Influence of physician confidentiality assurances on adolescents' willingness to disclose information and seek future health care. A randomized controlled trial

JAMA ◽  
1997 ◽  
Vol 278 (12) ◽  
pp. 1029-1034 ◽  
Author(s):  
C. A. Ford
Keyword(s):  
Health Care ◽  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Future Health ◽  
Randomized Controlled ◽  
Willingness To Disclose ◽  
Future Health Care

scholarly journals Japanese health and safety information for overseas visitors: protocol for a randomized controlled trial

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Mariko Nishikawa ◽  
Masaaki Yamanaka ◽  
Akira Shibanuma ◽  
Junko Kiriya ◽  
Masamine Jimba
Keyword(s):  
Health Care ◽  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Safety Information ◽  
Intervention Group ◽  
Health And Safety ◽  
Trial Registration ◽  
Control Group ◽  
Internet Portal ◽  
Randomized Controlled

Abstract Background Before the COVID-19 pandemic occurred in January 2020, the number of overseas visitors to Japan had increased threefold over the last decade. To minimize the risk of health problems, visitors should be able to access information on the health care systems of the places they visit. Most short-term overseas visitors are young adults. Although they are not very likely to get sick from noncommunicable diseases, they are at high risk for injury and often experience stomach ailments, fever, or nausea when travelling. The objective of this study is to evaluate culturally and linguistically appropriate health information on preventive health behaviours and the health care system in Japan. We will examine the level of satisfaction of overseas visitors to Japan with health care-related educational materials using a five-minute digital game named Sa-Chan Japan. Methods Our study is a randomized controlled trial (RCT). We will assess both satisfaction and motivation before, during, and after the interventions and examine the changes over time. The intervention group will comprise overseas visitors who will view and answer questions in an animation named Sa-Chan Japan. The control group will comprise overseas visitors who will watch an English digital animation named Mari Info Japan. We will recruit 1002 participants through the Macromill Internet portal. We will contact overseas visitors who have either visited or wish to visit Japan from the United Kingdom, United States, and Australia. The participants will fill out a self-administered questionnaire online in the first quarter of 2021. We will determine the participants’ levels of satisfaction with the CSQ-8 (8-item Client Satisfaction Questionnaire). We will analyse the median score of the overseas visitors with both the Wilcoxon rank-sum and the Wilcoxon signed-rank tests. Our protocol of randomized controlled trials follows the SPIRIT guidelines. Discussion Our research will utilize unique digital education strategies in a game that promotes health and safety among overseas visitors to Japan. We believe the results of this study will be useful in overcoming the current challenges regarding pretravel health requirements for overseas visitors worldwide. Trial registration Version 1 of this trial was registered in the UMIN-CTR (University Hospital Medical Information Network Center Clinical Trials Registry), and the trial registration data are available on UMIN000042483, November 17, 2020.

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 Smartphone Cardiac Rehabilitation, Assisted Self-Management Versus Usual Care: Protocol for a Multicenter Randomized Controlled Trial to Compare Effects and Costs Among People With Coronary Heart Disease (Preprint)

2019 ◽  
Author(s):  
Jonathan Charles Rawstorn ◽  
Kylie Ball ◽  
Brian Oldenburg ◽  
Clara K Chow ◽  
Sarah A McNaughton ◽  
...  
Keyword(s):  
Health Care ◽  
Coronary Heart Disease ◽  
Randomized Controlled Trial ◽  
Cardiac Rehabilitation ◽  
Usual Care ◽  
Controlled Trial ◽  
Self Management ◽  
Evidence Based ◽  
Randomized Controlled ◽  
Delivery Models

BACKGROUND Alternative evidence-based cardiac rehabilitation (CR) delivery models that overcome significant barriers to access and delivery are needed to address persistent low utilization. Models utilizing contemporary digital technologies could significantly improve reach and fidelity as complementary alternatives to traditional center-based programs. OBJECTIVE The aim of this study is to compare the effects and costs of the innovative <i>Smartphone Cardiac Rehabilitation, Assisted self-Management</i> (SCRAM) intervention with usual care CR. METHODS In this investigator-, assessor-, and statistician-blinded parallel 2-arm randomized controlled trial, 220 adults (18+ years) with coronary heart disease are being recruited from 3 hospitals in metropolitan and regional Victoria, Australia. Participants are randomized (1:1) to receive advice to engage with usual care CR or the SCRAM intervention. SCRAM is a 24-week dual-phase intervention that includes 12 weeks of real-time remote exercise supervision and coaching from exercise physiologists, which is followed by 12 weeks of data-driven nonreal-time remote coaching via telephone. Both intervention phases include evidence- and theory-based multifactorial behavior change support delivered via smartphone push notifications. Outcomes assessed at baseline, 12 weeks, and 24 weeks include maximal aerobic exercise capacity (primary outcome at 24 weeks), modifiable cardiovascular risk factors, exercise adherence, secondary prevention self-management behaviors, health-related quality of life, and adverse events. Economic and process evaluations will determine cost-effectiveness and participant perceptions of the treatment arms, respectively. RESULTS The trial was funded in November 2017 and received ethical approval in June 2018. Recruitment began in November 2018. As of September 2019, 54 participants have been randomized into the trial. CONCLUSIONS The innovative multiphase SCRAM intervention delivers real-time remote exercise supervision and evidence-based self-management behavioral support to participants, regardless of their geographic proximity to traditional center-based CR facilities. Our trial will provide unique and valuable information about effects of SCRAM on outcomes associated with cardiac and all-cause mortality, as well as acceptability and cost-effectiveness. These findings will be important to inform health care providers about the potential for innovative program delivery models, such as SCRAM, to be implemented at scale, as a complement to existing CR programs. The inclusion of a cohort comprising metropolitan-, regional-, and rural-dwelling participants will help to understand the role of this delivery model across health care contexts with diverse needs. CLINICALTRIAL Australian New Zealand Clinical Trials Registry (ACTRN): 12618001458224; anzctr.org.au/Trial/Registration/TrialReview.aspx?id=374508. INTERNATIONAL REGISTERED REPORT DERR1-10.2196/15022

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

scholarly journals Health TAPESTRY Ontario: Protocol for a Randomized Controlled Trial to Test Reproducibility and Implementation

2020 ◽  
Author(s):  
Dee Mangin ◽  
Larkin Lamarche ◽  
Sivan Bomze ◽  
Sayem Borhan ◽  
Tracy Browne ◽  
...  
Keyword(s):  
Physical Activity ◽  
Health Care ◽  
Randomized Controlled Trial ◽  
Primary Health Care ◽  
Controlled Trial ◽  
Care Team ◽  
Control Group ◽  
Randomized Controlled ◽  
Primary Health ◽  
Diverse Communities

Abstract Background: Health TAPESTRY (Health Teams Advancing Patient Experience: STRengthening qualitY) aims to help people stay healthier for longer where they live by providing person-focused care through the integration of four key program components: 1) trained volunteers who visit clients in their homes, 2) an interprofessional primary health care team, 3) use of technology to collect and share information, and 4) improved connections to community health and social services. The initial randomized controlled trial of Health TAPESTRY found promising results in terms of health care use and patient outcomes, indicating a shift from reactive to preventive care. The trial was based on one clinical academic centre, thus limiting generalizability. The study objectives are: 1) to test reproducibility of the established effectiveness of Health TAPESTRY on physical activity and hospitalizations, 2) to test the feasibility of, and understand the contributing factors to, the implementation of Health TAPESTRY in six diverse communities across Ontario, Canada, and 3) to determine the value for money of implementing Health TAPESTRY. Methods : This planned study is a pragmatic parallel randomized controlled trial with a delayed intervention for control participants at six months. This trial will simultaneously assess effectiveness and implementation in a real world setting (Type II hybrid) in six diverse communities across Ontario. Participants 70 years of age and older will be randomized into the Health TAPESTRY intervention or the control group (usual care). Intervention clients will receive an individualized plan of care from an interprofessional care team. The plan will be based on a client’s goals and current health risks identified through volunteer visits. The study’s outcomes are mapped onto the RE-AIM framework, with levels of physical activity and number of hospitalizations as the co-primary outcomes. The main analysis will be a comparison at six months. Discussion: It is important to evaluate the effectiveness and implementation of Health TAPESTRY in multiple communities prior to scaling or widespread adoption. Trial registration: ClinicalTrials.gov: NCT03397836 (posted January 12, 2018). Keywords: Primary health care, Randomized controlled trial, Integrated care, Interdisciplinary health care teams, Health care volunteers, Older adults, Implementation

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