UMIN-CTR Clinical Trial

Public title

Effectiveness of Family Involvement Related to Mobilization for Critically Ill Patients on Family Satisfaction: A Multicenter Randomized Controlled Trial

Acronym

FIRM-S trial

Scientific Title

Effectiveness of Family Involvement Related to Mobilization for Critically Ill Patients on Family Satisfaction: A Multicenter Randomized Controlled Trial

Scientific Title:Acronym

FIRM-S trial

Region

Japan

Condition

Post Intensive Care Syndrome-Family
Post Intensive Care Syndrome

Classification by specialty

Intensive care medicine

Adult

Classification by malignancy

Others

Genomic information

NO

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

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Family satisfaction at ICU discharge, assessed with the Japanese version of the FS-ICU 24R overall satisfaction score (0-100 scale; higher scores indicate greater satisfaction)

Key secondary outcomes

<Family participant outcomes>
PICS-F at 3, 6, and 12 months after randomization, defined as the presence of any of the following: IES-R >=25, HADS-A >=8, HADS-D >=8, or ICG >=25 (The ICG assessed only for bereaved family members whose patient died before or at hospital discharge). All assessments of the IES-R, HADS, and ICG will be conducted using the validated Japanese versions of these instruments.
IES-R at 3, 6, and 12 months.
IES-R >=25 at 3, 6, and 12 months.
Change in IES-R from baseline to 3, 6, and 12 months.
HADS-A at 3, 6, and 12 months.
HADS-A >=8 at 3, 6, and 12 months.
Change in HADS-A from baseline to 3, 6, and 12 months.
HADS-D at 3, 6, and 12 months.
HADS-D >=8 at 3, 6, and 12 months.
Change in HADS-D from baseline to 3, 6, and 12 months.
ICG >=25 at 3, 6, and 12 months.
EQ-5D at 3, 6, and 12 months.
Change in EQ-5D from baseline to 3, 6, and 12 months.
FS-ICU 24R domain scores for Satisfaction with Care and Satisfaction with Decision-Making.
FS-ICU 24R item-level scores.
Number of family visits.

<Patient participant outcomes>
ICU discharge disposition.
ICU length of stay.
Duration of invasive mechanical ventilation.
Ventilator-free days to day 28, defined as 28 minus the number of days on invasive ventilation between randomization and day 28; assigned 0 for deaths before day 28.
Hospital discharge disposition.
Hospital length of stay.
Incidence of delirium during the ICU stay.
Mean Mobilization Quantification Score (MQS) across ICU stay.
Mean rehabilitation time per session during ICU stay.
Number of days rehabilitation was performed.
Patient-reported EQ-5D at 3, 6, and 12 months for survivors.
Change in patient EQ-5D from baseline to 3, 6, and 12 months for survivors.
Barthel Index (BI) at 3, 6, and 12 months for survivors.
Change in BI from baseline to 3, 6, and 12 months for survivors.
HABC-M SR at 3, 6, and 12 months for survivors.

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

No treatment

Stratification

YES

Dynamic allocation

NO

Institution consideration

Blocking

YES

Concealment

Central registration

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Other

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.

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

18

years-old

<=

Age-upper limit

120

years-old

>

Gender

Male and Female

Key inclusion criteria

<Inclusion criteria for family participants>
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

<Inclusion criteria for patient participants>
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

<Exclusion criteria for family participants>
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

<Exclusion criteria for patient participants>
Previous enrollment in this trial
Native language other than Japanese

Target sample size

80

Name of lead principal investigator

1st name	Iwami
Middle name
Last name	Taku

Organization

Graduate School of Medicine, Kyoto University

Division name

Department of Preventive Services, School of Public Health

Zip code

6068501

Address

Yoshida-Konoe-cho, Sakyo-ku, Kyoto City

TEL

075-753-4400

Email

info@yobou.med.kyoto-u.ac.jp

Name of contact person

1st name	Takefumi
Middle name
Last name	Tsunemitsu

Organization

Graduate School of Medicine, Kyoto University

Division name

Department of Preventive Services, School of Public Health

Zip code

6068501

Address

Yoshida-Konoe-cho, Sakyo-ku, Kyoto City

TEL

075-753-4400

Homepage URL

Email

tsunemitsu0730@yahoo.co.jp

Institute

Kyoto University

Institute

Department

Personal name

Organization

Public Health Research Foundation

Organization

Division

Category of Funding Organization

Non profit foundation

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Kyoto University Graduate School and Faculty of Medicine, Ethics Committee

Address

53 Shogoin-kawahara-cho, Sakyo-ku, Kyoto 606-8507, Japan

Tel

075-366-7618

Email

ethcom@kuhp.kyoto-u.ac.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2025

Year

09

Month

25

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

Results

Results date posted

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Participant flow

Adverse events

Outcome measures

Plan to share IPD

IPD sharing Plan description

Recruitment status

Preinitiation

Date of protocol fixation

2025

Year

09

Month

01

Day

Date of IRB

Anticipated trial start date

2025

Year

12

Month

01

Day

Last follow-up date

2027

Year

03

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2025

Year

09

Month

22

Day

Last modified on

2025

Year

09

Month

22

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067634