An Opportunity During Antenatal Services to Strengthen Nurturing Care: Global and National Recommendations for Routine Ultrasound Before 24 Weeks Gestation

Introduction: The Healthy Pregnancy, Healthy Baby study (HPHB) augments a routine service (pregnancy ultrasound) with information about fetal and infant development and the importance of parent wellbeing and infant care, to assess whether it will improve child development and growth, parent-infant attachment, parental wellbeing and routine clinic attendance. This paper outlines the process of intervention development and implementation in a complex environment with multiple stakeholders.Methods: Study participants were recruited from pregnant women attending fetal ultrasound (US) at Chris Hani Baragwanath Hospital (CHBH), Soweto, South Africa. Partners were invited to attend all sessions. The HPHB intervention, a novel combination of a health and a parenting intervention that augments a routine service (US), is being tested through a randomized controlled trial with outcome assessments at 6 weeks and 6 months follow-up. The current study outlines the process of moving from intervention design to full implementation in a high-risk clinical setting.Results: Formative research informed the design and content of the intervention materials. Implementation is monitored through weekly reports and team meetings as well as formal and informal feedback received from staff and participants. Close collaborations with clinicians enhanced recruitment practices and provided clinical oversight of the trial procedures. Ongoing stakeholder engagement informed intervention procedures and strategies to address challenges that arise during implementation.Conclusion: This study emphasizes the importance of dynamic, inclusive and interactive approaches to intervention development and implementation, as well as the purposeful use of varied information from diverse sources in decision-making for effective implementation.

Download Full-text

Development and Design of a Nursing Intervention Following a Theory and Evidence-Based Approach to Promote Maternal Sensitivity and Preterm Infant Neurodevelopment in the NICU

10.21203/rs.3.rs-148048/v1 ◽

2021 ◽

Author(s):

Andréane Lavallée ◽

Marilyn Aita ◽

José Côté ◽

Linda Bell ◽

Bénédicte Grou

Keyword(s):

Preterm Infant ◽

Neonatal Intensive Care ◽

Infant Development ◽

Controlled Trial ◽

Maternal Sensitivity ◽

Nursing Intervention ◽

Current Evidence ◽

Infant Attachment ◽

Mrc Framework ◽

Infant Neurodevelopment

Abstract Background: Maternal sensitivity is an important predictor of long-term mother-infant attachment and infant development. Considering the behavioral specificities of preterm infants that may impede the development of maternal sensitivity, it is essential to promote these outcomes soon after a preterm birth. A systematic review showed that current evidence on the effectiveness of parent-infant intervention promoting parental sensitivity in the neonatal intensive care unit (NICU) is of low to very low quality. The aim of this project was to develop and design a novel nursing intervention to enhance maternal sensitivity and preterm infant neurodevelopment in the NICU. Methods: The Medical Research Council’s guidance to develop and evaluate complex health interventions, that is an evidence and theory-based approach, was used for this study. Thus, based on the MRC framework, three main steps were conducted: 1- Identifying existing empirical evidence; 2- Identifying and developing theory; 3- Modeling processes and outcomes.Results: We developed a guided participation intervention for mothers to participate in their preterm infant’s care and positioning (GP_Posit). GP_Posit is based upon the Attachment theory, the Guided participation theory as well as the Synactive theory of development. Conclusion: This novel intervention is being tested in a pilot randomized controlled trial (NCT03677752).

Download Full-text

Breastfeeding Training through Role-Play and Effects on Mother-infant Attachment Behaviours: A Randomised Controlled Trial

Africa Journal of Nursing and Midwifery ◽

10.25159/2520-5293/6232 ◽

2020 ◽

Vol 22 (1) ◽

Author(s):

Farokh Saljughi ◽

Mitra Savabi-Esfahani ◽

Shahnaz Kohan ◽

Soheila Ehsanpour

Keyword(s):

Pregnant Women ◽

Maternal Employment ◽

Controlled Trial ◽

Role Play ◽

Intervention Group ◽

Control Group ◽

Maternal Behaviour ◽

Infant Attachment ◽

Significant Difference ◽

History Of

Mother-infant attachment is an intimate, lasting and satisfying relationship that leads to better cognitive, emotional and social growth of the infant. The aim of this study was to determine the effects of breastfeeding training by role-play on mother-infant attachment behaviours. This research was a randomised clinical trial (parallel design). Inclusion criteria were: no history of mental disorders; ability to read and write the Persian language to complete the questionnaire; no history of drug and tobacco intake in primigravida women. The sample comprised 100 pregnant women (in 2 groups), selected through simple random sampling at healthcare centres. The researcher reviewed prenatal care registries of selected healthcare centres and extracted the names of pregnant women in their early third trimester. The data were imported into randomisation software. The control group received routine breastfeeding training, while the intervention group received routine training together with training through role-play. The data collection tool was the Maternal Behaviour Inventory Questionnaire. Consequently 75 samples were analysed in SPSS16. Independent t-tests and chi-square tests were used to examine the difference between the two groups. Results showed that the mean score of mother-infant attachment one week after delivery was significantly higher in the intervention group in comparison to that in the control group (p<0.001). No significant difference was observed between the two groups in maternal age, age of marriage, neonatal gender, maternal employment and education, number of parity, and number of abortions (P>0.05). Since breastfeeding training through role-play could affect mother-infant attachment, it is suggested that this type of training should be provided for pregnant women to promote mother-infant attachment and exclusive breastfeeding.

Download Full-text

A Multi-Domain Group-Based Intervention to Promote Physical Activity, Healthy Nutrition and Psychological Wellbeing in Older People with Losses in Intrinsic Capacity: AMICOPE Development Study

International Journal of Environmental Research and Public Health ◽

10.3390/ijerph18115979 ◽

2021 ◽

Vol 18 (11) ◽

pp. 5979

Author(s):

Sergi Blancafort Alias ◽

César Cuevas-Lara ◽

Nicolás Martínez-Velilla ◽

Fabricio Zambom-Ferraresi ◽

Maria Eugenia Soto ◽

...

Keyword(s):

Physical Activity ◽

Older People ◽

Preventive Intervention ◽

Controlled Trial ◽

Intervention Development ◽

World Health ◽

Psychological Wellbeing ◽

Healthy Nutrition ◽

Health And Social Care ◽

Intrinsic Capacity

The World Health Organization has developed the Integrated Care of Older People (ICOPE) strategy, a program based on the measurement of intrinsic capacity (IC) as “the composite of all physical and mental attributes on which an individual can draw”. Multicomponent interventions appear to be the most effective approach to enhance IC and to prevent frailty and disability since adapted physical activity is the preventive intervention that has shown the most evidence in the treatment of frailty and risk of falls. Our paper describes the development of a multi-domain group-based intervention addressed to older people living in the community, aimed at improving and/or maintaining intrinsic capacity by means of promoting physical activity, healthy nutrition, and psychological wellbeing in older people. The process of intervention development is described following the Guidance for reporting intervention development studies in health research (GUIDED). The result of this study is the AMICOPE intervention (Aptitude Multi-domain group-based intervention to improve and/or maintain IC in Older PEople) built upon the ICOPE framework and described following the Template for Intervention Description and Replication (TIDieR) guidelines. The intervention consists of 12 face-to-face sessions held weekly for 2.5 h over three months and facilitated by a pair of health and social care professionals. This study represents the first stage of the UK Medical Research Council framework for developing and evaluating a complex intervention. The next step should be carrying out a feasibility study for the AMICOPE intervention and, at a later stage, assessing the effectiveness in a randomized controlled trial.

Download Full-text

Development of an intervention to increase adherence to nebuliser treatment in adults with cystic fibrosis: CFHealthHub

Pilot and Feasibility Studies ◽

10.1186/s40814-020-00739-2 ◽

2021 ◽

Vol 7 (1) ◽

Author(s):

M. A. Arden ◽

M. Hutchings ◽

P. Whelan ◽

S. J. Drabble ◽

D. Beever ◽

...

Keyword(s):

Cystic Fibrosis ◽

Development Strategy ◽

Treatment Adherence ◽

Behaviour Change ◽

Multidisciplinary Team ◽

Treatment Plan ◽

Controlled Trial ◽

Intervention Development ◽

Evidence Base ◽

Behaviour Change Techniques

Abstract Background Cystic fibrosis (CF) is a life-limiting genetic condition in which daily therapies to maintain lung health are critical, yet treatment adherence is low. Previous interventions to increase adherence have been largely unsuccessful and this is likely due to a lack of focus on behavioural evidence and theory alongside input from people with CF. This intervention is based on a digital platform that collects and displays objective nebuliser adherence data. The purpose of this paper is to identify the specific components of an intervention to increase and maintain adherence to nebuliser treatments in adults with CF with a focus on reducing effort and treatment burden. Methods Intervention development was informed by the Behaviour Change Wheel (BCW) and person-based approach (PBA). A multidisciplinary team conducted qualitative research to inform a needs analysis, selected, and refined intervention components and methods of delivery, mapped adherence-related barriers and facilitators, associated intervention functions and behaviour change techniques, and utilised iterative feedback to develop and refine content and processes. Results Results indicated that people with CF need to understand their treatment, be able to monitor adherence, have treatment goals and feedback and confidence in their ability to adhere, have a treatment plan to develop habits for treatment, and be able to solve problems around treatment adherence. Behaviour change techniques were selected to address each of these needs and were incorporated into the digital intervention developed iteratively, alongside a manual and training for health professionals. Feedback from people with CF and clinicians helped to refine the intervention which could be tailored to individual patient needs. Conclusions The intervention development process is underpinned by a strong theoretical framework and evidence base and was developed by a multidisciplinary team with a range of skills and expertise integrated with substantial input from patients and clinicians. This multifaceted development strategy has ensured that the intervention is usable and acceptable to people with CF and clinicians, providing the best chance of success in supporting people with CF with different needs to increase and maintain their adherence. The intervention is being tested in a randomised controlled trial across 19 UK sites.

Download Full-text

DigiKnowIt News: Educating youth about pediatric clinical trials using an interactive, multimedia educational website

Journal of Child Health Care ◽

10.1177/13674935211003774 ◽

2021 ◽

pp. 136749352110037

Author(s):

Alison E. Parker ◽

Tracy M. Scull ◽

Abigail M. Morrison

Keyword(s):

Clinical Trials ◽

Interactive Multimedia ◽

Controlled Trial ◽

Intervention Group ◽

Control Group ◽

Wait List ◽

Wait List Control Group ◽

Wait List Control ◽

Satisfaction Questionnaire ◽

Study Participants

Pediatric clinical trials allow for the testing of appropriate and effective treatments for children. However, some challenges exist with recruitment. This study examined the effectiveness of DigiKnowIt News, an interactive, multimedia website (which includes activities, videos, and comic books) designed to educate children about clinical trials. A randomized controlled trial was conducted in 2018 with 91 participants ( M age = 10.92 years; SD = 2.06). Participants were randomly assigned to intervention or wait-list control groups and completed questionnaires at pretest and posttest (1 week later) about their knowledge, attitudes, beliefs about clinical trials, and self-efficacy for participating in clinical trials. Participants in the intervention group received access to DigiKnowIt News between pretest and posttest and completed a satisfaction questionnaire at posttest. At the end of the study, participants in the wait-list control group were offered the option to use the website and complete a satisfaction questionnaire. At posttest, participants in the intervention group, compared to participants in the wait-list control group, had more knowledge about clinical trials and more reported confidence for participating in clinical trials. Participants reported high levels of satisfaction with DigiKnowIt News. The findings suggest that an educational website can improve factors related to increasing rates of participation in clinical trials.

Download Full-text

Prevalence of Chlorhexidine-Resistant Methicillin-Resistant Staphylococcus aureus following Prolonged Exposure

Antimicrobial Agents and Chemotherapy ◽

10.1128/aac.02419-14 ◽

2014 ◽

Vol 58 (8) ◽

pp. 4404-4410 ◽

Cited By ~ 32

Author(s):

Carey D. Schlett ◽

Eugene V. Millar ◽

Katrina B. Crawford ◽

Tianyuan Cui ◽

Jeffrey B. Lanier ◽

...

Keyword(s):

Staphylococcus Aureus ◽

Molecular Analysis ◽

Prolonged Exposure ◽

Controlled Trial ◽

Epidemiological Data ◽

Methicillin Resistant ◽

Content Type ◽

Mupirocin Resistance ◽

High Level ◽

Study Participants

ABSTRACTChlorhexidine has been increasingly utilized in outpatient settings to control methicillin-resistantStaphylococcus aureus(MRSA) outbreaks and as a component of programs for MRSA decolonization and prevention of skin and soft-tissue infections (SSTIs). The objective of this study was to determine the prevalence of chlorhexidine resistance in clinical and colonizing MRSA isolates obtained in the context of a community-based cluster-randomized controlled trial for SSTI prevention, during which 10,030 soldiers were issued chlorhexidine for body washing. We obtained epidemiological data on study participants and performed molecular analysis of MRSA isolates, including PCR assays for determinants of chlorhexidine resistance and high-level mupirocin resistance and pulsed-field gel electrophoresis (PFGE). During the study period, May 2010 to January 2012, we identified 720 MRSA isolates, of which 615 (85.4%) were available for molecular analysis, i.e., 341 clinical and 274 colonizing isolates. Overall, only 10 (1.6%) of 615 isolates were chlorhexidine resistant, including three from the chlorhexidine group and seven from nonchlorhexidine groups (P> 0.99). Five (1.5%) of the 341 clinical isolates and five (1.8%) of the 274 colonizing isolates harbored chlorhexidine resistance genes, and four (40%) of the 10 possessed genetic determinants for mupirocin resistance. All chlorhexidine-resistant isolates were USA300. The overall prevalence of chlorhexidine resistance in MRSA isolates obtained from our study participants was low. We found no association between extended chlorhexidine use and the prevalence of chlorhexidine-resistant MRSA isolates; however, continued surveillance is warranted, as this agent continues to be utilized for infection control and prevention efforts.

Download Full-text

Factors Associated With Dropout of Participants in an App-Based Child Injury Prevention Study: Secondary Data Analysis of a Cluster Randomized Controlled Trial

Journal of Medical Internet Research ◽

10.2196/21636 ◽

2021 ◽

Vol 23 (1) ◽

pp. e21636

Author(s):

Jie Li ◽

Peishan Ning ◽

Peixia Cheng ◽

David C Schwebel ◽

Yang Yang ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Controlled Trial ◽

Intervention Group ◽

Demographic Characteristics ◽

Parenting Education ◽

Control Group ◽

Child Injury ◽

Factors Associated ◽

Randomized Controlled ◽

Study Participants

Background Mobile health (mHealth) interventions offer great potential to reach large populations and improve public health. However, high attrition rates threaten evaluation and implementation of mHealth intervention studies. Objective We explored factors associated with attrition of study participants in an mHealth randomized controlled trial (RCT) evaluating an intervention to reduce unintentional child injury risk in China. Methods The cluster RCT compared two groups of an app-based intervention for caregivers of 3-6–year-old children (Bao Hu San). The intervention group received unintentional child injury and parenting education, whereas only parenting education was implemented in the control group. The trial included 2920 study participants in Changsha, China, and lasted 6 months. Data on participant engagement (using the app) were collected electronically throughout the 6-month period. Associations between participant attrition and demographic characteristics, and between attrition and intervention engagement were tested and quantified separately for the intervention and control groups using the adjusted odds ratio (aOR) based on generalized linear mixed models. Results In total, 2920 caregivers from 20 eligible preschools participated, with 1510 in the intervention group and 1410 in the control group. The 6-month attrition rate differed significantly between the two groups (P<.001), at 28.9% (437/1510) in the intervention group and 35.7% (503/1410) in the control group. For the intervention group, the only significant predictor of attrition risk was participants who learned fewer knowledge segments (aOR 2.69, 95% CI 1.19-6.09). For the control group, significant predictors of attrition risk were lower monthly login frequency (aOR 1.48, 95% CI 1.00-2.18), learning fewer knowledge segments (aOR 1.70, 95% CI 1.02-2.81), and shorter learning durations during app engagement (aOR 2.39, 95% CI 1.11-5.15). Demographic characteristics were unrelated to attrition. Conclusions Engagement in the app intervention was associated with participant attrition. Researchers and practitioners should consider how to best engage participants in app-based interventions to reduce attrition. Trial Registration Chinese Clinical Trial Registry ChiCTR-IOR-17010438; http://www.chictr.org.cn/showproj.aspx?proj=17376 International Registered Report Identifier (IRRID) RR2-10.1186/s12889-018-5790-1

Download Full-text

Efficacy Trial for a Smartphone Game to Prevent HIV among Young Africans: Protocol for a Randomized Controlled Trial in the Context of COVID-19 (Preprint)

10.2196/preprints.35117 ◽

2021 ◽

Author(s):

Victor Mudhune ◽

Gaelle Sabben ◽

Ken Ondenge ◽

Calvin Mbeda ◽

Robert H. Lyles ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Controlled Trial ◽

Unprotected Sex ◽

Sub Saharan Africa ◽

Local Health Authority ◽

Successful Implementation ◽

Biological Testing ◽

Ongoing Research ◽

Randomized Controlled ◽

Study Participants

BACKGROUND Adolescent girls contribute about a quarter of all new HIV infections in sub-Saharan Africa. There is a need for more effective intervention approaches to help young adolescents safely navigate through adolescence and into adulthood. We are assessing the efficacy of Tumaini, a smartphone game designed to prevent HIV among young Africans. Against the background of COVID-19, meaningful alteration of the research protocol was necessary to ensure successful implementation, and retention of the study participants in ongoing research. OBJECTIVE The objective of our protocol is to: (1) determine if Tumaini delays sexual debut and increases condom use at first sex, and (2) determine whether it influences behavioral mediators of early and unprotected sex. METHODS Participants were recruited from Kisumu County, in Western Kenya. This study is a two-arm, individual-randomized controlled trial that enrolled 1,004 adolescents aged between 12 and 15 years. The intervention arm participants are playing Tumaini, while the control arm are provided with Brainilis, a commercially available control game. The study period will last 45 months. At baseline, participants in both arms completed a baseline survey and biological testing for HIV and HSV-2; participants will have annual gameplay sessions in years 1-3. They will also complete a total of 12 follow-up surveys. At endline, repeat biological testing will be conducted. Protocol adaptations were necessitated by the COVID-19 pandemic and implemented in accordance with local public health guidelines. RESULTS Participants were enrolled between October 2020 and November 2020. We plan to complete study procedures in September 2024. Enrolled participant sample was 50.1% female (n=499) and had a mean age of 14.0 years (SD=0.6 years). CONCLUSIONS This ongoing research demonstrates that with appropriate revisions to planned protocol activities guided by the need to maintain study integrity, protect both study participants and staff, and adherence to IRB and local health authority guidelines, human subject research is possible in the context of a global pandemic. If the trial demonstrates efficacy, Tumaini would provide an alternative, remote means of delivering age-appropriate education to pre-adolescents on safer sex, HIV prevention and effective life skills on a highly scalable, low cost and culturally adaptable platform. CLINICALTRIAL ClinicalTrials.gov (NCT04437667).

Download Full-text

Open-labelled randomised controlled trial of 12 hours versus 24 hours modified Pritchard regimen in the management of eclampsia and pre-eclampsia in Ghana (MOPEP Study): study protocol

BMJ Open ◽

10.1136/bmjopen-2019-032799 ◽

2019 ◽

Vol 9 (10) ◽

pp. e032799 ◽

Cited By ~ 1

Author(s):

Titus Beyuo ◽

Emma Lawrence ◽

Elizabeth S Langen ◽

Samuel A Oppong

Keyword(s):

Randomised Controlled Trial ◽

Health Outcomes ◽

Magnesium Sulfate ◽

Controlled Trial ◽

Secondary Outcome ◽

Control Group ◽

University Of Michigan ◽

Clinical Trial Registry ◽

Randomised Controlled ◽

Study Participants

IntroductionHypertensive disorders of pregnancy continue to be a major contributor to maternal and perinatal morbidity and mortality. Magnesium sulfate therapy is the standard of care for seizure prophylaxis and treatment for pre-eclampsia and eclampsia respectively, despite wide disparities in dosing regimens and routes of administration. This study compares the clinical efficacy of magnesium sulfate in the reduction of seizure occurrence or recurrence with the 12 hours versus 24 hours modified Pritchard regimens in the management of severe pre-eclampsia and eclampsia.Methods and analysisThis study is an open labelled randomised controlled trial. The study participants are patients admitted to the Korle Bu Teaching Hospital (KBTH) in Accra, Ghana with a diagnosis of antepartum, intrapartum or postpartum eclampsia or pre-eclampsia with severe features. All study participants will be administered a loading dose of magnesium sulfate, followed by maintenance dosing. Participants in the control group will receive magnesium sulfate for 24 hours after diagnosis, while those in the treatment group will receive magnesium sulfate for 12 hours after diagnosis. The primary outcome of this study is the occurrence of a seizure any time after the completion of treatment in the assigned group. Secondary outcome measures include maternal health outcomes, magnesium sulfate toxicities and fetal health outcomes. Data collection was started in October 2018 with a target enrolment of 1245 participants with severe pre-eclampsia and 844 participants with eclampsia with a projected study period of 2–3 years.Ethics and disseminationEthical approval was obtained from the KBTH Institutional Review Board (IRB) in Ghana. University of Michigan involvement is limited to protocol development and statistical analysis of de-identified data, and has been granted a Not Regulated Determination by the University of Michigan IRB. Results of the study will be shared at clinical forums at the KBTH and will be submitted for publication in an international peer-reviewed journal.Trial registration numberPan African Clinical Trial Registry through the South African Medical Research Council (PACTR201811515303983).

Download Full-text