Clinical trial NCT06237699: Effects of a Digital Diary on the Psychological Well-being of Former ICU Patients.
Official title: Diary Implementation as a Prelude to Integrated Interventions in Person-centered Care in the Intensive Care Unit
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Depression, Anxiety
Post Traumatic Stress Disorder
Quality of Life
Keywords: Quality of care
Digital ICU Diary
ICU survivors
Relatives
Lead sponsor: Erasmus Medical Center
Sponsor class: OTHER
Collaborators: name: ZonMw: The Netherlands Organisation for Health Research and Development
First posted: 2024-02-01
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Former ICU patients (ICU survivors) \& Relatives of (former) ICU patients

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?

Eligibility criteria: Inclusion criteria for former ICU patients and their relatives:

* Capacity to make decisions autonomously
* Proficiency in the Dutch language
* 18 years of age or older
* ICU length of stay \>48 hours
* No use of an ICU diary before (pre-measurement)
* Used the digital Post-IC diary for more than 1 day (post-measurement)

Exclusion criteria for former ICU patients and their relatives:

* Insufficient proficiency in the Dutch language to express themselves on the subject.
* Patients with a pre-admission diagnosis of psychosis or dementia.
* Use of a paper ICU diary.

Primary outcomes:
measure: Number of participants with Post Traumatic Stress Disorder (PTSD) [IES-R]
timeFrame: 1-3 months after ICU admission
measure: Number of participants with Anxiety or Depression-related symptoms [HADS]
timeFrame: 1-3 months after ICU admission
measure: The participants' level of quality of life [SF36]
timeFrame: 1-3 months after ICU admission
Secondary outcomes:
measure: Relatives' perspectives on the quality of care [CQI-R]
timeFrame: 1 month after ICU admission
Other outcomes:
Locations:
city: Rotterdam
country: Netherlands
facility: Erasmus University medical center
state: South-Holland
city: Enschede
country: Netherlands
facility: Medisch Spectrum Twente
city: Rotterdam
country: Netherlands
facility: Franciscus Gasthuis & Vlietland
city: Tilburg
country: Netherlands
facility: Elisabeth-TweeSteden ziekenhuis
Study officials:
References: