Clinical Research Directory

RISE for Nurse Preceptors

The purpose of this study is to determine whether RISE for Nurse Preceptors has a significant impact on nurse preceptors' burnout, resilience, insight, self-compassion, and empowerment, as well as mental well-being, in their personal lives and their working environment.

Estimating the Impact of Sexuality Education and Mobile Health Services on Reproductive Health and Empowerment Among Adolescents in Sierra Leone for the Family Planning Impact Lab

The goal of this randomized controlled trial is to learn if comprehensive sexuality education (CSE) and access to mobile sexual and reproductive health (SRH) services in secondary schools can improve short- and long-term health, well-being, social and economic outcomes among adolescents and young people in two districts of Sierra Leone. The main questions it aims to answer are: 1. How do CSE and mobile SRH services (individually and combined) change adolescent SRHR, well-being and socioeconomic outcomes in the short term and in the longer term (over 3 years)? 2. What are the economic costs of providing CSE and mobile SRH services? 3. How cost-effective is the provision of CSE and mobile SRH services, given its potential impact on health, socioeconomic, and well-being outcomes? 4. To what extent are CSE and mobile SRH services being implemented according to the original plan and timeline? Researchers will compare schools receiving CSE and mobile SRH services to schools not receiving these services, to see if adolescent SRHR, well-being and socioeconomic outcomes are better in those schools that received the services. The trial will compare four groups of schools, each with 60 participating schools: 1. No additional services (control schools) 2. Only CSE 3. Only mobile SRH services 4. CSE and mobile SRH services The implementation of these services will be led by Marie Stopes Sierra Leone (MSSL) in collaboration with the Ministry of Education. MSSL will ensure that participating schools: * Attend teacher training on the CSE curriculum before the study starts, followed by yearly refresher training during the study * Have sufficient time allocated to CSE in the weekly school schedule * Have adequate teaching materials \& equipment to teach CSE * Have guidance counsellors in each school who will monitor the implementation of CSE * Have a designated "safe space" which adolescents can access for menstrual products and care. * Have access to mobile SRH services (provided by MSSL staff) on the school premises 3 times per school year

Empowering Mothers Whose Babies Are Hospitalized in the Neonatal Intensive Care Unit

Family Integrated Care is designed to eliminate the barriers between parents and their infants in the NICU by involving parents of premature infants in their care. Parents are integrated into both the healthcare team and the care of their infant. Through this approach, parents are informed about how they can contribute to their infant's overall development, including neurological and sensory development, motor and behavioral progress, as well as practices such as touch, bonding, skin-to-skin contact, breastfeeding, and increasing breast milk production. They are also educated on general hygiene and care tasks such as diaper changing and body cleaning. This model places importance on the protection and enhancement of both the physical and psychological well-being of the parent and the infant. During this process, parents move beyond being mere "visitors" in the unit to becoming active "participants" and members of the care team. Family integrated care aims to support parents in becoming the primary caregivers for their infants, both during hospitalization and after discharge. This model not only provides education and counseling but also supports the family's comprehensive involvement in the infant's care.

Effect and Cost Effectiveness of a Dyadic Empowerment-based Heart Failure Management Program for Self-care

Global population aging has drastically increased healthcare spending worldwide, with the greatest portion going to hospital and community health services. Heart failure (HF), as the final form of many cardiovascular diseases resulting from insufficient myocardial pumping. Ineffective self-care is consistently identified as the major modifiable risk factor for HF decompensation requiring hospitalization. It refers to an active cognitive process that influence patients' engagement in self-care maintenance, symptom perception and self-care management. However, current studies pay much focus on interventions such as motivational interviewing and behavioural activation to enhance the HF-related self-care and health outcomes which only produces short-term benefits. In fact, the lack of a sustainable effect from the self-care supportive interventions might be related the use of patient-centric design in these studies, which totally ignores the fact that HF management takes place in a dyadic context. To advance, active strategies were adopted to mobilize collaborative effort of the dyad in actual disease management. This study aims to evaluate the effects and cost-effectiveness of a Dyadic empowerment-based Heart Failure Management Program (De-HF) for self-care, health outcomes, and health service utilization among HF patients who require family support after hospital discharge. The De-HF program is based on the Theory of Dyadic Illness Management to enhance the congruence in illness perception and active dyadic collaboration in managing HF via both face-to-face and online platforms.

Parent-to-parent Coaching While Awaiting Hospital Discharge With a Child With a Ventilator

The objective of the study is to pilot a parent-to-parent coaching model with experienced family members of children with Invasive Mechanical Ventilation (IMV) as parent coaches.

Co-Creation Workshops With MaKey MaKey to Promote Participation Among People With Mental Health Conditions

This pilot study aims to design, implement, and conduct an initial evaluation of a group-based co-creation workshop program using MaKey MaKey and Scratch for adults attending a mental health day hospital. The program will use low-cost creative technologies as tools to promote social participation, motivation, and empowerment through cooperative experiences adapted to participants' interests, abilities, and needs. The intervention will consist of six weekly sessions lasting approximately 90 minutes each, with the possibility of two additional sessions to complete and present the projects developed. Participants will collaborate in the design of musical activities, cooperative games, interactive narratives, or other creative projects. Assessments will be conducted before and after the intervention, and information will be collected on attendance, participation, usability, incidents, support needs, and adaptations. The feasibility and acceptability of the program, as well as participants' experiences, will also be explored to inform its improvement and potential future implementation in other mental health services.

Effects of a Financial Literacy and Gender-Transformative Couples Intervention on Parenting Practices in India

Many families in India experience intimate partner violence (IPV) and financial stress, both of which can harm the way parents interact with and discipline their children. When parents are under stress, they may be more likely to use harsh physical discipline or be less involved and warm with their children. Improving how couples communicate, manage money together, and relate to each other more fairly may help parents raise their children in healthier and more nurturing ways. This study examines whether a couples-based programme, "Let Us Grow Together: Economic Wellbeing for Families," improves parenting practices among married couples in India. The programme consists of six group sessions attended by husbands and wives together. Sessions cover financial skills such as budgeting, saving, and joint financial planning, alongside topics on respectful relationships, communication, and shared decision-making in the household. Sessions are delivered over approximately five months by trained male and female facilitators, with text message reminders sent between sessions to reinforce key messages. The study is nested within a larger randomised controlled trial called ECOVI (Disentangling and Preventing Economic Violence against Women), conducted across three Indian states: Maharashtra, Andhra Pradesh, and Rajasthan, involving 2,276 married couples. Villages or community groups are randomly assigned to either receive the programme or continue as usual. This random assignment means the study can reliably measure whether the programme, rather than some other factor, caused any changes in parenting. Parenting is assessed at the end of the study (endline) using questions from the s-EMBU-P Questionnaire, a widely used and validated tool. These questions ask mothers and fathers separately about three aspects of parenting: rejection/harsh parenting, emotional warmth/positive parenting and overprotection/control. The study also examines whether any improvements in parenting occur because the programme reduces violence between partners, improves parents' mental health, reduces family financial stress, or improves their relationship. All of these mediators are measured at baseline and endline. Both mothers and fathers are asked about their own parenting practices separately, making this one of the few studies to examine how such a programme affects fathers' and mothers' parenting practices in this context.

Program Intensive Habilitation (PIH) for Young Children With Early Brain Damage

By longitudinal, prospective research in children with neurodisabilities including severe motor impairments and their parents to explore the beneficial effects of participating in an intensive habilitation program on the child's adaptive functioning and parental empowerment in order to treat and reduce the consequences of early brain damage.

Evaluation of REACTS-IN, an Intervention to Improve Nutrition, Hygiene, and Sexual and Reproductive Health Services

This is an independent evaluation of World VIsion's 7-year quasi-experimental intervention to improve nutrition, nutrition-related rights and gender equality for women, adolescent girls, and children under five years of age in rural Bangladesh, Kenya, and Tanzania. The evaluation will collect baseline, midline, and end-line data from intervention communities, schools, and health facilities. Only baseline and endline will be collected on the comparison communities. The evaluation objectives are to test if the intervention improved indicators for (i) child anthropometry, (ii) maternal and child dietary practices, (iii) women's empowerment, and (iv) equitable health service access for nutrition and sexual and reproductive needs. The evaluation analysis will take into account gender differences in the indicators.

Physical Inactivity Among Patients With Cardiovascular Risk

The goal of this clinical trial is to learn if newly developed intervention package works to improve physical activity level among patients with intermediate cardiovascular risk factors. The main questions it aims to answer are: Does the INSPIRE-PA intervention increase the level of physical activity among participants with intermediate cardiovascular risk factors? * What changes occur in physical activity level, BMI and blood pressure following participation in the intervention? * Are there any challenges, barriers, or unintended effects experienced by participants during the intervention period? * Researchers will compare the INSPIRE-PA intervention to usual care to determine whether the empowerment-based strategy is effective in improving physical activity levels and reducing cardiovascular risk among patients attending government primary medical care Iinstitutions. Participants will: * Participate in the INSPIRE-PA program for 6 months * Attend scheduled follow-up visits at the primary medical care institution (e.g., every 2-4 weeks)for counselling, evaluation of physical activity level, and assessment of cardiovascular risk indicators * Engage in structured physical activity as recommended in the intervention package * Record their daily physical activity and any challenges or barriers in a physical activity logbook or diary * Undergo periodic measurements such as blood pressure, weight, waist circumference, and other relevant clinical assessments

Cultural Adaptation of a Web-Based App (myPlan Thailand) to Empower and Support Friends and Family of Intimate Partner Violence Survivors

This research will support and empower friends/family (F/F) of intimate partner violence (IPV) survivors in Thailand, where IPV is critical and common, and survivors first and foremost seek help for abuse from their F/F. myPlan app (www.myPlanapp.org) is a free mobile evidence-based intervention app to prevent IPV. The app was first developed in the United States (US) and has been disseminated to high-income countries (e.g., New Zealand, Canada, Australia) and lowincome (Kenya). One new hope for improving survivors' psychological and well-being is adapting and introducing the myPlan app for the concerned friends/family who support survivors in Thailand. Therefore, the propose of this longitudinal research study, Cultural Adaptation of a Web-Based App (myPlan Thailand) to Empower and Support Friends/Family of Intimate Partner Violence Survivors in Thailand, will have two consecutive phases with three aims: 1) To tailor the myPlan app content for concerned F/F members of Thai IPV survivors, 2) To integrate the adapted myPlan app content for concerned F/F members of Thai IPV survivors, 3) To test the feasibility and acceptability of the adapted myPlan app with concerned F/F members of Thai IPV survivors. Phase 1 (Year 1-2) will achieve aim 1-2 to tailor the myPlan app with Thai survivors and friends/family. The investigators will review current content and conduct in-depth interviews with survivors and concerned F/F members on social norms associated with IPV, informal support systems and the role/responsibility in helping survivors, safety strategies used by concerned F/F members and negative consequences for both survivor and F/F member providing support. Moreover, in phase 1, the adapted content will be pilot tested with concerned F/F members of survivors by using cognitive techniques and theater-testing methodology. Phase 2 (Year 3-4) will achieve aim 3 to test the feasibility and acceptability of the adapted myPlan app with F/F. The investigators will conduct a two-group RCT design with concerned F/F member randomized to receive a) the myPlan app for F/F member, or b) standard usual-care safety planning information. Primary outcomes for F/F members include change in knowledge and attitudes towards IPV and F/F empowerment to plan and take safety support survivor. Secondary outcomes will examine change in F/F' distress, frustration and consequences for supporting the survivor. This phase will also collect feasibility and acceptability data to informed a planned R01 submission in Year 3 of the study. The K43 application outlines a four-year plan to support a candidate who is a nursing instructor with 15 years of work in diverse projects, settings, and disciplines; which positions her for a successful career as an independent researcher in research field of intimate partner violence. The career development plan provides a sequence of carefully selected training and mentoring experiences, including coursework to increase research capacity, leadership skills, mentored research leading to a R01 proposal, peer reviewed publications, and professional networking, that will catapult this research to the next level of research achievement. The team will be a collaboration between the Boromarajonani College of Nursing Khon Kaen (BCNKK), Khon Kaen One Stop Crisis Center (OSCC), Johns Hopkins University (JHU), Notre Dame of Maryland University (NDM), and Auckland University of Technology (AUT), New Zealand.

Empowerment and Mobile Technology in the Control of Cardiovascular Risk Factors in Patients With Ischemic Stroke

The CARDIOSTROKE is a randomized trial comparing mobile-device assisted control of hypertension together with screening of occult atrial fibrillation to standard care in patients with recent ischemic stroke or transient ischemic attack.

Empowerment Program for New Graduated Nurses

This study aimed to develop a training program for the empowerment of newly graduated nurses and to evaluate the effectiveness of this program. The training program designed to empower newly graduated nurses is based on the theories of "structural empowerment" and "psychological empowerment." The training program consists of two parts: face-to-face theoretical training and online training. To evaluate the effectiveness of the training program to be developed for the empowerment of newly graduated nurses, the research was planned as a single-center, parallel-group randomized controlled study, following the Consolidated Reporting Trials Standards (CONSORT) guidelines. The main questions it aims to answer are: 1. Is there a difference between the structural empowerment perception levels of the experimental group nurses who received the empowerment training program and the control group nurses who went through the routine orientation program? 2. Is there a difference between the psychological empowerment perception levels of the experimental group nurses who received the empowerment training program and the control group nurses who went through the routine orientation program? The research population will be newly graduated nurses (12 months or less of experience) working at Koç University Hospital. Experimental and control groups are expected to apply questionnaires including the "Introductory Information Questionnaire, Empowerment Information Evaluation Questionnaire, Nursing Structural Empowerment Scale, and Psychological Empowerment Scale" as a pre-test. Nurses in the control and experimental groups will receive the routine practices of the institution. The training program developed in addition to the experimental group will be applied. Six months after the training, the experimental and control groups are expected to apply the questionnaires, including the Nursing Structural Empowerment Scale, the Psychological Empowerment Scale, and the Empowerment Information Evaluation Questionnaire as a post-test.

Impacts of the Indashyikirwa Program on Intimate Partner Violence in Syria

This study aims to evaluate the effectiveness of the Indashyikirwa program in enhancing women's empowerment and reducing Intimate Partner Violence (IPV) in conflict-affected communities in Northeast Syria. The intervention group will participate in the Indashyikirwa ("Agents of Change") program, which includes a comprehensive couples' training module and access to safe spaces. The control group will not receive the Indashyikirwa program. Both intervention and control groups are beneficieries of Small and Medium Enterprise (SME) support and Vocational Training (VT) to promote economic empowerment. The study employs a cluster-randomized controlled trial (cRCT) design. Out of 30 pre-identified villages, 15 villages were randomly assigned to receive the Indashyikirwa program and 15 villages will not receive the Indashyikirwa program. The villages were located within the same sub-districts to ensure a balanced geographic distribution of the intervention. Based on a power analysis with 80% power, at least 16 married couples from eligible SME and VT beneficiaries will be voluntarily enrolled in each village to receive the Indashyikirwa intervention. Similarly, 16 eligible SME and VT married couples from control villages will be enrolled using the same voluntary participation principle. To account for potential attrition, 20 couples per village will be initially enrolled, ensuring a robust sample size for analysis. This approach results in a total sample size of 600 couples (or 1,200 individual participants). The primary objective of this study is to assess the impact of Indashyikirwa program on key outcomes, including the reduction in IPV, transformation of gender norms, enhancement of women's empowerment, improvements in intra-household dynamics, economic benefits to the household. Data collection will involve structured surveys administered separately to both husbands and wives. Surveys will be conducted at four time points: baseline, 2 months post-intervention, 12 months post-intervention, and 24 months post-intervention.

Strengthening Contraceptive Counseling Services: Research Protocol for a Multi-phase Complex Intervention in Pakistan and Nigeria

High-quality contraceptive counseling can strengthen global efforts to reduce the unmet need for and suboptimal use of modern contraceptives. This study aims to identify a package of contraceptive counseling interventions for Pakistan and Nigeria designed to strengthen existing contraceptive services and determine its effectiveness in increasing clients' level of decision-making autonomy and meeting their contraceptive needs.

STOP DIABETES - Knowledge-based Solutions

The aim of the Stop Diabetes - Knowledge based solutions (StopDia) consortium project (University of Eastern Finland, National Institute for Health and Welfare, and Technical Research Centre of Finland) is to develop and test approaches to identify individuals at increased risk of type 2 diabetes and to empower them in adopting and maintaining a healthy lifestyle by combining individual and environment level strategies into a dual-process approach targeting deliberative and automatic processes of behavior. We also aim to identify barriers and facilitators of adopting a healthy lifestyle in the society, create a model for the prevention of type 2 diabetes by joint actions of health care, third sector, and other societal actors, and develop methods to monitor the cost-effectiveness of these actions. We will carry out a 1-year randomized controlled trial on the effects of among 10 000 individuals aged 18-70 years at increased risk of type 2 diabetes living in Finland. The participants will be randomized into the control group, the digital lifestyle intervention group, or the combined digital and face-to-face lifestyle intervention group. The aim of the interventions is to enhance diet quality, increase physical activity, decrease body weight, and improve glucose tolerance in individuals at increased risk of type 2 diabetes.