UVR-sensor wearable device intervention to improve sun behaviors and reduce sunburns in melanoma survivors: study protocol of a parallel-group randomized controlled trial

Abstract Background Individuals who have been diagnosed with melanoma have more than a 9-fold increased risk of developing another melanoma. Ultraviolet radiation (UVR) exposure following a melanoma diagnosis can be modified to reduce risk of a new melanoma diagnosis. Yet research shows that many melanoma survivors do not report optimal sun protection practices. The objective of this study is to evaluate the effectiveness of a UVR-sensor wearable device to improve sun protection behaviors and reduce sunburns in a randomized controlled trial (RCT) in melanoma survivors. Methods We will conduct an RCT among 368 melanoma survivors in two waves (Summer 2020, Summer 2021). This approach allows for adequate recruitment of the required sample and potential improvements to recruitment, compliance, and retention strategies between waves. The intervention includes an informational brochure about sun protection behaviors and a commercially available UVR-sensor wearable device (Shade), which accurately measures UVR. The device, along with its associated mobile application, measures and stores UVR exposure. As UVR exposure accumulates, the device provides notifications to increase sun protection action. Survivors in the control group receive the device and a separate mobile application that does not provide notifications or summary UVR exposure data. Participants will be asked to wear the device for 12 weeks. They will complete surveys about their sun behaviors at study entry, every 4 weeks during the intervention, and 1 year later. At the end of the intervention period, intervention and control groups will be compared for differences in a summary measure of sun protection habits and experience of a sunburn. We will also measure self-reported physical activity, depression, and anxiety to examine potential unintended negative consequences of the intervention. Discussion The study intervention will be completed Fall 2021, with anticipated results available in 2022. If this intervention improves sun protection behaviors in melanoma survivors, these findings would support expanding the use of this technology with other populations at high risk for melanoma. Trial registration ClinicalTrials.gov NCT03927742. Registered on April 15, 2019.

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Effectiveness of a web-based medication adherence tool with patient centered communication: Results of a clustered randomized controlled trial (Preprint)

10.2196/preprints.16141 ◽

2019 ◽

Author(s):

Jan van Lieshout ◽

Joyca Lacroix ◽

Aart van Halteren ◽

Martina Teichert

Keyword(s):

Randomized Controlled Trial ◽

Medication Adherence ◽

Controlled Trial ◽

Intervention Group ◽

Control Group ◽

Community Pharmacies ◽

Web Based ◽

Randomized Controlled ◽

Tailored Interventions ◽

Increased Risk

BACKGROUND Growing numbers of people use medication for chronic conditions; non-adherence is common, leading to poor disease control. A newly developed web-based tool to identify an increased risk for non-adherence with related potential individual barriers might facilitate tailored interventions and improve adherence. OBJECTIVE To assess the effectiveness of the newly developed tool to improve medication adherence. METHODS A cluster randomized controlled trial assessed the effectiveness of this adherence tool in patients initiating cardiovascular or oral blood glucose lowering medication. Participants were included in community pharmacies. They completed an online questionnaire comprising an assessments of their risk for medication non-adherence and subsequently of barriers to adherence. In pharmacies belonging to the intervention group, individual barriers displayed in a graphical profile on a tablet were discussed by pharmacists and patients at high non-adherence risk in face to face meetings and shared with their general practitioners and practice nurses. Tailored interventions were initiated by the healthcare providers. Barriers of control patients were not presented or discussed and these patients received usual care. The primary outcome was the difference in medication adherence at 8 months follow-up between patients with an increased non-adherence risk from intervention and control group, calculated from dispensing data. RESULTS Data from 492 participants in 15 community pharmacies were available for analyses (intervention 253, 7 pharmacies; control 239, 8 pharmacies). The intervention had no effect on medication adherence (-0.01; 95%CI -0.59 – 0.57; P= .96), neither in the post hoc per protocol analysis (0.19; 95%CI -0.50 – 0.89; P=.58). CONCLUSIONS This study showed no effectiveness of a risk stratification and tailored intervention addressing personal barriers for medication adherence. Various potential explanations for lack of effect were identified. These explanations relate for instance to high medication adherence in the control group, study power and fidelity. Process evaluation should elicit possible improvements and inform the redesign of intervention and implementation. CLINICALTRIAL The Netherlands National Trial Register: NTR5186. Date: May 18, 2015 (http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=5186)

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Nutritional support for lactating women with or without Azithromycin for infants compared to breast-feeding counselling alone, to improve six-month growth outcomes among infants of peri-urban slums of Karachi, Pakistan – a protocol of multi-arm assessor blinded randomized controlled trial (Mumta LW trial)

10.21203/rs.3.rs-24814/v1 ◽

2020 ◽

Author(s):

Ameer Muhammad ◽

Yasir Shafiq ◽

M Imran Nisar ◽

Benazir Baloch ◽

Amna Tanweer Yazdani ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Low Income ◽

Controlled Trial ◽

Intervention Group ◽

Relative Length ◽

Trial Registration ◽

Control Group ◽

Lactating Women ◽

Randomized Controlled ◽

Increased Risk

Abstract BackgroundGlobally, 45% of under-five deaths are, directly or indirectly, attributable to malnutrition, most of these deaths are in low- and middle-income countries (LMICs). Children in the first 6 months of life are particularly vulnerable. An estimated 4.7 million infants under the age of 6 months are moderately wasted whereas 3.8 million are severely wasted. Despite the increased risk to a child of a mother with nutritional decompensation, there are discrepancies in guidance in this area. MethodsThis is a community-based, open-label factorial randomized controlled trial, using parallel assignment with 1:1:1 allocation ratio, in low-income squatter settlements of urban Karachi, Pakistan. In the control group (Arm A), women are randomized to standard counseling only; whereas in the first intervention group (Arm B), lactating women receive two sachets of balanced energy-protein (BEP) supplementation per day from enrollment till the infant reaches six months of age, in the second intervention group (Arm C), lactating women receive same BEP as in intervention Arm B while their babies also receive a single stat dose (20mg/kg orally) of azithromycin at 42 days. The primary outcome is relative length velocity from 0 to 6 months by the limb of allocation. The primary analysis will be Intention-to-treat analysisTrial registrationRegistration of the trial is done at ClinicalTrials.gov. NCT03564652, registered on June 21, 2018. Trial registration data is available through https://clinicaltrials.gov/ct2/show/NCT03564652

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StudiCare mindfulness—study protocol of a randomized controlled trial evaluating an internet- and mobile-based intervention for college students with no and “on demand” guidance

Trials ◽

10.1186/s13063-020-04868-0 ◽

2020 ◽

Vol 21 (1) ◽

Author(s):

Ann-Marie Küchler ◽

Dana Schultchen ◽

Olga Pollatos ◽

Morten Moshagen ◽

David D. Ebert ◽

...

Keyword(s):

Mental Health ◽

College Students ◽

Randomized Controlled Trial ◽

Controlled Trial ◽

Population Level ◽

Control Group ◽

Cognitive Fusion ◽

On Demand ◽

Randomized Controlled ◽

Increased Risk

Abstract Background College is an exciting but also challenging time with an increased risk for mental health issues. Only a minority of the college students concerned get professional help, a problem that might be improvable by internet- and mobile-based interventions (IMIs). However, adherence of IMIs is a concern. While guidance might be a solution, it is resource-intensive, derailing potential implementation on population level. The first aim of this trial is to evaluate the efficacy of the IMI StudiCare Mindfulness (StudiCare-M) for college students with “on demand” and no guidance. The second aim is to examine potential moderators and mediators, contributing to the questions of “how” and “for whom” such interventions work. Methods In this three-armed randomized controlled trial, both an unguided and “guidance on demand” (GoD) condition of StudiCare-M are compared to a waitlist control group. StudiCare-M is based on principles of acceptance and commitment therapy and stress management and consists of 7 modules plus two booster sessions. Participants in the GoD condition may ask their e-coach for support whenever needed. A total of 387 college students with moderate to low mindfulness are recruited at 15+ cooperating universities in Germany, Austria, and Switzerland via circular emails. Assessments take place before as well as 1, 2, and 6 months after randomization. The primary outcome is mindfulness. Secondary outcomes include stress, depression, anxiety, interoception, presenteeism, wellbeing, intervention satisfaction, adherence, and potential side effects. Among examined moderators and mediators are sociodemographic variables, pre-treatment symptomatology, treatment expectancy, self-efficacy, cognitive fusion, emotion regulation, and alexithymia. All data will be analyzed according to intention-to-treat (ITT) principles. Discussion Providing effective interventions to help college students become more resilient can make a valuable contribution to the health and functionality of future society. If effective under the condition of minimal or no guidance, StudiCare-M offers a low-threshold potentially resource-efficient possibility to enhance college student mental health on a population level. Moderation- and mediation analyses will deliver further insights for optimization of target groups and intervention content. Trial registration WHO International Clinical Trials Registry Platform via the German Clinical Studies Trial Register DRKS00014774. Registered on 18 May 2018.

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Pharmacist-guided pre-emptive pharmacogenetic testing in antidepressant therapy (PrePGx): study protocol for an open-label, randomized controlled trial

Trials ◽

10.1186/s13063-021-05724-5 ◽

2021 ◽

Vol 22 (1) ◽

Author(s):

Céline K. Stäuble ◽

Markus L. Lampert ◽

Samuel Allemann ◽

Martin Hatzinger ◽

Kurt E. Hersberger ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Antidepressant Treatment ◽

Controlled Trial ◽

Response Rates ◽

Control Group ◽

Open Label ◽

Randomized Controlled ◽

Link Type ◽

Increased Risk ◽

Antidepressant Pharmacotherapy

Abstract Background It is known that only 50% of patients diagnosed with major depressive disorders (MDD) respond to the first-line antidepressant treatment. Accordingly, there is a need to improve response rates to reduce healthcare costs and patient suffering. One approach to increase rates of treatment response might be the integration of pharmacogenetic (PGx) testing to stratify antidepressant drug selection. The goal of PGx assessments is to identify patients who have an increased risk to experience adverse drug reactions or non-response to specific drugs. Especially for antidepressants, there is compiling evidence on PGx influencing drug exposure as well as response. Methods This study is an open-label, randomized controlled trial conducted in two study centers in Switzerland: (1) the Psychiatric Clinic of Solothurn and (2) the Private Clinic Wyss in Münchenbuchsee. Adult inpatients diagnosed with a unipolar moderate or severe depressive episode are recruited at clinic admission and are included in the study. If the adjustment to a new antidepressant pharmacotherapy is necessary, the participants are randomized to either Arm A (intervention group) or Arm B (control group). If no new antidepressant pharmacotherapy is introduced the participants will be followed up in an observational arm. The intervention is the service of pharmacist-guided pre-emptive PGx testing to support clinical decision making on antidepressant selection and dosing. As a comparison, in the control group, the antidepressant pharmacotherapy is selected by the treating physician according to current treatment guidelines (standard of care) without the knowledge of PGx test results and support of clinical pharmacists. The primary outcome of this study compares the response rates under antidepressant treatment after 4 weeks between intervention and control arm. Discussion The findings from this clinical trial are expected to have a direct impact on inter-professional collaborations for the handling and use of PGx data in psychiatric practice. Trial registration ClinicalTrials.govNCT04507555. Registered on August 11, 2020. Swiss National Clinical Trials Portal SNCTP000004015. Registered August 18, 2020.

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Commentary on Post, et al. Ultra-early tranexamic acid after subarachnoid hemorrhage: A randomized controlled trial. Lancet 2021

Surgical Neurology International ◽

10.25259/sni_242_2021 ◽

2021 ◽

Vol 12 ◽

pp. 156

Author(s):

Benjamin W. Y. Lo ◽

Hitoshi Fukuda ◽

Anderson C. O. Tsang ◽

David J. Langer ◽

Satoru Miyawaki ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Subarachnoid Hemorrhage ◽

Cerebral Ischemia ◽

Tranexamic Acid ◽

Controlled Trial ◽

Delayed Cerebral Ischemia ◽

Control Group ◽

Early Administration ◽

Randomized Controlled ◽

Increased Risk

Background: Tranexamic acid (TA) administration in aneurysmal subarachnoid hemorrhage (SAH) within the first 24 hours may reduce the incidence of early aneurysmal rebleeding. However, this is also the potential for an increased risk of delayed cerebral ischemia if TA is administered for more than 72 hours following the initial aneurysmal rupture. Methods: In the ultra-early tranexamic acid after subarachnoid hemorrhage randomized controlled trial by Post et al., patients were randomized to receive TA within the first 24 hours, or until start of aneurysm treatment. These results were compared to a matched control group. Results: Ultra-early administration (≤24 h) of TA reduced the incidence of rebleeding, and did not alter the incidence of delayed cerebral ischemia and/or extracranial thrombosis. Further, no significant differences were noted between the TA group and control arm in the incidence of good (modified Rankin scores 0-3) clinical outcomes at 6 months. Conclusion: Ultra-early administration of TA (≤24 h) resulted in a lower rate of recurrent hemorrhage, without increasing the incidence of delayed cerebral ischemia in SAH patients.

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DECOLONIZATION OF INTESTINAL CARRIAGE OF MDR/XDR GRAM-NEGATIVE BACTERIA WITH ORAL COLISTIN IN PATIENTS WITH HEMATOLOGICAL MALIGNANCIES: RESULTS OF A RANDOMIZED CONTROLLED TRIAL

Mediterranean Journal of Hematology and Infectious Diseases ◽

10.4084/mjhid.2018.030 ◽

2018 ◽

Vol 10 (1) ◽

pp. 2018030 ◽

Cited By ~ 4

Author(s):

Igor Stoma ◽

Igor Karpov ◽

Igor Iskrov ◽

Svetlana Krivenko ◽

Anatoly Uss ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Controlled Trial ◽

Post Treatment ◽

Rank Test ◽

Control Group ◽

Gram Negative Bacteria ◽

Intestinal Colonization ◽

Gram Negative ◽

Randomized Controlled ◽

Increased Risk

BackgroundIntestinal colonization by MDR/XDR gram-negative bacteria leads to an increased risk of subsequent bloodstream infections (BSI) in patients receiving chemotherapy as a treatment for hematologic malignancies.ObjectivesThe objective of this study was to evaluate the efficacy of oral colistin in eradicating the intestinal carriage of MDR/XDR Gram-negative bacteria in patients with hematological malignancies.MethodsIn a tertiary hematology center adult patients with intestinal colonization by MDR/XDR Gram-negative bacteria were included in a randomized controlled trial (RCT) during a period from November 2016 to October 2017. Patients were treated with oral colistin for 14 days or observed with the primary outcome set as a decolonization on day 21 post-treatment. Secondary outcomes included treatment safety and changes in MICs of isolated microorganisms. ClinicalTrials.gov Identifier: NCT02966457.ResultsShort-time positive effect (61.3% vs 32.3%; OR 3.32; 95% CI 1.17–9.44; p=0.0241) was demonstrated on the day 14 of colistin treatment, without any statistical difference on day 21 post-treatment. The incidence of BSI in decolonization group was lower in the first 30 days after the intervention (3.2% vs 12.9%), but overall in the 90-day observation period it did not show any advantages comparing to control group (log-rank test; p=0.4721). No serious adverse effects or increase in resistance to colistin was observed.ConclusionsThis study suggests that in hematological patients the strategy of selective intestinal decolonization by colistin may be beneficial to decrease the rate of MDR/XDR Gram-negative intestinal colonization and the risk of BSI in the short-term period, having no long-term sustainable effects.

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The effect of a multidisciplinary lifestyle program for patients with rheumatoid arthritis, an increased risk for rheumatoid arthritis or with metabolic syndrome-associated osteoarthritis: the “Plants for Joints” randomized controlled trial protocol

Trials ◽

10.1186/s13063-021-05682-y ◽

2021 ◽

Vol 22 (1) ◽

Author(s):

Wendy Walrabenstein ◽

Marike van der Leeden ◽

Peter Weijs ◽

Henriët van Middendorp ◽

Carlijn Wagenaar ◽

...

Keyword(s):

Rheumatoid Arthritis ◽

Metabolic Syndrome ◽

Randomized Controlled Trial ◽

Disease Activity ◽

Controlled Trial ◽

Control Group ◽

Lifestyle Interventions ◽

Randomized Controlled ◽

Lifestyle Program ◽

Increased Risk

AbstractLow-grade inflammation and metabolic syndrome are seen in many chronic diseases, including rheumatoid arthritis (RA) and osteoarthritis (OA). Lifestyle interventions which combine different non-pharmacological therapies have shown synergizing effects in improving outcomes in patients with other chronic diseases or increased risk thereof, especially cardiovascular disease. For RA and metabolic syndrome-associated OA (MSOA), whole food plant-based diets (WFPDs) have shown promising results. A WFPD, however, had not yet been combined with other lifestyle interventions for RA and OA patients. In this protocol paper, we therefore present Plants for Joints, a multidisciplinary lifestyle program, based on a WFPD, exercise, and stress management. The objective is to study the effect of this program on disease activity in patients with RA (randomized controlled trial [RCT] 1), on a risk score for developing RA in patients with anti-citrullinated protein antibody (ACPA) positive arthralgia (RCT 2) and on pain, stiffness, and function in patients with MSOA (RCT 3), all in comparison with usual care.We designed three 16-week observer-blind RCTs with a waiting-list control group for patients with RA with low to moderate disease activity (2.6 ≤ Disease Activity Score [DAS28] ≤ 5.1, RCT 1, n = 80), for patients at risk for RA, defined by ACPA-positive arthralgia (RCT 2, n = 16) and for patients with metabolic syndrome and OA in the knee and/or hip (RCT 3, n = 80). After personal counseling on diet and exercise, participants join 10 group meetings with 6–12 other patients to receive theoretical and practical training on a WFPD, exercise, and stress management, while medication remains unchanged. The waiting-list control group receives usual care, while entering the program after the RCT. Primary outcomes are: difference in mean change between intervention and control groups within 16 weeks for the DAS28 in RA patients (RCT 1), the RA-risk score for ACPA positive arthralgia patients (RCT 2), and the Western Ontario and McMaster Universities Arthritis Index (WOMAC) score for MSOA patients (RCT 3). Continued adherence to the lifestyle program is measured in a two-year observational extension study.

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Comparison of Pure Tone, Dichotic Digit Test and Speech in Noise in Persian Language Using a Mobile-Based Approach (Shenava® application) with the Audiometer Device: Protocol of the Randomized Controlled Trial

Frontiers in Health Informatics ◽

10.30699/fhi.v9i1.247 ◽

2020 ◽

Vol 9 (1) ◽

pp. 46

Author(s):

Firoozeh Khordastan ◽

Jila Afsharmanesh ◽

Maryam Amizadeh ◽

Afshin Sarafi Nejad

Keyword(s):

Randomized Controlled Trial ◽

Hearing Loss ◽

Mobile Application ◽

Pure Tone ◽

Controlled Trial ◽

Mobile App ◽

Control Group ◽

Hearing Tests ◽

Speech In Noise ◽

Randomized Controlled

Introduction: The global prevalence of hearing loss is around 5 percent in low to middle-income countries. The main purpose of this study is validating a mobile-based Pure Tone Audiometry (PTA), Dichotic Digit Test (DDT) and Speech in Noise (SIN) hearing tests for hearing loss screening purposes in Persian people comparing with routine audiometry exam results.Material and Methods: This is a single blind randomized controlled trial for comparing a mobile application for hearing screening exams. We designed and standardized PTA, DDT and SIN tests for Persian people and settled them into a specific developed mobile application called “Shenava®”. In the audiology clinic, we will recruit at least 100 healthy adult participants, 50 for the case and 50 for the control group. The first group will pass “Shenava®” and standard test respectively and the other group will pass the tests vice versa to prevent order bias.Results: The results of the tests performed by “Shenava®” and audiometry exam will be analyzed to ensure the accuracy and validity of the” Shenava®” in comparison with standard audiometric exam results.Conclution: Hearing tests are costly even for time and money and need a lot of efforts for audiologists and the patients. By designing a mobile app for hearing tests, we hope to be able to make diagnostic screening easier for hearing loss, and relying on the diagnostic value of this tool, it may encourage the patients to have a better follow up and effective treatment plan.

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Mobile application for monitoring patients under home oxygen therapy: a protocol for a randomized controlled trial

BMC Family Practice ◽

10.1186/s12875-021-01450-8 ◽

2021 ◽

Vol 22 (1) ◽

Author(s):

Anisbed Naranjo-Rojas ◽

Luis Ángel Perula-de-Torres ◽

Freiser Eceomo Cruz-Mosquera ◽

Guillermo Molina-Recio

Keyword(s):

Randomized Controlled Trial ◽

Mobile Application ◽

Oxygen Therapy ◽

Controlled Trial ◽

Control Group ◽

Home Oxygen Therapy ◽

Randomized Controlled ◽

Epidemiologic Surveillance ◽

Acute Exacerbations

Abstract Background Mobile technologies have become capable of changing the paradigm of healthcare services. A clear example is that, nowadays, these technologies are an important instrument for data collection processes, epidemiologic surveillance, health promotion and disease prevention. Therefore, technological tools should be exploited to optimize the monitoring of patients with chronic diseases, including patients who require home oxygen therapy. Purpose: The purpose of this study is to determine the efficacy of a mobile application in the clinical monitoring of patients under home oxygen therapy. Methods This is a randomized controlled trial includes subjects of 18 years or older diagnosed with Chronic Obstructive Pulmonary Disease (COPD) who are under home oxygen therapy. Subjects will be divided into two arms: the intervention group will include patients who will be monitored with a mobile application, and the control group will include patients monitored by conventional follow-up methods (periodic visits of a respiratory therapist). The following outcome variables will be considered to measure the effect of the intervention: identification of dyspnea self-management, number of acute exacerbations associated with oxygen therapy, and the occurrence of oxygen supply underuse. Discussion This study is expected to assess the efficacy of a mobile application in the follow up of patients under home oxygen therapy. It will also determine whether the monitoring of a six-month intervention by a team comprising a physician, a nurse and respiratory therapists can decrease acute exacerbations, determine the most appropriate oxygen dose, and identify the underuse of oxygen systems and supplies. Trial registration The study has been registered at ClinicalTrials.gov (NCT04820790; date of registration: March 29, 2021)

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Effects of sexual education mobile applications on men’s sexual awareness and satisfaction: A randomized controlled trial

Medical Technologies Journal ◽

10.26415/2572-004x-vol1iss4p129-130 ◽

2017 ◽

Vol 1 (4) ◽

pp. 129-130

Author(s):

Mojtaba Gholizadeh ◽

Hosein Shareh ◽

Lida Jarahi ◽

Mohammad Ahmadian ◽

Masoumeh Sarbaz ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Sex Education ◽

Sexual Satisfaction ◽

Mobile Applications ◽

Mobile Application ◽

Controlled Trial ◽

Intervention Group ◽

Sexual Education ◽

Control Group ◽

Randomized Controlled

BACKGROUND: Sexual education programs can improve sexual awareness and satisfaction. Yet, sex education is ignored in developing countries. Under such circumstances, we have used IT tools to improve sexual education. OBJECTIVE: In this article, we used a mobile application (mHealth) to impart sex education. Methods: A randomized controlled trial was held, in which participants were randomly assigned to one of two groups: The control group, with 25 participants, which received only counseling from sex therapists, and the intervention group, with 25 participants, which received the mobile application system in addition to counseling from sex therapists. Participants were persons referred to sex therapists at a clinic. In each group, sexual satisfaction and awareness were evaluated. We measured sexual satisfaction with the help of the Larson questionnaire and sexual awareness by the Ann Hooper questionnaire. Results: Our data demonstrated that sexual satisfaction was not statistically significant (P=0.44), but awareness showed statistically significant differences (P=0.007) in the intervention vs. the control group. Also, the mean in both groups had statistically significant differences before and after the intervention (P=0.001). Conclusion: Our results showed that mobile applications can improve sexual awareness but cannot affect sexual satisfaction in the short term. Trial Registration: The clinical trial was registered with the Iranian Registry of Clinical Trials (IRCT) under registration ID: IRCT2016110130640N1

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