Depression, AnxietyDIPICNCT06237699
Effects of a Digital Diary on the Psychological Well-being of Former ICU Patients.
An observational study of Depression, Anxiety and Post Traumatic Stress Disorder, run by Erasmus Medical Center at 4 sites in Netherlands.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depression, Anxiety, Post Traumatic Stress Disorder, Quality of Life
- What is being tested?
- Digital ICU diary
- How many people
- 400 participants
- Where
- 4 sitesNetherlands
- Study dates
- 1 May 2023to 31 May 2026
- How long will I take part?
- 3 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Former ICU patients (ICU survivors) \& Relatives of (former) ICU patients
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.
Trial locations and contacts
4 sites in 1 country.
Netherlands4 sites, 4 recruiting
- Recruiting
Medisch Spectrum Twente
Enschede
Martin Rinket
- Recruiting
Erasmus University medical center
Rotterdam, South Holland
Ista, w.ista@erasmusmc.nl
Erwin Ista, Dr.
- Recruiting
Franciscus Gasthuis & Vlietland
Rotterdam
Elke Berger, e.berger@franciscus.nl
Elke Berger, MSc
- Recruiting
Elisabeth-TweeSteden ziekenhuis
Tilburg
Annemarie de Vos
About this study
Official title: 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.
Read the 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?
- Being tested
- Digital ICU diary
- Keywords
- Quality of care, Digital ICU Diary, ICU survivors, Relatives
- Medical subject headings
- Depression, Anxiety Disorders, Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digital ICU diaryOther
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).
| Study group | Role | What they receive |
|---|---|---|
| ICU survivors without an ICU diary | Not described | |
| ICU relatives without an ICU diary | Not described | |
| ICU survivors with a digital ICU diary | Not described Receives: Other: Digital ICU diary | |
| ICU relatives with a digital ICU diary | Not described Receives: Other: Digital ICU diary |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with Post Traumatic Stress Disorder (PTSD) [IES-R]
PTSD-related symptoms measured with the IMPACT OF EVENTS SCALE-Revised (IES-R)
Measured: 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)
Measured: 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
Measured: 1-3 months after ICU admission
Secondary outcomes (1)
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)
Measured: 1 month after ICU admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2024
- Study start1 May 2023
- Primary completion31 Aug 2024 (estimated)
- Study completion31 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depression, AnxietyStudies of the same condition, open and under way.
- More trials run by Erasmus Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 400 participants (estimated)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Erasmus Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- ZonMw: The Netherlands Organisation for Health Research and Development
- Responsible party
- Principal investigator, Erwin Ista, Erasmus Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06237699
- Sponsor's protocol ID
- MEC-2022-0580
- Acronym
- DIPIC
- Status last verified
- Jan 2024
- First submitted
- 6 Jan 2024
- Last updated
- 1 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: We ask the participants permission if other studies can you the data also
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diary Implementation as a Prelude to Integrated Interventions in Person-centered Care in the Intensive Care Unit
- ClinicalTrials.gov ID
- NCT06237699
- Acronym / sponsor ID
- DIPIC / MEC-2022-0580
- Keywords
- Quality of care, Digital ICU Diary, ICU survivors, Relatives
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Erasmus Medical CenterUniversity, hospital or other
- Collaborators
- ZonMw: The Netherlands Organisation for Health Research and Development
- Study start
- 1 May 2023 (actual)
- Primary completion
- 31 Aug 2024 (estimated)
- Study completion
- 31 May 2026 (estimated)
- First posted
- 1 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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?
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Months
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Former ICU patients (ICU survivors) \& Relatives of (former) ICU patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Digital ICU diaryA 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). | Other | ICU relatives with a digital ICU diary, ICU survivors with a digital ICU diary |
Primary outcome
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)
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)
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 secondary outcome
Relatives' perspectives on the quality of care [CQI-R]
Time frame: 1 month after ICU admission
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2024.
- Individual participant dataSharing planned: Undecided. We ask the participants permission if other studies can you the data also
Related trials for Depression, Anxiety
Recruiting
Unified Protocol in Penitentiary Facilities
Depression Disorders, Anxiety
Not yet recruiting
Preventive and Personalized Digital Emotion Regulation Skills Intervention to Reduce Depression and Anxiety in Youths With Adverse Childhood Experiences
Adverse Childhood Experience, Depression / Major Depressive Disorder
Not yet recruitingObservational study
Functional Impact of Psychological Symptoms in Patients With Superior Semicircular Canal Dehiscence Syndrome (SSCD): a National Cross-sectional Study
Superior Semicircular Canal Dehiscence
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
Recruiting
Cultural Adaptation of an Online Parenting Intervention to Reduce the Risk of Depression and Anxiety in Adolescents
Risk of Depression and Anxiety
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Depression, Anxiety and Post Traumatic Stress Disorder, run by Erasmus Medical Center at 4 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Carola Schol (+31623949775, c.schol@erasmusmc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with Post Traumatic Stress Disorder (PTSD) [IES-R] (time frame: 1-3 months after ICU admission). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2024.