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 Decision aid on disclosure of mental health status to an employer: feasibility and outcomes of a randomised controlled trial

2013 ◽  
Vol 203 (5) ◽  
pp. 350-357 ◽  
Author(s):  
Claire Henderson ◽  
Elaine Brohan ◽  
Sarah Clement ◽  
Paul Williams ◽  
Francesca Lassman ◽  
...  
Keyword(s):  
Mental Health ◽  
Randomised Controlled Trial ◽  
Usual Care ◽  
Decision Aid ◽  
Controlled Trial ◽  
Intervention Group ◽  
Decisional Conflict ◽  
Full Time ◽  
Randomised Controlled

BackgroundMany mental health service users delay or avoid disclosing their condition to employers because of experience, or anticipation, of discrimination. However, non-disclosure precludes the ability to request ‘reasonable adjustments’. There have been no intervention studies to support decisionmaking about disclosure to an employer.AimsTo determine whether the decision aid has an effect that is sustained beyond its immediate impact; to determine whether a large-scale trial is feasible; and to optimise the designs of a larger trial and of the decision aid.MethodIn this exploratory randomised controlled trial (RCT) in London, participants were randomly assigned to use of a decision aid plus usual care or usual care alone. Follow-up was at 3 months. Primary outcomes were: (a) stage of decision-making; (b) decisional conflict; and (c) employment-related outcomes (trial registration number: NCT01379014).ResultsWe recruited 80 participants and interventions were completed for 36 out of 40 in the intervention group; in total 71 participants were followed up. Intention-to-treat analysis showed that reduction in decisional conflict was significantly greater in the intervention group than among controls (mean improvement −22.7 (s.d. = 15.2) v. −11.2 (s.d. = 18.1), P = 0.005). More of the intervention group than controls were in full-time employment at follow-up (P = 0.03).ConclusionsThe observed reduction in decisional conflict regarding disclosure has a number of potential benefits which next need to be tested in a definitive trial.

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.

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 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 Web-based decision aid tool for disclosure of a mental health condition in the workplace: a randomised controlled trial

2019 ◽  
Vol 76 (9) ◽  
pp. 595-602 ◽  
Author(s):  
Elizabeth Stratton ◽  
Isabella Choi ◽  
Rafael calvo ◽  
Ian Hickie ◽  
Claire Henderson ◽  
...  
Keyword(s):  
Mental Health ◽  
Decision Making ◽  
Depressive Symptoms ◽  
Randomised Controlled Trial ◽  
Decision Aid ◽  
Controlled Trial ◽  
Decisional Conflict ◽  
Web Based ◽  
Randomised Controlled

ObjectivesMaking decisions about disclosing a mental illness in the workplace is complicated. Decision aid tools are designed to help an individual make a specific choice. We developed a web-based decision aid to help inform decisions about disclosure for employees. This study aimed to examine the efficacy of this tool.MethodWe conducted a randomised controlled trial with recruitment, randomisation and data collection all online. Participants had access to the intervention for 2 weeks. Assessments occurred at baseline, postintervention and 6 weeks’ follow-up. The primary outcome was decisional conflict. Secondary outcomes were stage and satisfaction of decision-making and mental health symptoms.Results107 adult employees were randomised to READY (n=53) or the control (n=54). The sample was predominantly female (83.2%). Participants using READY showed greater reduction in decisional conflict at postintervention (F(1,104)=16.8, p<0.001) (d=0.49, 95% CI 0.1 to 0.9) and follow-up (F(1,104)=23.6, p<0.001) (d=0.61, 95% CI 0.1 to 0.9). At postintervention the READY group were at a later stage of decision-making (F(1,104)=6.9, p=0.010) which was sustained, and showed a greater reduction in depressive symptoms (F(1,104)=6.5, p=0.013). Twenty-eight per cent of READY users disclosed, and reported a greater improvement in mental health than those who did not disclose.ConclusionsREADY provides a confidential, flexible and effective tool to enhance employee’s decision-making about disclosure. Its use led to a comparative improvement in depressive symptoms compared with the current information provided by a leading mental health non-governmental organisation, without apparent harm. READY seems worth evaluating in other settings and, if these results are replicated, scaling for wider use.Trial registration numberACTRN12618000229279.

scholarly journals Communicating personalised statin therapy-effects as 10-year CVD-risk or CVD-free life-expectancy: does it improve decisional conflict? Three-armed, blinded, randomised controlled trial

BMJ Open ◽  
2021 ◽  
Vol 11 (7) ◽  
pp. e041673
Author(s):  
Nicole E M Jaspers ◽  
Frank L J Visseren ◽  
Yolanda van der Graaf ◽  
Yvo M Smulders ◽  
Olga C Damman ◽  
...  
Keyword(s):  
Decision Making ◽  
Randomised Controlled Trial ◽  
Life Expectancy ◽  
Statin Therapy ◽  
Controlled Trial ◽  
Decisional Conflict ◽  
P Value ◽  
Cvd Risk ◽  
Secondary Outcomes ◽  
Randomised Controlled

ObjectiveTo determine whether communicating personalised statin therapy-effects obtained by prognostic algorithm leads to lower decisional conflict associated with statin use in patients with stable cardiovascular disease (CVD) compared with standard (non-personalised) therapy-effects.DesignHypothesis-blinded, three-armed randomised controlled trialSetting and participants303 statin users with stable CVD enrolled in a cohortInterventionParticipants were randomised in a 1:1:1 ratio to standard practice (control-group) or one of two intervention arms. Intervention arms received standard practice plus (1) a personalised health profile, (2) educational videos and (3) a structured telephone consultation. Intervention arms received personalised estimates of prognostic changes associated with both discontinuation of current statin and intensification to the most potent statin type and dose (ie, atorvastatin 80 mg). Intervention arms differed in how these changes were expressed: either change in individual 10-year absolute CVD risk (iAR-group) or CVD-free life-expectancy (iLE-group) calculated with the SMART-REACH model (http://U-Prevent.com).OutcomePrimary outcome was patient decisional conflict score (DCS) after 1 month. The score varies from 0 (no conflict) to 100 (high conflict). Secondary outcomes were collected at 1 or 6 months: DCS, quality of life, illness perception, patient activation, patient perception of statin efficacy and shared decision-making, self-reported statin adherence, understanding of statin-therapy, post-randomisation low-density lipoprotein cholesterol level and physician opinion of the intervention. Outcomes are reported as median (25th– 75th percentile).ResultsDecisional conflict differed between the intervention arms: median control 27 (20–43), iAR-group 22 (11–30; p-value vs control 0.001) and iLE-group 25 (10–31; p-value vs control 0.021). No differences in secondary outcomes were observed.ConclusionIn patients with clinically manifest CVD, providing personalised estimations of treatment-effects resulted in a small but significant decrease in decisional conflict after 1 month. The results support the use of personalised predictions for supporting decision-making.Trial registrationNTR6227/NL6080.

scholarly journals Efficacy of a Multi-Component m-Health Diet, Physical Activity, and Sleep Intervention on Dietary Intake in Adults with Overweight and Obesity: A Randomised Controlled Trial

Nutrients ◽  
2021 ◽  
Vol 13 (7) ◽  
pp. 2468
Author(s):  
Sasha Fenton ◽  
Tracy L. Burrows ◽  
Clare E. Collins ◽  
Anna T. Rayward ◽  
Beatrice Murawski ◽  
...  
Keyword(s):  
Physical Activity ◽  
Weight Loss ◽  
Randomised Controlled Trial ◽  
Dietary Intake ◽  
Controlled Trial ◽  
Intervention Group ◽  
Weight Loss Intervention ◽  
Traditional Group ◽  
Traditional Diet ◽  
Randomised Controlled

This three-arm randomised controlled trial evaluated whether (1) a multi-component weight loss intervention targeting diet, physical activity (PA), and sleep was effective at improving dietary intake over six months and 12 months, compared with a control, and (2) the enhanced diet, PA, and sleep intervention was more effective at improving dietary intake than the traditional diet and PA intervention. A total of 116 adults (70% female, 44.5 years, BMI 31.7 kg/m2) were randomised to either traditional diet and PA intervention; enhanced diet, PA, and sleep intervention; or wait-list control. To examine between-group differences, intervention groups were pooled and compared with the control. Then, the two intervention groups were compared. At six months, the pooled intervention group consumed 1011 fewer kilojoules/day (95% CI −1922, −101), less sodium (−313.2 mg/day; 95% CI −591.3, −35.0), and higher %EI from fruit (+2.1%EI; 95% CI 0.1, 4.1) than the controls. There were no differences in intake between the enhanced and traditional groups at six months. At 12 months, the pooled intervention and control groups reported no significant differences. However, compared to the traditional group, the enhanced reported higher %EI from nutrient-dense foods (+7.4%EI; 95% CI 1.3, 13.5) and protein (+2.4%EI; 95% CI 0.1, 4.6), and reduced %EI from fried/takeaway foods (−3.6%EI; 95% CI −6.5, −0.7), baked sweet products (−2.0%EI; 95% CI −3.6, −0.4), and packaged snacks (−1.1%EI; 95% CI −2.2, −0.3). This weight loss intervention reduced total energy and sodium intakes as well as increased fruit intake in adults at six months. The enhanced intervention group reported improved dietary intake relative to the traditional group at 12 months.

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