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

NCT ID: NCT06237699

Last Updated: 2024-02-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

400 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-05-01

Study Completion Date

2026-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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?

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Depression, Anxiety Post Traumatic Stress Disorder Quality of Life

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

ICU survivors without an ICU diary

No interventions assigned to this group

ICU relatives without an ICU diary

No interventions assigned to this group

ICU survivors with a digital ICU diary

Digital ICU diary

Intervention Type 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

Digital ICU diary

Intervention Type 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).

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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).

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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

* 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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

ZonMw: The Netherlands Organisation for Health Research and Development

OTHER

Sponsor Role collaborator

Erasmus Medical Center

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Erwin Ista

Associate professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Erasmus University medical center

Rotterdam, South Holland, Netherlands

Site Status RECRUITING

Medisch Spectrum Twente

Enschede, , Netherlands

Site Status RECRUITING

Franciscus Gasthuis & Vlietland

Rotterdam, , Netherlands

Site Status RECRUITING

Elisabeth-TweeSteden ziekenhuis

Tilburg, , Netherlands

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Netherlands

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Carola Schol

Role: CONTACT

+31623949775

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Ista

Role: primary

Martin Rinket

Role: primary

Elke Berger

Role: primary

Annemarie de Vos

Role: primary

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

MEC-2022-0580

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Health Questionnaire Study
NCT06956378 ACTIVE_NOT_RECRUITING NA