NCT07631260

Brief Summary

To create a constructive ICU diary and to comprehend the effect of Constructive ICU Diary on Stress, Sleep Disturbances and Fatigue of Primary Family Caregiver in ICUs.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
142

participants targeted

Target at P50-P75 for not_applicable

Timeline
18mo left

Started Nov 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress63%
Nov 2023Dec 2027

Study Start

First participant enrolled

November 10, 2023

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

November 26, 2024

Completed
1.5 years until next milestone

First Posted

Study publicly available on registry

June 8, 2026

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Last Updated

June 8, 2026

Status Verified

June 1, 2026

Enrollment Period

4.1 years

First QC Date

November 26, 2024

Last Update Submit

June 3, 2026

Conditions

Sleep

Keywords

ICUfamily caregiversleep disturbance

Outcome Measures

Primary Outcomes (3)

  • sleep disturbance

    questionnaire

    one week

  • fatigue severity

    LFS

    one week

  • stress

    IES-R

    one week

Study Arms (2)

interventional

EXPERIMENTAL
Other: ICU diary

Control group

NO INTERVENTION

Interventions

ICU diaryOTHER

ICU diary

interventional

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • caregivers who has ICU patients using ventilators for more than 48 hours

You may not qualify if:

  • sleep disturbance history

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Taichung Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation

Taichung, Not in USA, 427, Taiwan

Location

MeSH Terms

Conditions

Parasomnias

Condition Hierarchy (Ancestors)

Sleep Wake DisordersNervous System DiseasesMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Sponsor

Study Record Dates

First Submitted

November 26, 2024

First Posted

June 8, 2026

Study Start

November 10, 2023

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2027

Last Updated

June 8, 2026

Record last verified: 2026-06

Locations

TW(1)