scholarly journals Nutritional counseling with or without mobile health technology: a randomized open-label standard-of-care-controlled trial in ALS

BMC Neurology ◽  
2019 ◽  
Vol 19 (1) ◽  
Author(s):  
Anne Marie Wills ◽  
Jamie Garry ◽  
Jane Hubbard ◽  
Taylor Mezoian ◽  
Christopher T. Breen ◽  
...  
Keyword(s):  
Mobile Health ◽  
Controlled Trial ◽  
Standard Of Care ◽  
Health Technology ◽  
Nutritional Counseling ◽  
Open Label ◽  
Mobile Health Technology

scholarly journals Nutritional counseling with or without mobile health technology: a randomized open-label standard-of-care-controlled trial in ALS

2018 ◽  
Author(s):  
Anne-Marie M Wills ◽  
Jamie Garry ◽  
Jane Hubbard ◽  
Taylor Mezoian ◽  
Christopher T Breen ◽  
...  
Keyword(s):  
Amyotrophic Lateral Sclerosis ◽  
Mobile Health ◽  
Standard Care ◽  
Controlled Trial ◽  
Standard Of Care ◽  
Health Technology ◽  
Calorie Intake ◽  
Nutritional Counseling ◽  
Open Label ◽  
Lateral Sclerosis

Abstract Background: Nutritional status is an important prognostic factor in Amyotrophic Lateral Sclerosis (ALS). We wished to study the safety, tolerability and efficacy of nutritional counseling with or without an mHealth application to maintain or increase body weight in ALS, compared to standard care. Methods: In this randomized open-label, standard-of-care-controlled, single-center clinical trial, we randomly assigned adults with ALS to one of three nutritional interventions: counseling by their physician or nurse (“standard care”), counseling by a registered dietitian (RD) (“in-person”), or counseling supported by a mHealth app (“mHealth”). Both intervention arms received tailored nutrition recommendations and recorded dietary intake and weight biweekly (mHealth) or monthly (in-person). The primary outcome of weight and secondary and tertiary outcomes of calorie intake, ALSFRS-R, and quality of life (QOL) were recorded at each clinic visit and analyzed in an ITT mixed model analysis. Results: A total of 88 participants were enrolled of whom 78 were included in this analysis. The three arms were well-balanced except for excess males in the mHealth arm and greater weight lost at baseline in the in-person arm. Participants in the mHealth arm increased their calorie intake at month 3 to an average of 94% (95% CI: 85, 103) of recommended calories, compared to 81% (95% CI: 72, 91, p= 0.06 vs. mHealth) in the standard care arm. After 6 months, calorie intake and change in weight was not different among the three arms. QOL scores in the mHealth arm were stable over three months (0.3 points, 95% CI: -1.7, 2.2) compared to worsening in standard care (-2.1 points, 95% CI: -4.0, -0.2, p = 0.09 vs. mHealth), but all scores declined by six months. ALSFRS-R total scores declined by an average of -2.6 points (95% CI: -5.1, -0.1) over six months in the mHealth arm (p=0.13 vs. standard care) compared to -5.8 points (95% CI: -8.2, -3.4, p=0.74 vs. standard care) in the in-person and -5.2 points (95% CI: -7.6, -2.9) in the standard care arm. Conclusions: Nutritional counseling is safe but did not increase weight compared to standard care in ALS patients. Trial Registration: Clinicaltrials.gov identifier NCT02418546. Registered April 16, 2015. Keywords: Amyotrophic Lateral Sclerosis, ALS, Neurodegenerative disease, mobile health technology, mHealth, nutrition, nutritional counseling, randomized controlled trial

scholarly journals Nutritional counseling with or without mobile health technology: a randomized open-label standard-of-care-controlled trial in ALS

2019 ◽  
Author(s):  
Anne-Marie M Wills ◽  
Jamie Garry ◽  
Jane Hubbard ◽  
Taylor Mezoian ◽  
Christopher T Breen ◽  
...  
Keyword(s):  
Standard Care ◽  
Mixed Model ◽  
Controlled Trial ◽  
Standard Of Care ◽  
Clinic Visit ◽  
Calorie Intake ◽  
Nutritional Counseling ◽  
Open Label ◽  
Nutritional Interventions ◽  
Mixed Model Analysis

Abstract Background Nutritional status is an important prognostic factor in Amyotrophic Lateral Sclerosis (ALS). We wished to study the safety, tolerability and efficacy of nutritional counseling with or without an mHealth application to maintain or increase body weight in ALS, compared to standard care. Methods In this randomized open-label, standard-of-care-controlled, single-center clinical trial, we randomly assigned adults with ALS to one of three nutritional interventions: counseling by their physician or nurse (“standard care”), counseling by a registered dietitian (RD) (“in-person”), or counseling supported by a mHealth app (“mHealth”). Both intervention arms received tailored nutrition recommendations and recorded dietary intake and weight biweekly (mHealth) or monthly (in-person). The primary outcome of weight and secondary and tertiary outcomes of calorie intake, ALSFRS-R, and quality of life (QOL) were recorded at each clinic visit and analyzed in an ITT mixed model analysis. Results A total of 88 participants were enrolled of whom 78 were included in this analysis. The three arms were well-balanced except for excess males in the mHealth arm and greater weight lost at baseline in the in-person arm. Participants in the mHealth arm increased their calorie intake at month 3 to an average of 94% (95% CI: 85, 103) of recommended calories, compared to 81% (95% CI: 72, 91, p= 0.06 vs. mHealth) in the standard care arm. After 6 months, calorie intake and change in weight was not different among the three arms. QOL scores in the mHealth arm were stable over three months (0.3 points, 95% CI: -1.7, 2.2) compared to worsening in standard care (-2.1 points, 95% CI: -4.0, -0.2, p = 0.09 vs. mHealth), but all scores declined by six months. ALSFRS-R total scores declined by an average of -2.6 points (95% CI: -5.1, -0.1) over six months in the mHealth arm (p=0.13 vs. standard care) compared to -5.8 points (95% CI: -8.2, -3.4, p=0.74 vs. standard care) in the in-person and -5.2 points (95% CI: -7.6, -2.9) in the standard care arm. Conclusions Nutritional counseling is safe but did not increase weight compared to standard care in ALS patients.

scholarly journals Nutritional counseling with or without mobile health technology: a randomized open-label standard-of-care-controlled trial in ALS

2019 ◽  
Author(s):  
Anne-Marie M Wills ◽  
Jamie Garry ◽  
Jane Hubbard ◽  
Taylor Mezoian ◽  
Christopher T Breen ◽  
...  
Keyword(s):  
Standard Care ◽  
Mixed Model ◽  
Controlled Trial ◽  
Standard Of Care ◽  
Clinic Visit ◽  
Calorie Intake ◽  
Nutritional Counseling ◽  
Open Label ◽  
Nutritional Interventions ◽  
Mixed Model Analysis

Abstract Background Nutritional status is an important prognostic factor in Amyotrophic Lateral Sclerosis (ALS). We wished to study the safety, tolerability and efficacy of nutritional counseling with or without an mHealth application to maintain or increase body weight in ALS, compared to standard care. Methods In this randomized open-label, standard-of-care-controlled, single-center clinical trial, we randomly assigned adults with ALS to one of three nutritional interventions: counseling by their physician or nurse (“standard care”), counseling by a registered dietitian (RD) (“in-person”), or counseling supported by a mHealth app (“mHealth”). Both intervention arms received tailored nutrition recommendations and recorded dietary intake and weight biweekly (mHealth) or monthly (in-person). The primary outcome of weight and secondary and tertiary outcomes of calorie intake, ALSFRS-R, and quality of life (QOL) were recorded at each clinic visit and analyzed in an ITT mixed model analysis. Results A total of 88 participants were enrolled of whom 78 were included in this analysis. The three arms were well-balanced except for excess males in the mHealth arm and greater weight lost at baseline in the in-person arm. Participants in the mHealth arm increased their calorie intake at month 3 to an average of 94% (95% CI: 85, 103) of recommended calories, compared to 81% (95% CI: 72, 91, p= 0.06 vs. mHealth) in the standard care arm. After 6 months, calorie intake and change in weight was not different among the three arms. QOL scores in the mHealth arm were stable over three months (0.3 points, 95% CI: -1.7, 2.2) compared to worsening in standard care (-2.1 points, 95% CI: -4.0, -0.2, p = 0.09 vs. mHealth), but all scores declined by six months. ALSFRS-R total scores declined by an average of -2.6 points (95% CI: -5.1, -0.1) over six months in the mHealth arm (p=0.13 vs. standard care) compared to -5.8 points (95% CI: -8.2, -3.4, p=0.74 vs. standard care) in the in-person and -5.2 points (95% CI: -7.6, -2.9) in the standard care arm. Conclusions Nutritional counseling is safe but did not increase weight compared to standard care in ALS patients.

scholarly journals Mobile Health Technology (mDiab) for the Prevention of Type 2 Diabetes: Protocol for a Randomized Controlled Trial

2017 ◽  
Vol 6 (12) ◽  
pp. e242 ◽  
Author(s):  
Shruti Muralidharan ◽  
Viswanathan Mohan ◽  
Ranjit Mohan Anjana ◽  
Sidhant Jena ◽  
Nikhil Tandon ◽  
...  
Keyword(s):  
Type 2 Diabetes ◽  
Randomized Controlled Trial ◽  
Mobile Health ◽  
Controlled Trial ◽  
Health Technology ◽  
Mobile Health Technology ◽  
Randomized Controlled

The neuroethical future of wearable and mobile health technology

2017 ◽  
Author(s):  
Karola V. Kreitmair ◽  
Mildred K. Cho
Keyword(s):  
Mobile Health ◽  
Ethical Issues ◽  
Health Technology ◽  
The Self ◽  
Ethical Challenges ◽  
Mobile Health Technology ◽  
Healthcare Settings ◽  
Healthcare It ◽  
Mobile Mental Health ◽  
Privacy And Confidentiality

Wearable and mobile health technology is becoming increasingly pervasive, both in professional healthcare settings and with individual consumers. This chapter delineates the various functionalities of this technology and identifies its different purposes. It then addresses the ethical challenges that this pervasiveness poses in the areas of accuracy and reliability of the technology, privacy and confidentiality of data, consent, and the democratization of healthcare. It also looks at mobile mental health apps as a case study to elucidate the discussion of ethical issues. Finally, the chapter turns to the question of how this technology and the associated “quantification of the self” affect traditional modes of epistemic access to and phenomenological conceptions of the self.

scholarly journals Randomized controlled trial of convalescent plasma therapy against standard therapy in patients with severe COVID-19 disease

2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Manaf AlQahtani ◽  
Abdulkarim Abdulrahman ◽  
Abdulrahman Almadani ◽  
Salman Yousif Alali ◽  
Alaa Mahmood Al Zamrooni ◽  
...  
Keyword(s):  
Standard Therapy ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Severe Disease ◽  
Pilot Trial ◽  
Standard Of Care ◽  
Primary Outcome Measure ◽  
Secondary Outcome ◽  
Open Label ◽  
Plasma Therapy

AbstractConvalescent plasma (CP) therapy in COVID-19 disease may improve clinical outcome in severe disease. This pilot study was undertaken to inform feasibility and safety of further definitive studies. This was a prospective, interventional and randomized open label pilot trial in patients with severe COVID-19. Twenty COVID-19 patients received two 200 ml transfusions of convalescent patient CP over 24-h compared with 20 who received standard of care. The primary outcome was the requirement for ventilation (non-invasive or mechanical ventilation). The secondary outcomes were biochemical parameters and mortality at 28 days. The CP group were a higher risk group with higher ferritin levels (p < 0.05) though respiratory indices did not differ. The primary outcome measure was required in 6 controls and 4 patients on CP (risk ratio 0.67, 95% CI 0.22–2.0, p = 0.72); mean time on ventilation (NIV or MV) did not differ. There were no differences in secondary measures at the end of the study. Two patients died in the control and one patient in the CP arm. There were no significant differences in the primary or secondary outcome measures between CP and standard therapy, although a larger definitive study is needed for confirmation. However, the study did show that CP therapy appears to be safe in hospitalized COVID-19 patients with hypoxia.Clinical trials registration NCT04356534: 22/04/2020.

scholarly journals COVIDENZA - A prospective, multicenter, randomized PHASE II clinical trial of enzalutamide treatment to decrease the morbidity in patients with Corona virus disease 2019 (COVID-19): a structured summary of a study protocol for a randomised controlled trial

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Karin Welén ◽  
Anna K Överby ◽  
Clas Ahlm ◽  
Eva Freyhult ◽  
David Robinsson ◽  
...  
Keyword(s):  
Mechanical Ventilation ◽  
Virus Disease ◽  
Controlled Trial ◽  
Scale Up ◽  
Standard Of Care ◽  
University Hospital ◽  
Ordinal Scale ◽  
Open Label ◽  
Full Protocol ◽  
Exploration Phase

Abstract Objectives The main goal of the COVIDENZA trial is to evaluate if inhibition of testosterone signalling by enzalutamide can improve the outcome of patients hospitalised for COVID-19. The hypothesis is based on the observation that the majority of patients in need of intensive care are male, and the connection between androgen receptor signalling and expression of TMPRSS2, an enzyme important for SARS-CoV-2 host cell internalization. Trial design Hospitalised COVID-19 patients will be randomised (2:1) to enzalutamide plus standard of care vs. standard of care designed to identify superiority. Participants Included participants, men or women above 50 years of age, must be hospitalised for PCR confirmed COVID-19 symptoms and not in need of immediate mechanical ventilation. Major exclusion criteria are breast-feeding or pregnant women, hormonal treatment for prostate or breast cancer, treatment with immunosuppressive drugs, current symptomatic unstable cardiovascular disease (see Additional file 1 for further details). The trial is registered at Umeå University Hospital, Region Västerbotten, Sweden and 8 hospitals are approved for inclusion in Sweden. Intervention and comparator Patients randomised to the treatment arm will be treated orally with 160 mg (4x40 mg) enzalutamide (Xtandi®) daily, for five consecutive days. The study is not placebo controlled. The comparator is standard of care treatment for patients hospitalised with COVID-19. Main outcomes The primary endpoints of the study are (time to) need of mechanical ventilation or discharge from hospital as assessed by a clinical 7-point ordinal scale (up to 30 days after inclusion). Randomisation Randomisation was stratified by center and sex. Each strata was randomized separately with block size six with a 2:1 allocation ratio (enzalutamide + “standard of care”: “standard of care”). The randomisation list, with consecutive subject numbers, was generated by an independent statistician using the PROC PLAN procedure of SAS version 9.4 software (SAS Institute, Inc, Cary, North Carolina) Blinding (masking) This is an open-label trial. Numbers to be randomised (sample size) The trial is designed to have three phases. The first, an exploration phase of 45 participants (30 treatment and 15 control) will focus on safety and includes a more extensive laboratory assessment as well as more frequent safety evaluation. The second prolongation phase, includes the first 100 participants followed by an interim analysis to define the power of the study. The third phase is the continuation of the study up to maximum 600 participants included in total. Trial Status The current protocol version is COVIDENZA v2.0 as of September 10, 2020. Recruitment started July 29, 2020 and is presently in safety pause after the first exploration phase. Recruitment is anticipated to be complete by 31 December 2021. Trial registration Eudract number 2020-002027-10 ClinicalTrials.gov Identifier: NCT04475601, registered June 8, 2020 Full protocol The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol.

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