Tokyo, Sept. 25 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059152) titled 'Effectiveness of Family Involvement Related to Mobilization for Critically Ill Patients on Family Satisfaction: A Multicenter Randomized Controlled Trial' on Sept. 25.

Study Type: Interventional

Study Design: Basic Design - Parallel Randomization - Randomized Blinding - Open -no one is blinded Control - No treatment

Primary Sponsor: Institute - Kyoto University

Condition: Condition - Post Intensive Care Syndrome-Family Post Intensive Care Syndrome Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - This study will investigate whether family participation in mobilization of critically ill patients admitted to the ICU, compared with no family participation, influences family satisfaction after ICU discharge and the incidence of Post intensive care syndrome-family (PICS-F) at 3, 6, and 12 months after randomization. In addition, the study will assess the safety of family participation in mobilization and its potential effects on patient outcomes, including discharge disposition and length of ICU and hospital stay. Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - Participants randomized to the intervention group will receive, in addition to usual ICU care, a complex intervention termed family involvement related to mobilization. In this study, "mobilization" refers to interventions aimed at restoring physical and social functioning in ICU patients, including early mobilization, exercise therapy, and respiratory training, delivered by physiotherapists, occupational therapists, or nurses with at least six months of ICU experience. Family participants allocated to the intervention arm will be contacted by healthcare providers, typically via telephone, with information regarding the scheduled start time of mobilization sessions. Upon arrival, family participants will be screened by staff to confirm overall good health and absence of infectious disease, and will be required to wear a mask and gloves. They will then participate in the mobilization alongside rehabilitation staff. Family participation will follow a standardized "Family Involvement in Mobilization Program", developed and shared among rehabilitation staff before trial initiation. The intervention also includes increased opportunities for family contact, visitation, and communication with healthcare providers, in addition to mobilization participation. The intervention will continue until 28 days after randomization or ICU discharge, whichever occurs first. After day 28, intervention delivery is optional and outcome measurements are no longer required. Family participants in the intervention arm who do not participate in any mobilization sessions will be considered protocol deviations. Interventions/Control_2 - The control group will receive usual ICU care as delivered at the participating sites. At the time of trial initiation, structured family participation in mobilization is not part of standard care in these ICUs. Thus, the control group can be considered "no family participation in mobilization." Family participants in the control group will not be intentionally contacted about mobilization schedules. No restrictions will be placed on other treatments for patients or families. If a family participant in the control group engages in mobilization, this will be considered a protocol deviation.

Eligibility: Age-lower limit - 18 years-old

Gender - Male and Female Key inclusion criteria - Age >=18 years Within the second degree of kinship with the patient participant or partner Independent in activities of daily living (ADL) Able to provide informed consent within 72 hours after the patient participant's ICU admission

Age >=18 years Emergency admission to the ICU Expected to require mechanical ventilation for >=48 hours Not expected to die prematurely The prediction of >=48 hours of ventilation and non-early death will be made by a physician with at least six months of ICU experience. Key exclusion criteria - Receiving psychiatric treatment Native language other than Japanese Anticipated difficulty visiting the hospital Anticipated difficulty completing web-based questionnaires Judged inappropriate by the attending physician

Previous enrollment in this trial Native language other than Japanese Target Size - 80

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2025 Year 09 Month 01 Day Anticipated trial start date - 2025 Year 12 Month 01 Day Last follow-up date - 2027 Year 03 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067634

Disclaimer: Curated by HT Syndication.