Evaluating the impact of diaries for ICU patients and their families
Efficacy of the Use of Diaries in Intensive Care Units
This study is testing if giving diaries to ICU patients and their families helps improve their mental health and quality of life compared to standard care.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 240 (estimated) |
| Ages | 18 Years to 100 Years |
| Sex | All |
| Sponsor | University of Barcelona Academic / other |
| Locations | 1 site (Barcelona) |
| Trial ID | NCT05288140 on ClinicalTrials.gov |
What this trial studies
This clinical trial assesses the effectiveness of using diaries for patients and their families in intensive care units compared to standard care. It involves a randomized, parallel, open-label design with two groups: one receiving a diary and the other following usual practice. The study aims to measure health-related quality of life, post-traumatic stress, and anxiety/depression at 2, 6, and 12 months post-ICU discharge using validated scales. A total of 240 participants will be involved, with data analyzed using IBM SPSS software.
Who should consider this trial
Good fit: Ideal candidates include patients admitted to the ICU who are sedated and mechanically ventilated for at least 24 hours.
Not a fit: Patients with psychiatric, mental, or cognitive issues, or those unwilling to participate voluntarily may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve the mental health and quality of life for ICU patients and their families.
How similar studies have performed: While the use of diaries in healthcare settings is not widely tested in ICUs, similar approaches in other contexts have shown positive outcomes.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * admitted intensive care unit * sedated and mechanically ventilated for 24hours * signed consent * not language barrier * willingness to attend follow-up visits Exclusion Criteria: * verbal manifestation of psychiatric, mental or cognitive antecedents * who do not coluntarily agree to participate
Where this trial is running
Barcelona
- Universidad de Barcelona — Barcelona, Spain (Recruiting)
Study contacts
- Study coordinator: Pilar Muñoz Rey
- Email: mpmunozr.germanstrias@gencat.cat
- Phone: 639534904
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.