Dataset Information

Caregiver-mediated exercises with e-health support for early supported discharge after stroke (CARE4STROKE): A randomized controlled trial.

ABSTRACT:

Background and purpose

We designed an 8-week caregiver-mediated exercise program with e-health support after stroke (CARE4STROKE) in addition to usual care with the aim to improve functional outcome and to facilitate early supported discharge by increasing the intensity of task specific training.

Methods

An observer-blinded randomized controlled trial in which 66 stroke patient-caregiver couples were included during inpatient rehabilitation. Patients allocated to the CARE4STROKE program trained an additional amount of 150 minutes a week with a caregiver and were compared to a control group that received usual care alone. Primary outcomes: self-reported mobility domain of the Stroke Impact Scale 3.0 (SIS) and length of stay (LOS). Secondary outcomes: motor impairment, strength, walking ability, balance, mobility and (Extended) Activities of Daily Living of patients, caregiver strain of caregivers, and mood, self-efficacy, fatigue and quality of life of both patients and caregivers. Outcomes were assessed at baseline, 8 and 12 weeks after randomization.

Results

No significant between-group differences were found regarding SIS-mobility after 8 (? 6.21, SD 5.16; P = 0.229) and 12 weeks (? 0.14, SD 2.87; P = 0.961), and LOS (P = 0.818). Significant effects in favor of the intervention group were found for patient's anxiety (? 2.01, SD 0.88; P = 0.023) and caregiver's depression (? 2.33, SD 0.77; P = 0.003) post intervention. Decreased anxiety in patients remained significant at the 12-week follow-up (? 1.01, SD 0.40; P = 0.009).

Conclusions

This proof-of concept trial did not find significant effects on both primary outcomes mobility and LOS as well as the secondary functional outcomes. Treatment contrast in terms of total exercise time may have been insufficient to achieve these effects. However, caregiver-mediated exercises showed a favorable impact on secondary outcome measures of mood for both patient and caregiver.

Clinical trial registration

NTR4300, URL- http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=4300.

SUBMITTER: Vloothuis JDM

PROVIDER: S-EPMC6453481 | biostudies-literature | 2019

REPOSITORIES: biostudies-literature

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Publications

Caregiver-mediated exercises with e-health support for early supported discharge after stroke (CARE4STROKE): A randomized controlled trial.

Vloothuis Judith D M JDM Mulder Marijn M Nijland Rinske H M RHM Goedhart Quirine S QS Konijnenbelt Manin M Mulder Henry H Hertogh Cees M P M CMPM van Tulder Maurits M van Wegen Erwin E H EEH Kwakkel Gert G

PloS one 20190408 4

<h4>Background and purpose</h4>We designed an 8-week caregiver-mediated exercise program with e-health support after stroke (CARE4STROKE) in addition to usual care with the aim to improve functional outcome and to facilitate early supported discharge by increasing the intensity of task specific training.<h4>Methods</h4>An observer-blinded randomized controlled trial in which 66 stroke patient-caregiver couples were included during inpatient rehabilitation. Patients allocated to the CARE4STROKE p ...[more]

PMID: 30958833

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Project description:BackgroundRecovery of walking ability is an important goal for patients poststroke, and a basic level of mobility is critical for an early discharge home. Caregiver-mediated exercises could be a resource-efficient strategy to augment exercise therapy and improve mobility in the first months poststroke. A combination of telerehabilitation and face-to-face support, blended care, may empower patient-caregiver dyads and smoothen the transition from professional support to self-management. The Armed4Stroke study aims to investigate the effects of a caregiver-mediated exercise program using a blended care approach in addition to usual care, on recovery of mobility in the first 6 months poststroke.MethodsA multicentre, observer-blinded randomized clinical trial in which 74 patient-caregiver dyads will be enrolled in the first 3 months poststroke. Dyads are randomly allocated to a caregiver-mediated exercises intervention or to a control group. The primary endpoint is the self-reported mobility domain of the Stroke Impact Scale. Secondary endpoints include care transition preparedness and psychological functioning of dyads, length of inpatient stay, gait-related measures and extended ADL of patients, and caregiver burden. Outcomes are assessed at enrolment, end of treatment and 6 months follow-up.ResultsDuring 8 weeks, caregivers are trained to become an exercise coach using a blended care approach. Dyads will receive a tailor-made, progressive training program containing task-specific exercises focusing on gait, balance, physical activity and outdoor activities. Dyads are asked to perform the training program a minimum of 5 times a week for 30 min per session, supported by a web-based telerehabilitation system with instruction videos and a messaging environment to communicate with their physiotherapist.ConclusionsWe hypothesize that the Armed4Stroke program will increase self-reported mobility and independence in ADL, facilitating an early discharge poststroke. In addition, we hypothesize that active involvement of caregivers and providing support using blended care, will improve the care transition when professional support tapers off. Therefore, the Armed4Stroke program may complement early supported discharge services.Trial registrationNetherlands Trial Register, NL7422 . Registered 11 December 2018.

Project description:BackgroundStroke is the disease with the highest costs for hospital care and also after discharge. Early supported discharge (ESD) has shown to be efficient and safe and the best results with well-organised discharge teams and patients with less severe strokes. The aim is to investigate if very early supported discharge (VESD) for stroke patients in need for on-going individualised rehabilitation at home is useful for the patient and cost effective.Methods/designA randomized controlled trial comparing VESD with ordinary discharge.Inclusion criteriaconfirmed stroke, >18 years of age, living within 30 min from the stroke unit, on day 2 0-16 points on the National institute of health stroke scale (NIHSS) and 50-100 points on the Barthel Index (BI), with BI 100 then the patient can be included if the Montreal Cognitive Assessment is < 26. Exclusion criteria are: NIHSS >16, BI < 50, life expectancy < 1 year, inability to speak or to communicate in Swedish. The inclusion occurs on day 4 and in block randomization of 20 and with blinded assessor.Primary outcomelevels of anxiety and depression.Secondary outcomesindependence, security, level of function, quality of health, needs of support in activities of daily living and caregiver burden. Power calculation is based on the level of anxiety and with a power of 80%, p-value 0.05 (2 sided test) 44 persons per group are needed. Data is gathered on co-morbidity, re-entry to hospital, mortality and a health economic analysis. Interviews will be accomplished with a strategic sample of 15 patients in the intervention group before discharge, within two weeks after homecoming and 3 months later. Interviews are also planned with 15 relatives in the intervention group 3 months after discharge.DiscussionThe ESD studies in the Cochrane review present hospital stays of a length that no longer exist in Sweden. There is not yet, to our knowledge, any study of early supported discharge with present length of hospital stay. Thus it is not clear if home rehabilitation nowadays without risks, is cost effective, or with the same patient usefulness as earlier studies.Trial registrationClinicalTrials.gov NCT01622205.

Project description:Stroke causes lasting disability and the burden of stroke is expected to increase substantially during the next decades. Optimal rehabilitation is therefore mandatory. Early supported discharge (ESD) has previously shown beneficial, but all major studies were carried out more than ten years ago. We wanted to implement and study the results of ESD in our community today with comparisons between ESD and treatment as usual, as well as between two different ESD models.Patients with acute stroke were included during a three year period (2008-11) in a randomised controlled study comparing two different ESD models to treatment as usual. The two ESD models differed by the location of treatment: either in a day unit or in the patients' homes. Patients in the ESD groups were followed by a multi-disciplinary ambulatory team in the stroke unit and discharged home as early as possible. The ESD models also comprised treatment by a multi-disciplinary community health team for up to five weeks and follow-up controls after 3 and 6 months. Primary outcome was modified Rankin Scale (mRS) at six months.Three-hundred-and-six patients were included. mRS scores and change scores were non-significantly better in the two ESD groups at 3 and 6 months. Within-group improvement from baseline to 3 months was significant in the ESD 1 (p?=?0.042) and ESD 2 (p?=?0.001) groups, but not in the controls. More patients in the pooled ESD groups were independent at 3 (p?=?0.086) and 6 months (p?=?0.122) compared to controls and there also was a significant difference in 3 month change score between them (p?=?0.049). There were no differences between the two ESD groups. Length of stay in the stroke unit was 11 days in all groups.Patients in the ESD groups tended to be more independent than controls at 3 and 6 months, but no clear statistically significant differences were found. The added effect of supported discharge and improved follow-up seems to be rather modest. The improved stroke treatment of today may necessitate larger patient samples to demonstrate additional benefit of ESD.Unique identifier: NCT00771771.

Project description:BackgroundImplementation of stroke early supported discharge (ESD) services has been recommended in many countries' clinical guidelines, based on clinical trial evidence. This is the first observational study to investigate the effectiveness of ESD service models operating in real-world conditions, at scale.Methods and resultsUsing historical prospective data from the United Kingdom Sentinel Stroke National Audit Programme (January 1, 2016-December 31, 2016), measures of ESD effectiveness were "days to ESD" (number of days from hospital discharge to first ESD contact; n=6222), "rehabilitation intensity" (total number of treatment days/total days with ESD; n=5891), and stroke survivor outcome (modified Rankin scale at ESD discharge; n=6222). ESD service models (derived from Sentinel Stroke National Audit Programme postacute organizational audit data) were categorized with a 17-item score, reflecting adoption of ESD consensus core components (evidence-based criteria). Multilevel modeling analysis was undertaken as patients were clustered within ESD teams across the Midlands, East, and North of England (n=31). A variety of ESD service models had been adopted, as reflected by variability in the ESD consensus score. Controlling for patient characteristics and Sentinel Stroke National Audit Programme hospital score, a 1-unit increase in ESD consensus score was significantly associated with a more responsive ESD service (reduced odds of patient being seen after ≥1 day of 29% [95% CI, 1%-49%] and increased treatment intensity by 2% [95% CI, 0.3%-4%]). There was no association with stroke survivor outcome measured by the modified Rankin Scale.ConclusionsThis study has shown that adopting defined core components of ESD is associated with providing a more responsive and intensive ESD service. This shows that adherence to evidence-based criteria is likely to result in a more effective ESD service as defined by process measures. Registration: URL: http://www.isrctn.com/; Unique identifier: ISRCTN15568163.

Project description:BackgroundThe evidence for rehabilitation interventions poststroke lack sufficient robustness. However, variation in treatment effects across countries have been given little attention.ObjectiveTo compare two identically protocolized trials conducted in different western countries in order to identify factors that may have caused variation in secondary trial outcomes.MethodsComparative study based on individual patient data (N = 129) from two randomized controlled trials, conducted in hospitals and rehabilitation facilities in the Netherlands (N = 66) and Australia (N = 63). Patients with stroke and their caregivers were randomly allocated to an 8-week caregiver-mediated exercises intervention (N = 63; 31 Australian and 32 Dutch) or to a control group (N = 66; 32 Australian and 34 Dutch). Patient characteristics, compliance, usual care and process measures were compared across countries. We examined if study setting significantly moderated the trial outcomes: Hospital Anxiety and Depression Scale, Fatigue Severity Scale and General Self-Efficacy Scale, measured at 8- and 12 weeks follow-up. In addition, we explored if factors that were significantly different across countries caused variation in these trial outcomes.ResultsMost patients suffered an ischemic stroke, were in the subacute phase and participated with their partner. Dutch patients were younger (P = 0.005) and had a lower functional status (P = 0.001). Australian patients were recruited earlier poststroke (P<0.001), spent less time in exercise therapy (P<0.001) and had a shorter length of stay (P<0.001). The level of contamination was higher (P = 0.040) among Dutch controls. No effect modification was observed and trial outcomes did not change after controlling for cross-country differences.ConclusionsThe present study highlighted important clinical differences across countries whilst using an identical study protocol. The observed differences could result in a different potential for recovery and variation in treatment effects across trials. We argue that we can proceed faster to evaluating interventions within international pragmatic trials.

Dataset Information

Caregiver-mediated exercises with e-health support for early supported discharge after stroke (CARE4STROKE): A randomized controlled trial.

Background and purpose

Methods

Results

Conclusions

Clinical trial registration

Publications

Caregiver-mediated exercises with e-health support for early supported discharge after stroke (CARE4STROKE): A randomized controlled trial.

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