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

NCT06237699 | Recruiting

• 1 other identifier: MEC-2022-0580
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 4

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.

Conditions

Depression, Anxiety; Post Traumatic Stress Disorder; Quality of Life

Keywords

Quality of care; Digital ICU Diary; ICU survivors; Relatives

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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 Outcomes (1)

• Relatives' perspectives on the quality of care [CQI-R]

  1 month after ICU admission

Study Arms (4)

ICU survivors without an ICU diary

ICU relatives without an ICU diary

ICU survivors with a digital ICU diary

Other: Digital ICU diary

ICU relatives with a digital ICU diary

Other: Digital ICU diary

Interventions

Digital ICU diary OTHER

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).

ICU relatives with a digital ICU diary; ICU survivors with a digital ICU diary

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Former ICU patients (ICU survivors) \& Relatives of (former) ICU patients

You may qualify if:

• Capacity to make decisions autonomously
• Proficiency in the Dutch language
• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Erasmus Medical Center: lead
• ZonMw: The Netherlands Organisation for Health Research and Development: collaborator

Study Sites (4)

Erasmus University medical center

Rotterdam, South Holland, Netherlands

RECRUITING

Medisch Spectrum Twente

Enschede, Netherlands

RECRUITING

Franciscus Gasthuis & Vlietland

Rotterdam, Netherlands

RECRUITING

Elisabeth-TweeSteden ziekenhuis

Tilburg, Netherlands

RECRUITING

MeSH Terms

Conditions

Depression; Anxiety Disorders; Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders

Central Study Contacts

Carola Schol

CONTACT

+31623949775; c.schol@erasmusmc.nl

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: January 6, 2024
• First Posted: February 1, 2024
• Study Start: May 1, 2023
• Primary Completion: August 31, 2024
• Study Completion (Estimated): May 31, 2026
• Last Updated: February 1, 2024

Record last verified: 2024-01

Locations

NL (4)