scholarly journals Implementation and Effects of an Information Technology-Based Intervention to Support Speech and Language Therapy Among Stroke Patients with Aphasia: Protocol for a Virtual Randomized Controlled Trial (Preprint)

2021 ◽  
Author(s):  
Esther Kim ◽  
Laura Laird ◽  
Carlee Wilson ◽  
Till Bieg ◽  
Phillip Mildner ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Lexical Retrieval ◽  
Evidence Based ◽  
Waitlist Control ◽  
Treatment Assessment ◽  
Randomized Controlled ◽  
Waitlist Control Group

BACKGROUND Mobile application-based therapies are increasingly being employed by speech-language pathologists in the rehabilitation of people with aphasia (PwA) as an adjunct or in lieu of traditional in-person therapy approaches. These apps can increase the intensity of treatment, and have been shown to result in meaningful outcomes across several domains OBJECTIVE VoiceAdapt is a mobile therapy app designed with user and stakeholder feedback within a user-centered design framework. VoiceAdapt uses two evidence-based lexical retrieval treatments to engage PwA to improve their naming abilities through interaction with the app. The purpose of the randomized controlled trial (RCT) proposed here is to examine the feasibility and clinical efficacy of training with VoiceAdapt on the language and communication outcomes of people with aphasia. METHODS A multicenter RCT is being conducted at two locations within Canada. A total of 80 people with aphasia will be recruited to participate in a two-arm, waitlist-controlled, crossover group RCT. After baseline assessment, participants will be randomized into an intervention group or a waitlist control group. Intervention group participants will engage in five weeks of training with the app, followed by post-treatment assessment and follow-up assessment after an additional five weeks. Those in the waitlist control group will have five weeks of no training, followed by a pre-treatment assessment, training for five weeks and post-treatment assessment. All aspects of the trial are being conducted remotely given the COVID-19 pandemic. RESULTS Recruitment of participants started in September 2020 and the study is expected to be completed by March 2022. Publication of results is expected within six months of study completion. CONCLUSIONS Results of the RCT will provide data to inform evidence-based practice on the use of technology-based solutions to treat aphasia. If positive results are obtained from this RCT, the VoiceAdapt app can be recommended as an efficacious means of improving lexical retrieval and communicative functioning in PwA within an easily accessible, cost-effective manner. Moreover, the implementation of this RCT through remote assessment and delivery can inform the profession on telerehabilitation practices and monitoring app-based home therapy programs. CLINICALTRIAL ClinicalTrials.gov NCT04108364; https://clinicaltrials.gov/ct2/show/NCT04108364

scholarly journals A web-based dietary intervention in early pregnancy and neonatal outcomes: a randomized controlled trial

2018 ◽  
Vol 41 (2) ◽  
pp. 371-378 ◽  
Author(s):  
R A K Kennedy ◽  
C M E Reynolds ◽  
S Cawley ◽  
E O’Malley ◽  
D M McCartney ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Standard Care ◽  
Dietary Intervention ◽  
Controlled Trial ◽  
Intervention Group ◽  
Neonatal Outcomes ◽  
Dietary Behaviour ◽  
Control Group ◽  
Evidence Based ◽  
Randomized Controlled

Abstract Background Maternal nutrition is a determinant of pregnancy outcomes. Few studies have evaluated the potential of online nutrition resources to modify behaviour. This randomized controlled trial aimed to determine whether access to a customized evidence-based nutrition website in pregnancy improved neonatal outcomes. Methods Women <18 weeks gestation were recruited at their convenience. The control group received standard care. In addition to standard care, the intervention group received access to an evidence-based nutrition website, customized to the preferences of pregnant women. Results Of the 250 women, there were no differences in characteristics between the two groups. Of the women, 91.0% reported they make a conscious effort currently to eat a healthy diet. However, only 19.6% met dietary requirements for calcium, 13.2% for iron, 2.7% for folate and 2.3% for iodine. The most popular website section was pregnancy nutrition advice but engagement was not sustained. Access to the website was not associated with any improvement in clinical outcomes (P > 0.05). Conclusions We found that provision of a customized website providing nutrition information, did not improve neonatal outcomes. Future studies should explore whether redesign with website interactivity or embedding information on popular digital platforms sustains women’s engagement and modifies dietary behaviour.

scholarly journals Mindfulness-Based Stress Reduction Specifically Improves Social Anhedonia among Adults with Chronic Stress

2021 ◽  
Author(s):  
Corinne Carlton ◽  
Ligia Antezana ◽  
Katelyn Mallory Garcia ◽  
Holly Sullivan-Toole ◽  
John Richey
Keyword(s):  
Randomized Controlled Trial ◽  
Chronic Stress ◽  
Stress Reduction ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Social Anhedonia ◽  
Randomized Controlled ◽  
Waitlist Control Group ◽  
The Relationship

This randomized controlled trial examined the effects of mindfulness on anhedonic symptoms in a sample of adults reporting high levels of chronic stress. Meditation-naïve adults (N=68, Mage=32, 62% female) were randomized to either an 8-week MBSR intervention group (N=35), or to a waitlist control group (N=33). We hypothesized that changes in mindfulness would mediate the relationship between condition and changes in anhedonic symptoms. Additionally, the present study aimed to determine if other theoretically-linked mechanisms (i.e., stress, negative affect(NA), depression) were involved in producing changes in anhedonic symptoms. Results provided evidence for full mediation of the effect of MBSR on social anhedonia through its essential mechanism of ΔMindfulness. These results highlight specificity of anhedonic symptoms targeted by MBSR, with social anhedonia symptoms being modified by changes in mindfulness whereas other anhedonic domains were not. Additionally, although associative relationships were present for stress, depression, NA, and anhedonic symptoms, no mediational relationships emerged.

scholarly journals Effectiveness of an Internet- and App-Based Intervention for College Students With Elevated Stress: Randomized Controlled Trial (Preprint)

2017 ◽  
Author(s):  
Mathias Harrer ◽  
Sophia Helen Adam ◽  
Rebecca Jessica Fleischmann ◽  
Harald Baumeister ◽  
Randy Auerbach ◽  
...  
Keyword(s):  
Mental Health ◽  
College Students ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Waitlist Control ◽  
Symptoms Of Depression ◽  
Randomized Controlled ◽  
Waitlist Control Group

BACKGROUND Mental health problems are highly prevalent among college students. Most students with poor mental health, however, do not receive professional help. Internet-based self-help formats may increase the utilization of treatment. OBJECTIVE The aim of this randomized controlled trial was to evaluate the efficacy of an internet-based, app-supported stress management intervention for college students. METHODS College students (n=150) with elevated levels of stress (Perceived Stress Scale 4-item version, PSS-4 ≥8) were randomly assigned to either an internet- and mobile-based stress intervention group with feedback on demand or a waitlist control group. Self-report data were assessed at baseline, posttreatment (7 weeks), and 3-month follow-up. The primary outcome was perceived stress posttreatment (PSS-4). Secondary outcomes included mental health outcomes, modifiable risk and protective factors, and college-related outcomes. Subgroup analyses were conducted in students with clinically relevant symptoms of depression (Center for Epidemiological Studies’ Depression Scale >17). RESULTS A total of 106 participants (76.8%) indicated that they were first-time help-seekers, and 77.3% (intervention group: 58/75; waitlist control group: 58/75) showed clinically relevant depressive symptoms at baseline. Findings indicated significant effects of the intervention compared with the waitlist control group for stress (d=0.69; 95% CI 0.36-1.02), anxiety (d=0.76; 95% CI 0.43-1.09), depression (d=0.63; 95% CI 0.30-0.96), college-related productivity (d=0.33; 95% CI 0.01-0.65), academic work impairment (d=0.34; 95% CI 0.01-0.66), and other outcomes after 7 weeks (posttreatment). Response rates for stress symptoms were significantly higher for the intervention group (69%, 52/75) compared with the waitlist control group (35%, 26/75, P<.001; number needed to treat=2.89, 95% CI 2.01-5.08) at posttest (7 weeks). Effects were sustained at 3-month follow-up, and similar findings emerged in students with symptoms of depression. CONCLUSIONS Internet- and mobile-based interventions could be an effective and cost-effective approach to reduce consequences of college-related stress and might potentially attract students with clinically relevant depression who would not otherwise seek help. CLINICALTRIAL German Clinical Trial Register DRKS00010212; http://www.drks.de/drks_web/navigate.do? navigationId=trial.HTML&TRIAL_ID=DRKS00010212 (Archived by WebCite at http://www.webcitation.org/6w55Ewhjd)

scholarly journals Effects of Horticultural Therapy on Asian Older Adults: A Randomized Controlled Trial

2018 ◽  
Vol 15 (8) ◽  
pp. 1705 ◽  
Author(s):  
Kheng Ng ◽  
Angelia Sia ◽  
Maxel Ng ◽  
Crystal Tan ◽  
Hui Chan ◽  
...  
Keyword(s):  
Older Adults ◽  
Randomized Controlled Trial ◽  
Social Connectedness ◽  
Controlled Trial ◽  
Well Being ◽  
Control Group ◽  
Horticultural Therapy ◽  
Waitlist Control ◽  
Randomized Controlled ◽  
Waitlist Control Group

The effect of horticultural therapy (HT) on immune and endocrine biomarkers remains largely unknown. We designed a waitlist-control randomized controlled trial to investigate the effectiveness of HT in improving mental well-being and modulating biomarker levels. A total of 59 older adults was recruited, with 29 randomly assigned to the HT intervention and 30 to the waitlist control group. The participants attended weekly intervention sessions for the first 3 months and monthly sessions for the subsequent 3 months. Biological and psychosocial data were collected. Biomarkers included IL-1β, IL-6, sgp-130, CXCL12/SDF-1α, CCL-5/RANTES, BDNF (brain-derived neurotrophic factor), hs-CRP, cortisol and DHEA (dehydroepiandrosterone). Psychosocial measures examined cognitive functions, depression, anxiety, psychological well-being, social connectedness and satisfaction with life. A significant reduction in plasma IL-6 level (p = 0.02) was observed in the HT intervention group. For the waitlist control group, significant reductions in plasma CXCL12 (SDF-1α) (p = 0.003), CXCL5 (RANTES) (p = 0.05) and BDNF (p = 0.003) were observed. A significant improvement in social connectedness was also observed in the HT group (p = 0.01). Conclusion: HT, in reducing plasma IL-6, may prevent inflammatory disorders and through maintaining plasma CXCL12 (SDF-1α), may maintain hematopoietic support to the brain. HT may be applied in communal gardening to enhance the well-being of older adults.

scholarly journals Increasing Access to Task-Oriented Community-Based Exercise Programs Through Healthcare-Community Partnerships to Improve Function Post-Stroke: Feasibility of a 2-Group Randomized Controlled Trial Protocol

2021 ◽  
Author(s):  
Gayatri Aravind ◽  
Kainat Bashir ◽  
Jill I. Cameron ◽  
Jo-Anne Howe ◽  
Susan B. Jaglal ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Exercise Program ◽  
Control Group ◽  
Community Based ◽  
Waitlist Control ◽  
Post Stroke ◽  
Randomized Controlled ◽  
Waitlist Control Group ◽  
Everyday Function

Abstract BackgroundObjectives were to describe the feasibility of a protocol for evaluating a community-based exercise program incorporating a healthcare-community partnership (CBEP-HCP) compared to a waitlist control group on improving everyday function among people post-stroke.MethodsA pilot 2-group randomized controlled trial was conducted in three cities in Ontario, Canada. Adults (≥ 18 years) living at home for ≥ 3 months post-stroke, and able to walk ≥ 10 metres without physical assistance were stratified by site and gait speed and randomly assigned to an exercise program or waitlist control group. Trained fitness instructors delivered a 1-hour, group exercise class, involving repetitive and progressive practice of balance/mobility tasks relevant to everyday function (e.g., sit-to-stand, walking, step-ups) twice a week for 12 weeks. The waitlist group was offered the exercise program at 10 months. Blinded assessors conducted evaluations at 3, 6 and 10 months post-baseline. Sensitivity to change of two measures of everyday function (Subjective Index of Physical and Social Outcome (SIPSO) and Nottingham Extended Activities of Daily Living (NEADL)) was compared. Qualitative interviews were conducted separately with 13 participants and 9 caregivers post-intervention. Quantitative and qualitative results were triangulated.ResultsThirty-three people with stroke were randomized to the intervention (n = 16) or waitlist group (n = 17); 68% of available caregivers agreed to participate. Recruitment rates were 2.4, 1.2, and 1.1 participants/month across sites and highest in the largest urban centre. Participants preferred a familiar healthcare professional to refer them to the study. Participants described a 10- or 12-month wait as too long and two people in the waitlist group withdrew for this reason. The exercise program was implemented per protocol across sites. Attendance was lowest (63% and 71% in the intervention and waitlist group, respectively) at 10-month evaluations. Participants described inclement weather, availability of transportation, and long commutes as barriers to attending evaluations and exercise classes. The SIPSO physical scale but not the NEADL detected change in the intervention group. Quantitative and qualitative results suggested an immediate effect of the intervention on balance, balance self-efficacy, everyday function (dressing, cooking), and overall health.ConclusionChallenges with recruitment, attendance, and retention will inform protocol revisions for a future trial.Trial Registration: ClinicalTrials.gov, NCT03122626. Registered April 17, 2017 - Retrospectively registered, https://www.clinicaltrials.gov/ct2/show/NCT03122626

Effectiveness of a web-based medication adherence tool with patient centered communication: Results of a clustered randomized controlled trial (Preprint)

2019 ◽  
Author(s):  
Jan van Lieshout ◽  
Joyca Lacroix ◽  
Aart van Halteren ◽  
Martina Teichert
Keyword(s):  
Randomized Controlled Trial ◽  
Medication Adherence ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Community Pharmacies ◽  
Web Based ◽  
Randomized Controlled ◽  
Tailored Interventions ◽  
Increased Risk

BACKGROUND Growing numbers of people use medication for chronic conditions; non-adherence is common, leading to poor disease control. A newly developed web-based tool to identify an increased risk for non-adherence with related potential individual barriers might facilitate tailored interventions and improve adherence. OBJECTIVE To assess the effectiveness of the newly developed tool to improve medication adherence. METHODS A cluster randomized controlled trial assessed the effectiveness of this adherence tool in patients initiating cardiovascular or oral blood glucose lowering medication. Participants were included in community pharmacies. They completed an online questionnaire comprising an assessments of their risk for medication non-adherence and subsequently of barriers to adherence. In pharmacies belonging to the intervention group, individual barriers displayed in a graphical profile on a tablet were discussed by pharmacists and patients at high non-adherence risk in face to face meetings and shared with their general practitioners and practice nurses. Tailored interventions were initiated by the healthcare providers. Barriers of control patients were not presented or discussed and these patients received usual care. The primary outcome was the difference in medication adherence at 8 months follow-up between patients with an increased non-adherence risk from intervention and control group, calculated from dispensing data. RESULTS Data from 492 participants in 15 community pharmacies were available for analyses (intervention 253, 7 pharmacies; control 239, 8 pharmacies). The intervention had no effect on medication adherence (-0.01; 95%CI -0.59 – 0.57; P= .96), neither in the post hoc per protocol analysis (0.19; 95%CI -0.50 – 0.89; P=.58). CONCLUSIONS This study showed no effectiveness of a risk stratification and tailored intervention addressing personal barriers for medication adherence. Various potential explanations for lack of effect were identified. These explanations relate for instance to high medication adherence in the control group, study power and fidelity. Process evaluation should elicit possible improvements and inform the redesign of intervention and implementation. CLINICALTRIAL The Netherlands National Trial Register: NTR5186. Date: May 18, 2015 (http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=5186)

scholarly journals Effect of leg wrapping technique on prevention of spinal induced hypotension and fetal acidosis during cesarean section: Randomized controlled trial

2019 ◽  
Vol 10 (2) ◽  
pp. 70
Author(s):  
Samah Nasser Abd El-Aziz El-Shora ◽  
Amina Mohamed Rashad El-Nemer
Keyword(s):  
Randomized Controlled Trial ◽  
Cesarean Section ◽  
Controlled Trial ◽  
Intervention Group ◽  
Cost Effective ◽  
Control Group ◽  
Induced Hypotension ◽  
Randomized Controlled ◽  
Significant Difference ◽  
Wrapping Technique

Background and aim: Hypotension during cesarean section (CS) under spinal anesthesia has been a subject of scientific study for more than 50 years and the search for the most effective strategy to achieve hemodynamic stability remains challenging. Aim: The study was carried out to apply leg wrapping technique for the prevention of spinal-induced hypotension (SIH) during CS.Methods: Randomized Controlled Trial design was utilized at cesarean delivery operating room Mansoura General Hospital in El-Mansoura City during the period from May 2018 to November 2018. A purposive sample of 88 pregnant women, assigned randomly to an intervention group (n = 44) in which their legs wrapped with elastic crepe bandage and control group (n = 44) in which no wrapping was done. Data collected for maternal, neonatal hemodynamic and signs of hypotension, the feasibility of application and cost analysis.Results: There was a statistically significant difference in the incidence of SIH and Ephedrine use among both groups (18.20% in leg wrapping group whereas 75% in control group). In addition, neonatal acidosis and NICU admission were less among leg wrapping group (11.40%, 9.10% respectively). Economically, leg wrapping technique was cost effective compared to the cost of the hospital regimen for treating SIH and admission to (NICU).Conclusion and recommendations: Leg wrapping technique was cost effective and an efficient method for decreasing SIH, neonatal acidosis and Ephedrine administration. It is recommended to apply leg wrapping technique in maternal hospitals' protocol of care for decreasing SIH during CS.

Investigating the Impact of Cognitive Training for Individuals With Bothersome Tinnitus: A Randomized Controlled Trial

2021 ◽  
pp. 019459982199474
Author(s):  
Maggie Xing ◽  
Dorina Kallogjeri ◽  
Jay F. Piccirillo
Keyword(s):  
Randomized Controlled Trial ◽  
Cognitive Training ◽  
Mixed Model ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Functional Index ◽  
Open Label ◽  
Randomized Controlled ◽  
The Impact

Objective To evaluate the effectiveness of cognitive training in improving tinnitus bother and to identify predictors of patient response. Study Design Prospective open-label randomized controlled trial. Setting Online. Methods Participants were adults with subjective idiopathic nonpulsatile tinnitus causing significant tinnitus-related distress. The intervention group trained by using auditory-intensive exercises for 20 minutes per day, 5 days per week, for 8 weeks. The active control group trained on the same schedule with non–auditory intensive games. Surveys were completed at baseline, 8 weeks, and 12 weeks. Results A total of 64 participants completed the study. The median age was 63 years (range, 25-69) in the intervention group and 61 years (34-68) in the control group. Mixed model analysis revealed that within-subject change in Tinnitus Functional Index in the intervention group was not different than the control group, with marginal mean differences (95% CI): 0.24 (–11.20 to 10.7) and 2.17 (–8.50 to 12.83) at 8 weeks and 2.33 (–8.6 to 13.3) and 3.36 (–7.91 to 14.6) at 12 weeks, respectively. When the 2 study groups were compared, the control group had higher Tinnitus Functional Index scores than the intervention group by 10.5 points at baseline (95% CI, –0.92 to 29.89), 8.1 at 8 weeks (95% CI, –3.27 to 19.42), and 9.4 at 12 weeks (95% CI, –2.45 to 21.34). Conclusion Auditory-intensive cognitive training was not associated with changes in self-reported tinnitus bother. Given the potential for neuroplasticity to affect tinnitus, we believe that future studies on cognitive training for tinnitus remain relevant.

scholarly journals Community Health Workers as a Strategy to Tackle Psychosocial Suffering Due to Physical Distancing: A Randomized Controlled Trial

2021 ◽  
Vol 18 (6) ◽  
pp. 3097
Author(s):  
Dorien Vanden Bossche ◽  
Susan Lagaert ◽  
Sara Willems ◽  
Peter Decat
Keyword(s):  
Randomized Controlled Trial ◽  
Community Health ◽  
Health Workers ◽  
Psychosocial Support ◽  
Controlled Trial ◽  
Intervention Group ◽  
Psychosocial Health ◽  
Control Group ◽  
Randomized Controlled ◽  
The Impact

Background: During the COVID-19 pandemic, many primary care professionals were overburdened and experienced difficulties reaching vulnerable patients and meeting the increased need for psychosocial support. This randomized controlled trial (RCT) tested whether a primary healthcare (PHC) based community health worker (CHW) intervention could tackle psychosocial suffering due to physical distancing measures in patients with limited social networks. Methods: CHWs provided 8 weeks of tailored psychosocial support to the intervention group. Control group patients received ‘care as usual’. The impact on feelings of emotional support, social isolation, social participation, anxiety and fear of COVID-19 were measured longitudinally using a face-to-face survey to determine their mean change from baseline. Self-rated change in psychosocial health at 8 weeks was determined. Results: We failed to find a significant effect of the intervention on the prespecified psychosocial health measures. However, the intervention did lead to significant improvement in self-rated change in psychosocial health. Conclusions: This study confirms partially the existing evidence on the effectiveness of CHW interventions as a strategy to address mental health in PHC in a COVID context. Further research is needed to elaborate the implementation of CHWs in PHC to reach vulnerable populations during and after health crises.

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