scholarly journals Effect of conversion from calcineurin inhibitors to everolimus on hepatitis C viremia in adult kidney transplant recipients

2018 ◽  
Vol 40 (2) ◽  
pp. 143-150 ◽  
Author(s):  
Larissa Sgaria Pacheco ◽  
Valter Duro Garcia ◽  
Ronivan Luis Dal Prá ◽  
Bruna Doleys Cardoso ◽  
Mariana Ferras Rodrigues ◽  
...  
Keyword(s):  
Hepatitis C ◽  
Controlled Trial ◽  
Calcineurin Inhibitors ◽  
Control Group ◽  
P Value ◽  
Kidney Transplant Recipients ◽  
Positive Serology ◽  
Open Label ◽  
Adult Kidney ◽  
Group 1

ABSTRACT Introduction: Currently, there is no specific immunosuppressive protocol for hepatitis C (HCV)-positive renal transplants recipients. Thus, the aim of this study was to evaluate the conversion effect to everolimus (EVR) on HCV in adult kidney recipients. Method: This is an exploratory single-center, prospective, randomized, open label controlled trial with renal allograft recipients with HCV-positive serology. Participants were randomized for conversion to EVR or maintenance of calcineurin inhibitors. Results: Thirty patients were randomized and 28 were followed-up for 12 months (conversion group, Group 1 =15 and control group, Group 2 =13). RT-PCR HCV levels reported in log values were comparable in both groups and among patients in the same group. The statistical analysis showed no interaction effect between time and group (p value G*M= 0.852), overtime intra-groups (p-value M=0.889) and between group (p-value G=0.286). Group 1 showed a higher incidence of dyslipidemia (p=0.03) and proteinuria events (p=0.01), while no difference was observed in the incidence of anemia (p=0.17), new onset of post-transplant diabetes mellitus (p=1.00) or urinary tract infection (p=0.60). The mean eGFR was similar in both groups. Conclusion: Our study did not show viral load decrease after conversion to EVR with maintenance of antiproliferative therapy.

scholarly journals Role of Interferon Therapy in Severe COVID-19: The COVIFERON Randomized Controlled Trial

2021 ◽  
Author(s):  
Ilad Alavi Darazam ◽  
Mohamad Amin Pourhoseingholi ◽  
Shervin Shokouhi ◽  
Seyed Sina Naghibi Irvani ◽  
Majid Mokhtari ◽  
...  
Keyword(s):  
Viral Infections ◽  
Controlled Trial ◽  
Ordinal Scale ◽  
Control Group ◽  
P Value ◽  
Open Label ◽  
Subcutaneous Injections ◽  
Positive Effects ◽  
Significant Difference ◽  
Registration Number

Abstract Type 1 Interferons (IFNs) have been associated with positive effects on Coronaviruses. Previous studies point towards the superior potency of IFNβ compared to IFNα against viral infections. We conducted a three-armed, individually-randomized, open-label, controlled trial of IFNβ1a and IFNβ1b, comparing them against each other and a control group. Patients were randomly assigned in a 1:1:1 ratio to IFNβ1a (subcutaneous injections of 12,000 IU on days 1, 3, 6), IFNβ1b (subcutaneous injections of 8,000,000 IU on days 1, 3, 6), or the control group. All three arms orally received Lopinavir/Ritonavir (400mg/100 mg twice a day for ten days) and a single dose of Hydroxychloroquine 400 mg on the first day. Our utilized primary outcome measure was Time To Clinical Improvement (TTCI) defined as the time from enrollment to discharge or a decline of two steps on the clinical seven-step ordinal scale, whichsoever came first. A total of 60 severely ill patients with positive RT-PCR and Chest CT scans underwent randomization (20 patients to each arm). In the Intention-To-Treat population, IFNβ1a was associated with a significant difference against the control group, in the TTCI; (HR; 2.36, 95% CI=1.10-5.17, P-value=0.031) while the IFNβ1b indicated no significant difference compared with the control; HR; 1.42, (95% CI=0•63-3•16, P-value=0•395). The median TTCI for both of the intervention groups was five days vs. seven days for the control group. The mortality was numerically lower in both of the intervention groups (20% in the IFNβ1a group and 30% in the IFNβ1b group vs. 45% in the control group). There were no significant differences between the three arms regarding the adverse events. In patients with laboratory-confirmed SARS-CoV-2 infection, as compared with the base therapeutic regiment, the benefit of a significant reduction in TTCI was observed in the IFNβ1a arm. This finding needs further confirmation in larger studies. Trial Registration Number: ClinicalTrials.gov, NCT04343768. (Submitted: 08/04/2020; First Online: 13/04/2020) (Registration Number: NCT04343768)

scholarly journals On Whether Therapeutic Plasma Exchange is Effective Against Severe/Critical COVID-19 Pneumonia

2021 ◽  
Author(s):  
Luca Cegolon ◽  
Behzad Einollahi ◽  
Sina Imanizadeh ◽  
Mohammad Rezapour ◽  
Mohammad Javanbakht ◽  
...  
Keyword(s):  
Plasma Exchange ◽  
Structural Equation ◽  
Cox Regression ◽  
Controlled Trial ◽  
Therapeutic Plasma Exchange ◽  
Equation Modeling ◽  
Control Group ◽  
P Value ◽  
Group 2 ◽  
Group 1

Abstract Background. There is a risk of novel mutations of SARS-CoV-2 that may render COVID-19 resistant to most of the therapies, including antiviral drugs. The evidence around the application of therapeutic plasma exchange (TPE) for the management of critically ill COVID-19 patients is still provisional and further investigations are needed to confirm its eventual beneficial effects. Methods. We therefore carried out a single-centered retrospective observational non-placebo-controlled trial enrolling 73 inpatients from Baqiyatallah Hospital in Tehran (Iran) with diagnosis of COVID-19 pneumonia confirmed by real-time polymerase chain reaction (RT-PCR) on nasopharyngeal swabs and high-resolution computerized tomography chest scan. These patients were broken down into two groups: Group 1 (30 patients) receiving standard of care (corticosteroids, ceftriaxone, azithromycin, pantoprazole, hydroxychloroquine, lopinavir/ritonavir); and Group 2 (43 patients) receiving the above regimen plus TPE (replacing 2 liter of patients’ plasma by a solution, 50% of normal plasma and 50% of albumin at 5%) administered according to various time schedules. The follow-up time was 30 days and all-cause mortality was the endpoint. Results. Deaths were 6 (14%) in Group 2 and 14 (47%) in Group 1. However, different harmful risk factors prevailed among patients not receiving TPE rather than being equally split between the intervention and control group. We used an algorithm of Structural Equation Modeling (of STATA) to summarize a large pool of potential confounders into a single score (called with the descriptive name “severity”). Disease severity was significantly (Wilkinson rank sum test p-value=0.0000) lower among COVID-19 patients undergoing TPE (median: -2.82; range: -5.18; 7.96) as compared to those non receiving TPE (median: -1.35; range: -3.89; 8.84), confirming that treatment assignment involved a selection bias of patients according to the severity of COVID-19 at hospital admission. The adjustment for confounding was carried out using severity as covariate in Cox regression models. The univariate Hazard Ratio (HR) of 0.68 (95%CI: 0.26; 1.80; p=0.441) for TPE turned to 1.19 (95%CI: 0.43; 3.29; p=0.741) after adjusting for severity. Conclusions. The lower mortality observed among patients receiving TPE was due to a lower severity of COVID-19 rather than TPE effects. TRIAL REGISTRATIONIRCT registration number: IRCT20080901001165N58 (Iranian Registry of Clinical Trials)Registration date: 2020-05-27, 1399/03/07 (retrospectively registered)

scholarly journals Safety and Effectiveness of High-Dose Vitamin C in Patients with COVID-19; A Randomized Controlled open-label Clinical Trial ‎

2021 ◽  
Author(s):  
Saeidreza JamaliMoghadamSiahkali ◽  
Besharat Zarezade ◽  
Sogol Koolaji ◽  
Seyed Ahmad Seyed Alinaghi ◽  
Abolfazl Zendehdel ◽  
...  
Keyword(s):  
Vitamin C ◽  
Controlled Trial ◽  
Control Treatment ◽  
Control Group ◽  
P Value ◽  
Case Group ◽  
High Dose ◽  
Open Label ◽  
Significant Difference ◽  
High Dose Vitamin

Abstract Background: To assess the effectiveness of vitamin C treatment against coronavirus disease 2019 (COVID-19)Methods: An open-label, randomized, and controlled trial was conducted on patients with severe COVID-19 infection. The case and control treatment groups each consisted of 30 patients. The control group received lopinavir/ritonavir and hydroxychloroquine and the case group received high-dose of vitamin C (six gr daily) added to the same regimen. Results: There were no statistically significant differences between two groups with respect to age and gender, laboratory results, and underlying diseases. On the 3rd day of hospitalization, the mean core body temperatures was significantly lower and SpO2 was higher In the case group (p value = 0.001, and 0.014, respectively). The median length of hospitalization in case group which was significantly longer than the control group (8.5 days vs. 6.5 days) (p value = 0.0280). There was no significant difference in SpO2 levels at discharge time, the length of ICU stay, and mortality between the two groups.Conclusions: We did not find significantly better outcomes in the group who were treated with high-dose vitamin C in addition to the main treatment regimen at discharge.Trial registration: The project was registered by Iranian Registry of Clinical Trials.IRCT20200411047025N1

scholarly journals On whether therapeutic plasma exchange is an effective cure for severe/critical COVID-19 pneumonia

2021 ◽  
Author(s):  
Luca Cegolon ◽  
Behzad Einollahi ◽  
Sina Imanizadeh ◽  
Mohammad Rezapour ◽  
Mohammad Javanbakht ◽  
...  
Keyword(s):  
Plasma Exchange ◽  
Structural Equation ◽  
Cox Regression ◽  
Controlled Trial ◽  
Therapeutic Plasma Exchange ◽  
Equation Modeling ◽  
Control Group ◽  
P Value ◽  
Group 2 ◽  
Group 1

There is a risk of novel mutations of SARS-CoV-2 that may render COVID-19 resistant to most of the therapies, including antiviral drugs. The evidence around the application of therapeutic plasma exchange (TPE) for the management of critically ill COVID-19 patients is still provisional and further investigations are needed to confirm its eventual beneficial effects. We therefore carried out a single-centered retrospective observational non-placebo-controlled trial enrolling 73 inpatients from Baqiyatallah Hospital in Tehran (Iran) with diagnosis of COVID-19 pneumonia confirmed by real-time polymerase chain reaction on nasopharyngeal swabs and high-resolution computerized tomography chest scan. These patients were broken down into two groups: Group 1 (30 patients) receiving standard of care (corticosteroids, ceftriaxone, azithromycin, pantoprazole, hydroxychloroquine, lopinavir/ritonavir); and Group 2 (43 patients) receiving the above regimen plus TPE (replacing 2 liter of patients plasma by a solution, 50% of normal plasma and 50% of albumin at 5%) administered according to various time schedules. The follow-up time was 30 days and all cause mortality was the endpoint. Deaths were 6 (14%) in Group 2 and 14 (47%) in Group 1. However, different harmful risk factors prevailed among patients not receiving TPE rather than being equally split between the intervention and control group. We used an algorithm of Structural Equation Modeling (of STATA) to summarize a large pool of potential confounders into a single score (called with the descriptive name Sseverity). Disease severity was significantly (Wilkinson rank sum test p-value=0.0000) lower among COVID-19 patients undergoing TPE (median: -2.82; range: -5.18; 7.96) as compared to those non receiving TPE (median: -1.35; range: -3.89; 8.84), confirming that treatment assignment involved a selection bias of patients according to the severity of COVID-19 at hospital admission. The adjustment for confounding was carried out using severity as covariate in Cox regression models. The univariate Hazard Ratio (HR) of 0.68 (95%CI: 0.26; 1.80; p=0.441) for TPE turned to 1.19 (95%CI: 0.43; 3.29; p=0.741) after adjusting for severity. Thus, the lower mortality observed among patients receiving TPE was due to a lower severity of COVID-19 rather than TPE effects. Keywords: Therapeutic plasma exchange (TPE), COVID-19, Clinical and laboratory indexes, Cytokine storm.

scholarly journals Role of interferon therapy in severe COVID-19: the COVIFERON randomized controlled trial

2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Ilad Alavi Darazam ◽  
Shervin Shokouhi ◽  
Mohamad Amin Pourhoseingholi ◽  
Seyed Sina Naghibi Irvani ◽  
Majid Mokhtari ◽  
...  
Keyword(s):  
Viral Infections ◽  
Controlled Trial ◽  
Ordinal Scale ◽  
Control Group ◽  
P Value ◽  
Open Label ◽  
Subcutaneous Injections ◽  
Positive Effects ◽  
Significant Difference ◽  
Registration Number

AbstractType 1 Interferons (IFNs) have been associated with positive effects on Coronaviruses. Previous studies point towards the superior potency of IFNβ compared to IFNα against viral infections. We conducted a three-armed, individually-randomized, open-label, controlled trial of IFNβ1a and IFNβ1b, comparing them against each other and a control group. Patients were randomly assigned in a 1:1:1 ratio to IFNβ1a (subcutaneous injections of 12,000 IU on days 1, 3, 6), IFNβ1b (subcutaneous injections of 8,000,000 IU on days 1, 3, 6), or the control group. All three arms orally received Lopinavir/Ritonavir (400 mg/100 mg twice a day for ten days) and a single dose of Hydroxychloroquine 400 mg on the first day. Our utilized primary outcome measure was Time To Clinical Improvement (TTCI) defined as the time from enrollment to discharge or a decline of two steps on the clinical seven-step ordinal scale, whichsoever came first. A total of 60 severely ill patients with positive RT-PCR and Chest CT scans underwent randomization (20 patients to each arm). In the Intention-To-Treat population, IFNβ1a was associated with a significant difference against the control group, in the TTCI; (HR; 2.36, 95% CI 1.10–5.17, P-value = 0.031) while the IFNβ1b indicated no significant difference compared with the control; HR; 1.42, (95% CI 0.63–3.16, P-value = 0.395). The median TTCI for both of the intervention groups was five days vs. seven days for the control group. The mortality was numerically lower in both of the intervention groups (20% in the IFNβ1a group and 30% in the IFNβ1b group vs. 45% in the control group). There were no significant differences between the three arms regarding the adverse events. In patients with laboratory-confirmed SARS-CoV-2 infection, as compared with the base therapeutic regiment, the benefit of a significant reduction in TTCI was observed in the IFNβ1a arm. This finding needs further confirmation in larger studies.Trial Registration Number: ClinicalTrials.gov, NCT04343768. (Submitted: 08/04/2020; First Online: 13/04/2020) (Registration Number: NCT04343768).

Feasibility and acceptability of instructions of daily care in overweight and obese knee osteoarthritis participants

2021 ◽  
Vol 17 ◽  
Author(s):  
Muhammad Tariq Rafiq ◽  
Mohamad Shariff A Hamid ◽  
Eliza Hafiz ◽  
Farid Ahmad Chaudhary ◽  
Muhammad Irfan Khan
Keyword(s):  
Knee Osteoarthritis ◽  
Controlled Trial ◽  
Weight Bearing ◽  
Joint Disease ◽  
Control Group ◽  
P Value ◽  
Open Label ◽  
Timed Up And Go ◽  
Knee Oa ◽  
Daily Care

Introduction: Knee osteoarthritis (OA) is a weight-bearing joint disease and more common in the overweight and obese persons. The objective of the study was to assess the feasibility and acceptability of instructions of daily care (IDC) on pain, mobility and body mass index (BMI) among knee OA participants who are overweight or obese. Material and Method: The study was an open-label randomized controlled trial of six-weeks. Forty overweight and obese participants with knee OA were randomly divided into two groups by a computer-generated number. The participants in the Instruction Group (IG) were provided with leaflets explaining IDC for the duration of six-weeks. Both groups were instructed to take low doses of the non-steroid anti-inflammatory drug (NSAIDs) on alternate days. The outcome measures were pain, mobility and BMI. The feasibility and acceptability of knee pain and mobility were assessed using a questionnaire designed by experts in rehabilitation. Results: Participants in the IG reported more statistically significant pain relief as assessed by the Western Ontario and McMaster Universities Osteoarthritis Index score (p=0.001) and improvement in mobility (p=0.000) assessed by the Timed Up and Go test score after six weeks compared to the Control Group (CG). Both groups did not demonstrate any significant change in BMI (p-value > 0.05), The results of descriptive statistics showed a significantly higher satisfaction score to participants who received a combination of IDC and NSAIDs, indicating an acceptable intervention. Conclusion: The IDC are effective and acceptable in terms of improving pain and mobility and should be recommended as the usual care of treatment.

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 Combination of InnoSEAL plus TR band compared with TR band alone for radial artery outcomes in patients undergoing transradial coronary intervention (InnoSEAL-II): an open-label randomised controlled trial (protocol)

BMJ Open ◽  
2020 ◽  
Vol 10 (12) ◽  
pp. e042101
Author(s):  
Saba Aijaz ◽  
Sana Sheikh ◽  
Asad Pathan
Keyword(s):  
Randomised Controlled Trial ◽  
Radial Artery ◽  
Controlled Trial ◽  
Coronary Intervention ◽  
Ease Of Use ◽  
P Value ◽  
Radial Compression ◽  
Open Label ◽  
Scientific Publications ◽  
Randomised Controlled

IntroductionAbout 2%–30% of cardiac catheterisation procedures get complicated by radial artery occlusion (RAO). Ensuring patent haemostasis appears to be an important factor in reducing RAO. Currently employed method is a radial compression device (RCD) such as transradial band (TRB) that take hours to achieve haemostasis and cause discomfort to the patients. Haemostatic pads offer an alternative to RCD with reduced time to achieve haemostasis. Our trial aims to determine the non-inferiority of the catecholamine chitosan-based pad (InnoSEAL haemostatic pad) used in conjunction with TRB (InnoSEAL +TRB) when compared with the TRB alone in reducing composite adverse access site outcomes.Methods and analysisIt will be an open-label, parallel, randomised controlled trial on 714 adult patients (325 in each arm) undergoing coronary procedure using transradial approach at a cardiac health facility over 7 months duration. InnoSEAL patch along with TRB will be used to control bleeding in intervention arm and TRB alone in control arm, which is the standard practice. Study primary outcomes include RAO and haematoma; secondary outcomes are compression time, patient discomfort, time to discharge and ease of use of the intervention technique by the healthcare staff. χ2 test will be used to compare the categorical outcomes between two arms and student’s t-test for continuous outcomes. A p value of <0.05 will be considered significant.Ethics and disseminationEthical approval for the study has been obtained from the Institutional Review Board of Tabba Heart Institute number IORG0007863. Findings will be disseminated through seminars and scientific publications.Trial registration numberNCT04380883; Pre-results.

scholarly journals Mobile Health to Improve Adherence and Patient Experience in Heart Transplantation Recipients: The mHeart Trial

Healthcare ◽  
2021 ◽  
Vol 9 (4) ◽  
pp. 463
Author(s):  
Mar Gomis-Pastor ◽  
Sonia Mirabet Perez ◽  
Eulalia Roig Minguell ◽  
Vicenç Brossa Loidi ◽  
Laura Lopez Lopez ◽  
...  
Keyword(s):  
Heart Transplantation ◽  
Patient Experience ◽  
Mobile Application ◽  
Standard Care ◽  
Controlled Trial ◽  
Intervention Group ◽  
Group Versus ◽  
Control Group ◽  
P Value ◽  
Adherence Score

Non-adherence after heart transplantation (HTx) is a significant problem. The main objective of this study was to evaluate if a mHealth strategy is more effective than standard care in improving adherence and patients’ experience in heart transplant recipients. Methods: This was a single-center, randomized controlled trial (RCT) in adult recipients >1.5 years post-HTx. Participants were randomized to standard care (control group) or to the mHeart Strategy (intervention group). For patients randomized to the mHeart strategy, multifaceted theory-based interventions were provided during the study period to optimize therapy management using the mHeart mobile application. Patient experience regarding their medication regimens were evaluated in a face-to-face interview. Medication adherence was assessed by performing self-reported questionnaires. A composite adherence score that included the SMAQ questionnaire, the coefficient of variation of drug levels and missing visits was also reported. Results: A total of 134 HTx recipients were randomized (intervention N = 71; control N = 63). Mean follow-up was 1.6 (SD 0.6) years. Improvement in adherence from baseline was significantly higher in the intervention group versus the control group according to the SMAQ questionnaire (85% vs. 46%, OR = 6.7 (2.9; 15.8), p-value < 0.001) and the composite score (51% vs. 23%, OR = 0.3 (0.1; 0.6), p-value = 0.001). Patients’ experiences with their drug therapy including knowledge of their medication timing intakes (p-value = 0.019) and the drug indications or uses that they remembered (p-value = 0.003) significantly improved in the intervention versus the control group. Conclusions: In our study, the mHealth-based strategy significantly improved adherence and patient beliefs regarding their medication regimens among the HTx population. The mHeart mobile application was used as a feasible tool for providing long-term, tailor-made interventions to HTx recipients to improve the goals assessed.

scholarly journals The CARESSES Randomised Controlled Trial: Exploring the Health-Related Impact of Culturally Competent Artificial Intelligence Embedded Into Socially Assistive Robots and Tested in Older Adult Care Homes

2021 ◽  
Author(s):  
Chris Papadopoulos ◽  
Nina Castro ◽  
Abiha Nigath ◽  
Rosemary Davidson ◽  
Nicholas Faulkes ◽  
...  
Keyword(s):  
Older Adult ◽  
Controlled Trial ◽  
Control Group ◽  
Culturally Competent ◽  
Adult Care ◽  
Assistive Robots ◽  
Sf 36 ◽  
Randomised Controlled ◽  
Experimental Group ◽  
Group 1

AbstractThis trial represents the final stage of the CARESSES project which aimed to develop and evaluate a culturally competent artificial intelligent system embedded into social robots to support older adult wellbeing. A parallel group, single-blind randomised controlled trial was conducted across older adult care homes in England and Japan. Participants randomly allocated to the Experimental Group or Control Group 1 received a Pepper robot for up 18 h across 2 weeks. Two versions of the CARESSES artificial intelligence were tested: a fully culturally competent system (Experimental Group) and a more limited version (Control Group 1). Control Group 2 (Care As Usual) participants did not receive a robot. Quantitative outcomes of interest reported in the current paper were health-related quality of life (SF-36), loneliness (ULS-8), and perceptions of robotic cultural competence (CCATool-Robotics). Thirty-three residents completed all procedures. The difference in SF-36 Emotional Wellbeing scores between Experimental Group and Care As Usual participants over time was significant (F[1] = 6.614, sig = .019, ηp2 = .258), as was the comparison between Any Robot used and Care As Usual (F[1] = 5.128, sig = .031, ηp2 = .146). There were no significant changes in SF-36 physical health subscales. ULS-8 loneliness scores slightly improved among Experimental and Control Group 1 participants compared to Care As Usual participants, but this was not significant. This study brings new evidence which cautiously supports the value of culturally competent socially assistive robots in improving the psychological wellbeing of older adults residing in care settings.

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