Non-randomised Feasibility Study Research Articles

Vocational rehabilitation to enhance return to work after trauma (ROWTATE): protocol for a non-randomised single-arm mixed-methods feasibility study

BackgroundTraumatic injuries are common amongst working-age adults. Survivors often experience physical and psychological problems, reduced quality of life and difficulty returning to work. Vocational rehabilitation improves work outcomes for a range of conditions but evidence of effectiveness for those with traumatic injuries is lacking. This study assesses feasibility of delivering a vocational rehabilitation intervention to enhance return to work and improve quality of life and wellbeing in people with at least moderate trauma to inform design of a definitive randomised controlled trial (RCT).MethodsNon-randomised, single-arm, multi-centre mixed-methods feasibility study with nested case studies and qualitative study. The case studies comprise interviews, observations of clinical contacts and review of clinical records. The qualitative study comprises interviews and/or focus groups. Participants will be recruited from two UK major trauma centres. Participants will comprise 40 patients aged 16–69 with an injury severity score of > 8 who will receive the intervention and complete questionnaires. Interviews will be conducted with 10 patients and their occupational therapists (OTs), clinical psychologists (CPs), employers and commissioners of rehabilitation services. Fidelity will be assessed in up to six patients by observations of OT and CP—patient contacts, review of patient records and intervention case report forms. OT and CP training will be evaluated using questionnaires and competence to deliver the intervention assessed using a team objective structured clinical examination and written task. Patients participating in and those declining participation in the study will be invited to take part in interviews/focus groups to explore barriers and facilitators to recruitment and retention. Outcomes include recruitment and retention rates, intervention fidelity, OT and CP competence to deliver the intervention, experiences of delivering or receiving the intervention and factors likely to influence definitive trial delivery.DiscussionEffective vocational rehabilitation interventions to enhance return to work amongst trauma patients are urgently needed because return to work is often delayed, with detrimental effects on health, financial stability, healthcare resource use and wider society. This protocol describes a feasibility study delivering a complex intervention to enhance return to work in those with at least moderate trauma.Trial registrationISRCTN: 74668529. Prospectively registered on 23 January 20

Trial in progress: A feasibility study of multi-platform profiling using biospecimens from patients with resected biliary tract cancer.

TPS359 Background: Biliary tract cancers (BTC) are rare malignancies with a high recurrence rate after resection of localized disease. FDA-approved systemic therapies for advanced disease are limited to combination chemotherapy and FGFR inhibitors for FGFR2-altered BTC. The tools of personalized medicine may guide management and expand treatment options for this disease. In multiple tumor types, circulating tumor DNA (ctDNA) has shown significant predictive power for recurrence after resection, but its utility has not yet been established in BTC. Organoid drug sensitivity screening may also inform and expand treatment options, particularly for patients without targetable mutations on next generation sequencing (NGS). Prospective concordance between organoid drug sensitivity and in vivo clinical responses to a given drug is needed to establish the value of this testing in BTC. We designed a clinical trial to determine the feasibility and physician-assessed utility of multi-platform profiling of resected BTC. Methods: This is an observational, non-randomized feasibility study to assess the ability to obtain NGS, ctDNA monitoring, and organoid drug sensitivity screening on patients with resected localized BTC. Secondary endpoints include physician-adjudicated utility of the profiling results for patient management, prospective concordance of organoid drug sensitivity with in vivo drug activity, and value of ctDNA in prediction of recurrence or response to therapy. Key eligibility criteria include a biopsy or clinical presentation consistent with BTC (excluding mixed HCC-cholangiocarcinoma), surgical candidacy for resection of measurable disease, and no prior targeted or investigational therapies. ctDNA is collected pre- and post-operatively, during adjuvant chemotherapy, during surveillance for up to 5 years and during systemic therapy for recurrent disease. Physician surveys are conducted before and after receipt of profiling results and then at time points where a change in management would be considered. Enrollment began in July 2020 with 5 of a planned 20 patients enrolled at the time of submission. Clinical trial information: NCT04561453.

Recognition and management of community-acquired acute kidney injury in low-resource settings in the ISN 0by25 trial: A multi-country feasibility study.

BackgroundAcute kidney injury (AKI) is increasingly encountered in community settings and contributes to morbidity, mortality, and increased resource utilization worldwide. In low-resource settings, lack of awareness of and limited access to diagnostic and therapeutic interventions likely influence patient management. We evaluated the feasibility of the use of point-of-care (POC) serum creatinine and urine dipstick testing with an education and training program to optimize the identification and management of AKI in the community in 3 low-resource countries.Methods and findingsPatients presenting to healthcare centers (HCCs) from 1 October 2016 to 29 September 2017 in the cities Cochabamba, Bolivia; Dharan, Nepal; and Blantyre, Malawi, were assessed utilizing a symptom-based risk score to identify patients at moderate to high AKI risk. POC testing for serum creatinine and urine dipstick at enrollment were utilized to classify these patients as having chronic kidney disease (CKD), acute kidney disease (AKD), or no kidney disease (NKD). Patients were followed for a maximum of 6 months with repeat POC testing. AKI development was assessed at 7 days, kidney recovery at 1 month, and progression to CKD and mortality at 3 and 6 months. Following an observation phase to establish baseline data, care providers and physicians in the HCCs were trained with a standardized protocol utilizing POC tests to evaluate and manage patients, guided by physicians in referral hospitals connected via mobile digital technology. We evaluated 3,577 patients, and 2,101 were enrolled: 978 in the observation phase and 1,123 in the intervention phase. Due to the high number of patients attending the centers daily, it was not feasible to screen all patients to assess the actual incidence of AKI. Of enrolled patients, 1,825/2,101 (87%) were adults, 1,117/2,101 (53%) were females, 399/2,101 (19%) were from Bolivia, 813/2,101 (39%) were from Malawi, and 889/2,101 (42%) were from Nepal. The age of enrolled patients ranged from 1 month to 96 years, with a mean of 43 years (SD 21) and a median of 43 years (IQR 27–62). Hypertension was the most common comorbidity (418/2,101; 20%). At enrollment, 197/2,101 (9.4%) had CKD, and 1,199/2,101 (57%) had AKD. AKI developed in 30% within 7 days. By 1 month, 268/978 (27%) patients in the observation phase and 203/1,123 (18%) in the intervention phase were lost to follow-up. In the intervention phase, more patients received fluids (observation 714/978 [73%] versus intervention 874/1,123 [78%]; 95% CI 0.63, 0.94; p = 0.012), hospitalization was reduced (observation 578/978 [59%] versus intervention 548/1,123 [49%]; 95% CI 0.55, 0.79; p < 0.001), and admitted patients with severe AKI did not show a significantly lower mortality during follow-up (observation 27/135 [20%] versus intervention 21/178 [11.8%]; 95% CI 0.98, 3.52; p = 0.057). Of 504 patients with kidney function assessed during the 6-month follow-up, de novo CKD arose in 79/484 (16.3%), with no difference between the observation and intervention phase (95% CI 0.91, 2.47; p = 0.101). Overall mortality was 273/2,101 (13%) and was highest in those who had CKD (24/106; 23%), followed by those with AKD (128/760; 17%), AKI (85/628; 14%), and NKD (36/607; 6%). The main limitation of our study was the inability to determine the actual incidence of kidney dysfunction in the health centers as it was not feasible to screen all the patients due to the high numbers seen daily.ConclusionsThis multicenter, non-randomized feasibility study in low-resource settings demonstrates that it is feasible to implement a comprehensive program utilizing POC testing and protocol-based management to improve the recognition and management of AKI and AKD in high-risk patients in primary care.

Compression gloves for patients with hand arthritis (C-GLOVES): A feasibility study.

Compression gloves are frequently provided to patients with hand arthritis. Evidence for effectiveness is limited. The aim of this study was to determine feasibility of recruitment, assessment and treatment procedures, in preparation for a future compression glove trial. A non-randomised feasibility study with out-patients with either undifferentiated inflammatory arthritis, rheumatoid arthritis or hand osteoarthritis, with moderate to severe hand pain. All received Isotoner™ compression gloves provided by rheumatology occupational therapists. The main outcomes were feasibility of recruitment, assessment and treatment procedures, trial outcome selection and sample size calculation. Participants were assessed at baseline and four weeks. Assessments included: numeric rating scales (0-10) of hand pain (on activity, at rest, at night) and stiffness; hand joint swelling; finger flexion; and hand function (Grip Ability Test). Of 318 patients screened, 86/204 (42%) of inflammatory and 68/114 (60%) of hand osteoarthritis patients were eligible. Of these, 41 (48%: age: 59.10 (SD 12.54) years) and 32 (47%: age: 60.75 (SD 8.64) years) respectively, consented. All completed four-week follow-up. Assessment and treatment protocols were feasible. Hand pain on activity and at night, stiffness, joint swelling, finger flexion and hand function improved: e.g. hand pain on activity: inflammatory arthritis change = -0.95 (SD 2.26; p = 0.01); osteoarthritis -1.57 (SD 1.78; p = 0.001). Participants reported improved hand pain, stiffness and hand function as main benefits. Procedures tested were feasible. The most relevant primary outcome was hand pain on activity. Future trials would need 161 participants (Inflammatory arthritis) and 151 (hand osteoarthritis).Trial registration: Clinical Trials.Gov: NCT01874067.

The Impact of a Functional Circuit Training Program in People with Chronic Stroke: A Non-Randomized Feasibility Study

The Impact of a Functional Circuit Training Program in People with Chronic Stroke: A Non-Randomized Feasibility Study

A feasibility study providing substance use treatment in the Black church

BackgroundBlack adults with substance use disorders (SUDs) experience health care disparities, including access to and retention in treatment. The Black church is a trusted institution in the Black community and could be a novel setting for providing SUD treatment. MethodWe conducted a nonrandomized feasibility study evaluating (1) whether it was possible to conduct a clinical trial of SUD treatment in this setting, (2) whether an adequate number of individuals with SUDs would participate in technology-based treatment in this setting, and (3) whether an adequate number of individuals would be retained in this setting. We evaluated computer-based training for cognitive behavioral therapy (CBT4CBT), with modifications that the church-based health advisors (CHAs), who delivered the intervention within the church, made. ResultsParticipants were 40 Black adults, all of whom met DSM-5 criteria for a current SUD, (55% severe). The mean number of sessions completed was 6.8 and 31 completed all 7 sessions of CBT4CBT. Both self-reports and weekly urine toxicology screens indicated reduction in substance use over time. ConclusionWe demonstrated feasibility, as we were able to (1) collect weekly data and protect participant confidentiality, (2) recruit an adequate number of individuals with SUD, with (3) high uptake and retention of an adapted CBT4CBT in the Black church. If demonstrated to be effective in a future randomized clinical trial, delivery of technology-based treatments in the Black church may prove a promising, easily disseminable strategy to provide evidence-based interventions to an underserved and undertreated population.

U-turn speed is a valid and reliable smartphone-based measure of multiple sclerosis-related gait and balance impairment

BackgroundPeople living with multiple sclerosis (MS) experience impairments in gait and mobility, that are not fully captured with manually timed walking tests or rating scales administered during periodic clinical visits. We have developed a smartphone-based assessment of ambulation performance, the 5 U-Turn Test (5UTT), a quantitative self-administered test of U-turn ability while walking, for people with MS (PwMS). Research questionWhat is the test-retest reliability and concurrent validity of U-turn speed, an unsupervised self-assessment of gait and balance impairment, measured using a body-worn smartphone during the 5UTT? Methods76 PwMS and 25 healthy controls (HCs) participated in a cross-sectional non-randomised interventional feasibility study. The 5UTT was self-administered daily and the median U-turn speed, measured during a 14-day session, was compared against existing validated in-clinic measures of MS-related disability. ResultsU-turn speed, measured during a 14-day session from the 5UTT, demonstrated good-to-excellent test-retest reliability in PwMS alone and combined with HCs (intraclass correlation coefficient [ICC] = 0.87 [95 % CI: 0.80–0.92]) and moderate-to-excellent reliability in HCs alone (ICC = 0.88 [95 % CI: 0.69–0.96]). U-turn speed was significantly correlated with in-clinic measures of walking speed, physical fatigue, ambulation impairment, overall MS-related disability and patients’ self-perception of quality of life, at baseline, Week 12 and Week 24. The minimal detectable change of the U-turn speed from the 5UTT was low (19.42 %) in PwMS and indicates a good precision of this measurement tool when compared with conventional in-clinic measures of walking performance. SignificanceThe frequent self-assessment of turn speed, as an outcome measure from a smartphone-based U-turn test, may represent an ecologically valid digital solution to remotely and reliably monitor gait and balance impairment in a home environment during MS clinical trials and practice.

The feasibility of a Comprehensive Resilience-building psychosocial Intervention (CREST) for people with dementia in the community: protocol for a non-randomised feasibility study

BackgroundA dementia diagnosis can prevent people from participating in society, leading to a further decline in cognitive, social and physical health. However, it may be possible for people with dementia to continue to live meaningful lives and continue to participate actively in society if a supportive psychosocial environment exists. Resilience theory, which focuses on strengthening personal attributes and external assets in the face of serious challenges, may provide a scaffold on which an inclusive multifaceted psychosocial supportive environment can be built. This protocol paper describes a study to determine the feasibility of conducting a multifaceted complex resilience building psychosocial intervention for people with dementia and their caregivers living in the community.MethodsThis is a non-randomised feasibility study. Ten participants with dementia and their primary caregivers living in the community will be recruited and receive the CREST intervention. The intervention provides (a) a 7-week cognitive stimulation programme followed by an 8-week physical exercise programme for people with dementia and (b) a 6-week educational programme for caregivers. Members of the wider community will be invited to a dementia awareness programme and GP practices to a dementia training workshop. Trained professionals will deliver all intervention components. Outcomes will assess the feasibility and acceptability of all study processes. The feasibility and acceptability of a range of outcomes to be collected in a future definitive trial, including economic measurements, will also be explored. Finally, social marketing will be used to map a route toward stigma change in dementia for use in a subsequent trial. Quantitative feasibility outcome assessments will be completed at baseline and after completion of the 15-week intervention while qualitative data will be collected at recruitment, baseline, during and post-intervention delivery.ConclusionThis feasibility study will provide evidence regarding the feasibility and acceptability of a comprehensive multifaceted psychosocial intervention programme for people with dementia and their caregivers (CREST). The results will be used to inform the development and implementation of a subsequent RCT, should the findings support feasibility.Trial registrationISRCTN25294519 Retrospectively registered 07.10.2019

Physical exercise during adjuvant chemotherapy for colorectal cancer\u2014a non-randomized feasibility study

BackgroundColorectal cancer (CRC) is the third most common cancer worldwide, and a large proportion of the patients receive adjuvant oxaliplatin-based chemotherapy. Most of these experience chemotherapy-induced peripheral neuropathy (CIPN), affecting quality of life. Evidence to advise exercise to reduce CIPN is limited. The primary aim of this study was to investigate the feasibility of an exercise intervention and data collection among CRC patients during adjuvant chemotherapy.Material and methodsThis non-randomized feasibility study included CRC patients admitted to adjuvant chemotherapy to an intervention consisting of supervised aerobic endurance, resistance, and balance exercises twice a week at the hospital in addition to home-based exercise once a week. A physiotherapist supervised the patients, and the intervention lasted throughout the period of adjuvant chemotherapy (12–24 weeks). Participants performed physical tests and filled in questionnaires at baseline, 3, 6, 9, and 12 months.Results and conclusionNineteen (63%) of 30 invited patients consented. A major barrier to recruit or consent to participation was long travel distance to the hospital. The completion rate of questionnaires and physical tests were near 100%. Seven participants dropped out, five before the intervention started. Median attendance to supervised exercise was 85%. There were no serious adverse events related to the intervention. Except for a planned higher intensity of endurance exercise, we found the intervention feasible and safe. Based on experiences in this study, some adjustments have been made for an upcoming randomized trial, including the supervised exercise taking place close to participants’ homes.Trial registrationNCT03885817, March 22, 2019, retrospectively registered.

341 - Exploring the feasibility and acceptability of a Comprehensive Resilience-building psychosocial intervention (CREST) for people with dementia in the community: a non-randomised feasibility study

Presenting Author: Priscilla Doyle, MAOrganisation: National University of Ireland Galway, Galway city, Galway, IrelandCo-Authors:Name: Niamh GallagherDegrees: B.A (International), M.A Health PromotionOrganisation: National University of Ireland Galway, Galway city, Galway, IrelandName: Siobhán SmythDegrees: RPN, PhDOrganisation: National University of Ireland Galway, Galway city, Galway, IrelandName: Dympna CaseyDegrees: RGN, BA, MA, PhdOrganisation: National University of Ireland Galway, Galway city, Galway, IrelandBackground:A dementia diagnosis can prevent people from participating in society, leading to a further decline in cognitive, social and physical health. However, it may be possible for people with dementia to continue to live meaningful lives and continue to participate actively in society if a supportive psychosocial environment exists. This feasibility study seeks to create such an environment by determining the feasibility of conducting a multifaceted complex resilience-building psychosocial intervention for people with dementia and their caregivers living in the community.Method:Ten participants with dementia and their primary caregivers living in the community were recruited and received the CREST intervention. The intervention provided (a) a 7-week cognitive stimulation programme (CST) followed by an 8-week physical exercise programme for people with dementia and (b) a 6-week educational programme for caregivers. Members of the wider community were invited to a dementia awareness programme and GP practices to a dementia-training workshop. Trained professionals delivered all intervention components. Outcomes assessed the feasibility and acceptability of all study processes such as: recruitment; intervention content and delivery; and data collection methods.Results:Recruiting participants was difficult, with local community organisations/groups proving more successful than GP practices. Preliminary results indicate that participants (people with dementia and carers) enjoyed the content of the CREST intervention, that the delivery method and timing worked well and overall found the programme beneficial. Carers reported that the educational programme provided them with valuable information which was accessible and easy to understand. However, the group activities and learning from each other was identified as crucial to their enjoyment and learning. The people with dementia likewise enjoyed the CST and exercise components, some reporting that the CST enhanced their concentration and that exercising with an exercise buddy was more sociable and enjoyable.Conclusion:The evidence from participants indicates that CREST is feasible and acceptable to carers and people with dementia in the community.

Evaluation of a clinical pharmacist team-based telehealth intervention in a rural clinic setting: a pilot study of feasibility, organizational perceptions, and return on investment

BackgroundRemote, centralized clinical pharmacist services provided by board-certified clinical pharmacists have been shown to effectively assist in chronic disease management. We assess the feasibility of implementing a pharmacist-led, remote, centralized pharmacy service to improve A1c levels in patient with diabetes in a rural clinic setting.MethodsThis was a non-randomized pilot and feasibility study. Participants were enrolled in a pharmacist-led telehealth intervention service, with data prior to enrollment used as baseline data for control. To be included, patients needed to have A1c readings of greater than 7% to be considered uncontrolled. A1c changes were reported for two groups based on A1c ranges: between 7 and 10% and ≥ 10%. Clinical pharmacists and clinical pharmacy interns initiated contact with patients via telephone communication and managed the patients remotely. The following outcomes were evaluated: organization perceptions (patients, providers, and clinic staff), changes in A1c, medication discrepancies, impact of an internally operated Patient Assistance Program, and potential return on investment (ROI).ResultsFifty-two patients were initially identified and referred to the service with 43 patients consenting to participate in the intervention. Patient and provider survey responses were recorded. In the initial analysis occurring during the first 3 to 5 months of the program, there was considerable improvement in diabetes control as measured by A1c. For patients with uncontrolled diabetes with a baseline A1c > 7% but less than < 10% and ≥ 10%, the intervention resulted in an A1c decrease of 0.57% and 2.55%, respectively. Clinical pharmacists and clinical pharmacy interns identified at least one medication discrepancy in 44% of patients, with number of discrepancies ranging from 1 to 5 per patient. At the conclusion of the study window, 42 potentially billable encounters were documented, which would have generated a net profit of $1140 USD, had they been submitted for reimbursement. Given the potential revenue generation, the service theoretically yields a ROI of 1.4 to 1.ConclusionsInitial results suggest that a pharmacist-led telehealth intervention has potential to decrease A1c levels in patients with diabetes, assist in identification of medication discrepancies, provide a positive return on investment for rural clinics, and potentially increase reimbursement for providers and clinics tasked with managing patients with uncontrolled diabetes.

Health-Enabling Technologies for Telerehabilitation of the Shoulder: A Feasibility and User Acceptance Study

Background After discharge from a rehabilitation center the continuation of therapy is necessary to secure already achieved healing progress and sustain (re-)integration into working life. To this end, home-based exercise programs are frequently prescribed. However, many patients do not perform their exercises as frequently as prescribed or even with incorrect movements. The telerehabilitation system AGT-Reha was developed to support patients with shoulder diseases during their home-based aftercare rehabilitation. Objectives The presented pilot study AGT-Reha-P2 evaluates the technical feasibility and user acceptance of the home-based telerehabilitation system AGT-Reha. Methods A nonblinded, nonrandomized exploratory feasibility study was conducted over a 2-year period in patients' homes. Twelve patients completed a 3-month telerehabilitation exercise program with AGT-Reha. Primary outcome measures are the satisfying technical functionality and user acceptance assessed by technical parameters, structured interviews, and a four-dimensional questionnaire. Secondary endpoints are the medical rehabilitation success measured by the active range of motion and the shoulder function (pain and disability) assessed by employing the Neutral-0 Method and the standardized questionnaire “Shoulder Pain and Disability Index” (SPADI), respectively. To prepare an efficacy trial, various standardized questionnaires were included in the study to measure ability to work, capacity to work, and subjective prognosis of work capacity. The participants have been assessed at three measurement points: prebaseline (admission to rehabilitation center), baseline (discharge from rehabilitation center), and posttherapy. Results Six participants used the first version of AGT-Reha, while six other patients used an improved version. Despite minor technical problems, all participants successfully trained on their own with AGT-Reha at home. On average, participants trained at least once per day during their training period. Five of the 12 participants showed clinically relevant improvements of shoulder function (improved SPADI score > 11). The work-related parameters suggested a positive impact. All participants would recommend the system, ten participants would likely reuse it, and seven participants would have wanted to continue their use after 3 months. Conclusion The findings show that home-based training with AGT-Reha is feasible and well accepted. Outcomes of SPADI indicate the effectiveness of aftercare with AGT-Reha. A controlled clinical trial to test this hypothesis will be conducted with a larger number of participants.

Does GP empathy influence patient enablement and success in lifestyle change among high risk patients?

BackgroundChronic lifestyle-related-diseases can be prevented by healthy lifestyle. Patients at high risk of disease may benefit from targeted health checks in general practice. However, general-practice-based-studies have shown that patient outcome, enablement, and well-being may be influenced by general practitioner (GP) empathy. The aim of this study is to investigate 1) how high risk patients evaluate their GPs’ empathy during a health check consultation, 2) whether the perceived GP empathy is associated with the patient’s enablement in immediate continuation of the health check consultation and 3) the patient’s subsequent lifestyle changes.MethodsThis study is part of a population based non-randomized feasibility study testing a complex intervention that systematically identifies citizens at high risk of lifestyle-related disease and with health-risk behavior and offers targeted preventive services in the Danish primary care sector. The ultimate aim of the intervention is to improve lifestyle and thereby reduce the risk of lifestyle-related disease. In the feasibility study a random sample of patients aged 30 to 59 years were invited to participate, and to fill in a questionnaire on lifestyle-risk factors. Participants deemed to be at high risk of disease were offered a focused clinical examination and a subsequent health check consultation at the GP. Following each health check consultation GP empathy and patient enablement were assessed using The Care Measure (CARE) and Patient Enablement Instrument (PEI). Patient’s perceived healthy-lifestyle change (y/n) was assessed after three months. The study has been approved by the Danish Data Protection Agency (J.nr 2015–57-0008) and registered at ClinicalTrial. Gov on June 13, 2016.ResultsTwenty-six GP’s participated in the study. Among 93 patients receiving a health check consultation 60 rated the GPs empathy. The median CARE-score was 40. The PEI median was 5.5 and 44.9% achieved a healthier lifestyle. No association was observed between GP empathy and patient enablement or a perceived healthier lifestyle.ConclusionNo statistical significant association between the CARE-score and patient enablement or a perceived healthier lifestyle was observed. Our results contrast previous findings and may to some extent be explained by a small sample size and the selected high-risk group.Trial registration numberNCT02797392.

A Dietary Mobile App for Patients Undergoing Hemodialysis: Prospective Pilot Study to Improve Dietary Intakes

BackgroundMobile technology has an impact on the health care sector, also within dietetics. Mobile health (mHealth) apps may be used for dietary assessment and self-monitoring, allowing for real-time reporting of food intakes. Changing eating behaviors is quite challenging, and patients undergoing hemodialysis, particularly, struggle to meet the target intakes set by dietary guidelines. Usage of mobile apps that are developed in a person-centered approach and in line with recommendations may support both patients and health care practitioners.ObjectiveThis study is a pilot that aims at estimating the potential efficacy of a dietary intervention using a theory-based, person-centered smartphone app. Results will be used to improve both the app and a planned large-scale trial intended to assess app efficacy thoroughly.MethodsA prospective pilot study was performed at the hemodialysis unit of Al Qassimi Hospital (The Emirate of Sharjah). All patients that fulfilled the study inclusion criteria were considered eligible to be enrolled in the pilot study. Upon successful installation of the app, users met with a dietitian once a week. Outcomes were measured at baseline (T0) and 2 weeks post app usage (T1). This pilot is reported as per guidelines for nonrandomized pilot and feasibility studies and in line with the CONSORT 2010 checklist for reporting pilot or feasibility trials.ResultsA total of 23 patients completed the pilot intervention. Mean energy intakes increased from 24.4 kcal/kg/day (SD 8.0) to 29.1 kcal/kg/day (SD 7.8) with a medium effect size (d=0.6, 95% CI 0.0-1.2). Mean protein intakes increased from 0.9 g/kg/day (SD 0.3) to 1.3 g/kg/day (SD 0.5) with a large effect size (d=1.0, 95% CI 0.4-1.6); mean intake of high biological value (%HBV) proteins also increased from 58.6% (SD 10.1) to 70.1% (SD 10.7) with a large effect size (d=1.1, 95% CI 0.5-1.7). Dietary intakes of minerals did not change, apart from sodium which decreased from a mean intake of 2218.8 mg/day (SD 631.6) to 1895.3 mg/day (SD 581.0) with a medium effect size (d=0.5, 95% CI 0.1-1.1). Mean serum phosphorus, potassium, and albumin levels did not change relevantly. Mean serum iron increased from 7.9 mg/dL (SD 2.8) to 11.5 mg/dL (SD 7.9) postintervention with a medium effect size (d=0.6, 95% CI 0.0-1.2).ConclusionsThis pilot study showed that the KELA.AE app has the potential to improve dietary intakes. Processes related to procedure, resources, tools, and app improvement for a future trial were assessed. A more extended intervention using a randomized controlled trial is required to estimate parameters concerning app efficacy accurately.

Simplifying Medication Regimens for People Receiving Community-Based Home Care Services: Outcomes of a Non-Randomized Pilot and Feasibility Study.

PurposeBeing able to manage a complex medication regimen is key to older people continuing to live at home. This study determined the feasibility of a multi-component intervention to simplify medication regimens for people receiving community-based home care services.Patients and MethodsResearch nurses recruited people receiving community-based home care services to participate in this non-randomized pilot and feasibility study (Australian New Zealand Clinical Trials Registry ACTRN12618001130257). Participants received a one-off clinical pharmacist intervention comprising medication reconciliation, assessment of capacity to self-manage medications, and application of a structured 5-step tool to identify medication simplification opportunities. A mixed-methods feasibility assessment with an explanatory design was undertaken to assess recruitment, protocol adherence and stakeholder acceptability. Data from interviews with 12 stakeholders were thematically analyzed. Secondary outcome measures, including medication discrepancies, and changes in number of medication administration times per day, quality of life, medication adherence and health service utilization, were determined over a 4-month follow-up.ResultsTwenty-five out of the target 50 participants were recruited. Initial recruitment was impacted by apparent uncertain role responsibilities in medication management, with some clients who declined to participate perceiving they would be unlikely to benefit or being reluctant to change regimens. However, with few exceptions, participants who received intervention did so with a high degree of protocol adherence and acceptability. Stakeholders valued the intervention and supported wider implementation. Discrepancies between the baseline medication history from the general medical practitioner and the pharmacist-compiled “best possible medication history” were identified for all participants’ regimens (median of 6 per participant), with one-third resolved at follow-up. Simplification was possible for 14 participants (56%) and implemented for 7 (50%) at follow-up. No significant changes in other secondary outcomes were observed.ConclusionThe intervention was delivered as planned, and valued by stakeholders. Recruitment barriers should be addressed before wider implementation.

An evidence-based structured one-year programme to sustain physical activity in patients with heart failure in primary care: A non-randomized longitudinal feasibility study.

AimThe primary objective of this non‐randomized feasibility study was to test a 1‐year model programme for sustaining/increasing patients’ motivation to perform daily physical activity.DesignNon‐randomized longitudinal feasibility study with a one‐group repeated measures design.MethodsThe study took place at a primary care centre in mid‐Sweden in 2017–2018. The model programme included individual and group‐based support, individualized physical activity prescriptions, a wrist‐worn activity tracker and an activity diary. The main outcomes were the participants’ perceptions of programme feasibility and scores on the Exercise Self‐Efficacy Scale.ResultsSeven patients were recruited. Six patients completed the programme that was perceived to imply learning, motivation and support. Compared with baseline, the median score of the Exercise Self‐Efficacy Scale improved 3 months after participants completed the programme.

What is the feasibility and observed effect of two implementation packages for stroke rehabilitation therapists implementing upper limb guidelines? A cluster controlled feasibility study

BackgroundHand and arm activity after stroke improves with evidence-based rehabilitation. Therapists face known barriers when providing evidence-based rehabilitation and require support to implement guidelines. The aim of this study was...

Application of Marte Meo\xae counselling with people with behavioural variant frontotemporal dementia and their primary carers (AMEO-FTD) \u2013 a non-randomized mixed-method feasibility study

BackgroundOne of the core symptoms of behavioural variant frontotemporal dementia (bvFTD) is the early loss of social cognitive abilities, which has a deteriorating impact on everyday interaction and the quality of dyadic relationships. Marte Meo® (MM) counselling is a video-based intervention that aims to maintain or improve the quality of dyadic relationships. This non-randomized mixed-method study aimed to evaluate the feasibility of the intervention in practice with primary carers of persons with bvFTD as well as the feasibility of a future confirmatory trial.MethodsA pilot effect study with a quasi-experimental, one-group, pre-post design and double pre-measurement was conducted. Data were collected at three time points (t0, t1 after 2 weeks, and t2 after 6 weeks) using videography and several measurement instruments. Between t1 and t2, each primary carer received five MM counselling sessions. The outcomes included positive and negative affect, behavioural and psychological symptoms in dementia (BPSD), the interpersonal abilities of the person with dementia, the sensitivity and distress of the primary carers due to BPSD, the manageability of BPSD, the personal goal attainment by means of MM counselling, and the quality of the dyadic relationships. The pilot process evaluation focused on the primary carers’ and the interventionist’s perceived benefits and perceptions of the intervention process using questionnaires and interviews.ResultsFive dyads were enrolled. Regarding the feasibility of the intervention, MM counselling seems to be appropriate and useful for the target group. Although the recruitment of persons with reliable bvFTD diagnoses was very time consuming and complex, the intervention was well accepted by the dyads, and regarding goal attainment, all carers benefited as much or even more than they expected. The study also showed that the benefits of MM counselling depend on whether the primary carer has accepted his/her relative’s dementia. Regarding the feasibility of a future confirmatory trial, certain outcomes, particularly positive affect, distress due to BPSD, and the quality of the dyadic relationship, seem to be appropriate for describing possible effects.ConclusionOverall, the intervention seems feasible for this target group. A future confirmatory trial should be planned as a multicentre pilot trial with an extension option.Trial registrationDRKS00014377. Registered retrospectively on April 11, 2018.

A multifaceted intervention to reduce antimicrobial prescribing in care homes: a non-randomised feasibility study and process evaluation

BackgroundThe most frequent acute health-care intervention that care home residents receive is the prescribing of medications. There are serious concerns about prescribing generally, and about antimicrobial prescribing in particular, with facilities such as care homes being described as an important ‘reservoir’ of antimicrobial resistance.ObjectivesTo evaluate the feasibility and acceptability of a multifaceted intervention on the prescribing of antimicrobials for the treatment of infections.DesignThis was a non-randomised feasibility study, using a mixed-methods design with normalization process theory as the underpinning theoretical framework and consisting of a number of interlinked strands: (1) recruitment of care homes; (2) adaptation of a Canadian intervention (a decision-making algorithm and an associated training programme) for implementation in UK care homes through rapid reviews of the literature, focus groups/interviews with care home staff, family members of residents and general practitioners (GPs), a consensus group with health-care professionals and development of a training programme; (3) implementation of the intervention; (4) a process evaluation consisting of observations of practice and focus groups with staff post implementation; and (5) a survey of a sample of care homes to ascertain interest in a larger study.SettingSix care homes – three in Northern Ireland and three in the West Midlands.ParticipantsCare home staff, GPs associated with the care homes and family members of residents.InterventionsA training programme for care home staff in the use of the decision-making algorithm, and implementation of the decision-making algorithm over a 6-month period in the six participating care homes. REACH (REduce Antimicrobial prescribing in Care Homes) Champions were appointed in each care home to support intervention implementation and the training of staff.Main outcome measuresThe acceptability of the intervention in terms of recruitment, delivery of training, feasibility of data collection from a variety of sources, implementation, practicality of use and the feasibility of measuring the appropriateness of prescribing.ResultsSix care homes from two jurisdictions were recruited, and the intervention was adapted and implemented. The intervention appeared to be broadly acceptable and was implemented largely as intended, although staff were concerned about the workload associated with study documentation. It was feasible to collect data from community pharmacies and care homes, but hospitalisation data from administrative sources could not be obtained. The survey indicated that there was interest in participating in a larger study.ConclusionsThe adapted and implemented intervention was largely acceptable to care home staff. Approaches to minimising the data-collection burden on staff will be examined, together with access to a range of data sources, with a view to conducting a larger randomised study.Trial registrationCurrent Controlled Trials ISRCTN10441831.FundingThis project was funded by the National Institute for Health Research (NIHR) Health Services and Delivery Research programme and will be published in full inHealth Services and Delivery Research; Vol. 8, No. 8. See the NIHR Journals Library website for further project information. Queen’s University Belfast acted as sponsor.

Three-Year Outcomes From the Harmony Native Outflow Tract Early Feasibility Study.

The Harmony transcatheter pulmonary valve (TPV) was designed for treatment of postoperative pulmonary valve regurgitation in patients with repaired right ventricular outflow tracts. The Native TPV EFS (Early Feasibility Study) is a prospective, multicenter, nonrandomized feasibility study. Three-year outcomes are reported. Of 20 implanted patients, 17 completed 3-year follow-up (maximum: 4.1 years). There were no deaths and 2 early explants. One patient did not complete the 3-year visit. In patients with available 3-year echocardiographic data, 1 had a mild paravalvular leak and the rest had none/trace; 1 patient had mild pulmonary valve regurgitation and the remainder had none/trace. The 3-year mean right ventricular outflow tract echocardiographic gradient was 15.7±5.5 mm Hg. Radiographically, no late frame fractures or erosions were identified. At 2 years, 2 patients presented with an increased echocardiographic outflow gradient (1 mixed lesion with moderate/severe pulmonary valve regurgitation). Computed tomography scans identified neointimal tissue ingrowth within the stent frame in both patients, and they were treated successfully with a transcatheter valve-in-valve procedure (Melody TPV). Additional follow-up computed tomography scans performed at 3.2±0.5 years after implant were obtained in 16 patients and revealed luminal tissue thickening at the inflow and outflow portion of the frame with no significant alteration of the valve housing. Three-year results from the Native TPV EFS revealed stable Harmony TPV device position, good valve function in most, and the absence of moderate/severe paravalvular leak and significant late frame fractures. Two patients developed significant neointimal proliferation requiring valve-in-valve treatment, while all others had no clinically significant right ventricular outflow tract obstruction. URL: https://www.clinicaltrials.gov. Unique identifier: NCT01762124.