Family-centered Care

9

Review clinical trials related to Family-centered Care. Use filters to narrow results by trial status, phase, treatment, biological sex and sponsor.

Condition / disease
Location
Status: Recruiting

Close Collaboration and Discharge Readiness

This prospective non-randomized controlled before-after comparison study aims to evaluate the effects of the Close Collaboration with Parents, a family-centered care intervention for NICU staff, on parents of the newborns in the neonatal intensive care unit (NICU). We focus on (1) family centered care of the NICU rated by parents, (2) parental anxiety symptoms, and (3) their discharge readiness. The intervention is planned to be implemented between December 2023 and December 2024. The investigators will collect data from parents whose newborns are admitted to the NICU before and after the intervention and compare the two groups. In most cases, the parents of the two groups belong to different cohorts.

Participants needed: 60
Trial details
Biological sex: AllType: ObservationalSponsor: Nagano Children's HospitalUpdated: Apr 13, 2026Locations: 1
Eligibility criteria

Infants who have been admitted to the NICU for 2 weeks or longer

Infants whose parent doesn't have Japanese as their mother tongue [+1]

Status: Recruiting

The Family-ICU Trial

Family inclusion in adult intensive care unit (ICU) rounds is recommended by critical care professional societies, yet widespread uptake of this practice is limited. A key barrier cited by ICU clinicians is insufficient evidence to support this practice. There is a need for robust evidence to support family participation in adult ICU rounds and influence change to routine clinical care. The primary purpose of this study is to assess whether family participation in adult ICU rounds improves family engagement in care. The secondary objectives are to assess family satisfaction, and anxiety and depression, to explore user experiences of family participation in ICU rounds, and to evaluate strategies to improve family member recruitment and retention rates. This is a stepped-wedge cluster randomized trial (n=194) at 6 Canadian ICUs. The stepped wedge cluster randomized trial is a pragmatic study design that overcomes methodological limitations in evaluating a healthcare service delivery intervention. In the stepped-wedge cluster design, there is random and sequential crossover of clusters from control (phase 1) to intervention (phase 2) until all clusters are exposed. The stepped-wedge design also allows each site to function as its own control. The stepped-wedge design is more powerful than a parallel design when substantial cluster level effects are present.

Participants needed: 194
Trial details
Age: 18+Biological sex: AllType: InterventionalSponsor: Lady Davis InstituteUpdated: Mar 31, 2026Locations: 2
Eligibility criteria

Adult family members (age ≥ 18 years) of ICU patients [+2]

Family members who do not wish to participate in care [+2]

Status: Recruiting

Effectiveness of Family-Integrated Newborn Care to Improve Outcomes for Preterm and Low-birth-weight Neonates

The goal of this quasi-experimental study is to learn if integrating family in newborn care units as a key partner can improve the outcomes of preterm and low-birth-weight neonates. The main question\[s\] that the study aims to answer: • Does the implementation of the FINC intervention impact the neonatal outcomes for preterm and low-birth weight neonates in NCUs in resource-limited settings of Tigray, Northern Ethiopia? Researchers will compare the Length of hospital stay among preterm and low-birth-weight neonates admitted to hospitals included in the intervention groups and compared to the neonates admitted to hospitals in the control group. In the intervention groups, family of preterm and low-birth-weight neonates will be trained, mentored, and integrated into the care targeted to their neonates.

Participants needed: 1,020
Trial details
Biological sex: AllType: InterventionalSponsor: Laerdal FoundationUpdated: Jan 23, 2026Locations: 2
Eligibility criteria

All neonates aged 0-28 days admitted to level-2 NCUs in the neonatal care unit,... [+1]

Neonates with major congenital anomalies [+2]

Status: Recruiting

Effects of Early Physiotherapy Program on the Infants in NICU

High-risk of Infants are defined as one with a history of negative environmental and biological factors that could lead to neuromotor developmental problems. This heterogeneous group encompasses premature babies born at less than 37 weeks, term babies with low birth weight (LBW), or babies with developmental delays due to various causes.Studies have highlighted that individual developmental care, family education, kangaroo care, and early physiotherapy approaches applied to at-risk infants in the neonatal intensive care unit (NICU) enhance infant development. However, further research is needed to determine the most effective interventions for infants who are more environmentally at risk and biologically vulnerable. Studies investigating the effectiveness of early intervention methods initiated in the NICU on the motor, cognitive, and behavioral outcomes of premature infants have highlighted that postural control interventions or physiotherapy consisting of developmental care programs implemented in the neonatal period improve motor development in the short term, but parent-implemented motor interventions are more effective in improving infants' cognitive and motor outcomes in the long term.The aim of this study is to examine the effects of family-based early physiotherapy approaches applied to at-risk infants in the NICU on motor, cognitive, language development and developmental outcomes at term age and in the long term (adjusted 3, 6, 9, 12 months).

Participants needed: 100
Trial details
Age: 28-42Biological sex: AllType: InterventionalSponsor: Kahramanmaras Sutcu Imam UniversityUpdated: Oct 1, 2025Locations: 1
Eligibility criteria

Newborns diagnosed with periventricular hemorrhage (PVH), intracranial hemorrhag... [+2]

Newborns with congenital malformations (spina bifida, congenital muscular tortic...

Status: Not yet recruiting

The Family Cares Trial

The goal of this pilot study is to learn if virtual peer support groups and strengths-based skills training can help family caregivers of ICU survivors providing ongoing support to ICU survivors after hospital discharge. The main question it aims to answer is: \- Are virtual peer support groups and/or strengths-based skills support feasible and acceptable for family caregivers of ICU survivors? Researchers will compare the intervention group (virtual peer support groups or strengths-based skills training) to the control group (no intervention) to see if the interventions improve caregiver outcomes and assess feasibility and acceptability. Participants will: * Participate in either virtual peer support groups or strengths-based skills training sessions (if assigned to the intervention arm). * Provide feedback on the feasibility and acceptability of the interventions (if assigned to the intervention arm). * Complete surveys and follow-up questionnaires (either online or by phone) to measure outcomes.

Participants needed: 60
Trial details
Age: 18+Biological sex: AllType: InterventionalSponsor: Lady Davis InstituteUpdated: May 22, 2025Locations: 2
Eligibility criteria

(1) Family member of a person admitted to an ICU for >48 hours and survived to h... [+3]

(1) Another family member participating in the study [+1]

Status: Recruiting

Increasing Family Engagement in Critical Care

The primary aim of this trial is to evaluate if the NGAGE tool improves care engagement in family members of ICU patients. The secondary objectives are to assess if the NGAGE tool improves communication, care satisfaction, psychological symptoms, and quality of life in family members of ICU patients. The NGAGE trial is a stepped wedge cluster randomized trial of 6 Canadian adult ICUs, involving 194 family members. A family member will be considered anyone with a biological, emotional, or legal relationship with the patient and whom the patient wishes to be involved in their care. There will be random and sequential crossover of clusters from control (phase 1) to intervention (phase 2) until all clusters are exposed. The intervention group will have access to the NGAGE tool, which has modules to Learn, Engage, and Report. "Engage" allows the family member to indicate their desired engagement activity, which is then transmitted to the treating healthcare team to provide the requested activity. "Learn" contains educational capsules about the ICU environment and information about care participation. "Report" allows the family member to provide real-time feedback to the healthcare team. The primary endpoint is the FAMily Engagement (FAME) score within 1 week of ICU discharge. Secondary endpoints are family-centered outcomes, including communication quality, satisfaction, and mental health (anxiety and depression) scores within 1 week of ICU discharge, and quality of life and mental health (anxiety, depression, and post-traumatic distress symptoms) at 6 months. The mean difference of the validated FAME score, a continuous variable, will be compared between groups.

Participants needed: 194
Trial details
Age: 18+Biological sex: AllType: InterventionalSponsor: Lady Davis InstituteUpdated: May 18, 2025Locations: 2
Eligibility criteria

Adult family members (age ≥ 18 years) of ICU patients [+2]

Family members who do not wish to participate in care [+2]

Status: Not yet recruiting

The Effect of Parental Presence on the Child's Comfort and Physiologic Parameters in PICU

The study was planned to be conducted and completed within 6 months after ethics committee approval was obtained. The research is a prospective, quasi-experimental study. The population of the study will consist of children hospitalized in the Pediatric Intensive Care Unit of SBU, Izmir Dr. Behçet Uz Pediatric Diseases and Surgery Training and Research Hospital. Randomization of children will be done to determine which children's data will be followed on the relevant visit day. Physiologic parameters including respiratory rate, pulse rate, oxygen saturation, body temperature, blood pressure and comfort levels of the children will be evaluated just before, during and after the parental visit (1st minute and 5th minute) and compared with those before the parental visit. All observations will be made by the same nurse to avoid bias in the study.

Participants needed: 50
Trial details
Age: 0-3Biological sex: AllType: ObservationalSponsor: Izmir Katip Celebi UniversityUpdated: Apr 9, 2025
Eligibility criteria

Being hospitalized in Behçet Uz Pediatric Intensive Care Unit [+1]

Status: Recruiting

Multidimensional Assessment of Infant, Parent and Staff Outcomes During a Family Centered Care Enhancement Project

This prospective single centre longitudinal cohort study enrols preterm infants ≤32+0 weeks of gestation and/or birthweight ≤1500g and their parents. Following a baseline period additional Family Centred Care elements are introduced as potentially better practices, these elements focus on four areas: the NICU (Neonatal Intensive Care Unit) environment, staff training, parental education and psychosocial support to the families. The effect of the implementation of additional Family Centred Care elements on infant, parent and staff outcomes are assessed. The parallel data collection enables to study the interrelation between these three important areas of research.

Participants needed: 495
Trial details
Age: 1-14Biological sex: AllType: ObservationalSponsor: University of GiessenUpdated: Mar 30, 2025Locations: 2
Eligibility criteria

≤32+0 weeks of gestational age (GA) and/or birthweight ≤1500g [+1]

severe congenital anomalies (e.g. cyanotic heart disease, severe lung hypoplasia... [+3]

Status: Not yet recruiting

A Digital Game on Promoting Family Well-being

Advances in information communication technologies (ICT) allow for ICT-assisted health promotion to become more common. Integrating ICT in health promotion has been suggested to offer many advantages compared to traditional approaches to promote family well-being. Research has also shown the positive effects of game-based approaches in enhancing health promotion interventions, especially with children. We will develop and conduct an online survey to assess the use of games and gamification for health promotion, as well as a family-based randomized controlled trial to promote healthy living.

Participants needed: 800
Trial details
Age: 10+Biological sex: AllType: InterventionalSponsor: The University of Hong KongUpdated: Oct 3, 2024Locations: 1
Eligibility criteria

Chinese-speaking; [+3]