Effects of a Digital Diary on the Psychological Well-being of Former ICU Patients.

Recruiting

• Conditions: Depression, Anxiety; Quality of Life; Post Traumatic Stress Disorder
• Interventions: Other: Digital ICU diary

• Registration Number: NCT06237699
• Lead Sponsor: Erasmus Medical Center

Brief Summary

Previous research on the impact of a diary on mental symptoms of PICS, PICS-F, and quality of life in former ICU patients and their relatives has focused specifically on a paper diary. While there has been research on the experiences of former ICU patients, relatives, and ICU nurses regarding the use of a digital diary, it is not known whether this diary has an impact on the psychological well-being and quality of life of former ICU patients and their relatives. A successful implementation of \[the digital diary\] enables this research. The aim of this study is, therefore, to provide an initial impression of the health-related effects of a digital diary on former ICU patients and their relatives.

Detailed Description

Objective: Exploring health-related effects of a digital ICU diary in former ICU patients and their relatives.

Research question 1: What is the effect of a digital ICU diary on the psychological well-being and quality of life in former ICU patients and their relatives? Research question 2: What is the effect of a digital ICU diary on the perceived quality of care and satisfaction with the ICU admission among relatives of former ICU patients?

Study Timeline

• Study Start: 2023-05-01
• Status Verified: 2024-01
• Study First Submitted: 2024-01-06
• Study First Submitted QC: 2024-01-25
• Last Update Submitted: 2024-01-25
• Study First Posted: 2024-02-01
• Last Update Posted: 2024-02-01
• Primary Completion: 2024-08-31
• Study Completion: 2026-05-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
ICU relatives with a digital ICU diary	Digital ICU diary	-
ICU survivors with a digital ICU diary	Digital ICU diary	-

Primary Outcome Measures

Name	Time	Method
Number of participants with Post Traumatic Stress Disorder (PTSD) [IES-R]	1-3 months after ICU admission	PTSD-related symptoms measured with the IMPACT OF EVENTS SCALE-Revised (IES-R)
Number of participants with Anxiety or Depression-related symptoms [HADS]	1-3 months after ICU admission	Anxiety-related and depression-related symptoms measured with Hospital Anxiety and Depression Scale (HADS)
The participants' level of quality of life [SF36]	1-3 months after ICU admission	The participants' level of quality of life measured with 36-Item Short Form Health Survey SF-36

Secondary Outcome Measures

Name	Time	Method
Relatives' perspectives on the quality of care [CQI-R]	1 month after ICU admission	Relatives' perspectives on quality of care and satisfaction measured with Consumer Quality Index- Relatives (CQI-R)

Trial Locations

Locations (4)

Erasmus University medical center; 🇳🇱 Rotterdam, South-Holland, Netherlands

Medisch Spectrum Twente; 🇳🇱 Enschede, Netherlands

Franciscus Gasthuis & Vlietland; 🇳🇱 Rotterdam, Netherlands

Elisabeth-TweeSteden ziekenhuis; 🇳🇱 Tilburg, Netherlands