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

Quality of Life Clinical Trial

— DIPIC  

Official title:

Diary Implementation as a Prelude to Integrated Interventions in Person-centered Care in the Intensive Care Unit

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06237699
• Other study ID #: MEC-2022-0580
• Status: Recruiting
• Start date: May 1, 2023
• Est. completion date: May 31, 2026

Study information

• Verified date: January 2024
• Source: Erasmus Medical Center
• Contact: Carola Schol
• Phone: +31623949775
• Email: c.schol[@]erasmusmc.nl
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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?

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: May 31, 2026
• Est. primary completion date: August 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Depression, Anxiety
• Post Traumatic Stress Disorder
• Quality of Life
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

Other:
• Digital ICU diary
A digital ICU diary is an electronic platform or application designed to facilitate the documentation and communication of the experiences, progress, and medical journey of patients in the Intensive Care Unit (ICU).

Locations

Country	Name	City	State
Netherlands	Medisch Spectrum Twente	Enschede
Netherlands	Erasmus University medical center	Rotterdam	South-Holland
Netherlands	Franciscus Gasthuis & Vlietland	Rotterdam
Netherlands	Elisabeth-TweeSteden ziekenhuis	Tilburg

Sponsors (2)

Lead Sponsor	Collaborator
Erasmus Medical Center	ZonMw: The Netherlands Organisation for Health Research and Development

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with Post Traumatic Stress Disorder (PTSD) [IES-R]	PTSD-related symptoms measured with the IMPACT OF EVENTS SCALE-Revised (IES-R)	1-3 months after ICU admission
Primary	Number of participants with Anxiety or Depression-related symptoms [HADS]	Anxiety-related and depression-related symptoms measured with Hospital Anxiety and Depression Scale (HADS)	1-3 months after ICU admission
Primary	The participants' level of quality of life [SF36]	The participants' level of quality of life measured with 36-Item Short Form Health Survey SF-36	1-3 months after ICU admission
Secondary	Relatives' perspectives on the quality of care [CQI-R]	Relatives' perspectives on quality of care and satisfaction measured with Consumer Quality Index- Relatives (CQI-R)	1 month after ICU admission