scholarly journals Adequate management of Phosphorus in hemodialysis using a dietary smartphone app: A pilot study (Preprint)

2020 ◽  
Author(s):  
Cosette Fakih El Khoury ◽  
Rik Crutzen ◽  
Jos M.G.A. Schols ◽  
Ruud J.G. Halfens ◽  
Mirey Karavetian
Keyword(s):  
Pilot Study ◽  
G Protein ◽  
Effect Size ◽  
Elevated Serum ◽  
Hemodialysis Patients ◽  
Mobile App ◽  
Serum Phosphorus ◽  
Smartphone App ◽  
Large Effect Size ◽  
Potential Efficacy

BACKGROUND The renal diet is complex and requires amendments in various nutrients. Elevated serum phosphorus is common among hemodialysis patients, and it is associated with many complications. Alternative approaches that support both dietitians and patients in overcoming these difficulties should be explored. Smartphone technology could be used to provide a source of accessible and reliable information. OBJECTIVE The aim of this pilot is to assess the potential efficacy of an intervention using KELA.AE on the phosphorous management in hemodialysis patients. Results will be used to improve both the application and a planned, rigorous large-scale trial intended to assess app efficacy. METHODS This is a pilot study performed at the hemodialysis unit of Al Qassimi Hospital (Emirate of Sharjah). All patients were assessed for eligibility, and based on inclusion criteria, they were considered for enrollment. Participants met with a dietitian once a week and used the mobile app. Outcomes were measured at baseline (T0) and two weeks post app usage (T1). This pilot is reported as per guidelines for non-randomized pilot and feasibility studies and in line with the CONSORT 2010 checklist for reporting pilot or feasibility trials. RESULTS Twenty-three subjects successfully completed the pilot. Patients knowledge improved to 68.1% (13.3) after intervention with a large effect size (d= 1.22, 95%CI 0.59-1.85). Dietary protein intakes increased from a mean of 0.9g/Kg (SD=0.3) per day to a mean of 1.3g/Kg (SD=0.5) per day with a large effect size (d= 1.07, 95%CI 0.45-1.69). Phosphorus to protein ratio dropped from a mean of 18.4 mg/g protein to 13.5mg/g protein with a large effect size (d= 0.83, 95%CI 0.22-1.43). There were no improvements in phosphorous intakes, self-reported non-adherence, and serum phosphorus. CONCLUSIONS The findings of this pilot reveal potential efficacy for the use of a smartphone app as a supportive nutrition education tool for the phosphorus management in hemodialysis. This pilot study showed that KELA.AE app has the potential to improve knowledge and dietary choices. Processes related to the procedure, resources, tools, and app improvement for a future trial were assessed. A rigorous randomized controlled trial should be performed to evaluate the efficacy, assessing app usage of a long-term intervention.

scholarly journals A Dietary Mobile App for Patients Undergoing Hemodialysis: Prospective Pilot Study to Improve Dietary Intakes

10.2196/17817 ◽  
2020 ◽  
Vol 22 (7) ◽  
pp. e17817
Author(s):  
Cosette Fakih El Khoury ◽  
Rik Crutzen ◽  
Jos M G A Schols ◽  
Ruud J G Halfens ◽  
Mirey Karavetian
Keyword(s):  
Health Care ◽  
Pilot Study ◽  
Effect Size ◽  
Mobile App ◽  
Dietary Guidelines ◽  
Medium Effect ◽  
Dietary Intakes ◽  
Large Effect Size ◽  
Prospective Pilot Study ◽  
Medium Effect Size

Background Mobile technology has an impact on the health care sector, also within dietetics. Mobile health (mHealth) apps may be used for dietary assessment and self-monitoring, allowing for real-time reporting of food intakes. Changing eating behaviors is quite challenging, and patients undergoing hemodialysis, particularly, struggle to meet the target intakes set by dietary guidelines. Usage of mobile apps that are developed in a person-centered approach and in line with recommendations may support both patients and health care practitioners. Objective This study is a pilot that aims at estimating the potential efficacy of a dietary intervention using a theory-based, person-centered smartphone app. Results will be used to improve both the app and a planned large-scale trial intended to assess app efficacy thoroughly. Methods A prospective pilot study was performed at the hemodialysis unit of Al Qassimi Hospital (The Emirate of Sharjah). All patients that fulfilled the study inclusion criteria were considered eligible to be enrolled in the pilot study. Upon successful installation of the app, users met with a dietitian once a week. Outcomes were measured at baseline (T0) and 2 weeks post app usage (T1). This pilot is reported as per guidelines for nonrandomized pilot and feasibility studies and in line with the CONSORT 2010 checklist for reporting pilot or feasibility trials. Results A total of 23 patients completed the pilot intervention. Mean energy intakes increased from 24.4 kcal/kg/day (SD 8.0) to 29.1 kcal/kg/day (SD 7.8) with a medium effect size (d=0.6, 95% CI 0.0-1.2). Mean protein intakes increased from 0.9 g/kg/day (SD 0.3) to 1.3 g/kg/day (SD 0.5) with a large effect size (d=1.0, 95% CI 0.4-1.6); mean intake of high biological value (%HBV) proteins also increased from 58.6% (SD 10.1) to 70.1% (SD 10.7) with a large effect size (d=1.1, 95% CI 0.5-1.7). Dietary intakes of minerals did not change, apart from sodium which decreased from a mean intake of 2218.8 mg/day (SD 631.6) to 1895.3 mg/day (SD 581.0) with a medium effect size (d=0.5, 95% CI 0.1-1.1). Mean serum phosphorus, potassium, and albumin levels did not change relevantly. Mean serum iron increased from 7.9 mg/dL (SD 2.8) to 11.5 mg/dL (SD 7.9) postintervention with a medium effect size (d=0.6, 95% CI 0.0-1.2). Conclusions This pilot study showed that the KELA.AE app has the potential to improve dietary intakes. Processes related to procedure, resources, tools, and app improvement for a future trial were assessed. A more extended intervention using a randomized controlled trial is required to estimate parameters concerning app efficacy accurately.

scholarly journals A Dietary Mobile App for Patients Undergoing Hemodialysis: Prospective Pilot Study to Improve Dietary Intakes (Preprint)

2020 ◽  
Author(s):  
Cosette Fakih El Khoury ◽  
Rik Crutzen ◽  
Jos M G A Schols ◽  
Ruud J G Halfens ◽  
Mirey Karavetian
Keyword(s):  
Health Care ◽  
Pilot Study ◽  
Effect Size ◽  
Mobile App ◽  
Dietary Guidelines ◽  
Medium Effect ◽  
Dietary Intakes ◽  
Large Effect Size ◽  
Prospective Pilot Study ◽  
Medium Effect Size

BACKGROUND Mobile technology has an impact on the health care sector, also within dietetics. Mobile health (mHealth) apps may be used for dietary assessment and self-monitoring, allowing for real-time reporting of food intakes. Changing eating behaviors is quite challenging, and patients undergoing hemodialysis, particularly, struggle to meet the target intakes set by dietary guidelines. Usage of mobile apps that are developed in a person-centered approach and in line with recommendations may support both patients and health care practitioners. OBJECTIVE This study is a pilot that aims at estimating the potential efficacy of a dietary intervention using a theory-based, person-centered smartphone app. Results will be used to improve both the app and a planned large-scale trial intended to assess app efficacy thoroughly. METHODS A prospective pilot study was performed at the hemodialysis unit of Al Qassimi Hospital (The Emirate of Sharjah). All patients that fulfilled the study inclusion criteria were considered eligible to be enrolled in the pilot study. Upon successful installation of the app, users met with a dietitian once a week. Outcomes were measured at baseline (T0) and 2 weeks post app usage (T1). This pilot is reported as per guidelines for nonrandomized pilot and feasibility studies and in line with the CONSORT 2010 checklist for reporting pilot or feasibility trials. RESULTS A total of 23 patients completed the pilot intervention. Mean energy intakes increased from 24.4 kcal/kg/day (SD 8.0) to 29.1 kcal/kg/day (SD 7.8) with a medium effect size (<i>d</i>=0.6, 95% CI 0.0-1.2). Mean protein intakes increased from 0.9 g/kg/day (SD 0.3) to 1.3 g/kg/day (SD 0.5) with a large effect size (<i>d</i>=1.0, 95% CI 0.4-1.6); mean intake of high biological value (%HBV) proteins also increased from 58.6% (SD 10.1) to 70.1% (SD 10.7) with a large effect size (<i>d</i>=1.1, 95% CI 0.5-1.7). Dietary intakes of minerals did not change, apart from sodium which decreased from a mean intake of 2218.8 mg/day (SD 631.6) to 1895.3 mg/day (SD 581.0) with a medium effect size (<i>d</i>=0.5, 95% CI 0.1-1.1). Mean serum phosphorus, potassium, and albumin levels did not change relevantly. Mean serum iron increased from 7.9 mg/dL (SD 2.8) to 11.5 mg/dL (SD 7.9) postintervention with a medium effect size (<i>d</i>=0.6, 95% CI 0.0-1.2). CONCLUSIONS This pilot study showed that the KELA.AE app has the potential to improve dietary intakes. Processes related to procedure, resources, tools, and app improvement for a future trial were assessed. A more extended intervention using a randomized controlled trial is required to estimate parameters concerning app efficacy accurately.

The effect of midodrine on lactate clearance in patients with septic shock: a pilot study

2021 ◽  
Author(s):  
Effat Davoudi-Monfared ◽  
Mostafa Mohammadi ◽  
Meysam Khoshavi ◽  
Hossein Khalili
Keyword(s):  
Septic Shock ◽  
Pilot Study ◽  
Effect Size ◽  
Critically Ill Patients ◽  
Lactate Clearance ◽  
Control Group ◽  
Large Effect Size ◽  
Group 13 ◽  
Registration Number ◽  
To Receive

Background: The effect of midodrine on lactate clearance has not been assessed in critically ill patients yet. Objective: The goal of this study was to assess the effect of adjunctive midodrine therapy on lactate clearance in patients with septic shock. Materials & methods: Patients with septic shock were assigned to receive either adjunctive midodrine 10 mg three-times a day for 5 days (midodrine group = 15 patients) or not (control group = 13 patients). Results: The lactate clearance was significantly faster in the midodrine group than the control group (p = 0.049) with a large effect size ([Formula: see text] = 0.141). Conclusion: When midodrine was added to intravenous vasopressors, it significantly accelerated lactate clearance in patients with septic shock. Trial registration number: IRCT20100228003449N25 (Clinicaltrials.gov).

scholarly journals Changes in serum albumin and other nutritional markers when using sucroferric oxyhydroxide as phosphate binder among hemodialysis patients: a historical cohort study

2019 ◽  
Vol 20 (1) ◽  
Author(s):  
Kamyar Kalantar-Zadeh ◽  
Linda H. Ficociello ◽  
Vidhya Parameswaran ◽  
Nicolaos V. Athienites ◽  
Claudy Mullon ◽  
...  
Keyword(s):  
Serum Albumin ◽  
Dietary Intake ◽  
Phosphate Binder ◽  
Clinical Care ◽  
Elevated Serum ◽  
Hemodialysis Patients ◽  
Serum Phosphorus ◽  
Pill Burden ◽  
Historical Cohort ◽  
Phosphorus Levels

Abstract Background Elevated serum phosphorus concentrations are common among maintenance hemodialysis patients. Protein is a major source of dietary phosphate, but restriction of protein intake can result in hypoalbuminemia and protein-energy wasting. We hypothesized that sucroferric oxyhydroxide (SO), a potent phosphate binder with a low pill burden, may reduce serum phosphorus levels in hemodialysis patients with hypoalbuminemia without adversely impacting albumin levels or dietary intake of protein. Methods We retrospectively examined de-identified data from 79 adult, in-center hemodialysis patients with baseline hypoalbuminemia (≤ 3.5 g/dL) switched to SO as part of routine clinical care for at least 1 year. Temporal changes (3-month intervals from baseline through Q4) in phosphate binder pill burden, serum phosphorous levels, nutritional markers, and equilibrated Kt/V were analyzed. Data from a matched reference group of non-hypoalbuminemic patients (N = 79) switched to SO were also examined. Results SO therapy was associated with a mean reduction of 45.7 and 45.1% in daily phosphate binder pill burden, and a mean reduction of 0.4 mg/dL and 0.51 mg/dL in serum phosphorus levels for the hypoalbuminemic and non-hypoalbuminemic patients, respectively. Hypoalbuminemic patients demonstrated significant increases in mean serum albumin levels from 3.50 mg/dL at baseline to 3.69, 3.74, 3.70, and 3.69 mg/dL during Q1 through Q4, respectively (P < 0.0001), whereas serum albumin levels remained unchanged in the non-hypoalbuminemic group. Conclusions Both hypoalbuminemic and non-hypoalbuminemic patients switching to SO exhibited significant reductions in serum phosphorus concentrations and daily phosphate binder pill burden. Among hypoalbuminemic patients, the initiation of SO therapy was also associated with increases in serum albumin, suggesting therapy may have allowed patients to increase their dietary intake of protein.

scholarly journals Changes in serum albumin and other nutritional markers when using sucroferric oxyhydroxide as phosphorus binder among hemodialysis patients: a historical cohort study

2019 ◽  
Author(s):  
Kamyar Kalantar-Zadeh ◽  
Linda H Ficociello ◽  
Vidhya Parameswaran ◽  
Nicolaos V. Athienites ◽  
Claudy Mullon ◽  
...  
Keyword(s):  
Serum Albumin ◽  
Dietary Intake ◽  
Phosphate Binder ◽  
Clinical Care ◽  
Elevated Serum ◽  
Hemodialysis Patients ◽  
Serum Phosphorus ◽  
Pill Burden ◽  
Historical Cohort ◽  
Phosphorus Levels

Abstract Background Elevated serum phosphorus concentrations are common among maintenance hemodialysis patients. Protein is a major source of dietary phosphate, but restriction of protein intake can result in hypoalbuminemia and protein-energy wasting. We hypothesized that sucroferric oxyhydroxide (SO), a potent phosphate binder with a low pill burden, may reduce serum phosphorus levels in hemodialysis patients with hypoalbuminemia without adversely impacting albumin levels or dietary intake of protein.Methods We retrospectively examined de-identified data from 79 adult, in-center hemodialysis patients with baseline hypoalbuminemia (≤ 3.5 g/dL) switched to SO as part of routine clinical care for at least 1 year. Temporal changes (3-month intervals from baseline through Q4) in phosphate binder pill burden, serum phosphorous levels, nutritional markers, and equilibrated Kt/V were analyzed. Data from a matched reference group of non-hypoalbuminemic patients ( N = 79) switched to SO were also examined.Results SO therapy was associated with a mean reduction of 45.7% and 45.1% in daily phosphate binder pill burden, and a mean reduction of 0.4 mg/dL and 0.51 mg/dL in serum phosphorus levels for the hypoalbuminemic and non-hypoalbuminemic patients, respectively. Hypoalbuminemic patients demonstrated significant increases in mean serum albumin levels from 3.50 mg/dL at baseline to 3.69, 3.74, 3.70, and 3.69 mg/dL during Q1 through Q4, respectively ( P < 0.0001), whereas serum albumin levels remained unchanged in the non-hypoalbuminemic group.Conclusions Both hypoalbuminemic and non-hypoalbuminemic patients switching to SO exhibited significant reductions in serum phosphorus concentrations and daily phosphate binder pill burden. Among hypoalbuminemic patients, the initiation of SO therapy was also associated with increases in serum albumin, suggesting therapy may have allowed patients to increase their dietary intake of protein.

An Efficient System for Eye Movement Desensitization and Reprocessing (EMDR) Therapy: Pilot Study (Preprint)

2020 ◽  
Author(s):  
Nicolae Goga ◽  
Costin-Anton Boiangiu ◽  
Andrei Vasilateanu ◽  
Alexandru-Filip Popovici ◽  
Marius-Valentin Drăgoi ◽  
...  
Keyword(s):  
Pilot Study ◽  
Outcome Measures ◽  
Effect Size ◽  
Traumatic Event ◽  
Secondary Outcome ◽  
Secondary Outcome Measure ◽  
Large Effect Size ◽  
Efficient System ◽  
Significant Difference ◽  
Post Test

BACKGROUND EMDR is a psychological therapy designed to treat emotional distress caused by a traumatic event from the past, most frequently in the PTSD treatment. We implemented a system based on video, tactile and audio sensors which includes an artificial intelligence chatbot that can replace the trained clinician in the EMDR procedure, thus making the system capable to act autonomously. OBJECTIVE This pilot study aims to develop an EMDR virtual assistant capable of assisting a user in performing an efficient therapy with a minimal intervention of a trained clinician. METHODS An EMDR virtual assistant was created that include audio, video and tactile sensors. A total of 31 participants were included in the pilot study, 14 males and 17 females, with ages between 19 and 33, (Mage = 26.2, SD = 4.21). Participants were invited to remember a traumatic event from their past that caused them discomfort, and they failed to overcome it. After accessing the traumatic memory, primary outcome measures (IES-R and STAI) and secondary outcome measures (VOC and SUD) instruments were applied in the pre-test condition. The designed intervention through application consisted of four phases of bilateral stimulation (visual, auditive, and sensorial). After the discussion with a specialist, and after the completion of the instruments on the pre-test assessment phase, the participants self-administered the intervention through the application and then completed again the instruments in the post-test phase. RESULTS The results showed that there was a significant difference in scores for the pre-test condition (M = 39.8, SD = 14.07) and post-test (M = 13.7, SD = 5.7) measured with IES-R scale; t(30) = 10.5, p < 0.001, and a large effect size (d = 1.89). Also, there are significant differences in scores for the pre-test condition (M = 56.7, SD = 8.3) and post-test (M = 33.8, SD = 4.6) regarding anxiety scores (STAI); t(30) = 11.7, p < 0.001, and a large effect size (d = 2,11) of intervention in reducing anxiety associated with the traumatic event. Related to the secondary outcome measure there was a significant pre- to post-intervention reduction in scores for both VOC; t(30) = 46.8, p < 0.00, and SUD; t(30) = 75.9, p < 0.001. It was shown that the higher scores decreased significantly at the end of the intervention. CONCLUSIONS Our results proved the efficiency of the virtual assistant system for EMDR in reducing anxiety, distress, and negative cognitions and emotions associated with traumatic memories. These findings are filling a gap in the existing literature regarding the efficiency and use of similar systems and could represent a starting point for developing applications and future controlled trials and protocols that can be used in similar cases.

scholarly journals Changes in serum albumin and other nutritional markers when using sucroferric oxyhydroxide as phosphorus binder among hemodialysis patients: a historical cohort study

2019 ◽  
Author(s):  
Kamyar Kalantar-Zadeh ◽  
Linda H Ficociello ◽  
Vidhya Parameswaran ◽  
Nicolaos V. Athienites ◽  
Claudy Mullon ◽  
...  
Keyword(s):  
Serum Albumin ◽  
Dietary Intake ◽  
Phosphate Binder ◽  
Clinical Care ◽  
Elevated Serum ◽  
Hemodialysis Patients ◽  
Serum Phosphorus ◽  
Pill Burden ◽  
Historical Cohort ◽  
Phosphorus Levels

Abstract Background Elevated serum phosphorus concentrations are common among maintenance hemodialysis patients. Protein is a major source of dietary phosphate, but restriction of protein intake can result in hypoalbuminemia and protein-energy wasting. We hypothesized that sucroferric oxyhydroxide (SO), a potent phosphate binder with a low pill burden, may reduce serum phosphorus levels in hemodialysis patients with hypoalbuminemia without adversely impacting albumin levels or dietary intake of protein.Methods We retrospectively examined de-identified data from 79 adult, in-center hemodialysis patients with baseline hypoalbuminemia (≤ 3.5 g/dL) switched to SO as part of routine clinical care for at least 1 year. Temporal changes (3-month intervals from baseline through Q4) in phosphate binder pill burden, serum phosphorous levels, nutritional markers, and equilibrated Kt/V were analyzed. Data from a matched reference group of non-hypoalbuminemic patients ( N = 79) switched to SO were also examined.Results SO therapy was associated with a mean reduction of 45.7% and 45.1% in daily phosphate binder pill burden, and a mean reduction of 0.4 mg/dL and 0.51 mg/dL in serum phosphorus levels for the hypoalbuminemic and non-hypoalbuminemic patients, respectively. Hypoalbuminemic patients demonstrated significant increases in mean serum albumin levels from 3.50 mg/dL at baseline to 3.69, 3.74, 3.70, and 3.69 mg/dL during Q1 through Q4, respectively ( P < 0.0001), whereas serum albumin levels remained unchanged in the non-hypoalbuminemic group.Conclusions Both hypoalbuminemic and non-hypoalbuminemic patients switching to SO exhibited significant reductions in serum phosphorus concentrations and daily phosphate binder pill burden. Among hypoalbuminemic patients, the initiation of SO therapy was also associated with increases in serum albumin, suggesting therapy may have allowed patients to increase their dietary intake of protein.

A pilot study of the Austin Playing Card Assessment: A tool to detect and find the degree of visual perceptual difficulties related to clutter

2020 ◽  
Vol 38 (2) ◽  
pp. 118-136
Author(s):  
Nicola McDowell
Keyword(s):  
Pilot Study ◽  
Experimental Design ◽  
Effect Size ◽  
Assessment Process ◽  
Research Subjects ◽  
Large Effect Size ◽  
Playing Card ◽  
Control Subjects ◽  
Cohen’S D ◽  
Cohen's D

The Austin Playing Card Assessment was developed to help identify visual perceptual difficulties related to clutter and to determine the nature of each child’s difficulties. The aim of this pilot study was to find out whether a task of progressively increasing difficulty, for pairing playing cards, is effective in identifying these kinds of visual difficulties. Parents of 11 research and 11 control subjects completed an inventory to ascertain whether their child’s visual behaviours were suggestive of visual perceptual difficulties. All participants completed the Austin Playing Card Assessment in two separate locations, with an ABA experimental design. The time taken to complete each level of the test was recorded. Structured observations were made of the participants’ visual behaviours when completing the assessment. Inventory scores from the research subjects indicated a higher likelihood of visual perceptual difficulties, whereas the control subjects’ scores did not. Research subjects were also slower at completing the Austin Playing Card Assessment. Independent T-tests comparing the time taken across all levels of difficulty ranged between p = .011 to p < .001. Cohen’s d calculations demonstrated a large effect size. Overall, research subjects demonstrated more indicators of visual perceptual difficulties. The Austin Playing Card Assessment has the potential to be effective for detecting and identifying visual perceptual difficulties in children. Information gathered through the assessment process could also be used to inform intervention. As this was a pilot study, further research is needed to support these findings.

scholarly journals Evaluating the Use of Mindfulness and Yoga Training on Forensic Inpatients: A Pilot Study

2020 ◽  
Vol 11 ◽  
Author(s):  
Christina Spinelli ◽  
Etienne Paradis-Gagné ◽  
Megan Per ◽  
Matthew H. Fleischmann ◽  
Viktoriya Manova ◽  
...  
Keyword(s):  
Emotion Regulation ◽  
Pilot Study ◽  
Effect Size ◽  
Dispositional Mindfulness ◽  
Emotion Regulation Strategies ◽  
Cognitive Emotion Regulation ◽  
Large Effect Size ◽  
Post Intervention ◽  
Regulation Strategies

Forensic inpatients (i. e., individuals found not responsible for a criminal offense on account of mental illness) represent an often marginalized and difficult-to-treat population. This has led to the need for research exploring the effectiveness of novel interventions. A Canadian forensic hospital has developed an 8-weeks mindfulness and yoga training program (MTP). This pilot study examined the potential effects of this program on patients' mindfulness, stress, and use of cognitive and emotion regulation strategies. A sample of 13 forensic inpatients (male = 92%) participating in the MTP program completed self-report measures assessing dispositional mindfulness, perceived stress, and use of cognitive emotion regulation strategies at baseline, post-intervention, and a 3-months follow-up. Repeated measure ANOVAs found a significant increase in the describe facet of mindfulness (p = 0.03) with a large effect size (ηp2 = 0.26) and a significant decrease in stress (p = 0.003) with a large effect size (ηp2 = 0.39). Pairwise comparisons revealed medium to large significant changes between baseline and post-intervention for both the describe facet (p = 0.03, Hedge's g = 0.55) and stress (p = 0.003, Hedge's g = 0.70). However, comparisons were insignificant between baseline and follow-up. No significant main effects were found on the use of cognitive emotion regulation strategies. This pilot study offers preliminary support for the use of the MTP as an adjunctive therapy in forensic inpatient treatment. Further investigation is needed into the long-term impacts of this training.

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