Series of virtual light therapy interventions for fatigue: a feasibility pilot study protocol for a series of personalised (N-of-1) trials.
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ABSTRACT: Introduction
Fatigue is one of the most commonly recorded patient symptoms that can result in deficits in aspects of psychomotor functioning, cognition, work performance and mood. Research shows that bright light and dim light therapy may be an efficacious way to reduce symptoms of fatigue. Still, the feasibility, scalability, individual treatment effects and adverse event heterogeneity of these treatments are unknown.Methods and analysis
The current study evaluates the feasibility, acceptability and effectiveness of a series of personalised (N-of-1) interventions for virtual delivery of bright light therapy and dim light therapy versus usual care treatment for fatigue in 60 participants. We hypothesise that this study will provide valuable information about implementing virtual, N-of-1 randomised controlled trials (RCTs) for fatigue. It will also offer results about determining participants' ratings of usability and satisfaction with the virtual, personalised intervention delivery system; evaluating participants' improvement of fatigue symptoms; and, in the long term, identify ways to integrate N-of-1 light therapy trials into patient care.Ethics and dissemination
This trial was approved by the Northwell Health Institutional Review Board. The trial results will be published in a peer-reviewed journal. All publications resulting from this series of personalised trials will follow the Consolidated Standards of Reporting Trials extension for N-of-1 trials CENT 2015 reporting guidelines.Registration details
This trial is registered in www.Clinicaltrials
gov (number NCT04707846).Trial registration number
NCT04707846.
SUBMITTER: Butler M
PROVIDER: S-EPMC9608534 | biostudies-literature | 2022 Oct
REPOSITORIES: biostudies-literature
Publications
Series of virtual light therapy interventions for fatigue: a feasibility pilot study protocol for a series of personalised (N-of-1) trials.
Butler Mark M D'Angelo Stefani S Lewis Courtney C Miller Danielle D Perrin Alexandra A Suls Jerry J Chandereng Thevaa T Cheung Ying Kuen YK Davidson Karina W KW
BMJ open 20221025 10
<h4>Introduction</h4>Fatigue is one of the most commonly recorded patient symptoms that can result in deficits in aspects of psychomotor functioning, cognition, work performance and mood. Research shows that bright light and dim light therapy may be an efficacious way to reduce symptoms of fatigue. Still, the feasibility, scalability, individual treatment effects and adverse event heterogeneity of these treatments are unknown.<h4>Methods and analysis</h4>The current study evaluates the feasibili ...[more]
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Project description:BackgroundFatigue is one of the most common symptoms treated in primary care and can lead to deficits in mental health and functioning. Light therapy can be an effective treatment for symptoms of fatigue; however, the feasibility, scalability, and individual-level heterogeneity of light therapy for fatigue are unknown.ObjectiveThis study aimed to evaluate the feasibility, acceptability, and effectiveness of a series of personalized (N-of-1) interventions for the virtual delivery of bright light (BL) therapy and dim light (DL) therapy versus usual care (UC) treatment for fatigue in 60 participants.MethodsParticipants completed satisfaction surveys comprising the System Usability Scale (SUS) and items assessing satisfaction with the components of the personalized trial. Symptoms of fatigue were measured using the Patient-Reported Outcomes Measurement Information System (PROMIS) daily, PROMIS weekly, and ecological momentary assessment (EMA) questionnaires delivered 3 times daily. Comparisons of fatigue between the BL, DL, and UC treatment periods were conducted using generalized linear mixed model analyses between participants and generalized least squares analyses within individual participants.ResultsParticipants rated the usability of the personalized trial as acceptable (average SUS score=78.9, SD 15.6), and 92% (49/53) of those who completed satisfaction surveys stated that they would recommend the trial to others. The levels of fatigue symptoms measured using the PROMIS daily fatigue measure were lower or improved in the BL (B=-1.63, 95% CI -2.63 to -0.63) and DL (B=-1.44, 95% CI -2.50 to -0.38) periods relative to UC. The treatment effects of BL and DL on the PROMIS daily measure varied among participants. Similar findings were demonstrated for the PROMIS weekly and EMA measures of fatigue symptoms.ConclusionsThe participant scores on the SUS and satisfaction surveys suggest that personalized N-of-1 trials of light therapy for fatigue symptoms are both feasible and acceptable. Both interventions produced significant (P<.05) reductions in participant-reported PROMIS and EMA fatigue symptoms relative to UC. However, the heterogeneity of these treatment effects across participants indicated that the effect of light therapy was not uniform. This heterogeneity along with high ratings of usability and satisfaction support the use of personalized N-of-1 research designs in evaluating the effect of light therapy on fatigue for each patient. Furthermore, the results of this trial provide additional support for the use of a series of personalized N-of-1 research trials.Trial registrationClinicalTrials.gov NCT04707846; https://clinicaltrials.gov/ct2/show/NCT04707846.
| S-EPMC10546268 | biostudies-literature
Project description:Chronic lower back pain (CLBP) affects 25% of U.S. adults and is associated with high costs due to physician visits and reduced productivity. Research shows that massage and yoga can be effective nonpharmacological treatments for CLBP, but the feasibility, scalability, individual treatment, and adverse-event heterogeneity of these treatments are unknown. The current study evaluated the feasibility and acceptability of a series of personalized (N-of-1) interventions for virtual delivery of massage and yoga or usual-care treatment for CLBP in 57 participants. We hypothesized that this study would provide valuable information about implementing a virtual, personalized platform for randomized controlled trials of personalized (N-of-1) interventions among individuals with CLBP. The study will do so by determining participants' ratings of usability and satisfaction with the virtual, personalized intervention delivery system and, in the long term, identifying ways to integrate these personalized trials into patient care. Of the 57 participants enrolled, two withdrew from the study and were not eligible to receive the primary outcome assessment. Thirty-seven of the remaining 55 participants (67.3%) completed satisfaction surveys comprising the System Usability Scale (SUS) and items assessing satisfaction with the components of the personalized trial. Participants rated the usability of the personalized trial as excellent (average SUS score = 85.8), 95% were satisfied with the personalized trial overall, and 100% stated they would recommend the trial to others. These results suggest that personalized trials of massage and yoga are highly feasible and acceptable to participants with CLBP.
| S-EPMC10443938 | biostudies-literature
Project description:BackgroundPoor sleep, defined as short-duration or poor-quality sleep, is a frequently reported condition with many deleterious effects including poorer cognitive functioning, increased accidents, and poorer health. Melatonin has been shown to be an efficacious treatment to manage symptoms of poor sleep. However, the treatment effects of melatonin on sleep can vary greatly between participants. Personalized, or N-of-1, trial designs represent a method for identifying the best treatment for individual participants. Although using N-of-1 trials of melatonin to treat poor sleep is possible, the feasibility, acceptability, and effectiveness of N-of-1 trials using melatonin are unknown. Using the National Institutes of Health Stage Model for Behavioral Intervention Development, a stage IB (intervention refinement, modification, and adaptation and pilot testing) design appeared to be needed to address these feasibility questions.ObjectiveThis trial series evaluates the feasibility, acceptability, and effectiveness of a series of personalized interventions for remote delivery of melatonin dose (3 and 0.5 mg) versus placebo supplements for self-reported poor sleep among 60 participants. The goal of this study is to provide valuable information about implementing remote N-of-1 randomized controlled trials to improve poor sleep.MethodsParticipants will complete a 2-week baseline followed by six 2-week alternating intervention periods of 3 mg of melatonin, 0.5 mg of melatonin, and placebo. Participants will be randomly assigned to 2 intervention orders. The feasibility and acceptability of the personalized trial approach will be determined with participants' ratings of usability and satisfaction with the remote, personalized intervention delivery system. The effectiveness of the intervention will be measured using participants' self-reported sleep quality and duration and Fitbit tracker-measured sleep duration and efficiency. Additional measures will include ecological momentary assessment measures of fatigue, stress, pain, mood, concentration, and confidence as well as measures of participant adherence to the intervention, use of the Fitbit tracker, and survey data collection.ResultsAs of the submission of this protocol, recruitment for this National Institutes of Health stage IB personalized trial series is approximately 78.3% complete (47/60). We expect recruitment and data collection to be finalized by June 2023.ConclusionsEvaluating the feasibility, acceptability, and effectiveness of a series of personalized interventions of melatonin will address the longer term aim of this program of research-is integrating N-of-1 trials useful patient care? The personalized trial series results will be published in a peer-reviewed journal and will follow the CONSORT (Consolidated Standards of Reporting Trials) extension for N-of-1 trials (CENT 2015) reporting guidelines. This trial series was approved by the Northwell Health institutional review board.Trial registrationClinicalTrials.gov NCT05349188; https://www.clinicaltrials.gov/study/NCT05349188.International registered report identifier (irrid)DERR1-10.2196/45313.
| S-EPMC10436115 | biostudies-literature
Project description:IntroductionPilot and feasibility trials aim to test whether a full trial can be conducted or if any procedures must be changed for the full trial. Pilot trials must be reported in a transparent, accurate and complete way. In this report, we present a protocol for a methodological survey with the following aims: (1) to determine the percentage of physiotherapy trial reports which claim to be pilot or feasibility trials that evaluate feasibility, (2) to determine the aspect of feasibility evaluated in the primary objectives of the pilot or feasibility trials, (3) to describe the completeness of reporting of abstracts and full articles of pilot or feasibility trials using the Consolidated Standards of Reporting Trials (CONSORT) extension to randomised pilot and feasibility trials and (4) to investigate factors associated with completeness of reporting of pilot or feasibility trials.Methods and analysisReports of randomised controlled trials indexed in the Physiotherapy Evidence Database (PEDro) that claim to be pilot or feasibility trials and published in 2011-2017 will be included. Two independent reviewers will confirm eligibility and classify the aspect of feasibility being evaluated in the objectives of the included pilot or feasibility trials. Completeness of reporting of both the abstract and the full article will be evaluated using the CONSORT extension to randomised pilot and feasibility trials. The primary analysis will be a descriptive analysis about the reporting quality of abstracts and full texts of pilot and feasibility trials. We will use generalised estimating equation analysis to explore factors associated with completeness of reporting.Ethics and disseminationThe results of this study will be disseminated by presentation at conferences and will be submitted for publication in a peer-reviewed journal. Ethical approval is not necessary for this study.
| S-EPMC6538092 | biostudies-literature
Project description:Regular physical activity has a positive effect on physical health, well-being, and life satisfaction of older adults. However, engaging in regular physical activity can be challenging for the elderly population because of reduced mobility, low motivation, or lack of the proper infrastructures in their communities.The objective of this paper was to study the feasibility of home-based online group training-under different group cohesion settings-and its effects on adherence and well-being among Russian older adults. We focused particularly on the technology usability and usage and on the adherence to the training (in light of premeasures of social support, enjoyment of physical activity, and leg muscle strength). As a secondary objective, we also explored the effects of the technology-supported intervention on subjective well-being and loneliness.Two pilot trials were carried out exploring two different group cohesion settings (weak cohesion and strong cohesion) in the period from 2015 to 2016 in Tomsk, Russian Federation. A total of 44 older adults (59-83 years) participated in the two pilots and followed a strength and balance training program (Otago) for 8 weeks with the help of a tablet-based virtual gym app. Participants in each pilot were assigned to an interaction condition, representing the online group exercising, and an individual condition, representing a home-based individual training. Both conditions featured persuasion strategies but differed in the ability to socialize and train together.Both interaction and individual groups reported a high usability of the technology. Trainees showed a high level of technology acceptance and, particularly, a high score in intention to future use (4.2-5.0 on a 5-point Likert scale). Private texting (short service message [SMS]) was used more than public texting, and the strong cohesion condition resulted in more messages per user. Joint participations to training sessions (copresence) were higher for the social group with higher cohesion. The overall adherence to the training was 74% (SD 27%). Higher levels of social support at baseline were associated with higher adherence in the low cohesion condition (F1,18=5.23, P=.03), whereas in the high cohesion, such association was not found. Overall improvement in the satisfaction with life score was observed between pre and post measures (F1,31=5.85, P=.02), but no decrease in loneliness.Online group exercising was proven feasible among healthy independently living older adults in Russia. The pilots suggest that a physical training performed in a virtual environment positively affect the life satisfaction of the trainees, but it does not provide support for a decrease in loneliness. High cohesion groups are preferable for group exercising, especially to mitigate effects of low social support on adherence. Further research in motivating group interactions in training settings is needed.
| S-EPMC5849795 | biostudies-literature
Project description:BackgroundClinically elevated preoperative distress and anxiety are common among patients undergoing cancer surgery. Preoperative interventions have been developed to mitigate this distress and anxiety but are inconsistent in efficacy and feasibility for broad implementation.ObjectiveThis preliminary pilot study aims to assess the feasibility and utility of a newly developed virtual reality (VR) intervention to expose patients awaiting breast cancer surgery to the operating room environment and a simulation of anesthetic induction.MethodsPatients undergoing breast cancer surgery (N=7) were assigned to the VR intervention or control (treatment as usual) group and completed self-report measures of distress and anxiety before surgery, on the day of surgery, and after surgery (5 and 30 d postoperatively). Those in the intervention group trialed the VR simulation 1 to 2 weeks preoperatively and provided qualitative and quantitative feedback. We assessed the feasibility of recruitment capability and study design and evaluated participants' impressions of the intervention using self-report rating scales and open-ended questions. We also descriptively examined distress and anxiety levels throughout the duration of the study.ResultsRecruitment occurred between December 2021 and December 2022 and progressed slowly (rate: 1 participant/7 wk on average; some hesitancy because of stress and being overwhelmed). All participants who consented to participate completed the entire study. All participants were female and aged 56 (SD 10.56) years on average. In total, 57% (4/7) of the participants were assigned to the intervention group. On average, intervention participants spent 12 minutes engaged in the VR simulation. In general, the intervention was rated favorably (eg, clear information, enjoyable, and attractive presentation; mean% agreement 95.00-96.25, SD 4.79-10.00) and as helpful (mean% agreement 87.50, SD 25.00). Participants described the intervention as realistic (eg, "It was realistic to my past surgical experiences"), impacting their degree of preparedness and expectations for surgery (eg, "The sounds and sights and procedures give you a test run; they prepare you for the actual day"), and having a calming or relaxing effect (eg, "You feel more relaxed for the surgery").ConclusionsThis preoperative VR intervention demonstrated preliminary feasibility among a sample of patients undergoing breast cancer surgery. Results and participant feedback will inform modifications to the VR intervention and the study design of a large-scale randomized controlled trial to examine the efficacy of this intervention.Trial registrationClinicalTrials.gov NCT04544618; https://clinicaltrials.gov/study/NCT04544618.
| S-EPMC10831694 | biostudies-literature
Project description:IntroductionTechnological advances are changing nursing practice; however, nurse-led virtual care for chronic disease management has not yet been adequately explored and described. This study will review and analyse the effects of nurse-led virtual services and describe the virtual intervention characteristics relevant to the scope of nursing practice in chronic disease management.Methods and analysisThis study will systematically review randomised controlled trials evaluating the effects of nurse-led virtual care interventions on patients with chronic conditions. Databases including PubMed, Embase, Web of Science, CINAHL, Chinese National Knowledge Infrastructure, Wanfang (Chinese) and VIP Chinese Science and Technology Periodicals will be searched. All studies will be screened and selected using the criteria described in 'population, intervention, comparison, outcome and study design' format. Relevant studies will be searched using the reference lists of eligible studies and review articles. The risk of bias will be assessed using the Joanna Briggs Institute Quality Appraisal Form. Two reviewers will independently extract data from all the included studies using a standardised data extraction form on the Covidence platform. RevMan V.5.3 software will be used to perform the meta-analysis. Data synthesis will be conducted with descriptive synthesis by summarising and tabulating the data and presenting them according to the research questions.Ethics and disseminationFormal ethical approval is not required as the data used in this systematic review are abstracted from the pre-existing literature. The results of this study will be disseminated through peer-reviewed journals and conference presentations.Prospero registration numberCRD42022361260.
| S-EPMC10186446 | biostudies-literature
Project description:Objective(i) Compare the feasibility of three load modification strategies to immediately increase hip contact force in people with hip osteoarthritis (OA) using real-time visual biofeedback during walking, and (ii) prospectively evaluate changes in pain and physical function following 6-weeks of walking using a prescribed personalised load modification strategy.DesignTwenty participants with symptomatic mild-to-moderate hip OA walked on an instrumented treadmill while motion capture and electromyographic data were recorded (normal walk), then under three conditions: (i)neutral trunk lean; (ii)neutral pelvic obliquity; (iii)increased step length. The biomechanical parameter of interest and corresponding target value were displayed in real-time. Hip contact forces were subsequently computed using a calibrated electromyography-informed neuromusculoskeletal model. A decision tree was used to prescribe a personalised load modification strategy to each participant for integration into walking over 6-weeks.ResultsOnly the step length modification significantly increased peak hip contact force compared to normal walking when performed by all participants (11.34 [95%CI 4.54,18.13]%, P < 0.01). After participants were prescribed a personalised load modification strategy, both neutral pelvis (n = 5, 11.88[95%CI -0.49,24.24]%) and step length (n = 10, 12.79[95%CI 0.49,25.09]%) subgroups increased peak hip contact force >10%. After 6-weeks, 77% and 46% of participants reported a clinically important improvement in hip pain during walking and physical function, respectively.ConclusionMost participants with hip OA could immediately increase hip contact force through personalised movement retraining by a magnitude estimated to promote cartilage heath and reported an improvement in symptoms after 6-weeks. Findings provide preliminary support for a personalised load modification-based intervention for hip OA.
| S-EPMC9718151 | biostudies-literature
Project description:IntroductionImplementing a health system-based hypertension programme may lower blood pressure (BP).MethodsWe performed a randomized, controlled pilot study to assess feasibility, acceptability, and safety of a home-based virtual hypertension programme integrating evidence-based strategies to overcome current barriers to BP control. Trained clinical pharmacists staffed the virtual collaborative care clinic (vCCC) to remotely manage hypertension using a BP dashboard and phone "visits" to monitor BP, adherence, side effects of medications, and prescribe anti-hypertensives. Patients with uncontrolled hypertension were identified via electronic health records. Enrolled patients were randomized to either vCCC or usual care for 3 months. We assessed patients' home BP monitoring behaviour, and patients', physicians', and pharmacists' perspectives on feasibility and acceptability of individual programme components.ResultsThirty-one patients (vCCC = 17, usual care = 14) from six physician clinics completed the pilot study. After 3 months, average BP decreased in the vCCC arm (P = 0.01), but not in the control arm (P = 0.45). The vCCC participants measured BP more (9.9 vs. 1.2 per week, P < 0.001). There were no intervention-related adverse events. Participating physicians (n = 6), pharmacists (n = 5), and patients (n = 31) rated all programme components with average scores of >4.0, a pre-specified benchmark. Nine adaptations in vCCC design and delivery were made based on potential barriers to implementing the programme and suggestions.ConclusionA home-based virtual hypertension programme using team-based care, technology, and a logical integration of evidence-based strategies is safe, acceptable, and feasible to intended users. These pilot data support studies to assess the effectiveness of this programme at a larger scale.
| S-EPMC10047620 | biostudies-literature
Project description:BackgroundWe investigated whether a novel 8-week personalised health behaviour support programme, focusing on the stability of symptoms and strategies to improve activities of daily living, was feasible and acceptable in adults with post-COVID syndrome.MethodsIn this randomised, controlled, pilot feasibility trial, 32 adults with post-COVID syndrome (continued symptoms for ≥ 12 weeks) were randomised 1:1 to receive personalised health behaviour support (self-reported physical activity and symptom diaries, plus seven one-to-one remotely delivered personalised self-management support sessions), once weekly for 8-weeks, or usual care (referral to online 'your COVID-19 recovery' programme). The primary outcome was the feasibility of recruiting and randomising adults with post-COVID syndrome. The secondary outcomes were to assess the acceptability and safety of the intervention and various outcome measures.ResultsOf the 48 adults who expressed interest in the study, 32 (67%) were eligible and completed the baseline assessment. All 32 adults were willing to be randomised to either the personalised health behaviour support programme (n = 17) or usual care (n = 15) and 27 (age: 45 ± 12 years) adults completed follow-up at 9 weeks. The intervention was deemed feasible, with high adherence (92% and 94% completion rates for the physical activity and symptom diaries, respectively) and excellent acceptability rates (94% 'liked the intervention a lot'). The intervention was deemed safe, with no symptom exacerbations reported.ConclusionAn 8-week personalised health behaviour support programme was feasible for adults with post-COVID syndrome, with good adherence and acceptability rates. Early pilot data from this small sample also suggests meaningful improvements in physical activity, fatigue and respiratory symptoms.Patient or public contributionPeople living with post-COVID syndrome were involved from the outset with the study design, review of study documentation and interpretation of the data following completion. Furthermore, several participants have supported the local dissemination of findings following the completion of the study.
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