scholarly journals Pregnant Women’s Attitudes Toward and Experiences With a Tablet Intervention to Promote Safety Behaviors in a Randomized Controlled Trial: Qualitative Study (Preprint)

2021 ◽  
Author(s):  
Bente Walter ◽  
Hege Indreboe ◽  
Mirjam Lukasse ◽  
Lena Henriksen ◽  
Lisa Garnweidner-Holme
Keyword(s):  
Health Care ◽  
Randomized Controlled Trial ◽  
Antenatal Care ◽  
Health Care Professionals ◽  
Controlled Trial ◽  
Control Group ◽  
Safety Behaviors ◽  
Face To Face ◽  
Randomized Controlled ◽  
At Home

BACKGROUND Intimate partner violence (IPV) is recognized as a global health problem. Women with low education and limited resources are more vulnerable, as are immigrant women. There is a lack of evidence on how health care professionals should communicate about and intervene against IPV during pregnancy. Earlier research has shown that when women manage digital questionnaires, they are more likely to disclose IPV. However, little is known about how women experience eHealth interventions with safety behaviors to prevent IPV. OBJECTIVE The aim of this study was to explore pregnant women’s attitudes toward and experiences with a tablet intervention to promote safety behaviors in a randomized controlled trial (RCT) in antenatal care. METHODS Individual semistructured interviews were conducted with 10 women who participated in the Safe Pregnancy Study. The Safe Pregnancy Study was a randomized controlled trial (RCT) using a tablet intervention containing IPV questions and a film to promote safety behaviors. Six women from the intervention group and four women from the control group were recruited. The content was available in Norwegian, Somali, and Urdu. Five of the women participating in the interviews spoke Norwegian at home and five spoke another language. The majority of the women who did not speak Norwegian at home perceived themselves as relatively well integrated. The interviews were conducted at different maternal and child health centers (MCHCs) in Norway between March 2020 and June 2020. The analysis was guided by thematic analysis. RESULTS Women who participated in the tablet intervention appreciated being asked questions about IPV on a tablet. However, it was important to supplement the tablet intervention with face-to-face communication with a midwife. The MCHC was regarded as a suitable place to answer questions and watch a film about safety behaviors. Women suggested making the tablet intervention available in other settings where women meet health care professionals. Some women expressed uncertainty about their anonymity regarding their answers in the questionnaire. We found no real differences between ethnic Norwegian and immigrant women’s attitudes toward and experiences with the tablet intervention. CONCLUSIONS Questions about IPV and a film about safety behaviors on a tablet, as a supplement to face-to-face communication, might initiate and facilitate communication about IPV in antenatal care. Uncertainty regarding anonymity has to be addressed when questions about IPV are being asked on a tablet. CLINICALTRIAL ClinicalTrials.gov NCT03397277; https://clinicaltrials.gov/ct2/show/NCT03397277

scholarly journals Pregnant Women’s Attitudes Toward and Experiences With a Tablet Intervention to Promote Safety Behaviors in a Randomized Controlled Trial: Qualitative Study

10.2196/28680 ◽  
2021 ◽  
Vol 5 (7) ◽  
pp. e28680
Author(s):  
Bente Walter ◽  
Hege Indreboe ◽  
Mirjam Lukasse ◽  
Lena Henriksen ◽  
Lisa Garnweidner-Holme
Keyword(s):  
Health Care ◽  
Randomized Controlled Trial ◽  
Antenatal Care ◽  
Health Care Professionals ◽  
Controlled Trial ◽  
Control Group ◽  
Safety Behaviors ◽  
Face To Face ◽  
Randomized Controlled ◽  
At Home

Background Intimate partner violence (IPV) is recognized as a global health problem. Women with low education and limited resources are more vulnerable, as are immigrant women. There is a lack of evidence on how health care professionals should communicate about and intervene against IPV during pregnancy. Earlier research has shown that when women manage digital questionnaires, they are more likely to disclose IPV. However, little is known about how women experience eHealth interventions with safety behaviors to prevent IPV. Objective The aim of this study was to explore pregnant women’s attitudes toward and experiences with a tablet intervention to promote safety behaviors in a randomized controlled trial (RCT) in antenatal care. Methods Individual semistructured interviews were conducted with 10 women who participated in the Safe Pregnancy Study. The Safe Pregnancy Study was a randomized controlled trial (RCT) using a tablet intervention containing IPV questions and a film to promote safety behaviors. Six women from the intervention group and four women from the control group were recruited. The content was available in Norwegian, Somali, and Urdu. Five of the women participating in the interviews spoke Norwegian at home and five spoke another language. The majority of the women who did not speak Norwegian at home perceived themselves as relatively well integrated. The interviews were conducted at different maternal and child health centers (MCHCs) in Norway between March 2020 and June 2020. The analysis was guided by thematic analysis. Results Women who participated in the tablet intervention appreciated being asked questions about IPV on a tablet. However, it was important to supplement the tablet intervention with face-to-face communication with a midwife. The MCHC was regarded as a suitable place to answer questions and watch a film about safety behaviors. Women suggested making the tablet intervention available in other settings where women meet health care professionals. Some women expressed uncertainty about their anonymity regarding their answers in the questionnaire. We found no real differences between ethnic Norwegian and immigrant women’s attitudes toward and experiences with the tablet intervention. Conclusions Questions about IPV and a film about safety behaviors on a tablet, as a supplement to face-to-face communication, might initiate and facilitate communication about IPV in antenatal care. Uncertainty regarding anonymity has to be addressed when questions about IPV are being asked on a tablet. Trial Registration ClinicalTrials.gov NCT03397277; https://clinicaltrials.gov/ct2/show/NCT03397277

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 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

Popular diets

2011 ◽  
pp. 213-216
Keyword(s):  
Health Care ◽  
Randomized Controlled Trial ◽  
Health Care Professionals ◽  
Controlled Trial ◽  
Potential Harm ◽  
Randomized Controlled ◽  
Scientific Principles

This section is included to help orientate health-care professionals to diets that their patients may initiate or possibly seek advice about. It does not validate their efficacy. For many, evidence of benefit in the form of a randomized controlled trial is not available. However, the concerns, described below, about potential harm resulting from some diets are based on scientific principles....

scholarly journals Do home pregnancy tests bring women to community health workers for antenatal care counselling? A randomized controlled trial in Madagascar

2019 ◽  
Vol 34 (8) ◽  
pp. 566-573
Author(s):  
Alison B Comfort ◽  
Randall C Juras ◽  
Sarah E K Bradley ◽  
Justin Ranjalahy Rasolofomanana ◽  
Anja Noeliarivelo Ranjalahy ◽  
...  
Keyword(s):  
At Risk ◽  
Randomized Controlled Trial ◽  
Reproductive Health ◽  
Health Services ◽  
Antenatal Care ◽  
Health Workers ◽  
Controlled Trial ◽  
Control Group ◽  
Reproductive Health Services ◽  
Randomized Controlled

Abstract Task-shifting the provision of pregnancy tests to community health workers (CHWs) in low-resource settings has the potential to reach significantly more underserved women at risk of pregnancy with essential reproductive health services. This study assessed whether an intervention to supply CHWs with home pregnancy tests brought more clients for antenatal care (ANC) counselling. We implemented a randomized controlled trial among CHWs providing reproductive health services to women in Eastern Madagascar. We used ordinary least squares regressions to estimate the effect of the intervention, with district- and month-fixed effects and CHW baseline characteristics as control variables. Our outcomes of interest included whether the intervention increased: (1) the number of women at risk of pregnancy who sought services from CHWs; (2) the number of these women who knew they were pregnant by the end of visit; and (3) the number of these women who received ANC counselling during visit. We found that providing pregnancy tests to CHWs to distribute to their clients for free significantly increased the number of women at risk of pregnancy who sought services from CHWs. At follow-up, treatment-group CHWs provided services to 6.3 clients compared with 4.2 clients among control-group CHWs, which represents a 50% relative increase from the control-group mean. A significantly higher number of these clients knew they were pregnant by the end of the visit, with a mean of 0.95 in treatment compared with 0.10 in control (Coeff. 0.86; 95% CI 0.59–1.13). A significantly higher number of these clients received antenatal counselling at the visit (Coeff. 0.4; 95% CI 0.14–0.64). Introducing free home pregnancy tests as part of community-based health services can improve pregnancy care by attracting more clients at risk of pregnancy to services at the community level, enabling more women to confirm they are pregnant and receive antenatal counselling.

scholarly journals The effect of cryotherapy on chemotherapy induced oral mucositis in Egyptian cancer patients: A randomized controlled trial

2019 ◽  
Vol 9 (11) ◽  
pp. 63
Author(s):  
Hanan Mohamed Mohamed Soliman
Keyword(s):  
Randomized Controlled Trial ◽  
Cancer Patients ◽  
Oral Mucositis ◽  
Health Care Professionals ◽  
Controlled Trial ◽  
Routine Care ◽  
Control Group ◽  
Adverse Side Effect ◽  
Randomized Controlled ◽  
Oral Cryotherapy

Background and objective: Oral Mucositis (OM) is a common adverse side-effect caused by cancer treatments (chemotherapy and/or radiotherapy).  And can lead to mucosa toxicity. Patients with OM may experience extreme pain and may not be able to eat, drink and talk and, as a result, their quality of life is impaired. Treatment and prevention of OM in adult patients treated with chemotherapy are challenging issues for health care professionals. The aim of this study was to evaluate the effect of cryotherapy on incidence and severity of chemotherapy-induced OM and OM related pain in patients treated with combined chemotherapy (Fluorouracil and Leucovorin).Methods: This study is a randomized controlled trial with a random assignment to cryotherapy and control groups. The study was conducted on 40 cancer patients who underwent chemotherapy. The 20 patients in cryotherapy group were received instructions for sucking ice cubes in their mouth for five minutes before, during and shortly after chemotherapy. The 20 patients in control group received routine care. OM and pain severity were evaluated at 7th, 14th and 21st days of the study after chemotherapy using WHO Mucositis grading and-Numeric Pain Rating Scale.Results: In the majority of patients in cryotherapy group, oral Mucositis was not detected (Grade 0) at 7th, 14th and 21st days similarly incidence of grade 1 and 2 of OM in cryotherapy group significantly lowered when compared with control group where p < .001. During the study period, patients in the control group exhibit a significantly higher level of oral discomfort (p = .001).Conclusions: Oral cryotherapy due to its easy administration, tolerability and lack of adverse effects which makes it a very important method for decreasing the severity and incidence of OM and OM associated pain. The oncology nurses have a pivotal role in the application and success of cryotherapy.

scholarly journals Efficacy of nano-carbonate apatite dentifrice in relief from dentin hypersensitivity following non-surgical periodontal therapy: A randomized controlled trial

2019 ◽  
Author(s):  
Pei-Hui Ding ◽  
Anna Dai ◽  
Hua-Jiao Hu ◽  
Jia-Ping Huang ◽  
Jia-Mei Liu ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Test Group ◽  
Periodontal Therapy ◽  
Control Group ◽  
Carbonate Apatite ◽  
Dentine Hypersensitivity ◽  
Randomized Controlled ◽  
At Home

Abstract Background: Dentine hypersensitivity (DH) could occur or intensify after non-surgical periodontal therapy because of the exposure of dentine tubules. It has been demonstrated that nano-sized particles could seal these the dentine tubules. This randomized controlled trial aimed to investigate the efficacy of dentifrice containing nano-carbonate apatite (n-CAP) in reducing dentine hypersensitivity (DH) after non-surgical periodontal therapy. Methods: 48 periodontitis patients with DH were included in this clinical trial. After non-surgical periodontal therapy, patients included were randomized to test and control group and the respective dentifrices were applied at chairside, after which they were instructed to brush teeth with the allocated dentifrices twice a day at home. Periodontal parameters were recorded at baseline and the last follow-up. DH was measured by air-blast test and recorded by visual analogue scale (VAS) and Schiff sensitivity scale at baseline, after polishing (0 week) and 2/4/6 weeks. Results: 45 participants completed the follow-up. Periodontal parameters were improved and comparable between groups. Significant reduction in DH was observed in both groups at all time-points compared to baseline in terms of VAS and Schiff score. The test group achieved significantly greater relief from hypersensitivity compared with the control group after 4-week at-home use (for VAS, test group: 0.66 ± 0.68 versus control group: 0.84 ± 0.78, p = 0.005; for Schiff score, test group: 0.69 ± 0.71 versus control group: 0.97 ± 0.77, p < 0.001). Conclusions: Home-use of n-CAP based dentifrice provided a significantly better alleviation of DH following non-surgical periodontal therapy after 4 weeks compared to the control product. Trail registration: Chinese Clinical Trials Registry (No. ChiCTR-IPR-17011678, http://www.chictr.org.cn/, registered 16 June, 2017)

scholarly journals An Internet-Based Cognitive Behavioral Program for Adolescents With Anxiety: Pilot Randomized Controlled Trial (Preprint)

2019 ◽  
Author(s):  
Kathleen O'Connor ◽  
Alexa Bagnell ◽  
Patrick McGrath ◽  
Lori Wozney ◽  
Ashley Radomski ◽  
...  
Keyword(s):  
Health Care ◽  
Randomized Controlled Trial ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Cognitive Behavioral ◽  
Retention Rates ◽  
Control Group ◽  
Consequence Analysis ◽  
Randomized Controlled ◽  
Cost Consequence

BACKGROUND Internet-based cognitive behavioral therapy (ICBT) is a treatment approach recently developed and studied to provide frontline treatment to adolescents with anxiety disorders. OBJECTIVE This study aimed to pilot procedures and obtain data on methodological processes and intervention satisfaction to determine the feasibility of a definitive randomized controlled trial (RCT) to test the effectiveness of a self-managed ICBT program, Breathe (Being Real, Easing Anxiety: Tools Helping Electronically), for adolescents with anxiety concerns. METHODS This study employed a two-arm, multisite, pilot RCT. Adolescents aged 13 to 17 years with a self-identified anxiety concern were recruited online from health care settings and school-based mental health care services across Canada between April 2014 and May 2016. We compared 8 weeks of ICBT with ad hoc telephone and email support (Breathe experimental group) to access to a static webpage listing anxiety resources (control group). The primary outcome was the change in self-reported anxiety from baseline to 8 weeks (posttreatment), which was used to determine the sample size for a definitive RCT. Secondary outcomes were recruitment and retention rates, a minimal clinically important difference (MCID) for the primary outcome, intervention acceptability and satisfaction, use of cointerventions, and health care resource use, including a cost-consequence analysis. RESULTS Of the 588 adolescents screened, 94 were eligible and enrolled in the study (49 adolescents were allocated to Breathe and 45 were allocated to the control group). Analysis was based on 74% (70/94) of adolescents who completed baseline measures and progressed through the study. Enrolled adolescents were, on average, 15.3 years old (SD 1.2) and female (63/70, 90%). Retention rates at 8 weeks were 28% (13/46; Breathe group) and 58% (24/43; control group). Overall, 39% (14/36) of adolescents provided feedback on completion of the Breathe program. Adolescents’ scores on a satisfaction survey indicated a moderate level of satisfaction. All but one adolescent indicated that Breathe was easy to use and they understood all the material presented. The most frequent barrier identified for program completion was difficulty in completing exposure activities. The power analysis indicated that 177 adolescents per group would be needed to detect a medium effect size (<i>d</i>=0.3) between groups in a definitive trial. Data for calculating an MCID or conducting a cost-consequence analysis were insufficient due to a low response rate at 8 weeks. CONCLUSIONS Adolescents were moderately satisfied with Breathe. However, program adjustments will be needed to address attrition and reduce perceived barriers to completing key aspects of the program. A definitive RCT to evaluate the effectiveness of the program is feasible if protocol adjustments are made to improve recruitment and retention to ensure timely study completion and increase the completeness of the data at each outcome measurement time point. CLINICALTRIAL ClinicalTrials.gov NCT02059226; http://clinicaltrials.gov/ct2/show/NCT02059226.

scholarly journals Post-hospital medical respite care for homeless people in Denmark: A randomized controlled trial and cost-utility analysis.

2019 ◽  
Author(s):  
Camilla Nygaard Bring ◽  
Marie Kruse ◽  
Mikkel Ankarfeldt ◽  
Nina Brünés ◽  
Maja Pedersen ◽  
...  
Keyword(s):  
Health Care ◽  
Randomized Controlled Trial ◽  
Cost Effectiveness ◽  
Controlled Trial ◽  
Intervention Group ◽  
Homeless People ◽  
Respite Care ◽  
Control Group ◽  
Randomized Controlled ◽  
The Cost

Abstract Background: Being homeless entails higher mortality, morbidity, and prevalence of psychiatric diseases. This can lead to more frequent and expensive use of health care services. Medical respite care enables an opportunity to recuperate after a hospitalization and has shown a positive effect on readmissions, but little is known about the cost-effectiveness of medical respite care for homeless people discharged from acute hospitalization. Therefore, the aim of the present study was to investigate the cost-effectiveness of a 2-week stay in post-hospital medical respite care. Methods: A randomized controlled trial and cost-utility analysis, from a societal perspective, was conducted between April 2014 and December 2015. Homeless people aged >18 years with an acute admission were included from 10 different hospitals in the Capital Region of Denmark. The intervention group (n=53) was offered a 2-week medical respite care stay at a Red Cross facility and the control group (n=43) was discharged without any extra help (usual care), but with the opportunity to seek help in shelters and from street nurses and doctors in the municipalities. The primary outcome was the difference in health care costs 3 months following inclusion in the study. Secondary outcomes were change in health-related quality of life and health care costs 6 months following inclusion in the study. Data were collected through Danish registries, financial management systems in the municipalities and at the Red Cross, and by using the EQ-5D questionnaire. Results: After 3 and 6 months, the intervention group had €4,761 (p=0.10) and €8,515 (p=0.04) lower costs than the control group, respectively. The higher costs in the control group were mainly related to acute admissions. Both groups had minor quality-adjusted life year gains. Conclusions: This is the first randomized controlled trial to investigate the cost-effectiveness of a 2-week medical respite care stay for homeless people after hospitalization. The study showed that a medical respite care stay for homeless people is cost-effective. Furthermore, this study illustrates that it is possible to perform research with satisfying follow-up with a target group that is hard to reach. Trial registration: ClinicalTrials.gov Identifier: NCT02649595

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