Maximising Abilities, Negotiating and Generating Exercise options (MANAGE) in people with multiple sclerosis: A feasibility randomised controlled trial

2021 ◽  
pp. 026921552110649
Author(s):  
Julie Louie ◽  
Katherine Baquie ◽  
Justin Offerman ◽  
Catherine L. Granger ◽  
Fary Khan ◽  
...  
Keyword(s):  
Multiple Sclerosis ◽  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Community Integration ◽  
Intervention Group ◽  
Alternative Methods ◽  
Functional Reach ◽  
Feasibility Randomised Controlled Trial ◽  
High Adherence ◽  
Randomised Controlled

Objective To investigate the feasibility and preliminary efficacy of a group self-management exercise and education program in people with multiple sclerosis. Design Feasibility randomised controlled trial. Setting Outpatient rehabilitation facility. Subjects Twenty-three adults (age 48.6 (11.7) years) recruited from a Multiple Sclerosis Clinic register. Interventions The intervention group undertook a 12-week group program incorporating behaviour change education, exercise and community integration. This was compared with a waitlist control group. Main measures Feasibility was measured by recruitment, adherence and safety. Efficacy outcomes included measures of physical function (6-metre and 6-min walk, Functional Reach) and self-report questionnaires (fatigue, quality of life, exercise benefits and barriers) at baseline, 6, 12 and 24 weeks. Results Of 74 individuals identified through the register, 48 (65%) were contacted and deemed eligible, and 23 (48%) agreed to participate. There was high adherence for attendance at education (57 of 72, 79%) and exercise (135 of 174, 78%) sessions. No adverse safety events occurred within the intervention sessions. Missed attendances at assessment sessions was high (5 to 8 participants missed at each time point) predominately due to health issues. The intervention group demonstrated positive changes in walking endurance, Functional Reach and fatigue, whereas the control had some reductions in walking speed and more perceived exercise barriers. Conclusions The MANAGE program appears feasible and safe for people with mild-to-moderate multiple sclerosis, with high adherence to exercise and education sessions. Future trials should consider strategies such as flexible scheduling or alternative methods of data collection to improve follow-up assessment attendance.

scholarly journals A feasibility randomised controlled trial of the DECIDE intervention: Dementia carers making informed decisions

BJPsych Open ◽  
2017 ◽  
Vol 3 (1) ◽  
pp. 12-14 ◽  
Author(s):  
Kathryn Lord ◽  
Gill Livingston ◽  
Claudia Cooper
Keyword(s):  
Randomised Controlled Trial ◽  
Family Conflict ◽  
Decision Aid ◽  
Controlled Trial ◽  
Intervention Group ◽  
Decisional Conflict ◽  
Manual Aiming ◽  
Family Carers ◽  
Feasibility Randomised Controlled Trial ◽  
Randomised Controlled

SummaryFamily carers report high levels of decisional conflict when deciding whether their relative with dementia can continue to be cared for in their own home. We tested, in a feasibility randomised controlled trial, the first decision aid (the DECIDE manual) aiming to reduce such conflict. Twenty family carers received the DECIDE intervention, and 21 received usual treatment. The intervention group had reduced decisional conflict compared with controls (mean difference −11.96, 95% confidence interval −20.10 to −3.83, P=0.005). All carers receiving the intervention completed and valued it, despite some still reporting difficulties with family conflict and problems negotiating services.

scholarly journals Optimising Psychoeducation for Transient Ischaemic Attack and Minor Stroke Management (OPTIMISM): Protocol for a feasibility randomised controlled trial

2020 ◽  
Vol 2 ◽  
pp. 24
Author(s):  
Eirini Kontou ◽  
Marion Walker ◽  
Shirley Thomas ◽  
Caroline Watkins ◽  
Holly Griffiths ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Transient Ischaemic Attack ◽  
Controlled Trial ◽  
Intervention Group ◽  
Minor Stroke ◽  
Control Group ◽  
Warning Sign ◽  
Feasibility Randomised Controlled Trial ◽  
Ischaemic Attack ◽  
Randomised Controlled

Background: A transient ischaemic attack (TIA) and minor stroke are medical emergencies and often a warning sign of future strokes if remain untreated. Few studies have investigated the long-term psychosocial effects of TIA and minor stroke. Secondary prevention and medical management are often the primary focus with limited access offered for further psychosocial support. Psychoeducational interventions can provide education and advice to people with physical health conditions and, with suitable tailoring, could be appropriate for people after TIA and minor stroke. This study aims to develop a group psychoeducational intervention for people after TIA and minor stroke and to test whether it is acceptable and feasible. Methods: This mixed-methodology study involves two phases: Phase 1) A qualitative study to determine the content of a suitable intervention; Phase 2) A single-centre feasibility randomised controlled trial to evaluate the acceptability of this intervention. The overall study has ethical approval. Stroke survivors have been involved in designing and monitoring the trial. The aim is to recruit 30-40 participants from a Stroke/TIA Service, within 6 months following their diagnosis. Participants will be randomly allocated to either the usual care control group or the intervention group (psychoeducational programme). The programme will consist of six group sessions based on providing education, psychological and social support. The primary outcomes will relate to the feasibility aims of the study. Outcomes will be collected at 3 and 6 months to assess mood, quality of life, knowledge and satisfaction, and resource use. Discussion: There is a need to develop and evaluate effective interventions that enhance the education provided to people after TIA and minor stroke and to promote their psychosocial wellbeing. Findings will indicate the acceptability of the intervention and parameters needed to conduct a definitive trial. Registration: ClinicalTrials.gov ID NCT02550392; registered on 15 September 2015; status: completed.

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.

scholarly journals Online patient simulation training to improve clinical reasoning: A feasibility randomised controlled trial

2020 ◽  
Author(s):  
Ruth Plackett ◽  
Angelos P Kassianos ◽  
Maria Kambouri ◽  
Natasha Kay ◽  
Sophie Mylan ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Clinical Reasoning ◽  
Controlled Trial ◽  
Intervention Group ◽  
Diagnostic Errors ◽  
Control Group ◽  
Feasibility Randomised Controlled Trial ◽  
Reasoning Skills ◽  
Randomised Controlled ◽  
Clinical Reasoning Skills

Abstract Background: Online patient simulations (OPS) are a novel method for teaching clinical reasoning skills to students and could contribute to reducing diagnostic errors. However, little is known about how best to implement and evaluate OPS in medical curricula. The aim of this study was to assess the feasibility, acceptability and potential effects of eCREST — the electronic Clinical Reasoning Educational Simulation Tool.Methods: A feasibility randomised controlled trial was conducted with final year undergraduate students from three UK medical schools in academic year 2016/2017 (cohort one) and 2017/2018 (cohort two). Student volunteers were recruited in cohort one via email and on teaching days, and in cohort two eCREST was also integrated into a relevant module in the curriculum. The intervention group received three patient cases and the control group received teaching as usual; allocation ratio was 1:1. Researchers were blind to allocation. Clinical reasoning skills were measured using a survey after one week and a patient case after one month.Results: Across schools, 264 students participated (18.2% of all eligible). Cohort two had greater uptake (183/833, 22%) than cohort one (81/621, 13%). After one week, 99/137 (72%) of the intervention and 86/127 (68%) of the control group remained in the study. eCREST improved students’ ability to gather essential information from patients over controls (OR =1.4; 95% CI 1.1-1.7, n =148). Of the intervention group, most (84/98, 82%) agreed eCREST helped them to learn clinical reasoning skills.Conclusions: eCREST was highly acceptable and improved data gathering skills that could reduce diagnostic errors. Uptake was low but improved when integrated into course delivery. A summative trial is needed to estimate effectiveness.

scholarly journals Comparing individual and group intervention for psychological adjustment in people with multiple sclerosis: a feasibility randomised controlled trial

2016 ◽  
Vol 30 (12) ◽  
pp. 1156-1164 ◽  
Author(s):  
Roshan das Nair ◽  
Eirini Kontou ◽  
Kathryn Smale ◽  
Alex Barker ◽  
Nadina B Lincoln
Keyword(s):  
Quality Of Life ◽  
Multiple Sclerosis ◽  
Randomised Controlled Trial ◽  
Group Intervention ◽  
Controlled Trial ◽  
Depression Scale ◽  
Individual Treatment ◽  
Feasibility Randomised Controlled Trial ◽  
Randomised Controlled

Objective: To modify a published group intervention for adjustment to multiple sclerosis (MS) to suit an individual format, and to assess the feasibility of a randomised controlled trial (RCT) to compare individual and group intervention for people with multiple sclerosis and low mood. Design: Feasibility randomised controlled trial. Setting: Participants were recruited through healthcare professionals at a hospital-based multiple sclerosis service and the MS Society. Subjects: People with multiple sclerosis. Interventions: Adjustment to multiple sclerosis in individual or group delivery format. Main measures: Participants completed mood and quality of life assessments at baseline and at four-month follow-up. Measures of feasibility included: recruitment rate, acceptability of randomisation and the intervention (content and format), and whether the intervention could be adapted for individual delivery. Participants were screened for inclusion using the General Health Questionnaire-12 and Hospital Anxiety and Depression Scale, and were randomly allocated to receive either individual or group intervention, with the same content. Results: Twenty-one participants were recruited (mean age 48.5 years, SD 10.5) and were randomly allocated to individual ( n=11) or group ( n=10) intervention. Of those offered individual treatment, nine (82%) completed all six sessions. Of those allocated to group intervention, two (20%) attended all six sessions and three (30%) attended five sessions. There were no statistically significant differences between the groups on the outcome measures of mood and quality of life. Conclusions: The intervention could be provided on an individual basis and the trial design was feasible. There were lower attendance rates at group sessions compared to individual sessions.

scholarly journals Balance Right in Multiple Sclerosis (BRiMS): a feasibility randomised controlled trial of a falls prevention programme

2021 ◽  
Vol 7 (1) ◽  
Author(s):  
H. Gunn ◽  
K. N. Stevens ◽  
S. Creanor ◽  
J. Andrade ◽  
L. Paul ◽  
...  
Keyword(s):  
Multiple Sclerosis ◽  
Randomised Controlled Trial ◽  
Usual Care ◽  
Controlled Trial ◽  
Intervention Group ◽  
Retention Rates ◽  
Clinical Neurology ◽  
Completion Rates ◽  
Definitive Trial ◽  
Randomised Controlled

Abstract Background Balance, mobility impairments and falls are problematic for people with multiple sclerosis (MS). The “Balance Right in MS (BRiMS)” intervention, a 13-week home and group-based exercise and education programme, aims to improve balance and minimise falls. This study aimed to evaluate the feasibility of undertaking a multi-centre randomised controlled trial and to collect the necessary data to design a definitive trial. Methods This randomised controlled feasibility study recruited from four United Kingdom NHS clinical neurology services. Patients ≥ 18 years with secondary progressive MS (Expanded Disability Status Scale 4 to 7) reporting more than two falls in the preceding 6 months were recruited. Participants were block-randomised to either a manualised 13-week education and exercise programme (BRiMS) plus usual care, or usual care alone. Feasibility assessment evaluated recruitment and retention rates, adherence to group assignment and data completeness. Proposed outcomes for the definitive trial (including impact of MS, mobility, quality of life and falls) and economic data were collected at baseline, 13 and 27 weeks, and participants completed daily paper falls diaries. Results Fifty-six participants (mean age 59.7 years, 66% female, median EDSS 6.0) were recruited in 5 months; 30 randomised to the intervention group. Ten (18%) participants withdrew, 7 from the intervention group. Two additional participants were lost to follow up at the final assessment point. Completion rates were > 98% for all outcomes apart from the falls diary (return rate 62%). After adjusting for baseline score, mean intervention—usual care between-group differences for the potential primary outcomes at week 27 were MS Walking Scale-12v2: − 7.7 (95% confidence interval [CI] − 17.2 to 1.8) and MS Impact Scale-29v2: physical 0.6 (CI − 7.8 to 9), psychological − 0.4 (CI − 9.9 to 9). In total, 715 falls were reported, rate ratio (intervention:usual care) for falls 0.81 (0.41 to 2.26) and injurious falls 0.44 (0.41 to 2.23). Conclusions Procedures were practical, and retention, programme engagement and outcome completion rates satisfied a priori progression criteria. Challenges were experienced in completion and return of daily falls diaries. Refinement of methods for reporting falls is therefore required, but we consider a full trial to be feasible. Trial registration ISRCTN13587999 Date of registration: 29 September 2016

Sign in / Sign up

Export Citation Format

Share Document