical students. The students’ reports of entering an uncommon meeting-ground for personal empowerment supports effectiveness studies of TARA in this context.

Prospective Study of Serration Angioplasty in the Infrapopliteal Arteries Using the Serranator Device: PRELUDE BTK Study

A prospective, multicenter, single-arm feasibility study (dates not included). Forty-six patients with limb-threatening ischemia (80%; n = 37) or claudication (20%; n = 9) with 53 “infrapopliteal” artery stenotic (72%) or occluded (28%) lesions underwent treatment with the Serranator device (Cagent Vascular, Wayne, Pa). Device success was 92%. Freedom from major adverse limb events plus death was 96% after 30 days. One lesion (2%) required a bailout stent for dissection. The Rutherford classification score had improved by one or more levels for 70% of the patients, with 42% having a score of 0, at 6 months. Serrations were present in all treated lesions in nine patients who had undergone optical coherence tomography or intravascular ultrasound. Serranator treatment of “infrapopliteal” artery stenoses showed excellent lumen gain with minimal evidence of arterial injury and good clinical results. Imaging studies showed serrations without significant dissection, supporting the device's proposed mechanism of action.

Intraoperative Indocyanine Green Dye Use in Ovarian Torsion: A Feasibility Study

To determine the feasibility of intravenous indocyanine green (ICG)dyeuse inpatients withadnexal torsion to intraoperatively evaluate ovarian perfusion after detorsion. A prospective multicenter single-arm feasibility study. A teaching hospital. A total of 12 nonpregnant patients, 18 to 45 years old with surgically confirmed adnexal torsion. Torsion was surgically confirmed, the involved adnexa were untwisted laparoscopically, and ICG dye was injected intravenously. The absence or presence of ICG perfusion was documented, and the clinical decision for ovarian conservation or removal was determined by the surgeon. The primary outcome was feasibility of using ICG dye including measures such as time to visualized perfusion and operative time. Secondary outcomes included presence or absence of ovarian preservation and postoperative follow-up measures. Intraoperative visualization of ICG perfusion to the detorsed adnexa was achieved in 10 patients (83%) in a median time of 1 minute (0, 2), resulting in entire (n=9) or partial (n=1) ovarian conservation. Perfusion was absent in 2 cases, and postoophorectomy histologic necrosis was confirmed in one case. Median operative time was 74 minutes (48, 94). There were no adverse events related to ICG dye use. Intraoperative ICG dye use in this study was logistically feasible and conservation of the entire or partial ovary was observed in 83% of patients, including one case where preoperative Doppler flow was absent.

An anti-inflammatory diet intervention for knee osteoarthritis: a feasibility study

BackgroundKnee osteoarthritis has an inflammatory component that is linked to pain and joint pathology, yet common non-surgical and non-pharmacological interventions (e.g., exercise, calorie restricting diets) do not typically target inflammation. We aimed to evaluate the feasibility of a telehealth delivered anti-inflammatory diet intervention for knee osteoarthritis.MethodsThis 9-week single-arm feasibility study recruited participants aged 40–85 years with symptomatic knee osteoarthritis (inclusion criteria: average pain ≥4/10 or maximal pain ≥5/10 during past week). All participants received a telehealth-delivered anti-inflammatory dietary education intervention involving 1:1 consultations at baseline, 3- and 6-week follow-up. The diet emphasised nutrient-dense wholefoods and minimally processed anti-inflammatory foods and discouraged processed foods considered to be pro-inflammatory. The primary outcome of feasibility was assessed via: i) eligibility, recruitment and retention rates; ii) self-reported dietary adherence; iii) adverse events; and iv) treatment satisfaction. Post-intervention interviews evaluated the acceptability of the dietary intervention delivered via telehealth. Secondary outcomes included changes in self-reported body mass, Knee injury and Osteoarthritis Outcome Score (KOOS), health-related quality of life (EuroQoL-5D), analgesic use and global rating of change. Worthwhile effects were determined by the minimal detectable change (MDC) for all five KOOS-subscales (pain, symptoms, activities of daily living, sport/recreation, quality of life) being contained within the 95% confidence interval.ResultsForty-eight of seventy-three (66%) individuals screened were eligible and 28 enrolled over 2 months (82% female, mean age 66 ± 8 years, body mass index 30.7 ± 4.8 kg.m−2). Six participants withdrew prior to final follow-up (21% drop-out). Of those with final follow-up data, attendance at scheduled telehealth consultations was 99%. Self-reported adherence to diet during the 9-week intervention period: everyday = 27%, most of time = 68% and some of time = 5%. Two minor adverse events were reported. Change scores contained the MDC within the 95% confidence interval for all five KOOS subscales. Suggestions to improve study design and limit drop-out included an initial face-to-face consultation and more comprehensive habitual dietary intake data collection.ConclusionThis study supports the feasibility of a full-scale randomised controlled trial to determine the efficacy of a primarily telehealth-delivered anti-inflammatory dietary education intervention in adults with symptomatic knee osteoarthritis.Trial registrationACTRN12620000229976 prospectively on 25/2/2020.

Feasibility of using activity trackers and apps to increase physical activity in whole families: The Step it Up Family intervention.

ObjectiveThis study examined the feasibility of an activity tracker and app intervention to increase physical activity in whole families.MethodsThis was a single-arm feasibility study with pre–post-intervention measures. Between 2017 and 2018, 40 families (58 children aged 6–10 years, 39 mothers, 33 fathers) participated in the 6-week Step it Up Family programme in Queensland, Australia. It was delivered using Garmin activity trackers and apps, weekly motivational text messages and an introductory session. Online surveys and semi-structured interviews conducted with parents assessed intervention usage, acceptability, usability, perceived usefulness, use of physical activity self-management strategies and programme influence. Analyses included descriptive statistics, Wilcoxon signed-rank test and qualitative content analysis.ResultsOverall, 38 families completed the post-intervention survey (95% family retention; 90% children, 95% mothers, 88% fathers). Garmin activity tracker usage was high (i.e. nearly 24/7 during the 6 weeks intervention). Families also used the Garmin apps regularly (i.e. mostly 2–6 times per week). Further, 80% of mothers and 52% of fathers read the motivational mobile text messages. Usability and perceived usefulness of the Garmin activity trackers and apps were rated high. Both parents significantly increased their use of physical activity self-management strategies from pre to post-intervention. Parents expressed that the intervention had increased awareness of physical (in)activity in the family, encouraged to be active and promoted outdoor family activities.ConclusionsUsing activity trackers and apps to increase physical activity in the whole family was well received by children and parents which suggests that this intervention approach is feasible. However, further testing is needed amongst more diverse family populations. These early findings support the implementation of a randomised controlled trial to examine intervention efficacy.

Delivery of Home-Based Exercise Interventions in Older Adults Facilitated by Amazon Alexa: A 12-week Feasibility Trial.

To evaluate the feasibility of using voice-controlled intelligent personal assistants (VIPAs) to remotely deliver and monitor an individually-tailored, home-based exercise program to older adults living independently and alone. 12-week, prospective single-arm feasibility study. Community residences. 15 adults aged 60 to 89 years living alone. All participants were prescribed home-based muscle strengthening, weight-bearing impact and balance exercises, increasing from two to four 10-minute sessions per day over 12 weeks. Sessions were delivered using VIPAs (Amazon Alexa Echo Show 5; "Alexa") and a novel software program ("Buddy Link"). The program was individualized by an exercise physiologist based on participant voice responses to Alexa questions. Study outcomes were feasibility (rate of retention, adherence, and adverse events), usability (System Usability Scale) and changes to quality of life (European Quality of Life Scale), and lower-extremity function (30 second sit-to-stand test). All 15 participants (mean age, 70.3 years) completed the study (retention 100%). Mean adherence to the exercise program was 115% (i.e., collectively all participants were prescribed 8640 exercises but completed 9944 exercises) with no adverse events reported to be related to the intervention and usability scored as above average (75/100). Other outcomes did not significantly change across the 12-week follow-up (all P>0.05). In this feasibility study of community-dwelling older adults living alone, a home-based exercise program delivered and monitored remotely by an exercise physiologist using VIPAs was safe and feasible.

Conversational Agent for Healthy Lifestyle Behavior Change: Web-Based Feasibility Study.

BackgroundThe rising incidence of chronic diseases is a growing concern, especially in Singapore, which is one of the high-income countries with the highest prevalence of diabetes. Interventions that promote healthy lifestyle behavior changes have been proven to be effective in reducing the progression of prediabetes to diabetes, but their in-person delivery may not be feasible on a large scale. Novel technologies such as conversational agents are a potential alternative for delivering behavioral interventions that promote healthy lifestyle behavior changes to the public.ObjectiveThe aim of this study is to assess the feasibility and acceptability of using a conversational agent promoting healthy lifestyle behavior changes in the general population in Singapore.MethodsWe performed a web-based, single-arm feasibility study. The participants were recruited through Facebook over 4 weeks. The Facebook Messenger conversational agent was used to deliver the intervention. The conversations focused on diet, exercise, sleep, and stress and aimed to promote healthy lifestyle behavior changes and improve the participants’ knowledge of diabetes. Messages were sent to the participants four times a week (once for each of the 4 topics of focus) for 4 weeks. We assessed the feasibility of recruitment, defined as at least 75% (150/200) of our target sample of 200 participants in 4 weeks, as well as retention, defined as 33% (66/200) of the recruited sample completing the study. We also assessed the participants’ satisfaction with, and usability of, the conversational agent. In addition, we performed baseline and follow-up assessments of quality of life, diabetes knowledge and risk perception, diet, exercise, sleep, and stress.ResultsWe recruited 37.5% (75/200) of the target sample size in 1 month. Of the 75 eligible participants, 60 (80%) provided digital informed consent and completed baseline assessments. Of these 60 participants, 56 (93%) followed the study through till completion. Retention was high at 93% (56/60), along with engagement, denoted by 50% (30/60) of the participants communicating with the conversational agent at each interaction. Acceptability, usability, and satisfaction were generally high. Preliminary efficacy of the intervention showed no definitive improvements in health-related behavior.ConclusionsThe delivery of a conversational agent for healthy lifestyle behavior change through Facebook Messenger was feasible and acceptable. We were unable to recruit our planned sample solely using the free options in Facebook. However, participant retention and conversational agent engagement rates were high. Our findings provide important insights to inform the design of a future randomized controlled trial.

Acceptability and adherence to a Mediterranean diet in the postnatal period to prevent type 2 diabetes in women with gestational diabetes in the UK: a protocol for a single-arm feasibility study (MERIT)

IntroductionWomen with gestational diabetes are at increased risk of developing type 2 diabetes later in life. In at-risk general populations, Mediterranean-style diet helps prevent type 2 diabetes. But its effect...