A rehabilitation intervention to improve recovery after an episode of delirium in adults over 65 years (RecoverED): study protocol for a multi-centre, single-arm feasibility study
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SUBMITTER: Allan L
PROVIDER: S-EPMC10503099 | biostudies-literature | 2023 Jan
REPOSITORIES: biostudies-literature
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Project description:ObjectiveThe objective of this study was to assess the feasibility of delivering Art skill-based Rehabilitation Training (ART), a novel upper limb motor training program, to patients with stroke as an adjunct to standard care in an inpatient setting.DesignFeasibility study.SettingInpatient stroke rehabilitation unit at a university hospital.ParticipantsThirty-eight patients admitted to a stroke rehabilitation unit with upper limb motor impairment were enrolled in the ART program facilitated by trained non-healthcare professionals between December 2017 and June 2021.InterventionThe ART program included nine, one-hour sessions of supervised tracing and freehand drawing tasks completed with both hands. This program was intended to be delivered at a frequency of three times per week over a duration of 3 weeks or for the length of inpatient stay.Main outcome measuresFeasibility outcomes included ART program adherence, acceptability, and safety.ResultsThirty-two (84%) participants with subacute stroke completed the ART program and 30 (79%) were included in the study analysis. Participants completed 93-100% of the ART tasks in a median [IQR] of 8 [6-10] ART sessions over a median [IQR] duration of 15 [7-19] days. ART program facilitators effectively provided upper limb assistance to patients with more severe upper limb impairments. Adherence and acceptability were high and no study-related adverse events occurred.ConclusionThe ART program was feasible to deliver and highly acceptable to patients with stroke. Further research is warranted to explore the impact of ART on upper limb sensorimotor function and use.
| S-EPMC9515518 | biostudies-literature
Project description:BackgroundThe positive effects of cardiac rehabilitation are well established. However, it has an inherent challenge, namely the low attendance rate among older vulnerable patients, which illustrates the need for effective interventions. Peer mentoring is a low-cost intervention that has the potential to improve cardiac rehabilitation attendance and improve physical and psychological outcomes among older patients. The aim of this study was to test the feasibility and acceptability of a peer-mentor intervention among older vulnerable myocardial infarction patients referred to cardiac rehabilitation.MethodsThe study was conducted as a single-arm feasibility study and designed as a mixed methods intervention study. Patients admitted to a university hospital in Denmark between September 2020 and December 2020 received a 24-week peer-mentor intervention. The feasibility of the intervention was evaluated based on five criteria by Orsmond and Cohn: (a) recruitment capability, (b) data-collection procedures, (c) intervention acceptability, (d) available resources, and (e) participant responses to the intervention. Data were collected through self-administrated questionnaires, closed-ended telephone interviews, semi-structured interviews, and document sheets.ResultsTwenty patients were offered the peer-mentor intervention. The intervention proved feasible, with a low dropout rate and high acceptability. However, the original inclusion criteria only involved vulnerable women, and this proved not to be feasible, and were therefore revised to also include vulnerable male patients. Peer mentors (n = 17) were monitored during the intervention period, and the findings indicate that their mentoring role did not cause any harm. The peer-mentor intervention showed signs of effectiveness, as a high rate of cardiac rehabilitation attendance was achieved among patients. Quality of life also increased among patients. This was the case for emotional, physical, and global quality of life measures at 24-week follow-up.ConclusionThe peer-mentor intervention is a feasible and acceptable intervention that holds the potential to increase both cardiac rehabilitation attendance and quality of life in older vulnerable patients. This finding paves the way for peer-mentor interventions to be tested in randomized controlled trials, with a view toward reducing inequality in cardiac rehabilitation attendance. However, some of the original study procedures were not feasible, and as such was revised.Trial registrationThe feasibility study was registered at ClinicalTrials.gov ( ClinicalTrials.gov identification number: NCT04507529 ), August 11, 2020.
| S-EPMC9360730 | biostudies-literature
Project description:BackgroundResearch impact is an emerging measure of research achievement alongside traditional academic outputs such as publications. We present the results of applying the Framework to Assess the Impact from Translational health research (FAIT) to the Centre for Research Excellence (CRE) in Stroke Rehabilitation and Brain Recovery (CRE-Stroke, 2014-2019) and report on the feasibility and lessons from the application of FAIT to a CRE rather than a discrete research project.MethodsData were gathered via online surveys, in-depth interviews, document analysis and review of relevant websites/databases to report on the three major FAIT methods: the modified Payback Framework, an assessment of costs against monetized consequences, and a narrative account of the impact generated from CRE-Stroke activities. FAIT was applied during the last 4 years of CRE-Stroke operation.ResultsWith an economic investment of AU$ 3.9 million over 5 years, CRE-Stroke delivered a return on investment that included AU$ 18.8 million in leveraged grants, fellowships and consultancies. Collectively, CRE-Stroke members produced 354 publications that were accessed 470,000 times and cited over 7220 times. CRE-Stroke supported 26 PhDs, 39 postdocs and seven novice clinician researchers. There were 59 capacity-building events benefiting 744 individuals including policy-makers and consumers. CRE-Stroke created research infrastructure (including a research register of stroke survivors and a brain biobank), and its global leadership produced international consensus recommendations to influence the stroke research landscape worldwide. Members contributed to the Australian Living Stroke Guidelines: four researchers' outputs were directly referenced. Based only on the consequences that could be monetized, CRE-Stroke returned AU$ 4.82 for every dollar invested in the CRE.ConclusionThis case example in the developing field of impact assessment illustrates how researchers can use evidence to demonstrate and report the impact of and returns on research investment. The prospective application of FAIT by a dedicated research impact team demonstrated impact in broad categories of knowledge-gain, capacity-building, new infrastructure, input to policy and economic benefits. The methods can be used by other research teams to provide comprehensive evidence to governments and other research funders about what has been generated from their research investment but requires dedicated resources to complete.
| S-EPMC10152619 | biostudies-literature
Project description:ObjectivesArm weakness is common after stroke; repetitive activity is critical for recovery but people struggle with knowing what to do, volume, and monitoring progress. We studied the feasibility and acceptability of OnTrack, a digital intervention supporting arm and hand rehabilitation in acute and home settings.DesignA mixed-method, single-arm study evaluating the feasibility of OnTrack for hospital and home use. An independent process evaluation assessed the intervention's fidelity, dose and reach. Amendments to the protocol were necessary after COVID-19.SettingAcute stroke services and home settings in North West London.Participants12 adults with a stroke diagnosis <6 months previously (first or recurrent) requiring arm rehabilitation in hospital and/or home.Intervention12 weeks using the OnTrack system comprising arm tracking and coaching support for self-management.Primary and secondary outcome measuresRecruitment, retention and completion rates; compliance and adherence to the intervention; reasons for study decline/withdrawal.Intervention fidelity and acceptability, evaluated through an independent process evaluation.Patient measures including activity baseline, healthcare activation, arm function and impairment collected at baseline, week 7 and week 14 of participation to assess suitability for a randomised controlled trial (RCT).Results181 individuals screened, 37 met eligibility criteria, 24 recruited (65%); of these, 15 (63%) were recruited before COVID-19, and 9 (37%) during. 12 completed the intervention (50%). Despite COVID-19 disruptions, recruitment, retention and completion were in line with prestudy expectations and acceptable for a definitive trial. Participants felt the study requirements were acceptable and the intervention usable. Fidelity of delivery was acceptable according to predetermined fidelity markers. Outcome measures collected helped determine sample size estimates and primary outcomes for an RCT.ConclusionsThe intervention was found to be usable and acceptable by participants; study feasibility objectives were met and demonstrated that a definitive RCT would be viable and acceptable.Trial registration numberNCT03944486.
| S-EPMC9528675 | biostudies-literature
Project description:ObjectivesThis clinical trial primarily aimed to investigate the effects of blonanserin on social functioning in patients with first-episode schizophrenia.MethodsIn this prospective, multi-centre, single-arm clinical trial study, blonanserin (flexible oral dose ranging from 8mg to 24mg per day) was given 26 weeks. Outcome measures included the Personal and Social Performance (PSP) scale for evaluating social functioning, the Measurement and Treatment Research to Improve Cognition in Schizophrenia Consensus Cognitive Battery (MCCB) for measuring neurocognitive performance, and the Positive and Negative Syndrome Scale (PANSS) for assessing symptom severity. The primary endpoint was social function improvement evaluated by PSP scale at the end of blonanserin treatment. And the secondary endpoint was to validate the efficacy and neurocognitive effects of blonanserin. Adverse drug reactions (ADRs) were also recorded and analysed.ResultsA total of 96 patients with first-episode schizophrenia were recruited and proceeded to analysis. Fifty-one participants (53.1%) completed the PSP scale measurements at baseline and week 26. Following 26 weeks of blonanserin treatment, all outcome measurements demonstrated significant improvement during the follow-up period. Notably, PSP scores exhibited a continuous increase up to 68.1% ± 103.7% at the end of the treatment (46.6 ± 14.6 at baseline, 69.4 ± 17.4 at week 26, p<0.001), indicating positive effects on social functioning that were already noticeable by week 8.ConclusionBlonanserin treatment exhibited favourable effects on social functioning in individuals with first-episode schizophrenia. The results suggest that blonanserin was effective treatment options for patients with schizophrenia encountering functional impairments.
| S-EPMC10988613 | biostudies-literature
Project description:IntroductionOlder adults with cancer suffer from the combined effects of ageing, cancer disease and treatment side effects. The main treatment for patients with haematological malignancies is chemotherapy, associated with significant toxicities. Chemotherapy can alter patients' physical function and quality of life which are often already diminished in older patients due to ageing and comorbidities. It therefore seems essential to develop and to evaluate interventions capable of preventing physical and psychosocial decline and its consequences. Promoting physical activity is a promising approach to improve physical function and quality of life in older adults with cancer, but there are limited data on the feasibility of such interventions among older patients with haematological malignancies, concomitant to chemotherapy.Methods and analysisOCAPI (OnCogeriatric and Individualized Physical Activity) is a single-arm, interdisciplinary, prospective, interventional, feasibility study. It is intended to include 40 patients (20 patients with acute myeloid leukaemia and 20 patients with non-Hodgkin's lymphoma) over 65 years in an individualised 6-month physical activity programme. The programme consists of individually supervised exercise sessions with an increasing volume of physical activity either at home and/or in a laminar airflow room (depending on the disease and treatment regimen) followed by unsupervised sessions and phone follow-ups. Patients will receive an activity tracker during the 6 months of the programme. Evaluations will take place at inclusion and at 3, 6 and 12 months to assess the feasibility of the programme and to explore potential changes in physical, psychosocial and clinical outcomes. The results will generate preliminary data to implement a larger randomised controlled trial.Ethics and disseminationThe study protocol was approved by the French ethics committee (Comité de protection des personnes Est I, N°ID-RCB 2019-A01231-56, 12 July 2019). All participants will have to sign and date an informed consent form. The findings will be disseminated in peer-reviewed journals and academic conferences.Trial registration numberNCT04052126.
| S-EPMC8183222 | biostudies-literature
Project description:BackgroundShoulder pain is a highly prevalent complaint and disorders of the rotator cuff, including tears, are thought to be the most common cause. The number of operations repair the torn rotator cuff has risen significantly in recent years. While surgical techniques have progressed, becoming less invasive and more secure, rehabilitation programmes have remained largely like those initially developed when surgical techniques were less advanced and more invasive. Uncertainty remains in relation to the length of post-surgical immobilisation and the amount of early load permitted at the repair site. In the context of this uncertainty, current practice is to follow a generally cautious approach, including long periods of immobilisation in a sling and avoidance of early active rehabilitation. Systematic review evidence suggests early mobilisation might be beneficial but further high-quality studies are required to evaluate this.Methods/designRaCeR is a two-arm, multi-centre pilot and feasibility randomised controlled trial with nested qualitative interviews. A total of 76 patients with non-traumatic rotator cuff tears who are scheduled to have a surgical repair will be recruited from up to five UK NHS hospitals and randomly allocated to either early patient-directed rehabilitation or standard rehabilitation that incorporates sling immobilisation. RaCeR will assess the feasibility of a future, substantive, multi-centre randomised controlled trial to test the hypothesis that, compared to standard rehabilitation incorporating sling immobilisation, early patient-directed rehabilitation is both more clinically effective and more cost-effective. In addition, a sample of patients and clinicians will be interviewed to understand the acceptability of the interventions and the barriers and enablers to adherence to the interventions.DiscussionResearch to date suggests that there is the possibility of reducing the patient burden associated with post-operative immobilisation following surgery to repair the torn rotator cuff and improve clinical outcomes. There is a clear need for a high-quality, adequately powered, randomised trial to better inform clinical practice. Prior to a large-scale trial, we first need to undertake a pilot and feasibility trial to address current uncertainties about recruitment, retention and barriers to adherence to the interventions, particularly in relation to whether patients will be willing to begin moving their arm early after their operation.Trial registrationISRCTN Registry, 18357968 . Registered on 10 August 2018.
| S-EPMC6554931 | biostudies-literature
Project description:ObjectiveThe aim of this study was to explore the feasibility of conducting a randomized controlled trial of dynamic Lycra® orthoses as an adjunct to arm rehabilitation after stroke and to explore the magnitude and direction of change on arm outcomes.DesignThis is a single-blind, two-arm parallel group, feasibility randomized controlled trial.SettingIn-patient rehabilitation.SubjectsThe study participants were stroke survivors with arm hemiparesis two to four weeks after stroke receiving in-patient rehabilitation.InterventionsParticipants were randomized 2:1 to wear Lycra® gauntlets for eight hours daily for eight weeks, plus usual rehabilitation (n = 27), or to usual rehabilitation only (n = 16).Main measuresRecruitment, retention, fidelity, adverse events and completeness of data collection were examined at 8 and 16 weeks; arm function (activity limitation; Action Research Arm Test, Motor Activity Log) and impairment (Nine-hole Peg Test, Motricity Index, Modified Tardieu Scale). Structured interviews explored acceptability.ResultsOf the target of 51, 43 (84%) participants were recruited. Retention at 8 weeks was 32 (79%) and 24 (56%) at 16 weeks. In total, 11 (52%) intervention group participants and 6 (50%) control group participants (odds ratio = 1.3, 95% confidence interval = 0.2 to 7.8) had improved Action Research Arm Test level by 8 weeks; at 16 weeks, this was 8 (61%) intervention and 6 (75.0%) control participants (odds ratio = 1.1, 95% confidence interval = 0.1 to 13.1). Change on other measures favoured control participants. Acceptability was influenced by 26 adverse reactions.ConclusionRecruitment and retention were low, and adverse reactions were problematic. There were no indications of clinically relevant effects, but the small sample means definitive conclusions cannot be made. A definitive trial is not warranted without orthoses adaptation.
| S-EPMC6613174 | biostudies-literature
Project description:AimExercise can improve psychiatric symptoms, neurocognitive functioning and physical health in schizophrenia. However, the effects in early psychosis have not been explored. This study aimed to assess the feasibility of an exercise intervention for early psychosis and to determine if it was associated with changes in physical and mental health.MethodsThirty-one patients with first-episode psychosis (FEP) were recruited from early intervention services to a 10-week exercise intervention. The intervention group received individualized training programmes, aiming to achieve ≥90 min of moderate-to-vigorous activity each week, using exercise programmes tailored to individual preferences and needs. A comparison FEP sample from the same services (n = 7) received treatment as usual.ResultsRates of consent and retention in the exercise group were 94% and 81%, respectively. Participants achieved an average of 107 min of moderate-to-vigorous exercise per week. Positive and Negative Syndrome Scale total scores reduced by 13.3 points after 10 weeks of exercise, which was significantly greater than the treatment as usual comparison group (P = 0.010). The greatest differences were observed in negative symptoms, which reduced by 33% in the intervention group (P = 0.013). Significant improvements were also observed in psychosocial functioning and verbal short-term memory. Increases in cardiovascular fitness and processing speed were positively associated with the amounts of exercise achieved by participants.ConclusionIndividualized exercise training could provide a feasible treatment option for improving symptomatic, neurocognitive and metabolic outcomes in FEP.
| S-EPMC6001796 | biostudies-literature
Project description:IntroductionMalawi has a substantial burden of chronic respiratory diseases (CRDs) which cause significant morbidity and loss of economic productivity, affecting patients, families and health systems. Pulmonary rehabilitation (PR) is a highly recommended non-pharmacological intervention in the clinical management of people with CRDs. However, Malawi lacks published evidence on the implementation of PR for people with CRDs. This trial will test the feasibility and acceptability of implementing a culturally appropriate hospital-based PR programme among adults with functionally limiting CRDs at Queen Elizabeth Central Hospital in Blantyre, Malawi.Methods and analysisThis is a single-centre mixed-methods pre-post single-arm feasibility trial. Ten patients aged ≥18 years, with a spirometry confirmed diagnosis of a CRD and breathlessness of ≥2 on the modified Medical Research Council dyspnoea scale, will be consecutively recruited. Their baseline lung function, exercise tolerance and health status will be assessed; including spirometry, Incremental Shuttle Walk Test and Chronic Obstructive Pulmonary Disease Assessment Test, respectively. Pretrial semistructured in-depth interviews will explore their experiences of living with CRD and potential enablers and barriers to their PR uptake. Along with international PR guidelines, these data will inform culturally appropriate delivery of PR. We initially propose a 6-week, twice-weekly, supervised centre-based PR programme, with an additional weekly home-based non-supervised session. Using combination of researcher observation, interaction with the participants, field notes and informal interviews with the participants, we will assess the feasibility of running the programme in the following areas: participants' recruitment, retention, engagement and protocol adherence. Following programme completion (after 6 weeks), repeat assessments of lung function, exercise tolerance and health status will be conducted. Quantitative changes in clinical outcomes will be described in relation to published minimal clinically important differences. Post-trial semistructured interviews will capture participants' perceived impact of the PR programme on their quality of life, enablers, and barriers to fully engaging with the programme, and allow iteration of its design.Ethics and disseminationEthical approval for this trial was obtained from University of Malawi College of Medicine Research and Ethics Committee (COMREC), Blantyre, Malawi (protocol number: P.07/19/2752) and University of Leicester Research Ethics Committee, Leicester, UK (ethics reference: 31574). The results of the trial will be disseminated through oral presentations at local and international scientific conferences or seminars and publication in a peer-reviewed journal. We will also engage the participants who complete the PR trial and the Science Communication Department at Malawi-Liverpool-Wellcome Trust Clinical Research Programme to organise community outreach activities within Blantyre to educate communities about CRDs and PR. We will also broadcast our trial results through national radio station programmes such as the weekly "Thanzi la Onse" (Health of All) programme by Times Radio Malawi. We will formally present our trial results to Blantyre District Health Office and Malawi Ministry of Health.Trial registration numberISRCTN13836793.
| S-EPMC8804676 | biostudies-literature