scholarly journals Comparing a Mobile Phone Automated System With a Paper and Email Data Collection System: Substudy Within a Randomized Controlled Trial (Preprint)

2019 ◽  
Author(s):  
Diana M Bond ◽  
Jeremy Hammond ◽  
Antonia W Shand ◽  
Natasha Nassar
Keyword(s):  
Randomized Controlled Trial ◽  
Data Collection ◽  
Cost Analysis ◽  
Mobile Phone ◽  
Response Rate ◽  
Controlled Trial ◽  
Treatment Compliance ◽  
Automated System ◽  
Collection System ◽  
Randomized Controlled

BACKGROUND Traditional data collection methods using paper and email are increasingly being replaced by data collection using mobile phones, although there is limited evidence evaluating the impact of mobile phone technology as part of an automated research management system on data collection and health outcomes. OBJECTIVE The aim of this study is to compare a web-based mobile phone automated system (MPAS) with a more traditional delivery and data collection system combining paper and email data collection (PEDC) in a cohort of breastfeeding women. METHODS We conducted a substudy of a randomized controlled trial in Sydney, Australia, which included women with uncomplicated term births who intended to breastfeed. Women were recruited within 72 hours of giving birth. A quasi-randomized number of women were recruited using the PEDC system, and the remainder were recruited using the MPAS. The outcomes assessed included the effectiveness of data collection, impact on study outcomes, response rate, acceptability, and cost analysis between the MPAS and PEDC methods. RESULTS Women were recruited between April 2015 and December 2016. The analysis included 555 women: 471 using the MPAS and 84 using the PEDC. There were no differences in clinical outcomes between the 2 groups. At the end of the 8-week treatment phase, the MPAS group showed an increased response rate compared with the PEDC group (56% vs 37%; <i>P</i>&lt;.001), which was also seen at the 2-, 6-, and 12-month follow-ups. At the 2-month follow-up, the MPAS participants also showed an increased rate of self-reported treatment compliance (70% vs 56%; <i>P</i>&lt;.001) and a higher recommendation rate for future use (95% vs 64%; <i>P</i>&lt;.001) as compared with the PEDC group. The cost analysis between the 2 groups was comparable. CONCLUSIONS MPAS is an effective and acceptable method for improving the overall management, treatment compliance, and methodological quality of clinical research to ensure the validity and reliability of findings.

scholarly journals Comparing a Mobile Phone Automated System With a Paper and Email Data Collection System: Substudy Within a Randomized Controlled Trial

10.2196/15284 ◽  
2020 ◽  
Vol 8 (8) ◽  
pp. e15284
Author(s):  
Diana M Bond ◽  
Jeremy Hammond ◽  
Antonia W Shand ◽  
Natasha Nassar
Keyword(s):  
Randomized Controlled Trial ◽  
Data Collection ◽  
Cost Analysis ◽  
Mobile Phone ◽  
Response Rate ◽  
Controlled Trial ◽  
Treatment Compliance ◽  
Automated System ◽  
Collection System ◽  
Randomized Controlled

Background Traditional data collection methods using paper and email are increasingly being replaced by data collection using mobile phones, although there is limited evidence evaluating the impact of mobile phone technology as part of an automated research management system on data collection and health outcomes. Objective The aim of this study is to compare a web-based mobile phone automated system (MPAS) with a more traditional delivery and data collection system combining paper and email data collection (PEDC) in a cohort of breastfeeding women. Methods We conducted a substudy of a randomized controlled trial in Sydney, Australia, which included women with uncomplicated term births who intended to breastfeed. Women were recruited within 72 hours of giving birth. A quasi-randomized number of women were recruited using the PEDC system, and the remainder were recruited using the MPAS. The outcomes assessed included the effectiveness of data collection, impact on study outcomes, response rate, acceptability, and cost analysis between the MPAS and PEDC methods. Results Women were recruited between April 2015 and December 2016. The analysis included 555 women: 471 using the MPAS and 84 using the PEDC. There were no differences in clinical outcomes between the 2 groups. At the end of the 8-week treatment phase, the MPAS group showed an increased response rate compared with the PEDC group (56% vs 37%; P<.001), which was also seen at the 2-, 6-, and 12-month follow-ups. At the 2-month follow-up, the MPAS participants also showed an increased rate of self-reported treatment compliance (70% vs 56%; P<.001) and a higher recommendation rate for future use (95% vs 64%; P<.001) as compared with the PEDC group. The cost analysis between the 2 groups was comparable. Conclusions MPAS is an effective and acceptable method for improving the overall management, treatment compliance, and methodological quality of clinical research to ensure the validity and reliability of findings.

Auricular Vagus Nerve Acupressure for Patients with Emotional Distress under the COVID-19 Pandemic: A Smartphone-based, Randomized，Controlled Trial (Preprint)

2020 ◽  
Author(s):  
Peijing Rong ◽  
Lei Wang ◽  
Lingling Yu ◽  
Junying Wang ◽  
Yan Ma ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Vagus Nerve ◽  
Emotional Distress ◽  
Response Rate ◽  
Controlled Trial ◽  
Depression Scale ◽  
Randomized Controlled ◽  
Falling Asleep ◽  
Global Spread ◽  
Study Sites

BACKGROUND The global spread of the 2019 coronavirus diseases (COVID-19) has caused emotional distress. However, whether auricular vagus nerve acupressure (AVNA) is effective in improving emotional distress under the COVID-19 has not been well-documented. OBJECTIVE To confirm whether AVNA is effective in improving emotional distress under the COVID-19 pandemic. METHODS A smartphone-based online, randomized, controlled trial was designed in four study sites, including Wuhan, Beijing, Shenyang, and Guangzhou of China, from 26 February 2020 to 28 April 2020. Participants were randomly assigned to three times of AVNA (n = 191) or usual care (UC, n = 215) for 14 days. The primary outcome was the response rate, which was the proportion of participants whose Hospital Anxiety and Depression Scale (HADS) score reduced from baseline by ≥ 50%. The assessment was conducted at baseline, 3 days, and 14 days. RESULTS The AVNA group had a markedly higher response rate than the UC group at 3 days (35.6% vs. 24.9%, P = 0.02) and at 14 days (70.7% vs. 60.6%, P = 0.02). The AVNA group showed significantly greater reduction in score of HADS at the two measurement points and BAI at 3 days (P ≤ 0.03), with average respective effect size of 0.217 and 0.195. Participants with AVNA spent less time falling asleep and rated their sleep quality being remarkably higher than those with UC at endpoint. CONCLUSIONS AVNA can be recommended for patients with emotional distress under the current COVID-19 pandemic and other emergent events. CLINICALTRIAL www.chictr.org.cn Identifier: ChiCTR2000030078.

scholarly journals Group versus individual antenatal and first year postpartum care: Study protocol for a multi-country cluster randomized controlled trial in Kenya and Nigeria

2019 ◽  
Vol 2 ◽  
pp. 56 ◽  
Author(s):  
Mark M. Kabue ◽  
Lindsay Grenier ◽  
Stephanie Suhowatsky ◽  
Jaiyeola Oyetunji ◽  
Emmanuel Ugwa ◽  
...  
Keyword(s):  
Health Care ◽  
Randomized Controlled Trial ◽  
Data Collection ◽  
Pregnant Women ◽  
Controlled Trial ◽  
Phase 1 ◽  
First Year ◽  
Phase 2 ◽  
Randomized Controlled ◽  
Cluster Randomized

Background: Antenatal care (ANC) in many low- and middle-income countries is under-utilized and of sub-optimal quality. Group ANC (G-ANC) is an intervention designed to improve the experience and provision of ANC for groups of women (cohorts) at similar stages of pregnancy. Methods: A two-arm, two-phase, cluster randomized controlled trial (cRCT) (non-blinded) is being conducted in Kenya and Nigeria. Public health facilities were matched and randomized to either standard individual ANC (control) or G-ANC (intervention) prior to enrollment. Participants include pregnant women attending first ANC at gestational age <24 weeks, health care providers, and sub-national health managers. Enrollment ended in June 2017 for both countries. In the intervention arm, pregnant women are assigned to cohorts at first ANC visit and receive subsequent care together during five meetings facilitated by a health care provider (Phase 1). After birth, the same cohorts meet four times over 12 months with their babies (Phase 2). Data collection was performed through surveys, clinical data extraction, focus group discussions, and in-depth interviews. Phase 1 data collection ended in January 2018 and Phase 2 concludes in November 2018. Intention-to-treat analysis will be used to evaluate primary outcomes for Phases 1 and 2: health facility delivery and use of a modern method of family planning at 12 months postpartum, respectively. Data analysis and reporting of results will be consistent with norms for cRCTs. General estimating equation models that account for clustering will be employed for primary outcome analyzes. Results: Overall 1,075 and 1,013 pregnant women were enrolled in Nigeria and Kenya, respectively. Final study results will be available in February 2019. Conclusions: This is the first cRCT on G-ANC in Africa. It is among the first to examine the effects of continuing group care through the first year postpartum. Registration: Pan African Clinical Trials Registry PACTR201706002254227 May 02, 2017

scholarly journals Mobile Phone-Based Telemonitoring for Heart Failure Management: A Randomized Controlled Trial

2012 ◽  
Vol 14 (1) ◽  
pp. e31 ◽  
Author(s):  
Emily Seto ◽  
Kevin J Leonard ◽  
Joseph A Cafazzo ◽  
Jan Barnsley ◽  
Caterina Masino ◽  
...  
Keyword(s):  
Heart Failure ◽  
Randomized Controlled Trial ◽  
Mobile Phone ◽  
Controlled Trial ◽  
Heart Failure Management ◽  
Randomized Controlled

scholarly journals Assessing the Effectiveness and Acceptability of a Personalized Mobile Phone App in Improving Adherence to Oral Hygiene Advice in Orthodontic Patients: Protocol for a Feasibility Study and a Randomized Controlled Trial

10.2196/18021 ◽  
2021 ◽  
Vol 10 (1) ◽  
pp. e18021
Author(s):  
Mohammad Owaise Sharif ◽  
Jonathon Timothy Newton ◽  
Susan J Cunningham
Keyword(s):  
Health Care ◽  
Randomized Controlled Trial ◽  
Behavior Change ◽  
Mobile Phone ◽  
Mobile Phones ◽  
Orthodontic Treatment ◽  
Controlled Trial ◽  
Phase 1 ◽  
Adherence To Treatment ◽  
Randomized Controlled

Background Orthodontic treatment is a common health care intervention; treatment duration can be lengthy (2-3 years on average), and adherence to treatment advice is therefore essential for successful outcomes. It has been reported that up to 43% of patients fail to complete treatment, and there are currently no useful predictors of noncompletion. Given that the National Health Service England annual expenditure on primary-care orthodontic treatment is in excess of £200 million (US $267 million), noncompletion of treatment represents a significant inefficient use of public resources. Improving adherence to treatment is therefore essential. This necessitates behavior change, and interventions that improve adherence and are designed to elicit behavioral change must address an individual’s capability, opportunity, and motivation. Mobile phones are potentially an invaluable tool in this regard, as they are readily available and can be used in a number of ways to address an individual’s capability, opportunity, and motivation. Objective This study will assess the effectiveness and acceptability of a personalized mobile phone app in improving adherence to orthodontic treatment advice by way of a randomized controlled trial. Methods This study will be conducted in 2 phases at the Eastman Dental Hospital, University College London Hospitals Foundation Trust. Phase 1 is feasibility testing of the My Braces app. Participants will be asked to complete the user version of the Mobile Application Rating Scale. The app will be amended following analysis of the responses, if appropriate. Phase 2 is a randomized controlled trial to test the effectiveness and acceptability of the My Braces app. Results This study was approved by the London – Bloomsbury Research Ethics Committee on November 5, 2019 (reference 19/LO/1555). No patients have been recruited to date. The anticipated start date for recruitment to phase 1 is October 2020. Conclusions Given the availability, affordability, and versatility of mobile phones, it is proposed that they will aid in improving adherence to treatment advice and hence improve treatment completion rates. If effective, the applicability of this methodology to developing behavior change/modification interventions and improving adherence to treatment across health care provides an exciting opportunity. Trial Registration ClinicalTrials.gov NCT04184739; https://clinicaltrials.gov/ct2/show/NCT04184739 International Registered Report Identifier (IRRID) PRR1-10.2196/18021

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