SPIN Self-Management Feasibility Trial

Author(s):  
Author(s):  
Matthew F. Muldoon ◽  
Julian Einhorn ◽  
Jonathan G. Yabes ◽  
Danielle Burton ◽  
Taya Irizarry ◽  
...  

2020 ◽  
pp. 026921552095638
Author(s):  
Stefanie Schnabel ◽  
Frederike van Wijck ◽  
Brenda Bain ◽  
Mark Barber ◽  
Philippa Dall ◽  
...  

Objective: To explore the experiences of stroke survivors and their carers of augmented arm rehabilitation including supported self-management in terms of its acceptability, appropriateness and relevance. Design: A qualitative design, nested within a larger, multi-centre randomized controlled feasibility trial that compared augmented arm rehabilitation starting at three or nine weeks after stroke, with usual care. Semi-structured interviews were conducted with participants in both augmented arm rehabilitation groups. Normalization Process Theory was used to inform the topic guide and map the findings. Framework analysis was applied. Setting: Interviews were conducted in stroke survivors’ homes, at Glasgow Caledonian University and in hospital. Participants: 17 stroke survivors and five carers were interviewed after completion of augmented arm rehabilitation. Intervention: Evidence-based augmented arm rehabilitation (27 additional hours over six weeks), including therapist-led sessions and supported self-management. Results: Three main themes were identified: (1) acceptability of the intervention (2) supported self-management and (3) coping with the intervention. All stroke survivors coped well with the intensity of the augmented arm rehabilitation programme. The majority of stroke survivors engaged in supported self-management and implemented activities into their daily routine. However, the findings suggest that some stroke survivors (male >70 years) had difficulties with self-management, needing a higher level of support. Conclusion: Augmented arm rehabilitation commencing within nine weeks post stroke was reported to be well tolerated. The findings suggested that supported self-management seemed acceptable and appropriate to those who saw the relevance of the rehabilitation activities for their daily lives, and embedded them into their daily routines.


Trials ◽  
2015 ◽  
Vol 16 (1) ◽  
Author(s):  
Rebecca E. A. Walwyn ◽  
Amy M. Russell ◽  
Louise D. Bryant ◽  
Amanda J. Farrin ◽  
Alexandra M. Wright-Hughes ◽  
...  

2020 ◽  
Author(s):  
Nicole E Carmona ◽  
Aleksandra Usyantynsky ◽  
Samlau Kutana ◽  
Penny Corkum ◽  
Joanna Henderson ◽  
...  

BACKGROUND Sleep disturbance and its daytime sequelae is a pervasive problem in adolescents and young adults (AYA), associated with negative mental health and academic outcomes. The sleep problems of AYA are complex and transdiagnostic, including delayed sleep phase issues, insomnia, hypersomnia and hypersomnolence. Effective interventions must be both evidence-based and tailored to the individual. AYAs have a preference for both self-management and digital approaches, and leveraging these preferences is helpful given the dearth of AYA treatment providers trained in behavioural sleep medicine. We involved AYA stakeholders in the co-design of a behavioural, self-management, transdiagnostic sleep app called Delivering Online Zzz’s with Empirical support (DOZE). OBJECTIVE The primary objective was to test the feasibility and acceptability of DOZE in a community AYA sample aged 15 to 24 years. A secondary objective was to evaluate sleep and related outcomes in this nonclinical sample. METHODS Participants (n=51) used DOZE for a period of 4 weeks in which they completed sleep diaries, received feedback on their sleep, set goals in identified target areas, and accessed tips to help them achieve their goals. Participants completed measures of acceptability and satisfaction at baseline and endpoint. Google Analytics data were used to understand patterns of app usage to assess feasibility. Participants completed questionnaires assessing fatigue, sleepiness, chronotype, depression, anxiety, and health-related quality of life at baseline and endpoint to evaluate changes in these clinical outcomes. RESULTS The app was appraised as highly acceptable on the items “easy to use”, “easy to understand”, “time commitment”, and “overall satisfaction,” and was rated as highly credible at pre- and post-test (i.e., treatment was “logical”; “confident treatment approach would work”, “confident recommending app to a friend”). Google Analytics supported that AYAs logged on frequently and completed the diary within 2 hours of waking and tracked most days in each 14-day period (Ms=10.52 and 9.81, respectively). The most common goals set were: decreasing schedule variability (41.0%), naps (20.5%) and lingering in bed in the morning (13.3%). The most frequent tips accessed were: how to wind-down before bed, how to help with being a night owl, and how to get up regularly in the P=morning. There were statistically significant improvements on indices of sleep disturbance including lingering in bed in the morning (P=.030), total time awake (P=.022), sleep efficiency (P=.002), and total sleep time (P = .031), as well as self-reported insomnia severity (P=.001), anxiety (P=.002), depression (P=.004), and energy/fatigue (P=.011). CONCLUSIONS These results support the feasibility, acceptability and preliminary efficacy of DOZE, a free self-management, transdiagnostic sleep app. AYAs are able to set and achieve goals based on tailored feedback on their sleep habits, consistent with research suggesting that AYAs prefer autonomy in their healthcare choices and produce good results when given the tools to support their autonomy. CLINICALTRIAL NCT03960294


BMJ Open ◽  
2021 ◽  
Vol 11 (7) ◽  
pp. e045389
Author(s):  
Anna M Anderson ◽  
Elizabeth C Lavender ◽  
Esther Dusabe-Richards ◽  
Teumzghi F Mebrahtu ◽  
Linda McGowan ◽  
...  

ObjectiveTo determine the feasibility of conducting a randomised controlled trial (RCT) of a peer mentorship intervention to improve self-management of osteoarthritis (OA).DesignSix-month parallel group non-blinded randomised feasibility trial.SettingOne secondary care and one primary care UK National Health Service Trust.ParticipantsFifty adults aged ≥55 years old with hip and/or knee OA.InterventionsParticipants were allocated 1:1 to the intervention or control group using an online randomisation service. Intervention group participants received usual care (information resources) and up to eight community-based self-management support sessions delivered by a peer mentor (trained volunteer with hip and/or knee OA). Control group participants received usual care only.Outcome measuresKey feasibility outcomes were participant and peer mentor recruitment and attrition, intervention completion and the sample size required for a definitive RCT. Based on these feasibility outcomes, four success criteria for proceeding to a definitive RCT were prespecified. Patient-reported outcomes were collected via questionnaires at baseline, 8 weeks and 6 months.ResultsNinety-six individuals were screened, 65 were eligible and 50 were randomised (25 per group). Of the 24 participants who commenced the intervention, 20 completed it. Four participants did not complete the 6-month questionnaire. Twenty-one individuals were eligible for the peer mentor role, 15 were trained and 5 withdrew prior to being matched with a participant. No intervention-related harms occurred. Allowing for 20% attrition, the sample size required for a definitive RCT was calculated as 170 participants. The intervention group showed improvements in self-management compared with the control group.ConclusionsThe feasibility outcomes achieved the prespecified criteria for proceeding to an RCT. The exploratory analyses suggest peer mentorship may improve OA self-management. An RCT of the OA peer mentorship intervention is therefore warranted with minor modifications to the intervention and trial procedures.Trial registration numberISRCTN:50675542.


2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Ciara M. E. Daly ◽  
Lynette Loi ◽  
Jo Booth ◽  
Dalia Saidan ◽  
Karen Guerrero ◽  
...  

Abstract Background Transcutaneous tibial nerve stimulation (TTNS) has been used to treat overactive bladder (OAB), however patient experiences and views of this treatment are lacking. The aim of this study was to explore women’s experiences of OAB and TTNS treatment and the perceived factors influencing participation and adherence. Methods Semi-structured, individual interviews conducted as part of a mixed-methods, randomised, feasibility trial of self-managed versus HCP-led TTNS. Interviews were audio recorded and transcribed verbatim. Reflexive thematic analysis was undertaken using Booth et al. (Neurourol Urodynam. 2017;37:528–41) approach. Results 16 women were interviewed, 8 self-managing TTNS at home and 8 receiving TTNS in twice-weekly hospital clinic appointments. Women self-managing OAB considered TTNS easy to administer, flexible and favourably ‘convenient’, especially when the participant was bound by work and other life commitments. In contrast to OAB symptoms ‘dominating life’, self-managing bladder treatment was empowering and fitted around home life demands. Flexibility and control engendered by self-management, facilitated women’s willingness to participate in TTNS. Women attending a hospital clinic for TTNS enjoyed the social aspects but found the routine appointments constrained their lives. Motivation to continue TTNS in the longer term was dependent on perception of benefit. Conclusions This study provides novel insights into women’s experiences of self-managing their OAB using TTNS compared to HCP-led management in the clinical setting. It highlights positive experiences self-managing TTNS at home and a willingness to continue in the longer term, facilitated by ease of use and convenience. Trial Registration 1/11/2018: ClinicalTrials.gov Identifier: NCT03727711.


2020 ◽  
Author(s):  
Julie Latchem-Hastings ◽  
Elizabeth Randell ◽  
Kate Button ◽  
Fiona Jones ◽  
Rachel Lowe ◽  
...  

Abstract Background. We have co-designed a tailored blended physiotherapy intervention for people with Progressive Multiple Sclerosis (MS) who often struggle to access support for physical activity. Underpinned by self-management principles, the Lifestyle, Exercise and Activity Package for people with MS intervention, which we call the LEAP-MS intervention, incorporates face-to-face or online physiotherapy coaching sessions with an accompanying online physical activity platform. The LEAP-MS platform is a multi-user system enabling user and physiotherapist to co-create activity plans. The LEAP-MS platform consists of an information and activity suite, interactive components enabling selection of exercises into an activity programme, goal setting, and activity logging. The platform also facilitates online remote support from a physiotherapist through an embedded online messaging function. We aim to evaluate the LEAP-MS platform in a feasibility trial. Methods. LEAP-MS will be evaluated within a single arm feasibility study with embedded process evaluation. After registration and initial eligible screening, 21 participants will be required to complete baseline self-completion measures. This will be followed by an initial home-based or online coaching session with a physiotherapist (who has received tailored self-management and digital resource training) and access to the online intervention for an initial three-month period. During this period participants are given the option to request up to five further home-based or online physiotherapy coaching sessions. Follow-up questionnaires and semi-structured interviews will be administered three months after baseline with participants and intervention physiotherapists. The LEAP-MS platform will be available to participants for a further three months. Usage of the LEAP-MS platform will be tracked during the full six-month period and final follow up will be conducted six months after baseline. Discussion. Feasibility outcomes (recruitment, retention, intervention uptake and safety) will be reported. The process evaluation will be undertaken to identify possible mechanisms for any observed effects. The data here will inform full scale evaluations of this co-produced, blended physiotherapy intervention. Trial registration: ClinicalTrials.gov NCT03951181. Registered 15th May 2019 https://clinicaltrials.gov/ct2/show/NCT03951181


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