scholarly journals A randomized controlled trial of very early rehabilitation in speech after stroke

2016 ◽  
Vol 11 (5) ◽  
pp. 586-592 ◽  
Author(s):  
Erin Godecke ◽  
Elizabeth A Armstrong ◽  
Tapan Rai ◽  
Sandy Middleton ◽  
Natalie Ciccone ◽  
...  
Keyword(s):  
Cost Effectiveness ◽  
Usual Care ◽  
Policy Development ◽  
Rating Scale ◽  
Controlled Trial ◽  
Early Rehabilitation ◽  
Open Label ◽  
Post Stroke ◽  
Aphasia Therapy ◽  
Quality Of Life Scale

Rationale The efficacy of rehabilitation therapy for aphasia caused by stroke is uncertain. Aims and hypothesis The Very Early Rehabilitation of Speech (VERSE) trial aims to determine if intensive prescribed aphasia therapy (VERSE) is more effective and cost saving than non-prescribed, intensive (usual care-plus) and non-intensive usual care (UC) therapy when started within 15 days of stroke onset and continued daily over four weeks. We hypothesize that aphasia therapy when started very early after stroke and delivered daily could enhance recovery of communication compared with UC. Sample size estimates A total of 246 participants (82 per arm) will provide 80% power to detect a 4.4% improvement on aphasia quotient between VERSE and UC plus at a significance level of α = 0.05. Setting Acute-care hospitals and accompanying rehabilitation services throughout Australia, 2014–2017. Design Three-arm, prospective, randomized, parallel group, open-label, blinded endpoint assessment (PROBE) trial. Participants Acute stroke in previous 14 days and aphasia diagnosed by aphasia quotient (AQ) of the Western Aphasia Battery (WAB). Randomization Computer-generated blocked randomization procedure stratified by aphasia severity according to Western Aphasia Battery, to one of three arms. Intervention All participants receive UC—usual ward-based aphasia therapy. Arm 1: UC—no additional therapy; Arm 2: UC-plus usual ward-based therapy; Arm 3: VERSE therapy—a prescribed and structured aphasia therapy program. Arms 2 and 3 receive a total of 20 additional sessions (45–60 min, provided daily) of aphasia therapy. The additional intervention must be provided before day 50 post stroke. Study outcome measures The aphasia quotient of Western Aphasia Battery at 12 weeks post stroke. Secondary outcomes include discourse measures, the Stroke and Aphasia Quality of Life Scale-39 and the Aphasia Depression Rating Scale at 12 and 26 weeks. Economic evaluation Incremental cost-effectiveness ratios at 26 weeks will be reported. Discussion This trial is designed to test whether the intensive and prescribed VERSE intervention is effective in promoting maximum recovery and preventing costly health complications in a vulnerable population of survivors of stroke. It will also provide novel, prospective, aphasia specific cost-effectiveness data to guide future policy development for this population.

scholarly journals Constraint-induced or multi-modal personalized aphasia rehabilitation (COMPARE): A randomized controlled trial for stroke-related chronic aphasia

2019 ◽  
Vol 14 (9) ◽  
pp. 972-976 ◽  
Author(s):  
Miranda L Rose ◽  
David Copland ◽  
Lyndsey Nickels ◽  
Leanne Togher ◽  
Marcus Meinzer ◽  
...  
Keyword(s):  
Cost Effectiveness ◽  
Controlled Trial ◽  
Cost Effective ◽  
Open Label ◽  
Post Intervention ◽  
Aphasia Therapy ◽  
Quality Of Life Scale ◽  
Chronic Aphasia ◽  
Aphasia Treatment ◽  
Effectiveness Index

Rationale The comparative efficacy and cost-effectiveness of constraint-induced and multi-modality aphasia therapy in chronic stroke are unknown. Aims and hypotheses In the COMPARE trial, we aim to determine whether Multi-Modal Aphasia Treatment (M-MAT) and Constraint-Induced Aphasia Therapy Plus (CIAT-Plus) are superior to usual care (UC) for chronic post-stroke aphasia. Primary hypothesis: CIAT-Plus and M-MAT will reduce aphasia severity (Western Aphasia Battery-Revised Aphasia Quotient (WAB-R-AQ)) compared with UC: CIAT-Plus superior for moderate aphasia; M-MAT superior for mild and severe aphasia. Sample size estimates A total of 216 participants (72 per arm) will provide 90% power to detect a 5-point difference on the WAB-R-AQ between CIAT-Plus or M-MAT and UC at α = 0.05. Methods and design Prospective, randomized, parallel group, open-label, assessor blinded trial. Participants: Stroke >6 months; aphasia severity categorized using WAB-R-AQ. Computer-generated blocked and stratified randomization by aphasia severity (mild, moderate, and severe), to 3 arms: CIAT-Plus, M-MAT (both 30 h therapy over two weeks); UC (self-reported usual community care). Study outcomes WAB-R-AQ immediately post-intervention. Secondary outcomes: WAB-R-AQ at 12-week follow-up; naming scores, discourse measures, Communicative Effectiveness Index, Scenario Test, and Stroke and Aphasia Quality of Life Scale-39 g immediately and at 12 weeks post-intervention; incremental cost-effectiveness ratios compared with UC at 12 weeks. Discussion This trial will determine whether CIAT-Plus and M-MAT are superior and more cost-effective than UC in chronic aphasia. Participant subgroups with the greatest response to CIAT-Plus and M-MAT will be described.

scholarly journals Self-managed, computerised word finding therapy as an add-on to usual care for chronic aphasia post-stroke: An economic evaluation

2020 ◽  
pp. 026921552097534
Author(s):  
Nicholas R Latimer ◽  
Arjun Bhadhuri ◽  
Abu O Alshreef ◽  
Rebecca Palmer ◽  
Elizabeth Cross ◽  
...  
Keyword(s):  
Cost Effectiveness ◽  
Usual Care ◽  
Low Cost ◽  
Controlled Trial ◽  
Life Time ◽  
Cost Effective ◽  
Quality Adjusted Life Year ◽  
Post Stroke ◽  
Word Finding ◽  
The Cost

Objective: To examine the cost-effectiveness of self-managed computerised word finding therapy as an add-on to usual care for people with aphasia post-stroke. Design: Cost-effectiveness modelling over a life-time period, taking a UK National Health Service (NHS) and personal social service perspective. Setting: Based on the Big CACTUS randomised controlled trial, conducted in 21 UK NHS speech and language therapy departments. Participants: Big CACTUS included 278 people with long-standing aphasia post-stroke. Interventions: Computerised word finding therapy plus usual care; usual care alone; usual care plus attention control. Main measures: Incremental cost-effectiveness ratios (ICER) were calculated, comparing the cost per quality adjusted life year (QALY) gained for each intervention. Credible intervals (CrI) for costs and QALYs, and probabilities of cost-effectiveness, were obtained using probabilistic sensitivity analysis. Subgroup and scenario analyses investigated cost-effectiveness in different subsets of the population, and the sensitivity of results to key model inputs. Results: Adding computerised word finding therapy to usual care had an ICER of £42,686 per QALY gained compared with usual care alone (incremental QALY gain: 0.02 per patient (95% CrI: −0.05 to 0.10); incremental costs: £732.73 per patient (95% CrI: £674.23 to £798.05)). ICERs for subgroups with mild or moderate word finding difficulties were £22,371 and £21,262 per QALY gained respectively. Conclusion: Computerised word finding therapy represents a low cost add-on to usual care, but QALY gains and estimates of cost-effectiveness are uncertain. Computerised therapy is more likely to be cost-effective for people with mild or moderate, as opposed to severe, word finding difficulties.

scholarly journals Promoting Independence in Dementia (PRIDE): protocol for a feasibility randomised controlled trial

Trials ◽  
2019 ◽  
Vol 20 (1) ◽  
Author(s):  
Aisha Shafayat ◽  
Emese Csipke ◽  
Lucy Bradshaw ◽  
Georgina Charlesworth ◽  
Florence Day ◽  
...  
Keyword(s):  
Cost Effectiveness ◽  
Randomised Controlled Trial ◽  
Usual Care ◽  
Rating Scale ◽  
Controlled Trial ◽  
Randomised Trial ◽  
Mild Dementia ◽  
Link Type ◽  
Feasibility Randomised Controlled Trial ◽  
Randomised Controlled

Abstract Background Memory services often see people with early stage dementia who are largely independent and able to participate in community activities but who run the risk of reducing activities and social networks. PRIDE is a self-management intervention designed to promote living well and enhance independence for people with mild dementia. This study aims to examine the feasibility of conducting a definitive randomised trial comparing the clinical and cost-effectiveness of the PRIDE intervention offered in addition to usual care or with usual care alone. Methods/design PRIDE is a parallel, two-arm, multicentre, feasibility, randomised controlled trial (RCT). Eligible participants aged 18 or over who have mild dementia (defined as a score of 0.5 or 1 on the Clinical Dementia Rating Scale) who can participate in the intervention and provide informed consent will be randomised (1:1) to treatment with the PRIDE intervention delivered in addition to usual care, or usual care only. Participants will be followed-up at 3 and 6 month’s post-randomisation. There will be an option for a supporter to join each participant. Each supporter will be provided with questionnaires at baseline and follow-ups at 3 to 6 months. Embedded qualitative research with both participants and supporters will explore their perspectives on the intervention investigating a range of themes including acceptability and barriers and facilitators to delivery and participation. The feasibility of conducting a full RCT associated with participant recruitment and follow-up of both conditions, intervention delivery including the recruitment, training, retention of PRIDE trained facilitators, clinical outcomes, intervention and resource use costs and the acceptability of the intervention and study related procedures will be examined. Discussion This study will assess whether a definitive randomised trial comparing the clinical and cost-effectiveness of whether the PRIDE intervention offered in addition to usual care is feasible in comparison to usual care alone, and if so, will provide data to inform the design and conduct of a future trial. Trial registration ISRCTN, ISRCTN11288961, registered on 23 October 2019, http://www.isrctn.com/ISRCTN12345678 Protocol V2.1 dated 19 June 2019.

scholarly journals TRIal to slow the Progression Of Diabetes (TRIPOD): study protocol for a randomized controlled trial using wireless technology and incentives

Trials ◽  
2019 ◽  
Vol 20 (1) ◽  
Author(s):  
Robyn Su May Lim ◽  
Daphne Su Lyn Gardner ◽  
Yong Mong Bee ◽  
Yin Bun Cheung ◽  
Joann Bairavi ◽  
...  
Keyword(s):  
Cost Effectiveness ◽  
Usual Care ◽  
Financial Incentives ◽  
Diabetes Management ◽  
Controlled Trial ◽  
Health Utility Index ◽  
Work Productivity ◽  
Blood Glucose Monitoring ◽  
Open Label ◽  
Activity Impairment

Abstract Background The outcomes for those with type 2 diabetes mellitus (T2DM) in Singapore are poor. In this TRIal to slow the Progression Of Diabetes (TRIPOD), we will evaluate the effectiveness and cost-effectiveness of a comprehensive diabetes management package (DMP), with or without a financial incentives program, M-POWER Rewards, in efforts to improve HbA1c levels for individuals with T2DM. Methods/design TRIPOD is a randomized, open-label, controlled, multi-center, superiority trial with three parallel arms: (1) usual care only, (2) usual care with DMP, and (3) usual care with DMP plus M-POWER Rewards. A total of 339 adults with sub-optimally controlled T2DM (self-reported HbA1c 7.5–11.0%) will be block randomized according to a 1:1:1 allocation ratio to the three arms. The primary outcome is mean change in HbA1c level at Month 12 from baseline. Secondary outcomes include mean change in HbA1c level at Months 6, 18, and 24; mean changes at Months 6, 12, 18, and 24 in weight, blood pressure, and self-reported physical activity, weight monitoring, blood glucose monitoring, medication adherence, diabetes self-management, sleep quality, work productivity and daily activity impairment, and health utility index; and proportion of participants initiating insulin treatment by Months 6, 12, 18, and 24. Incremental cost-effectiveness ratios will be computed based on costs per improvement in HbA1c at Month 12 and converted to cost per quality-adjusted life year gained. Discussion The TRIPOD study will present insights about the long-term cost-effectiveness and financial viability of the interventions and the potential for integrating within usual care. Trial registration ClinicalTrials.gov, NCT03800680. Registered on 11 January 2019.

scholarly journals Evaluation of FindMyApps: protocol for a randomized controlled trial of the effectiveness and cost-effectiveness of a tablet-based intervention to improve self-management and social participation of community-dwelling people with mild dementia, compared to usual tablet use

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
David Peter Neal ◽  
Yvonne J. F. Kerkhof ◽  
Teake P. Ettema ◽  
Majon Muller ◽  
Judith Bosmans ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Cost Effectiveness ◽  
Usual Care ◽  
Social Participation ◽  
Controlled Trial ◽  
Community Dwelling ◽  
Self Management ◽  
Tablet Computer ◽  
Randomized Controlled ◽  
People With Dementia

Abstract Background For the rising number of people living with dementia, cost-effective community-based interventions to support psychosocial care are needed. The FindMyApps intervention has been developed with and for people with dementia and their caregivers, to help them use tablets to facilitate self-management and engagement in meaningful social activities. A feasibility study and exploratory pilot trial evaluating FindMyApps have been carried out. This definitive trial further evaluates the effectiveness of the intervention and, for the first time, the cost-effectiveness. Methods A randomized controlled non-blinded single-center two-arm superiority trial will be conducted. Community-dwelling people with Mild Cognitive Impairment (MCI), or dementia with a Mini Mental-State Examination (MMSE) of > 17 and < 26, or Global Deterioration Scale 3 or 4, with an informal caregiver and access to a wireless internet connection will be included. In total, 150 patient-caregiver dyads will be randomly allocated to receive either usual care (control arm – tablet computer; n = 75 dyads) or usual care and the FindMyApps intervention (experimental arm – tablet computer and FindMyApps; n = 75 dyads). The primary outcomes are: for people with dementia, self-management and social participation; for caregivers, sense of competence. In addition to a main effect analysis, a cost-effectiveness analysis will be performed. In line with MRC guidance for evaluation of complex interventions a process evaluation will also be undertaken. Discussion Results of the trial are expected to be available in 2023 and will be submitted for publication in international peer-reviewed scientific journals, in addition to conference presentations and reporting via the EU Marie Sklodowska-Curie DISTINCT ITN network. By providing evidence for or against the effectiveness and cost-effectiveness of the FindMyApps intervention, the results of the trial will influence national implementation of FindMyApps. We hope that the results of the trial will further stimulate research and development at the intersection of technology and psycho-social care in dementia. We hope to further demonstrate that the randomized controlled trial is a valuable and feasible means of evaluating new digital technologies, to stimulate further high-quality research in this growing field. Trial registration number Netherlands Trial Register: NL8157; registered 15th November 2019.

Safety of phosphatidylserine containing omega3 fatty acids in ADHD children: A double-blind placebo-controlled trial followed by an open-label extension

2013 ◽  
Vol 28 (6) ◽  
pp. 386-391 ◽  
Author(s):  
I. Manor ◽  
A. Magen ◽  
D. Keidar ◽  
S. Rosen ◽  
H. Tasker ◽  
...  
Keyword(s):  
Fatty Acids ◽  
Rating Scale ◽  
Controlled Trial ◽  
Study Groups ◽  
Open Label ◽  
Double Blind ◽  
Blood Biochemical ◽  
Study Results ◽  
Open Label Extension ◽  
Safety Parameters

AbstractObjective:To evaluate the safety of phosphatidylserine (PS) enriched with omega3 fatty acids, mainly eicosapentaenoic (PS-Omega3) in children with attention-deficit hyperactivity disorder (ADHD).Methods:Two hundred children diagnosed with ADHD were randomised to receive either PS-Omega3 (300 mg PS-Omega3/day) or placebo for 15 weeks. One hundred and fifty children continued into an open-label extension for an additional 15 weeks in which they all consumed PS-Omega3 (150 mg PS-Omega3/day). Standard blood biochemical and haematological safety parameters, blood pressure, heart rate, weight and height were evaluated. Adverse events and the Side Effect Rating Scale were also assessed.Results:One hundred and sixty-two participants completed the double-blind phase. No significant differences were noted between the two study groups in any of the safety parameters evaluated. One hundred and forty participants completed the open-label phase. At the end of this phase, no significant changes from baseline were observed in any of the studied parameters among participants who consumed PS-Omega3 for 30 weeks.Conclusions:Study results demonstrate that consumption of PS-Omega3 by children with ADHD, as indicated in a 30-week evaluation period, is safe and well tolerated, without any negative effect on body weight or growth.

TeleClinical Care: A randomised controlled trial of a smartphone-based model of care to support cardiac patients transitioning from hospital to the community (Preprint)

2021 ◽  
Author(s):  
Praveen Indraratna ◽  
Uzzal Biswas ◽  
James McVeigh ◽  
Andrew Mamo ◽  
Joseph Magdy ◽  
...  
Keyword(s):  
Cost Effectiveness ◽  
Medication Adherence ◽  
Randomised Controlled Trial ◽  
Cardiac Rehabilitation ◽  
Usual Care ◽  
Controlled Trial ◽  
Smartphone App ◽  
Model Of Care ◽  
Intervention Cost ◽  
Randomised Controlled

BACKGROUND This is the first randomised controlled trial (RCT) of a mobile health intervention that combines telemonitoring and educational components for both acute coronary syndrome (ACS) and heart failure (HF) inpatients to prevent readmission. OBJECTIVE Objective: To evaluate the feasibility, efficacy and cost-effectiveness of a smartphone app-based model of care (TeleClinical Care – TCC) plus usual care in patients being discharged from hospital after an ACS or HF admission, in comparison to usual care alone. METHODS Methods: In this pilot, 2-centre RCT, a smartphone app-based model of care (TeleClinical Care – TCC) was applied at discharge. The primary endpoint was the incidence of unplanned 30-day readmissions. Secondary endpoints included all-cause readmissions, cardiac readmissions, cardiac rehabilitation completion, medication adherence, cost-effectiveness and user satisfaction. Intervention arm participants received the app and Bluetooth-enabled devices for measuring weight, blood pressure and physical activity daily, plus usual care. The devices automatically transmitted recordings to the patient’s smartphone and then subsequently to a central server. Abnormal readings were flagged by email to a monitoring team. Control participants received usual care. RESULTS Results: 164 hospital inpatients were randomised at the time of discharge (TCC n=81, control n = 83, mean age 61.5 years, 79% male, 78% admitted with ACS). There were 11 unplanned 30-day readmissions in both groups (P = .97). Over a mean follow-up of 193 days, the intervention was associated with a significant reduction in unplanned hospital readmissions (21 vs. 41 readmissions, P = 0.015), including cardiac readmissions (11 vs. 25, P = .025), and higher rates of cardiac rehabilitation completion (39% vs. 18%, P = .025) and medication adherence (75% vs. 50%, P = .002). The average usability rating of the app was 4.5/5. The intervention cost AUD $6,028 per cardiac readmission saved. When modelled in a mainstream clinical setting, however, enrolment of 237 patients was projected to have the same healthcare expenditure compared to usual care, and enrolment of 500 patients was projected to save approximately AUD $100,000. CONCLUSIONS Conclusion: TCC was feasible and safe for ACS and HF inpatients. The incidence of 30-day readmissions was similar, however long-term benefits were demonstrated including fewer total readmissions over 6 months, improved medication adherence and improved cardiac rehabilitation completion. CLINICALTRIAL The study was registered with the Australia New Zealand Clinical Trials Registry (ACTRN12618001547235).

scholarly journals Clinical effectiveness and cost-effectiveness of a multifaceted podiatry intervention for falls prevention in older people: a multicentre cohort randomised controlled trial (the REducing Falls with ORthoses and a Multifaceted podiatry intervention trial)

2017 ◽  
Vol 21 (24) ◽  
pp. 1-198 ◽  
Author(s):  
Sarah Cockayne ◽  
Sara Rodgers ◽  
Lorraine Green ◽  
Caroline Fairhurst ◽  
Joy Adamson ◽  
...  
Keyword(s):  
Cost Effectiveness ◽  
Usual Care ◽  
Incidence Rate ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Intervention Group ◽  
Clinical Effectiveness ◽  
Cost Effective ◽  
Falls Prevention ◽  
Randomised Controlled

BackgroundFalls are a serious cause of morbidity and cost to individuals and society. Evidence suggests that foot problems and inappropriate footwear may increase the risk of falling. Podiatric interventions could help reduce falls; however, there is limited evidence regarding their clinical effectiveness and cost-effectiveness.ObjectivesTo determine the clinical effectiveness and cost-effectiveness of a multifaceted podiatry intervention for preventing falls in community-dwelling older people at risk of falling, relative to usual care.DesignA pragmatic, multicentred, cohort randomised controlled trial with an economic evaluation and qualitative study.SettingNine NHS trusts in the UK and one site in Ireland.ParticipantsIn total, 1010 participants aged ≥ 65 years were randomised (intervention,n = 493; usual care,n = 517) via a secure, remote service. Blinding was not possible.InterventionsAll participants received a falls prevention leaflet and routine care from their podiatrist and general practitioner. The intervention also consisted of footwear advice, footwear provision if required, foot orthoses and foot- and ankle-strengthening exercises.Main outcome measuresThe primary outcome was the incidence rate of falls per participant in the 12 months following randomisation. The secondary outcomes included the proportion of fallers and multiple fallers, time to first fall, fear of falling, fracture rate, health-related quality of life (HRQoL) and cost-effectiveness.ResultsThe primary analysis consisted of 484 (98.2%) intervention and 507 (98.1%) usual-care participants. There was a non-statistically significant reduction in the incidence rate of falls in the intervention group [adjusted incidence rate ratio 0.88, 95% confidence interval (CI) 0.73 to 1.05;p = 0.16]. The proportion of participants experiencing a fall was lower (50% vs. 55%, adjusted odds ratio 0.78, 95% CI 0.60 to 1.00;p = 0.05). No differences were observed in key secondary outcomes. No serious, unexpected and related adverse events were reported. The intervention costs £252.17 more per participant (95% CI –£69.48 to £589.38) than usual care, was marginally more beneficial in terms of HRQoL measured via the EuroQoL-5 Dimensions [mean quality-adjusted life-year (QALY) difference 0.0129, 95% CI –0.0050 to 0.0314 QALYs] and had a 65% probability of being cost-effective at the National Institute for Health and Care Excellence threshold of £30,000 per QALY gained. The intervention was generally acceptable to podiatrists and trial participants.LimitationsOwing to the difficulty in calculating a sample size for a count outcome, the sample size was based on detecting a difference in the proportion of participants experiencing at least one fall, and not the primary outcome. We are therefore unable to confirm if the trial was sufficiently powered for the primary outcome. The findings are not generalisable to patients who are not receiving podiatry care.ConclusionsThe intervention was safe and potentially effective. Although the primary outcome measure did not reach significance, a lower fall rate was observed in the intervention group. The reduction in the proportion of older adults who experienced a fall was of borderline statistical significance. The economic evaluation suggests that the intervention could be cost-effective.Future workFurther research could examine whether or not the intervention could be delivered in group sessions, by physiotherapists, or in high-risk patients.Trial registrationCurrent Controlled Trials ISRCTN68240461.FundingThis project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full inHealth Technology Assessment; Vol. 21, No. 24. See the NIHR Journals Library website for further project information.

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