Stroke survivors with aphasia often experience reduced psychosocial well-being. Intensive comprehensive aphasia programs (ICAPs) are an ideal model in which to treat persons with aphasia (PWAs) to ...improve both cognitive-linguistic impairments and psychosocial well-being.
To investigate the impact of a university-based ICAP on psychosocial well-being using measures of depression, aphasia-related quality of life, and communicative participation.
Thirty-seven PWAs (13 females, 24 males; mean age of 65 years; mean time post onset of 60 months) participated in a university-based ICAP across six ICAP sessions. Psychosocial outcome measures were administered before and after participating in an ICAP including: Geriatric Depression Scale (GDS), Assessment of Living with Aphasia (ALA), and Communicative Effectiveness Index (CETI). Paired samples t-tests were used to compare pre- and post-ICAP performance on each measure, and Pearson's r correlation coefficients were used to evaluate potential relations between measures, as well as relations between measures and demographic and treatment variables.
Depression, as measured by the GDS, significantly decreased pre- to post-ICAP. Pre-treatment scores for the GDS and ALA were significantly correlated. Change scores for the GDS were predictive of change scores for the ALA and CETI. PWAs who had the lowest educational attainment showed the greatest change on the GDS and ALA.
Results suggest that the ICAP service delivery model has the potential to improve psychosocial well-being by reducing depression and improving quality of life. Findings provide preliminary evidence that the ICAP model can be efficacious when implemented in a university setting.
Stroke survivors with aphasia who participate in intensive post-acute aphasia rehabilitation programs make a variety of significant investments. As the number of Intensive Comprehensive Aphasia ...Programs (ICAPs) increase across healthcare settings worldwide, patient perspectives of this innovative service delivery become increasingly important. Stakeholder perspectives can provide meaningful contributions to intervention implementation, growth, and sustainability.
The purpose of this pilot study was to qualitatively explore patient perspectives about the experience of participating in a university-based ICAP implemented by graduate student clinicians.
Researchers used an interpretive phenomenological approach to analyze nine structured interviews from five stroke survivors with aphasia who described their lived experiences during an ICAP. Thematic analysis involved an iterative and collaborative coding process. Transcripts were coded and themes were developed from the patients' shared perspectives. Trustworthiness was maximized through acknowledgement of the researchers' positionality and bias, variation in the sample, member checks, and sustained relationships between stakeholders.
Three primary themes emerged from patient interviews: (1) the ICAP is hard work; (2) the impact of the ICAP on communication is noticeable, and (3) relationships "make" the ICAP.
Themes support emerging evidence that ICAPs implemented by graduate student clinicians may be a worthwhile investment for many stroke survivors with aphasia, thereby contributing to the cost-benefit utility and implementation feasibility of this service delivery model. Stroke survivors with aphasia reported mixed levels of acceptability pertaining to the perceptible impact on communication improvement, and the challenging, rewarding, frequent, and varied opportunities to interact with others.
Intensive Comprehensive Aphasia Programs (ICAPs) implement evidence-based, holistic therapies in a short-duration cohort model. ICAPs are growing in popularity, yet there are still relatively few ...programs, partially due to the high cost of running an ICAP. ICAPs implemented by graduate student clinicians can reduce the overall cost of an ICAP, but Phase I efficacy data for cognitive-linguistic outcomes for an ICAP carried out by graduate students has yet to be reported.
To investigate the impact of a graduate student-run ICAP on measures of cognitive-linguistic change, and to identify relationships between individual and treatment variables and cognitive-linguistic function across pre- and post-ICAP administration.
Fifty-three stroke survivors with chronic aphasia (33 males, 20 females; 32 first-time participants and 21 repeat participants; mean age = 65 years; mean time post-onset = 34 months) participated in an ICAP implemented by graduate students across eight cohorts. Cognitive-linguistic outcome measures included: Western Aphasia Battery, Revised (WAB-R); Boston Naming Test, Second Edition (BNT-2); and Raven's Coloured Progressive Matrices (RCPM). Paired samples t-tests were used to compare pre- and post-ICAP performance for each measure, and Pearson's r correlation coefficients were used to evaluate relationships between measures, as well as individual and treatment variables.
Statistically significant change was observed on all three measures post-treatment, with small to no effect size. Participants who had completed a previous ICAP showed greater change on the WAB-R and RCPM, but no other individual or treatment variables significantly predicted change on outcome measures.
Results provide Phase I, proof-of-concept evidence of positive cognitive-linguistic change in stroke survivors with aphasia following ICAP participation. An ICAP implemented by graduate student clinicians produced significant improvements for persons with chronic aphasia.
Intensive Comprehensive Aphasia Programs (ICAPs) were first described in 2013 with an international survey documenting 12 unique programs. ICAPs involve high dose intervention delivered in both group ...and individual settings, targeting communication across impairment, functioning, participation, and contextual domains. In this study, we aimed to investigate international growth in ICAPs.
We developed a 43-item questionnaire expanding on the original 2013 version to investigate program modifications, activities, protocolised therapies, software and apps, and family involvement. The survey was disseminated to aphasia clinicians and researchers internationally (November 2019-February 2020).
Thirty-nine unique respondents completed the survey from nine countries. Twenty-one met the criteria for an ICAP or modified ICAP (mICAP): 14 ICAPs; 7 mICAPs, and 13 of these were new programs. ICAPs differed from mICAPs with greater emphasis on group sessions, use of technology, total communication, advocacy, and art activities. A large range of protocolised therapies were used across programs. An increased focus on mood and psychosocial well-being was observed compared to the 2013 survey.
The number and comprehensiveness of ICAPs has grown since 2013 with development of modified versions. Future research should focus on comparative efficacy of ICAPs/mICAPs and other forms of aphasia interventions and factors underpinning growth and sustainability.
Implications for Rehabilitation
Clinicians who coordinate or are considering commencing an ICAP in future can use these results to consider the design of their program.
Coordinators should carefully consider the components of their ICAPs and advise consumers whether they meet the definition of an ICAP or a mICAP.
With the increasing number of ICAPs across the globe, clinicians commencing an ICAP may wish to contact existing ICAPs within their country for advice.
Program sustainability may be challenging and these results provide an indication of some of the key challenges coordinators may face.
Background: Although aphasia rehabilitation has been shown to be efficacious, many questions remain regarding how best to deliver treatment to maximise functional gains for persons with aphasia. ...Treatment-delivery variables, such as intensity and dosage, are likely to influence both behavioural and structural changes during anomia treatment. While numerous protocols have concluded that treatment intensity positively impacts functional outcomes, few studies to date have examined the role that dose plays in patient outcomes for anomia treatment.
Aims: This study sought to investigate how manipulating dose of repeated confrontation naming within sessions influences naming in persons with aphasia. Repeated practice of confrontation naming, without feedback, was hypothesised to improve trained but not untrained words, to be persistent after withdrawal, and to be sensitive to the number of trials (i.e., dose) within sessions.
Methods and Procedures: A single-subject ABA design, with replication across seven participants with aphasia, was used to investigate the influence of repeated confrontation naming attempts on the acquisition and maintenance of trained pictures relative to untrained pictures. Training involved repeated attempts to name pictures, along with repeated exposure to pictures of objects (nouns) and their names, without feedback. The primary independent variable was within session dose; the dependent variable was naming accuracy.
Outcomes and Results: Naming accuracy improved for all participants for trained pictures across both acquisition and maintenance phases per visual inspection; such positive effects were not observed for untrained pictures. Effect-size calculations indicate that three of seven participants demonstrated considerable change for trained items, while one of seven participants demonstrated meaningful change for untrained items. The high-dose condition elicited small effect sizes for one participant, and large effect sizes for two of seven participants, while the low-dose condition elicited small and medium effect sizes for two of seven participants.
Conclusions: Participants across a variety of aphasia severity levels responded positively to two doses of repeated confrontation naming practice, without feedback, across phases of this naming protocol. Results are in line with principles of neuroplasticity and demonstrate that repeated practice, without feedback, can produce significant and persistent changes in naming ability for some persons with aphasia.
Catheter-based renal denervation has significantly reduced blood pressure in previous studies. Following a positive pilot trial, the SPYRAL HTN-OFF MED (SPYRAL Pivotal) trial was designed to assess ...the efficacy of renal denervation in the absence of antihypertensive medications.
In this international, prospective, single-blinded, sham-controlled trial, done at 44 study sites in Australia, Austria, Canada, Germany, Greece, Ireland, Japan, the UK, and the USA, hypertensive patients with office systolic blood pressure of 150 mm Hg to less than 180 mm Hg were randomly assigned 1:1 to either a renal denervation or sham procedure. The primary efficacy endpoint was baseline-adjusted change in 24-h systolic blood pressure and the secondary efficacy endpoint was baseline-adjusted change in office systolic blood pressure from baseline to 3 months after the procedure. We used a Bayesian design with an informative prior, so the primary analysis combines evidence from the pilot and Pivotal trials. The primary efficacy and safety analyses were done in the intention-to-treat population. This trial is registered at ClinicalTrials.gov, NCT02439749.
From June 25, 2015, to Oct 15, 2019, 331 patients were randomly assigned to either renal denervation (n=166) or a sham procedure (n=165). The primary and secondary efficacy endpoints were met, with posterior probability of superiority more than 0·999 for both. The treatment difference between the two groups for 24-h systolic blood pressure was −3·9 mm Hg (Bayesian 95% credible interval −6·2 to −1·6) and for office systolic blood pressure the difference was −6·5 mm Hg (−9·6 to −3·5). No major device-related or procedural-related safety events occurred up to 3 months.
SPYRAL Pivotal showed the superiority of catheter-based renal denervation compared with a sham procedure to safely lower blood pressure in the absence of antihypertensive medications.
Medtronic.
Previous randomised renal denervation studies did not show consistent efficacy in reducing blood pressure. The objective of our study was to evaluate the effect of renal denervation on blood pressure ...in the absence of antihypertensive medications.
SPYRAL HTN-OFF MED was a multicentre, international, single-blind, randomised, sham-controlled, proof-of-concept trial. Patients were enrolled at 21 centres in the USA, Europe, Japan, and Australia. Eligible patients were drug-naive or discontinued their antihypertensive medications. Patients with an office systolic blood pressure (SBP) of 150 mm Hg or greater and less than 180 mm Hg, office diastolic blood pressure (DBP) of 90 mm Hg or greater, and a mean 24-h ambulatory SBP of 140 mm Hg or greater and less than 170 mm Hg at second screening underwent renal angiography and were randomly assigned to renal denervation or sham control. Patients, caregivers, and those assessing blood pressure were blinded to randomisation assignments. The primary endpoint, change in 24-h blood pressure at 3 months, was compared between groups. Drug surveillance was done to ensure patient compliance with absence of antihypertensive medication. The primary analysis was done in the intention-to-treat population. Safety events were assessed at 3 months. This study is registered with ClinicalTrials.gov, number NCT02439749.
Between June 25, 2015, and Jan 30, 2017, 353 patients were screened. 80 patients were randomly assigned to renal denervation (n=38) or sham control (n=42) and followed up for 3 months. Office and 24-h ambulatory blood pressure decreased significantly from baseline to 3 months in the renal denervation group: 24-h SBP −5·5 mm Hg (95% CI −9·1 to −2·0; p=0·0031), 24-h DBP −4·8 mm Hg (−7·0 to −2·6; p<0·0001), office SBP −10·0 mm Hg (−15·1 to −4·9; p=0·0004), and office DBP −5·3 mm Hg (−7·8 to −2·7; p=0·0002). No significant changes were seen in the sham-control group: 24-h SBP −0·5 mm Hg (95% CI −3·9 to 2·9; p=0·7644), 24-h DBP −0·4 mm Hg (−2·2 to 1·4; p=0·6448), office SBP −2·3 mm Hg (−6·1 to 1·6; p=0·2381), and office DBP −0·3 mm Hg (−2·9 to 2·2; p=0·8052). The mean difference between the groups favoured renal denervation for 3-month change in both office and 24-h blood pressure from baseline: 24-h SBP −5·0 mm Hg (95% CI −9·9 to −0·2; p=0·0414), 24-h DBP −4·4 mm Hg (−7·2 to −1·6; p=0·0024), office SBP −7·7 mm Hg (−14·0 to −1·5; p=0·0155), and office DBP −4·9 mm Hg (−8·5 to −1·4; p=0·0077). Baseline-adjusted analyses showed similar findings. There were no major adverse events in either group.
Results from SPYRAL HTN-OFF MED provide biological proof of principle for the blood-pressure-lowering efficacy of renal denervation.
Medtronic.
The purpose of this study was to identify predictors and clinical implications of permanent pacemaker (PPM) implantation after transcatheter aortic valve replacement (TAVR).
Cardiac conduction ...disturbances requiring PPM are a frequent complication of TAVR. However, limited data is available regarding this complication after TAVR with a balloon-expandable valve.
The study included patients without prior pacemaker who underwent TAVR in the PARTNER (Placement of AoRtic TraNscathetER Valves) trial and registry and investigated predictors and clinical effect of new PPM.
Of 2,559 TAVR patients, 586 were excluded due to pre-existing PPM. A new PPM was required in 173 of the remaining 1,973 patients (8.8%). By multivariable analysis, predictors of PPM included right bundle branch block (odds ratio OR: 7.03, 95% confidence interval CI: 4.92 to 10.06, p < 0.001), prosthesis diameter/left ventricular (LV) outflow tract diameter (for each 0.1 increment, OR: 1.29, 95% CI: 1.10 to 1.51, p = 0.002), LV end-diastolic diameter (for each 1 cm, OR: 0.68, 95% CI: 0.53 to 0.87, p = 0.003), and treatment in continued access registry (OR: 1.77, 95% CI: 1.08 to 2.92, p = 0.025). Patients requiring PPM had a longer mean duration of post-procedure hospitalization (7.3 ± 2.7 days vs. 6.2 ± 2.8 days, p = 0.001). At 1 year, new PPM was associated with significantly higher repeat hospitalization (23.9% vs. 18.2%, p = 0.05) and mortality or repeat hospitalization (42.0% vs. 32.6%, p = 0.007). There was no difference between groups in LV ejection fraction at 1 year.
PPM was required in 8.8% of patients without prior PPM who underwent TAVR with a balloon-expandable valve in the PARTNER trial and registry. In addition to pre-existing right bundle branch block, the prosthesis to LV outflow tract diameter ratio and the LV end-diastolic diameter were identified as novel predictors of PPM after TAVR. New PPM was associated with a longer duration of hospitalization and higher rates of repeat hospitalization and mortality or repeat hospitalization at 1 year. (THE PARTNER TRIAL: Placement of AoRtic TraNscathetER Valves Trial; NCT00530894).
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