scholarly journals Study protocol for a randomised controlled trial of a web-based behavioural lifestyle programme for emPOWERment in early Multiple Sclerosis (POWER@MS1)

BMJ Open ◽  
2021 ◽  
Vol 11 (2) ◽  
pp. e041720
Author(s):  
Nicole Krause ◽  
Karin Riemann-Lorenz ◽  
Tanja Steffen ◽  
Anne Christin Rahn ◽  
Jana Pöttgen ◽  
...  
Keyword(s):  
Multiple Sclerosis ◽  
Randomised Controlled Trial ◽  
Process Evaluation ◽  
Behaviour Change ◽  
Standard Care ◽  
Controlled Trial ◽  
Web Based ◽  
Complex Behaviour ◽  
Randomised Controlled ◽  
Lifestyle Programme

IntroductionMultiple sclerosis (MS) is an inflammatory and degenerative disease of the central nervous system that mainly affects young adults. Uncertainty is a major psychological burden of the disease from diagnosis to prognosis, enhanced by the pressure to make early decisions on a diverse set of immunotherapies. Watchful waiting for 1–2 years while adapting goals and lifestyle habits to life with a chronic disease represents another reasonable option for persons with MS (PwMS). A behaviour change programme based on evidence-based patient information (EBPI) is not available in standard care. This randomised controlled trial (RCT) with an embedded process evaluation investigates the efficacy and cost-effectiveness of a web-based behavioural lifestyle programme to change lifestyle behaviour and reduce inflammatory disease activity in PwMS.Methods and analysisA web-based behavioural intervention will be evaluated in an RCT aiming to recruit 328 persons with clinically isolated syndrome, suspected MS or confirmed MS for less than 1 year, who have not yet started immunotherapy. Moreover, a mixed-methods process evaluation and a health economic evaluation will be carried out. Participants will be recruited in at least 16 MS centres across Germany and randomised to an intervention group with 12 months of access to EBPI about lifestyle factors in MS, combined with a complex behaviour change programme or to a control group (optimised standard care). The combined primary endpoint is the incidence of new T2 lesions on MRI or confirmed relapses.Ethics and disseminationThe study has been approved by the Ethics Committee of the Hamburg Chamber of Physicians (PV6015). Trial results will be communicated at scientific conferences and meetings and presented on relevant patient websites and in patient education seminars.Trial registration numberClinicalTrials.gov Registry (NCT03968172); Pre-results.

scholarly journals Development and evaluation of an interactive web-based decision-making programme on relapse management for people with multiple sclerosis (POWER@MS2)—study protocol for a randomised controlled trial

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Anne Christin Rahn ◽  
Lisa Wenzel ◽  
Andrea Icks ◽  
Alexander Stahmann ◽  
Jutta Scheiderbauer ◽  
...  
Keyword(s):  
Multiple Sclerosis ◽  
Decision Making ◽  
Mixed Methods ◽  
Randomised Controlled Trial ◽  
Process Evaluation ◽  
Controlled Trial ◽  
Web Based ◽  
Link Type ◽  
Oral Corticosteroids ◽  
Randomised Controlled

Abstract Introduction Multiple sclerosis is a chronic inflammatory, degenerative disease of the central nervous system manifesting at first with relapses in about 85% of cases. In Germany, intravenous therapy with high-dose corticosteroids is the treatment standard of acute relapses. The treatment leads to a faster reduction of symptoms in about 25 of 100 treated patients but has no proven long-term benefits over placebo treatment. Intravenous treatment is not superior to oral treatment. Therefore, informed decisions on relapse management are required. An earlier randomised controlled trial showed that evidence-based patient information and education on relapse management leads to more informed decisions and more relapses not treated or treated with oral corticosteroids. This study aims to evaluate whether a web-based relapse management programme will positively change relapse management and strengthen autonomy in people with multiple sclerosis. Methods The pragmatic double-blind randomised controlled trial is accompanied by a mixed-methods process evaluation and a health economic evaluation and follows the UK Medical Research Council guidance on developing and evaluating complex interventions. A total of 188 people with possible or relapsing-remitting multiple sclerosis with ≥ 1 relapse within the last year and/or ≥ 2 relapses within the last 2 years will be recruited and randomised using blocks. The intervention group receives a web- and dialogue-based decision aid on relapse management, a nurse-led webinar and access to a monitored chat forum. The control group receives standard information, which will be made available via the same online platform as the intervention. The primary endpoint is the proportion of relapses not treated or treated with oral corticosteroids. Key secondary endpoints are the annualised relapse rate, decision-making, empowerment, quality of life and cost-effectiveness. Facilitators and barriers will be assessed by mixed-methods process evaluation measures. The study ends when 81 relapses have been documented or after 24 months of observation per individual patient. Analyses will follow the intention-to-treat principle. Discussion We hypothesise that the intervention will enhance patient empowerment and have a positive impact on patients’ relapse management. Trial registration ClinicalTrials.govNCT04233970. Registered on 18 January 2020

scholarly journals Evaluation of an interactive web-based programme on relapse management for people with multiple sclerosis (POWER@MS2): study protocol for a process evaluation accompanying a randomised controlled trial

BMJ Open ◽  
2021 ◽  
Vol 11 (10) ◽  
pp. e046874
Author(s):  
Lisa Wenzel ◽  
Christoph Heesen ◽  
Jutta Scheiderbauer ◽  
Markus van de Loo ◽  
Sascha Köpke ◽  
...  
Keyword(s):  
Multiple Sclerosis ◽  
Randomised Controlled Trial ◽  
Process Evaluation ◽  
Controlled Trial ◽  
Qualitative Interviews ◽  
Complex Interventions ◽  
Intervention Programme ◽  
Online Chat ◽  
Web Based ◽  
Randomised Controlled

IntroductionProcess evaluations accompanying complex interventions examine the implementation process of the underlying intervention, identify mechanisms of impact and assess contextual factors. This paper presents the protocol for a process evaluation conducted alongside the randomised controlled trial POWER@MS2. The trial comprises the evaluation of a web-based complex intervention on relapse management in 188 people with multiple sclerosis conducted in 20 centres. The web-based intervention programme focuses on relapse treatment decision making and includes a decision aid, a nurse-led webinar and an online chat. With the process evaluation presented here, we aim to assess participants’ responses to and interactions with the intervention to understand how and why the intervention produces change.Methods and analysisA mixed methods design is used to explore the acceptance of the intervention as well as its use and impact on participants. Participants are people with multiple sclerosis, neurologists, nurses and stakeholders. Quantitative semistandardised evaluation forms will be collected throughout the study. Qualitative semistructured telephone interviews will be conducted at the end of the study with selected participants, especially people with multiple sclerosis and neurologists. Quantitative data will be collected and analysed descriptively. Based on the results, the qualitative interviews will be conducted and analysed thematically, and the results will be merged in a joint display table.Ethics and disseminationThe process evaluation has received ethical approval from the Ethical Committee of the University of Lübeck (reference 19–024). Findings will be disseminated in peer-reviewed journals, at conferences, meetings and on relevant patient websites.Trial registration numberNCT04233970.

scholarly journals Implementing supportive exercise interventions in the colorectal cancer care pathway: a process evaluation of the PREPARE-ABC randomised controlled trial.

2021 ◽  
Author(s):  
Jamie Murdoch ◽  
Anna Varley ◽  
Jane McCulloch ◽  
Megan Jones ◽  
Laura B. Thomas ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Randomised Controlled Trial ◽  
Process Evaluation ◽  
Standard Care ◽  
Care Pathway ◽  
Controlled Trial ◽  
Structured Interviews ◽  
Exercise Interventions ◽  
Intervention Delivery ◽  
Randomised Controlled

Abstract Background: A colorectal resection is standard treatment for patients with colorectal cancer (CRC). However, the procedure results in significant post-operative mortality and reduced quality of life. Maximising pre-operative cardiopulmonary fitness could improve post-surgical outcomes. PREPARE-ABC is a multi-centre, three-armed, randomised controlled trial investigating the effects of exercise interventions, with motivational support on short and longer-term recovery outcomes in CRC patients undergoing major lower-gastrointestinal surgery. The trial included an internal pilot phase with parallel process evaluation. The aim of the process evaluation was to optimise intervention implementation for the main trial.Methods: Mixed methods process evaluation conducted in 14 UK hospitals between November 2016 and March 2018. Data included a site profile questionnaire and telephone scoping interview with hospital staff, 34 qualitative observations of standard care and 14 observations of intervention delivery, 13 semi-structured interviews with healthcare professionals (HCPs) and 28 semi-structured interviews with patients. Data analysis focused on describing intervention delivery within each arm, assessing fidelity, acceptability and how variation in delivery was linked to contextual characteristics.Results: Standard care exercise advice was typically limited to maintaining current activity levels, and with lead-in time to surgery affecting whether any exercise advice was provided. Variation in HCP capacity affected the ability of colorectal units to deploy staff to deliver the intervention. Patients’ exercise history and motivation prior to surgery influenced HCP perceptions and delivery of the motivational components. Observations indicated a high level of fidelity to delivery of the exercise interventions. All but one of the 28 interviewed patients reported increasing exercise levels as a result of receiving the intervention, with most finding them motivational and greatly valuing the enhanced level of social support (versus standard care) provided by staff.Conclusion: Hospital-supervised and home-based exercise interventions were highly acceptable for most patients undergoing surgery for CRC. Delivery of pre- and post-operative exercise within the CRC care pathway is feasible but systematic planning of capacity and resources is required to optimise implementation.

scholarly journals Individualised behaviour change strategies for physical activity in multiple sclerosis (IPAC-MS): protocol for a randomised controlled trial

Trials ◽  
2019 ◽  
Vol 20 (1) ◽  
Author(s):  
Farren L. Goulding ◽  
Charity D. Evans ◽  
Katherine B. Knox ◽  
Hyun J. Lim ◽  
Michael C. Levin ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Physical Activity ◽  
Multiple Sclerosis ◽  
Randomised Controlled Trial ◽  
Behaviour Change ◽  
Controlled Trial ◽  
Activity Level ◽  
Change Strategies ◽  
Randomised Controlled

Abstract Background Multiple sclerosis (MS) is a chronic, degenerative disease of the central nervous system. Because of the long-term and unpredictable nature of the disease, the burden of MS is significant from both a patient and societal perspective. Despite a recent influx of disease-modifying therapies to treat MS, many individuals continue to experience disability that negatively affects productivity and quality of life. Previous research indicates that physical activity has a positive impact on walking function in individuals with MS, in addition to the usual beneficial effects on overall health. However, most people with MS are not active enough to gain these benefits, and a lack of support to initiate and maintain physical activity has been identified as a major barrier. This study will evaluate the impact of a novel intervention involving individualised behaviour change strategies delivered by neurophysiotherapists on increasing physical activity levels in individuals with MS who are currently inactive. Methods/design This single-blind, parallel-group, randomised controlled trial will be conducted in Saskatchewan, Canada. Eligible participants include individuals with MS who are ambulatory but identified as currently inactive by the self-reported Godin Leisure-Time Exercise Questionnaire (GLTEQ). The intervention will be delivered by neurophysiotherapists and includes individualised behaviour change strategies aimed at increasing physical activity over a 12-month period. The control group will receive usual care during the 12-month study period. The primary outcome is the change in physical activity level, as measured by the change in the GLTEQ score from baseline to 12 months. Secondary outcomes include the change in patient-reported outcome measures assessing MS-specific symptoms, confidence and quality of life. Discussion Physical activity has been identified as a top research priority by the MS community. Findings from this novel study may result in new knowledge that could significantly impact the management and overall health of individuals with MS. Trial registration ClinicalTrials.gov, NCT04027114. Registered on 10 July 2019.

scholarly journals Effect of a web-based behaviour change program on weight loss: a randomised controlled trial

2014 ◽  
Vol 73 (OCE2) ◽  
Author(s):  
S. Watson ◽  
J. V. Woodside ◽  
A. McGrath ◽  
C. Cardwell ◽  
I. S. Young ◽  
...  
Keyword(s):  
Weight Loss ◽  
Randomised Controlled Trial ◽  
Behaviour Change ◽  
Controlled Trial ◽  
Web Based ◽  
Randomised Controlled

scholarly journals ‘I can do this’: a qualitative exploration of acceptability and experiences of a physical activity behaviour change intervention in people with multiple sclerosis in the UK

BMJ Open ◽  
2020 ◽  
Vol 10 (3) ◽  
pp. e029831 ◽  
Author(s):  
Jennifer Fortune ◽  
Meriel Norris ◽  
Andrea Stennett ◽  
Cherry Kilbride ◽  
Grace Lavelle ◽  
...  
Keyword(s):  
Physical Activity ◽  
Multiple Sclerosis ◽  
Randomised Controlled Trial ◽  
Behaviour Change ◽  
Controlled Trial ◽  
Behaviour Change Intervention ◽  
Structured Interviews ◽  
Framework Analysis ◽  
Feasibility Randomised Controlled Trial ◽  
Randomised Controlled

ObjectivesThe purpose of this study was to explore the experiences of people with multiple sclerosis (MS) who participated in iStep-MS, a feasibility randomised controlled trial of a behaviour change intervention that aimed to increase physical activity and reduce sedentary behaviour.DesignA qualitative approach was undertaken embedded in the feasibility randomised controlled trial. One-to-one semi-structured interviews were conducted and analysed using Framework analysis.SettingParticipants were recruited from a single MS therapy centre in the southeast of England, UK.ParticipantsSixty people with MS were randomly allocated in a 1:1 ratio to the intervention or usual care. Following a purposive sampling strategy, 15 participants from the intervention arm undertook 1:1 semi-structured interviews.InterventionsThe iStep-MS intervention consisted of four therapist-led sessions over 12 weeks, supported by a handbook and pedometer.ResultsThree themes were identified from the data.“I can do this”: developing competence in physical activityhighlights the enhanced physical activity confidence gained through goal setting and accomplishment. “I felt valued”: the nurturing cultureprovides an overview of the supportive and non-judgemental environment created by the programme structure and therapeutic relationship. Finally, “What can I do?”: empowered enactmentdescribes the transition from the supported iStep-MS intervention to intrinsically motivated physical activity enactment.ConclusionsOverall, this study supports the acceptability of the iStep-MS intervention and identified key areas that supported participants to be physically active.Trial registration numberISRCTN15343862.

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