COVID-19 Follow-App. Mobile App-Based Monitoring of COVID-19 Patients after Hospital Discharge: A Single-Center, Open-Label, Randomized Clinical Trial

Introduction: In the midst of a pandemic, apps can be used to provide close follow-up, ensure that patients are monitored at home, avoid excessive pressure on medical facilities, prevent the movement of people (both patients and health professionals), and reduce the risk of infection. Objective: To adapt and validate the use of a smartphone application for outpatient follow-up of COVID-19 patients after hospital discharge. Methods: We conducted an open-label clinical trial at Hospital Universitari Vall d’Hebron in Barcelona, Spain. Patients were randomly assigned in a 1:1 ratio to be followed by the Farmalarm app or by their primary care center. The primary endpoint was the reduction in the need for in-person return visits. Results: From 31 March to 4 May 2020, 150 patients were enrolled in the study at hospital discharge: 74 patients were randomized to the experimental group, and 76 to the control group. All patients in the control group and all except for six in the experimental group completed the study. During hospitalization, before study inclusion, all but 4 (97.3%) had viral pneumonia, 91 (60.7%) required supplemental oxygen, and 16 (10.7%) required intensive care unit (ICU) admission. COVID-19–related return visits to the emergency department were significantly higher in the control group (7.9% vs. 0%; p = 0.028) in the per-protocol analysis. Telephone consultations with the emergency department were performed by 12 (15.8%) patients in the control group and 0 (0%) in the experimental group (p < 0.001). Satisfaction with outpatient monitoring was rated higher by the experimental group (5 vs. 4 points; p < 0.001). Conclusions: Following COVID-19 hospital discharge, home follow-up via a mobile app was effective in reducing in-person return visits without undermining patient satisfaction or perception of health, compared with standard follow-up.

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Marital Problems and Treatment Outcome in Depressed Women

The British Journal of Psychiatry ◽

10.1192/bjp.151.5.652 ◽

1987 ◽

Vol 151 (5) ◽

pp. 652-659 ◽

Cited By ~ 24

Author(s):

Roslyn H. Corney

Keyword(s):

Clinical Trial ◽

Social Work ◽

Social Workers ◽

Control Group ◽

Women Patients ◽

Marital Problems ◽

Routine Treatment ◽

Work Intervention ◽

Experimental Group

In a clinical trial investigating the effectiveness of social work intervention with depressed women patients in general practice, 80 women were randomly allocated to an experimental group for referral to attached social workers or to a control group for routine treatment by their GPs. They were reassessed at 6 and 12 months. The results indicated that women who had major marital problems were more likely to be depressed at follow-up than those with good relationships. However, patients with marital difficulties in the experimental group made more improvement than the controls. Women initially assessed as suffering from ‘acute on chronic’ depression and having major marital difficulties were found to benefit most from social work intervention.

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Quantifying Withdrawal of Consent, Loss to Follow-Up, Early Drug Discontinuation, and Censoring in Oncology Trials

Journal of the National Comprehensive Cancer Network ◽

10.6004/jnccn.2021.7015 ◽

2021 ◽

pp. 1-8

Author(s):

Brooke E. Wilson ◽

Michelle B. Nadler ◽

Alexandra Desnoyers ◽

Eitan Amir

Keyword(s):

Censored Data ◽

Control Group ◽

Drug Discontinuation ◽

Open Label ◽

Loss To Follow Up ◽

Significant Difference ◽

And Control ◽

Experimental Group ◽

Early Drug

Background: Censoring due to early drug discontinuation (EDD) or withdrawal of consent or loss to follow-up (WCLFU) can result in postrandomization bias. In oncology, censoring rules vary with no defined standards. In this study, we sought to describe the planned handling and transparency of censoring data in oncology trials supporting FDA approval and to compare EDD and WCLFU in experimental and control arms. Methods: We searched FDA archives to identify solid tumor drug approvals and their associated trials between 2015 and 2019, and extracted the planned handling and reporting of censored data. We compared the proportion of WCLFU and EDD between the experimental and control arms by using generalized estimating equations, and performed logistic regression to identify trial characteristics associated with WCLFU occurring more frequently in the control group. Results: Censoring rules were defined adequately in 48 (59%) of 81 included studies. Only 14 (17%) reported proportions of censored participants clearly. The proportion of WCLFU was higher in the control group than in the experimental group (mean, 3.9% vs 2.5%; β-coefficient, −2.2; 95% CI, −3.1 to −1.3; P<.001). EDD was numerically higher in the experimental arm in 61% of studies, but there was no statistically significant difference in the proportion of EDD between the experimental and control groups (mean, 21.6% vs 19.9%, respectively; β-coefficient, 0.27; 95% CI, −0.32 to 0.87; P=.37). The proportion of EDD due to adverse effects (AEs) was higher in the experimental group (mean, 13.2% vs 8.5%; β-coefficient, 1.5; 95% CI, 0.57–2.45; P=.002). WCLFU was higher in the control group in studies with an active control group (odds ratio [OR], 10.1; P<.001) and in open label studies (OR, 3.00; P=.08). Conclusions: There are significant differences in WCLFU and EDD for AEs between the experimental and control arms in oncology trials. This may introduce postrandomization bias. Trials should improve the reporting and handling of censored data so that clinicians and patients are fully informed regarding the expected benefits of a treatment.

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Using a mobile health app to improve patients’ adherence to hypertension treatment: a non-randomized clinical trial

PeerJ ◽

10.7717/peerj.11491 ◽

2021 ◽

Vol 9 ◽

pp. e11491

Author(s):

Simiane Salete Volpi ◽

Daiana Biduski ◽

Ericles Andrei Bellei ◽

Danieli Tefili ◽

Lynn McCleary ◽

...

Keyword(s):

Clinical Trial ◽

User Experience ◽

Mobile Health ◽

Control Group ◽

Hypertension Treatment ◽

Men And Women ◽

Access To Health ◽

Mhealth Apps ◽

Experimental Group

Poor adherence to hypertension treatment increases complications of the disease and is characterized by a lack of awareness and acceptance of ongoing treatment. Mobile health (mHealth) apps can optimize processes and facilitate access to health information by combining treatment methods with attractive solutions. In this study, we aimed at verifying the influence of using an mHealth app on patients’ adherence to hypertension treatment, also examining how user experience toward the app influenced the outcomes. A total of 49 participants completed the study, men and women, diagnosed with hypertension and ongoing medical treatment. For 12 weeks, the control group continued with conventional monitoring, while the experimental group used an mHealth app. From the experimental group, at baseline, 8% were non-adherent, 64% were partial adherents and 28% were adherent to the treatment. Baseline in the control group indicated 4.2% non-adherents, 58.3% partial adherents, and 37.5% adherents. After follow-up, the experimental group had an increase to 92% adherent, 8% partially adherent, and 0% non-adherent (P < 0.001). In the control group, adherence after follow-up remained virtually the same (P ≥ 0.999). Results of user experience were substantially positive and indicate that the participants in the experimental group had a satisfactory perception of the app. In conclusion, this study suggests that using an mHealth app can empower patients to manage their own health and increase adherence to hypertension treatment, especially when the app provides a positive user experience.

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Effect of Lingual Frenotomy on Tongue and Lip Rest Position: A Nonrandomized Clinical Trial

International Archives of Otorhinolaryngology ◽

10.1055/s-0041-1726050 ◽

2021 ◽

Author(s):

Roberta Lopes Castro Martinelli ◽

Irene Queiroz Marchesan ◽

Reinaldo Jordão Gusmão ◽

Giédre Berretin-Felix

Keyword(s):

Clinical Trial ◽

Hard Palate ◽

Constant Pressure ◽

Control Group ◽

Quiet Sleep ◽

Sleep Phase ◽

Rest Position ◽

Breathing Disorders ◽

Experimental Group

Abstract Introduction The tongue plays an important role in the development of craniofacial structures. At rest, the light and constant pressure of the tongue against the hard palate, counterbalanced by the pressure provided by proper lip sealing, serves as a guide for maxillary growth. Ankyloglossia makes tongue coupling against the hard palate difficult, impacting maxillary development, which may lead to breathing disorders. Objective To verify the effect of lingual frenotomy on the resting position of the tongue and lips in infants with ankyloglossia. Methods The sample consisted of 334 infants aged between 1 and 60 days old diagnosed with ankyloglossia. The groups were divided in: a) experimental group (EG), which consisted of infants whose mothers agreed with lingual frenotomy; b) control group (CG), which consisted of infants whose mothers either refused lingual frenotomy or were waiting for surgery. Both the position of the lips and of the tongue at rest were assessed while the infants were sleeping during the quiet sleep phase. For mothers who refused their infants to undergo the surgical procedure, a follow-up of the infants was proposed to verify possible interference of the frenulum with the resting position of the tongue and lips. Infants whose mothers agreed with surgery were referred for lingual frenotomy. Results Regarding the position of the tongue and lips at rest at the initial and final assessments, the statistical analysis demonstrated significant differences between both groups. Conclusion Lingual frenotomy enabled infants diagnosed with ankyloglossia to maintain both tongue coupling against the hard palate and closed lips at rest.

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Improved shoulder stability through plyometric, proprioceptive and strength exercises in rugby players. A randomized clinical trial

10.31083/jomh.2021.021 ◽

2021 ◽

Keyword(s):

Clinical Trial ◽

Repeated Measures ◽

Exercise Program ◽

Control Group ◽

Strength Exercises ◽

Pre Treatment ◽

Rugby Players ◽

Experimental Group ◽

Shoulder Stability

Background: The shoulder is one of the most frequently injured joints in rugby. Improving muscle strength can increase glenohumeral joint stability, thus preventing injuries to this joint. Purpose: Evaluating the effectiveness of a plyometric, proprioceptive and strength exercise program in promoting shoulder stability in rugby players. Study design: Randomized single blind clinical trial, with follow up. Level of evidence, 2. Methods: Thirty federated rugby players were included in the study and randomized to the two study groups. The experimental group performed an exercise program including plyometric exercises using a ﬁtness ball, proprioceptive exercises with BodyBlade® and strength training with elastic bands. The intervention lasted four weeks, with two weekly sessions lasting 15 minutes each. The control group continued with their usual routine. The study variable was glenohumeral stability, measured with the Closed Kinetic Chain Upper Extremity Stability test and the Y-Balance test. Three evaluations (pre-treatment, post-treatment and follow-up) were carried out. Changes were calculated after each evaluation and repeated measures analysis was performed. Results: Stability improved after the intervention and when comparing pre-treatment and follow-up assessments (P < 0.05) in the experimental group. There were differences between the two groups (P < 0.05) and between the different study evaluations (P < 0.001). Conclusion: A protocol based on plyometric, proprioceptive and strength exercises improves glenohumeral stability. This improvement can be maintained for four weeks.

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Effectiveness and Safety of Niclosamaide as Add-on Therapy to the Standard of Care Measures in COVID-19 Management: Randomized controlled clinical trial

10.1101/2021.06.10.21258709 ◽

2021 ◽

Author(s):

Ahmed S. Abdulamir ◽

Faiq I. Gorial ◽

Sattar J Saaedi ◽

Mohammed Fauzi Maulood ◽

Hashim Ali Hashim ◽

...

Keyword(s):

Clinical Trial ◽

Survival Rate ◽

Viral Infections ◽

Standard Of Care ◽

Antiviral Effect ◽

Control Group ◽

Controlled Clinical Trial ◽

Open Label ◽

Randomized Controlled ◽

Experimental Group

Background: COVID-19 pandemic has ignited the urge for repurposing old drugs as candidate antiviral medicines to treat novel challenges of viral infections. Niclosamide (NCS) is an anti-parasitic drug of known antiviral potential. Therefore, this study attempts to investigate the antiviral effect and safety of NCS on SARS-CoV-2 caused COVID-19 patients. Methods: Randomized controlled open label clinical trial encompassed 75 COVID-19 patients treated with standard of care plus NCS were included as experimental group and 75 COVID-19 patients treated with only standard of care therapy as control group. Each group was composed of 25 mild, 25 moderate and 25 severe patients. Survival rate, time to recovery, and side effects were the main endpoints for the assessment of the therapeutic effect and safety of NCS. Results: NCS did not enhance survival rate as three of severe COVID-19 patients in NCS and in control groups died (P>0.05). However, NCS, compared to control group, reduced the time to recovery in moderate and severe COVID-19 patients about 5 and 3 days, respectively but not in mild patients (P≤0.05). Most interestingly, NCS lowered time to recovery up to five days in patients with co-morbidities (P≤0.05) whereas only one day lowered in patients without co-morbidities (P>0.05). Conclusion: It is concluded that NCS accelerates time to recovery about 3 to 5 days in moderate to severe COVID-19 patients especially those with co-morbidities; hence, NCS is of clinical benefit for freeing hospital beds for more patients in pandemic crisis.

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The effectiveness of positive training on happiness, aggression and hope in adolescents with leukemia in Ahvaz

Indian Journal of Positive Psychology ◽

10.15614/ijpp.v9i01.11735 ◽

2018 ◽

Vol 9 (01) ◽

Author(s):

Marzieh . Shamkhani ◽

Ali . Khalafi

Keyword(s):

Sampling Method ◽

Analysis Of Covariance ◽

Control Group ◽

Positive Attitudes ◽

Measurement Tools ◽

Post Test ◽

Aggression Questionnaire ◽

Experimental Group ◽

Period Measurement

The purpose of this study was to determine the effectiveness of positive learning on happiness, Aggression and hope for adolescents with leukemia in Ahvaz. The sample consisted of 30 people who were selected by available sampling method. 15 subjects in the experimental group and 15 in the control group were randomly assigned. The experimental design was a pre-test-post-test type with control group and follow-up period. Measurement tools included Oxford Happiness Inventory (Argyle, 1989); Ahwaz's Aggression Questionnaire (Zahedifar, Najarian, and Shokrkon, 2000); Hope Scale (Schneider, 1991). To run, at first, the pre-test was taken from both groups. Then, the experimental group was trained in 14 sessions of 90 minutes, and after each group, they were subjected to post-test. And one month later, the follow-up process was completed. Data analysis was performed using multivariate covariance analysis (MANCOVA) and one-way analysis of covariance (ANCOVA). The results showed that positive attitudes toward happiness, aggressiveness and hopefulness of adolescents with leukemia in Ahvaz were effective.

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Effects of a positive thinking program on hope and sleep quality in Iranian patients with thalassemia: a randomized clinical trial

BMC Psychology ◽

10.1186/s40359-021-00547-0 ◽

2021 ◽

Vol 9 (1) ◽

Author(s):

Somayeh Makaremnia ◽

Marieh Dehghan Manshadi ◽

Zahra Khademian

Keyword(s):

Clinical Trial ◽

Sleep Quality ◽

Training Program ◽

Randomized Clinical Trial ◽

Thalassemia Major ◽

Trial Registration ◽

Control Group ◽

Positive Thinking ◽

Experimental Group

Abstract Background Thalassemia have a negative impact on the patients' psychological health and sleep quality. This study aimed to determine the effects of a positive thinking training program on hope and sleep quality of patients with thalassemia major. Methods This randomized clinical trial was conducted on 78 patients with thalassemia major including 36 males (46.2%) and 42 females (53.8%) with a mean age of 25.56 ± 29.6 in Iran. Subjects were randomly assigned into experimental and control groups. Experimental group received 16 h training based on positive thinking materials published by Martin Seligman. Control group received only usual programs. Data were collected at baseline, as well as immediately and one month after the intervention, using Snyder’s Hope Scale and the Pittsburgh Sleep Quality Index. Data analysis was performed using SPSS Software 18.0; statistical tests included the independent T-test, the Chi-square, Mann Whitney, and Friedman test. Significance level was set at 0.05 in this study. Results The experimental group had a significantly higher mean hope score compared to the control group immediately (45.38 ± 7.82 vs. 35.32 ± 5.54, P < 0.001) and one month following intervention (44.67 ± 3.47 vs. 35 ± .54, P < 0.001). Moreover, the mean sleep quality scores of the experimental group was significantly greater than that for control group immediately (5.35 ± 2.02 vs. 7 ± 2.4, P = 0.004) and one month after the intervention (4.23 ± 2.2 vs.7.02 ± 3.03, P < 0.001). Conclusion Since our training program on positive thinking improved hope and quality of sleep in patients with thalassemia major, we recommend the use of such courses as an important step toward promotion of hope and sleep quality among these patients. Trial registration The name of the registry: Iranian Registry of Clinical Trials. Trial Registration Number: IRCT2017010431774N1. URL of the trial registry record: https://en.irct.ir/trial/24923. Registration Date: 07/03/2017.

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Effectiveness of Abdominal and Gluteus Medius Training in Lumbo-Pelvic Stability and Adductor Strength in Female Soccer Players. A Randomized Controlled Study

International Journal of Environmental Research and Public Health ◽

10.3390/ijerph18041528 ◽

2021 ◽

Vol 18 (4) ◽

pp. 1528

Author(s):

Héctor Guerrero-Tapia ◽

Rodrigo Martín-Baeza ◽

Rubén Cuesta-Barriuso

Keyword(s):

Repeated Measures ◽

Gluteus Medius ◽

Soccer Players ◽

Controlled Study ◽

Control Group ◽

Extrinsic Factors ◽

Randomized Controlled ◽

Limb Injuries ◽

Experimental Group

Background. Abdominal and lumbo-pelvic stability alterations may be the origin of lower limb injuries, such as adductor pathology in soccer players. Imbalance can be caused by both intrinsic and extrinsic factors. Methods: In this randomized controlled trial over 8 weeks, 25 female footballers were randomly allocated to an experimental group (isometric abdominal training and gluteus medius-specific training) or a control group (isometric abdominal training). Evaluations were performed at baseline, at the end of the intervention and after a 4-week follow-up period. The exercise protocol in common for both groups included three exercises: Plank, Lateral plank and Bird dog. Specific exercises for the gluteus medius were: Pelvic drop and Stabilization of the gluteus medius in knee valgus. Outcome measures were lumbar-pelvic stability and adductor strength. Results: After the intervention, there was an increase in lumbo-pelvic stability in both groups, being greater in the control group than in the experimental group (mean differences [MD]: 4.84 vs. MD: 9.58; p < 0.01) with differences in the analysis of repeated measures (p < 0.001), but not in group interaction (p = 0.26). Changes were found in adductor strength in the experimental group (MD: −2.48; p < 0.001 in the left adductor; MD: −1.48; p < 0.01 in right adductor) and control group (MD: −1.68; p < 0.001 in the left adductor; MD: −2.05; p < 0.001 in the right adductor) after the intervention, with differences in the analysis of repeated measures in left (p < 0.001) and right (p < 0.001) adductor strength. Conclusions: An abdominal and gluteal training protocol shows no advantage over a protocol of abdominal training alone for lumbo-pelvic stability and adductor strength, while improvements in both variables are maintained at four weeks follow-up.

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