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

January 25, 2024 updated by: Erwin Ista, Erasmus Medical Center

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

400

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Netherlands
      • Enschede, Netherlands
        • Recruiting
        • Medisch Spectrum Twente
        • Contact:
          • Martin Rinket
      • Rotterdam, Netherlands
        • Recruiting
        • Franciscus Gasthuis & Vlietland
        • Contact:
        • Sub-Investigator:
          • Elke Berger, MSc
      • Tilburg, Netherlands
        • Recruiting
        • Elisabeth-TweeSteden Ziekenhuis
        • Contact:
          • Annemarie de Vos
    • South-Holland
      • Rotterdam, South-Holland, Netherlands
        • Recruiting
        • Erasmus University Medical Center
        • Contact:
        • Principal Investigator:
          • Erwin Ista, Dr.
        • Principal Investigator:
          • Margo van Mol, Dr.
        • Sub-Investigator:
          • Carola Schol, MSc

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

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

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
ICU survivors without an ICU diary
ICU relatives without an ICU diary
ICU survivors with a digital ICU diary
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).
ICU relatives with a digital ICU diary
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants with Post Traumatic Stress Disorder (PTSD) [IES-R]
Time Frame: 1-3 months after ICU admission
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]
Time Frame: 1-3 months after ICU admission
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]
Time Frame: 1-3 months after ICU admission
The participants' level of quality of life measured with 36-Item Short Form Health Survey SF-36
1-3 months after ICU admission

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Erasmus Medical Center

Collaborators

ZonMw: The Netherlands Organisation for Health Research and Development

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2023

Primary Completion (Estimated)

August 31, 2024

Study Completion (Estimated)

May 31, 2026

Study Registration Dates

First Submitted

January 6, 2024

First Submitted That Met QC Criteria

January 25, 2024

First Posted (Estimated)

February 1, 2024

Study Record Updates

Last Update Posted (Estimated)

February 1, 2024

Last Update Submitted That Met QC Criteria

January 25, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MEC-2022-0580

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

We ask the participants permission if other studies can you the data also

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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