Design of a Mobile Application and Evaluation of Its Effects on Psychological Parameters of Covid-19 Inpatients: A Protocol for a Randomized Controlled Trial

Background: Panic of the disease and the associated concerns can lower the quality of life and physical performance. As long as the COVID-19 pandemic is ever on the rise, the psychological pandemic of the disease is on the rise, too. The high prevalence of COVID-19 has further increased physicians' work pressure. Patients' needs are not met adequately by physicians. It seems essential to use aids to monitor patients' needs and serve them properly. Thus, in the present research, suggestions are made on how to evaluate patients' physical and psychological conditions during the treatment via a mobile application.Methods and Analysis: The present research is a randomized, two parallel-group, controlled trial. One-hundred-twelve inpatients diagnosed with the coronavirus will be assigned randomly to the control and intervention groups. In the intervention group, a mobile application will be provided to educate patients, establish two-way interactions between patients and care providers and record patients' symptoms. Those in the control group will receive the usual care. The primary outcome is the change to the depression anxiety stress scales-21 (DASS-21) score from the baseline to 2 weeks after discharge from hospital. It will be measured at the baseline, at the time of discharge, and two weeks later.Ethics and Dissemination: The Ethics committee of Mashhad University of Medical Sciences' approval date was 2020-04-19 with IR.MUMS.REC.1399.118 reference code. Thus far, participants' recruitment has not been completed and is scheduled to end in March 2021. The results will be disseminated in a peer-reviewed journal.Trial Registration: IRCT20170922036314N4 (https://www.irct.ir/trial/47383).

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A patient-centered mobile intervention to promote self-management and improve patient outcomes in chronic heart failure: The ManageHF4Life trial (Preprint)

10.2196/preprints.26185 ◽

2020 ◽

Author(s):

Michael P. Dorsch ◽

Karen B. Farris ◽

Brigid E. Rowell ◽

Scott L. Hummel ◽

Todd M. Koelling

Keyword(s):

Heart Failure ◽

Mobile Application ◽

Controlled Trial ◽

Intervention Group ◽

Self Care ◽

Self Management ◽

Control Group ◽

Patient Centered ◽

Self Monitoring ◽

Heart Failure Questionnaire

BACKGROUND Successful management of heart failure (HF) involves guideline based medical therapy as well as self-care behavior. As a result, the management of HF is moving toward a proactive real-time technological model of assisting patients with monitoring and self-management. OBJECTIVE Evaluate the effectiveness of a mobile application intervention that enhances self-monitoring on health-related quality of life, self-management, and reduces HF readmissions. METHODS A single-center randomized controlled trial was performed. Patients greater than 45 years of age and admitted for acute decompensated HF or recently discharged in the past 4 weeks were included. The intervention group used a mobile application (App). The intervention prompted daily self-monitoring and promoted self-management. The control group (No App) received usual care. The primary outcome was the change in Minnesota Living with Heart Failure Questionnaire (MLHFQ) from baseline to 6 and 12 weeks. Secondary outcomes were the Self-Care Heart Failure Index (SCHFI) questionnaire and recurrent HF admissions. RESULTS Eighty-three patients were enrolled and completed all baseline assessments. Baseline characteristics were similar between groups with the exception of HF etiology. The App group had a reduced MLHFQ at 6 weeks (37.5 ± 3.5 vs. 48.2 ± 3.7, P=0.039) but not at 12 weeks (44.2 ± 4 vs. 45.9 ± 4, P=0.778) compared to No App. There was no effect of the App on the SCHFI at 6 or 12 weeks. The time to first HF admission was not statistically different between the App versus No App groups (HR 0.89, 95% CI 0.39-2.02, P=0.781) over 12 weeks. CONCLUSIONS The mobile application intervention improved MLHFQ at 6 weeks, but did not sustain its effects at 12 weeks. No effect was seen on HF self-care. Further research is needed to enhance engagement in the application for a longer period of time and to determine if the application can reduce HF admissions in a larger study. CLINICALTRIAL NCT03149510

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

Healthcare ◽

10.3390/healthcare9040463 ◽

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.

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EVALUATION OF EFFECTIVENESS OF AROGYA KASHAYAM-20 IN COVID-19 CASES - A RANDOMIZED CONTROLLED STUDY

10.31219/osf.io/au3ct ◽

2021 ◽

Author(s):

Umesh Shukla ◽

Nitin Ujjaliya

Keyword(s):

Controlled Trial ◽

Care Center ◽

Large Population ◽

Intervention Group ◽

Controlled Study ◽

Control Group ◽

Rt Pcr ◽

Randomized Controlled ◽

Group A ◽

Negative Conversion

Introduction: The characteristic clinical features of Covid-19 disease range between asymptomatic to mild-moderate symptoms. Studies suggest that a large population (80%) presents its asymptomatic or milder form. Remaining 20 percent, owing to severity of the diseases, need hospital-based care. Many treatment protocols and strategies have been promoted and recommended by authorities including WHO, but nothing has actually been finalized till date. The present study was planned to evaluate the effectiveness of an Ayurvedic formulation viz. Arogya Kashayam-20 in the hospitalized cases of Covid-19.Aim: To evaluate the effectiveness of Arogya Kashayam-20 in the cases of COVID-19 particularly the negative conversion of RTPCR in 10 days duration.Material and Methods: This was a randomized controlled trial conducted at COVID-19 Care Center, Pt. Khushilal Sharma Government Ayurveda College & Institute, Bhopal, Madhya Pradesh with a sample size of 112 participants, aged between 16 to 60 years of either sex. Participants were divided in two groups viz. group A and B. Both the groups received Hydroxychloroquine (HCQ), vitamin C and Zinc as per the prevailing ICMR guidelines and group 'A' received additionally Arogya Kashayam-20 for 10 days. Outcome measure of the study was to see the negative conversion RT-PCR test after intervention period of 10 days. CTRI Registration: CTRI/2020/06/026221. Results: Among the 60 cases registered in study group (group A), 51 cases (85.00%) were reported with negative RTPCR on 10th day. Out of 52 cases registered in control group (group B); 39 cases (75.00%) were tested negative RTPCR on 10th day. In both the groups all the cases were discharged asymptomatically on 10th day as per the prevailing ICMR guidelines. No ADR/AE observed during the intervention period.Conclusion: The study observes that the add on intervention group has a better outcome in terms of RT-PCR negative reports after 10 days comparing to the control group.

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Evaluating the effects of a mindfulness mobile application on student pharmacists’ stress, burnout, and mindfulness

American Journal of Health-System Pharmacy ◽

10.1093/ajhp/zxab467 ◽

2021 ◽

Author(s):

Angela Chu ◽

Tyler M Rose ◽

Danielle A Gundrum ◽

Tressa E McMorris ◽

Eytan A Klausner ◽

...

Keyword(s):

Mobile Application ◽

Controlled Trial ◽

Intervention Group ◽

Secondary Outcome ◽

Control Group ◽

Intervention Period ◽

Entire Study ◽

Positive Effects ◽

Waitlist Control Group

Abstract Disclaimer In an effort to expedite the publication of articles, AJHP is posting manuscripts online as soon as possible after acceptance. Accepted manuscripts have been peer-reviewed and copyedited, but are posted online before technical formatting and author proofing. These manuscripts are not the final version of record and will be replaced with the final article (formatted per AJHP style and proofed by the authors) at a later time. Purpose Pharmacists report high levels of burnout. Mindfulness approaches have been demonstrated to have positive results in the general population and in other healthcare professions. However, limited studies have been performed evaluating mindfulness approaches in student pharmacists. The aim of this study was to evaluate the effectiveness of daily use of a mindfulness mobile application in improving student pharmacists’ perceived stress, burnout, and mindfulness. Methods This study was a randomized, longitudinal, waitlist-controlled trial. The intervention group was asked to meditate using the mindfulness application Headspace daily for at least 6 weeks. The waitlist control group was asked to abstain from using the application for the entire study. Stress, burnout, and mindfulness were assessed using validated survey instruments at baseline, 6 weeks, and 10 weeks. A secondary outcome was to assess the persistence of application use after the intervention period. Results Fifty-six participants completed the study. The intervention group reported significantly lower scores on stress and burnout at 6 weeks compared to the control group. The intervention group also reported significantly higher scores on mindfulness. The differences in stress, burnout, and mindfulness persisted at follow-up. The mean percentage of students in the intervention group who used the application each day was 90% over the intervention period and 62% over the follow-up period. Conclusion A mindfulness mobile application significantly improved student pharmacists’ stress, burnout, and mindfulness with daily use. Most participants continued to use the application for 4 weeks after the end of the intervention. Positive effects on stress and mindfulness persisted even with decreased use.

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Effect of Flowable Thrombin-Containing Collagen-Based Hemostatic Matrix for Preventing Pancreatic Fistula after Pancreatectomy: A Randomized Clinical Trial

Journal of Clinical Medicine ◽

10.3390/jcm9103085 ◽

2020 ◽

Vol 9 (10) ◽

pp. 3085

Author(s):

Yejong Park ◽

Jae Hyung Ko ◽

Dae Ryong Kang ◽

Jun Hyeok Lee ◽

Dae Wook Hwang ◽

...

Keyword(s):

Pancreatic Fistula ◽

Distal Pancreatectomy ◽

Intervention Group ◽

Length Of Hospital Stay ◽

Multivariate Logistic Regression Model ◽

Control Group ◽

Drain Removal ◽

Parallel Group ◽

Secondary Endpoints ◽

Group A

Background: The aim of this study was to evaluate the safety and efficacy of a flowable hemostatic matrix, and their effects for postoperative pancreatic fistula (POPF) after pancreatectomy. Methods: This was a randomized, clinical, single-center, single-blind (participant), non-inferiority, phase IV, and parallel-group trial. The primary endpoint was the incidence of POPF. The secondary endpoints were risk factors for POPF, drain removal days, incidence of complication, 90-day mortality, and length of hospital stay. Results: This study evaluated a total of 53 patients, of whom 26 patients were in the intervention group (flowable hemostatic matrix) and 27 patients were in the control group (thrombin-coated collagen patch). POPF was more common in the control group than in the intervention group (59.3% vs. 30.8%, p = 0.037). Among participants who underwent distal pancreatectomy, POPF (33.3% vs. 92.3%, p = 0.004), and clinically relevant POPF (8.3% vs. 46.2%, p = 0.027) was more common in the control group. A multivariate logistic regression model identified flowable hemostatic matrix use as an independent negative risk factor for POPF, especially in cases of distal pancreatectomy (DP) (odds ratio 17.379, 95% confidential interval 1.453–207.870, p = 0.024). Conclusion: Flowable hemostatic matrix application is a simple, feasible, and effective method of preventing POPF after pancreatectomy, especially for patients with DP. Non-inferiority was demonstrated in the efficacy of preventing POPF in the intervention group compared to the control group.

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The Effects of the Dietary Approaches to Stop Hypertension (DASH) Diet on Metabolic Syndrome in Hospitalized Schizophrenic Patients: A Randomized Controlled Trial

Nutrients ◽

10.3390/nu11122950 ◽

2019 ◽

Vol 11 (12) ◽

pp. 2950 ◽

Cited By ~ 1

Author(s):

Tamara Sorić ◽

Mladen Mavar ◽

Ivana Rumbak

Keyword(s):

Metabolic Syndrome ◽

Randomized Controlled Trial ◽

Controlled Trial ◽

Intervention Group ◽

Control Group ◽

Dash Diet ◽

Randomized Controlled ◽

Parallel Group ◽

Schizophrenic Patients ◽

The Relationship

The relationship between the Dietary Approaches to Stop Hypertension (DASH) diet and metabolic syndrome (MetS) in people with schizophrenia is unknown and remains to be investigated. Therefore, we have conducted a three-month parallel-group randomized controlled trial. Sixty-seven hospitalized schizophrenic patients with MetS [n = 33 in the intervention group (IG) and n = 34 in the control group (CG)] completed the intervention. The IG followed the DASH diet with the caloric restriction of approximately 1673.6 kJ/day (400 kcal/day) when compared to the standard hospital diet followed by the CG. Simultaneously, both groups participated in a nutrition counseling program. Anthropometric and biochemical parameters and blood pressure were measured at the baseline and after three months, while nutrient intakes during the intervention were assessed using three non-consecutive 24-hour dietary recalls. The analyses were carried out based on the per-protocol approach. At three months, the MetS prevalence significantly decreased in both the IG and the CG (75.8%, p = 0.002, and 67.7%, p = 0.0003, respectively; odds ratio = 0.9; 95% confidence interval = 0.43–1.87). No significant differences in the prevalence of MetS and its features were found between the groups.

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Plaque Removal Efficacy of Dental floss Compare to Water Jet Following Single Use

10.53350/pjmhs2115123439 ◽

2021 ◽

Vol 15 (12) ◽

pp. 3439-3441

Author(s):

Syed Midhat Batool ◽

Madiha Rasheed ◽

Kawish Syed ◽

Afaq Farooq ◽

Zain Ayub ◽

...

Keyword(s):

Controlled Trial ◽

Intervention Group ◽

Water Jet ◽

Tooth Brushing ◽

Control Group ◽

Dental Floss ◽

Plaque Removal ◽

Group A ◽

The Mean ◽

Group B

Background: Dental plaque (biofilm) is a well-known contributor to the onset and progression of many dental illnesses. Plaque is a natural biofilm that develops on oral surfaces and contains a wide variety of organisms. As a result, it is critical to control plaque formation, particularly in the young population, by implementing effective preventive strategies. Objective: To assess and compare plaque removal efficacy of water flosser and string floss in patients. Study design: Randomized controlled trial Place and Duration of study: Department of Periodontology, Sardar Begum Dental College, Gandhara University from 1st March 2019 to 31st May 2019. Methodology: Seventy patients were enrolled. Patients were randomly allocated to one of two groups, group A (using dental floss) as the control group and group B (using waterpik) as the intervention group, using the lottery technique. Patients were randomly allocated to one of two groups, group A (control group), using dental floss and group B (intervention group), using waterpik utilizing the lottery technique. All participants were taught correct brushing technique utilizing the Modified Bass technique and manufacturer's instructions for using waterpik as well as normal flossing instructions for using Dental floss. Results: The mean age presentation was 34.23±6.78 years. The females were 42 (60%) males were 28 (40%). The mean percentage showed that those using water flosser with tooth brushing had low plaque score than using string floss with tooth brushing. The independent t test showed that water flosser is significantly more effective (p=0.001) in plaque reduction than conventional string floss. Conclusion: A water flosser coupled with hand brushing is more effective in eliminating plaque than string floss. Plaque removal was 20-30% higher in the group that used a water flosser. Key words: Efficacy, Dental floss, Water jet

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Effectiveness of One-Way Text Messaging on Attendance to Follow-Up Cervical Cancer Screening Among Human Papillomavirus–Positive Tanzanian Women (Connected2Care): Parallel-Group Randomized Controlled Trial (Preprint)

10.2196/preprints.15863 ◽

2019 ◽

Author(s):

Ditte S Linde ◽

Marianne S Andersen ◽

Julius Mwaiselage ◽

Rachel Manongi ◽

Susanne K Kjaer ◽

...

Keyword(s):

Cervical Cancer ◽

Cancer Screening ◽

Cervical Cancer Screening ◽

Controlled Trial ◽

Intervention Group ◽

Text Messages ◽

Control Group ◽

Randomized Controlled ◽

Parallel Group

BACKGROUND Rapid human papillomavirus (HPV) DNA testing is an emerging cervical cancer screening strategy in resource-limited countries, yet it requires follow-up of women who test HPV positive. OBJECTIVE This study aimed to determine if one-way text messages improved attendance to a 14-month follow-up cervical cancer screening among HPV-positive women. METHODS This multicenter, parallel-group randomized controlled trial was conducted at 3 hospitals in Tanzania. Eligible participants were aged between 25 and 60 years, had tested positive to a rapid HPV test during a patient-initiated screening, had been informed of their HPV result, and had a private mobile phone with a valid number. Participants were randomly assigned in a 1:1 ratio to the intervention or control group through an incorporated algorithm in the text message system. The intervention group received one-way text messages, and the control group received no text messages. The primary outcome was attendance at a 14-month health provider-initiated follow-up screening. Participants were not blinded, but outcome assessors were. The analysis was based on intention to treat. RESULTS Between August 2015 and July 2017, 4080 women were screened for cervical cancer, of which 705 were included in this trial—358 women were allocated to the intervention group, and 347 women were allocated to the control group. Moreover, 16 women were excluded before the analysis because they developed cervical cancer or died (8 from each group). In the intervention group, 24.0% (84/350) women attended their follow-up screening, and in the control group, 23.8% (80/335) women attended their follow-up screening (risk ratio 1.02, 95% CI 0.79-1.33). CONCLUSIONS Attendance to a health provider-initiated follow-up cervical cancer screening among HPV-positive women was strikingly low, and one-way text messages did not improve the attendance rate. Implementation of rapid HPV testing as a primary screening method at the clinic level entails the challenge of ensuring a proper follow-up of women. CLINICALTRIAL ClinicalTrials.gov NCT02509702; https://clinicaltrials.gov/ct2/show/NCT02509702. INTERNATIONAL REGISTERED REPORT RR2-10.2196/10.2196/15863

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Comparison of binocular game and patching in treating mild to moderate anisometropic amblyopia: a study protocol for a randomized controlled trial

Trials ◽

10.1186/s13063-021-05735-2 ◽

2021 ◽

Vol 22 (1) ◽

Author(s):

Mohammad Etezad Razavi ◽

Marzieh Najjaran ◽

Jaber Mohseni ◽

Shokoufeh Aalaei

Keyword(s):

Clinical Trials ◽

Study Protocol ◽

Randomized Clinical Trials ◽

Controlled Trial ◽

Intervention Group ◽

Control Group ◽

Medical Sciences ◽

Treatment Needs ◽

Parallel Group ◽

Research Designs

Abstract Background Amblyopia, as a neurodevelopmental preventable visual disorder, affects approximately 1.1 % in Asia. A binocular approach to treating amblyopia has been recently proposed. Whether the binocular playing game treatment is comparable to patching treatment needs further randomized clinical trials. To address this, the present research, designs, develops, and evaluates a new binocular game to treat amblyopia. Methods This study has been designed as a non-inferiority, randomized, two parallel-group, controlled trial. Forty-four patients between 4 and 12 years diagnosed with amblyopia will be randomly assigned to the control and intervention groups. In the intervention group, amblyopia treatment is provided with red-green anaglyphic glasses and a red filter placed in front of the amblyopic eye, along with a game to be played for 30 min twice a day. Those in the control group will receive patch therapy according to amblyopia treatment study protocol. The primary outcome is to change visual acuity in the amblyopic eye from the baseline to 3 months after randomization. Ethics and dissemination The Ethics Committee of Mashhad University of Medical sciences’ approval date was February 28, 2018, with a reference code of IR.MUMS.fm.REC.1396.783. Thus far, the recruitment of participants has not been completed and is scheduled to end in September 2021. The results will be disseminated in a peer-reviewed journal. Trial registration Iranian Registry of Clinical Trials IRCT20180217038768N1. Registered on 22 April 2019.

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A Randomized Controlled Trial of Hydroxychloroquine as Prophylaxis for COVID-19 among Health Care Providers

The Open Public Health Journal ◽

10.2174/1874944502114010600 ◽

2021 ◽

Vol 14 (1) ◽

pp. 600-604

Author(s):

Ramin Parvizrad ◽

Ghasem Mosayebi ◽

Nader Zarinfar ◽

Morteza Mousavi-Hasanzadeh ◽

Seyedeh Zahra Razavi ◽

...

Keyword(s):

Health Care Providers ◽

Controlled Trial ◽

White Blood Cells ◽

Intervention Group ◽

Healthcare Services ◽

Care Group ◽

Control Group ◽

Care Providers ◽

Level Of Evidence ◽

Significant Difference

Background: Although there is a growing consensus that hydroxychloroquine may not be effective in the treatment of COVID-19 patients, there is still little high-quality evidence about the prophylactic effects of this medication. In this study, we aimed to evaluate the efficiency of hydroxychloroquine in preventing COVID-19 infection among healthcare workers. Methods: In this clinical trial, 90 healthcare providers from two referral hospitals of COVID-19 were divided into the hydroxychloroquine group (400 mg/week for eight weeks) and the routine-care group. Serum CRP levels and the frequency of T-helper (CD4+ cells) and T-cytotoxic (CD8+ cells) were assessed at the beginning and end of the study. The groups were compared in terms of White Blood cells (WBCs), polymorph nuclear cells (PMNs), lymphocytes (LYM), hemoglobin (Hb), and platelets (Plt.). Results: The results revealed no significant differences between the two groups in terms of WBC, PMN, LYM, Hb, Plt., CD4, and CD8. The mean difference of the CD4:CD8 ratio showed a significantly higher decrease (P=0.05) in hydroxychloroquine group than in the control group (0.18 vs. 0.02). The incidence of COVID-19 was 15% (95%CI: 12-18%) in the control group and 10% (95%CI: 8-12%) in the intervention group; however, no significant difference was observed between the two groups in this regard (P=0.45). Conclusion: Our study findings boost an increasing level of evidence that hydroxychloroquine is not an effective prophylactic medication against COVID-19 and might even exacerbate the profile of pandemic containment efforts by adding more pain to patients’ life and healthcare services.

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