Post-Intensive Care SyndromeFOREVERNCT04961697
Family and Patient Outcomes After Pediatric Intensive Care (FOREVER)
A study testing Hospital diaries in people with Post-Intensive Care Syndrome and Anxiety, run by D'Or Institute for Research and Education at 1 site in Brazil.
Trial summary
This study aims to evaluate in the Brazilian context, the impact of the implementation of a diary program on patient and family-centered outcomes after PICU discharge. The intervention investigated will be the use of hospital diaries for the critically ill child in a cross-over study, randomized by clusters in four… Read more about this study
- Who is it for?
- Ages 29 days to 12 years
- Conditions the study is for
- Post-Intensive Care Syndrome, Anxiety, Depression
- What is being tested?
- Hospital diaries
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 431 participants
- Where
- 1 siteBrazil
- Study dates
- 20 Dec 2019to 16 Dec 2021
- Phase
- Interventional
- 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 29 days to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Patients between age limits admitted in PICU for clinical or surgical reasons with 36 or more hours of stay and their main family member.
- Physicians, registered nurses, nurse technicians, physical therapists and other professionals working in participants PICU involved in caring for patients and their families and taking notes in the diaries
Who cannot join
- Patients admitted for monitorization or elective low-complexity surgeries
- Patients readmitted between the first admission and the first follow-up visit
- Patients in palliative care
- Families with linguistic or comprehension barriers
- Families residencies situated outside Rio de Janeiro metropolitan region
Trial locations and contacts
1 site in 1 country.
Brazil1 site
D'Or Institute for Research and Education
Rio de Janeiro, Rio de Janeiro, 22281-100
About this study
Official title: Family and Patient Outcomes After Pediatric Intensive Care
This study aims to evaluate in the Brazilian context, the impact of the implementation of a diary program on patient and family-centered outcomes after PICU discharge. The intervention investigated will be the use of hospital diaries for the critically ill child in a cross-over study, randomized by clusters in four PICUs of Rio de Janeiro. Family members of children aged 29 days to 12 years, admitted for more than 36 hours will be included and data collection will take place upon admission, at PICU discharge and 60 days after discharge from the PICU.
Family-centered outcomes assessed will be: satisfaction with care, anxiety and depression at discharge, incidence of anxiety, depression, PTSD, burden and quality of life in follow-up. Patient-centered outcomes will be assessed in children at discharge and follow-up - quality of life and incidence of new morbidities will be evaluated. The association of clinical, social and demographic variables with family- and patient-centered outcomes will be investigated on an exploratory basis. Burnout Syndrome in PICU health professionals will be assessed before and after the intervention as a proxy of intervention security for PICU staff.
Read the detailed description
More than one third of parents and patients admitted to Pediatric Intensive Care Units (PICU) develop Anxiety, Depression and Posttraumatic Stress Disorder (PTSD), with consequent decrease in quality of life and great social impact, known as Pediatric and Family Post-Intensive Care Syndrome (PICS and PICS-F). Strategies that minimize negative outcomes after discharge have been adopted, such as the use of hospital diaries to regularly record the impressions of family members and health professionals about the patient's evolution, hosting parents and encouraging their direct participation in care.
This study aims to evaluate in the Brazilian context, the impact of the implementation of a diary program on patient and family-centered outcomes after discharge. The intervention investigated will be the use of hospital diaries for the critically ill child in a cross-over study, randomized by clusters in four PICUs of Rio de Janeiro, totaling 200 family members in the intervention group and 200 controls. Family members of children aged 29 days to 12 years, admitted for more than 36 hours will be included and data collection will take place upon admission, at discharge and 60 days after discharge from the PICU. Family-centered outcomes assessed will be: satisfaction with care, anxiety and depression at discharge, incidence of anxiety, depression, PTSD, burden and quality of life in follow-up. Quality of life and incidence of new morbidities will be evaluated in children at discharge and follow-up, as well as Burnout Syndrome in the health team. The association of clinical, social and demographic variables with family- and patient-centered outcomes will be investigated on an exploratory basis.
With this study, we aim to contribute to a better knowledge about different family-centered outcomes in intensive care, allowing reduction of health problems and the development of policies that seek to alleviate suffering, to humanize intensive environments and encourage participation of family members in child care during hospitalization.
- Conditions
- Post-Intensive Care Syndrome, Anxiety, Depression, Stress Disorders, Post-Traumatic, Quality of Life, Satisfaction, Patient
- Being tested
- Hospital diaries
- Keywords
- Post-Intensive Care Syndrome, Anxiety, Depression, Post-Traumatic Stress Disorder, Health-related Quality of Life, Satisfaction with Care
- Medical subject headings
- postintensive care syndrome, Anxiety Disorders, Depression, Stress Disorders, Post-Traumatic, Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hospital diariesBehavioural
Diaries will be used by family members, PICU staff or even the patient himself. They will take daily notes expressing feelings and thoughts and describing events that might help chronologically to better understand the course of disease and PICU stay. Photographs and other important PICU memories may also be used in the diary.
| Study group | Role | What they receive |
|---|---|---|
| PICU with diaries | Experimental | The main family member of a critically ill child will receive a diary upon PICU admission.
Except for the diaries intervention, this group of patients will be submitted to usual PICU routine care. Receives: Behavioral: Hospital diaries |
| PICU without diaries | No intervention | This group of critically ill patients and family members will not receive diaries, but will also be submitted to usual PICU routine care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of anxiety symptoms in family member from critically ill child.
Proportion of main family member positive for anxiety symptoms as measured by HADS (Hospital Anxiety and Depression Scale from Zigmond and Snaith), a self-report standardized 14-item questionnaire covering an anxiety 7-question subscale and a depression 7-question subscale. Each subscale includes Likert-scaled questions ranging from 0 to 3. Presence of anxiety symptoms will be determined when 9 or more points on each subscale.
Measured: 45-60 days after PICU discharge
Incidence of depression symptoms in family member from critically ill child.
Proportion of main family member positive for depression symptoms as measured by HADS (Hospital Anxiety and Depression Scale from Zigmond and Snaith), a self-report standardized 14-item questionnaire covering an anxiety 7-question subscale and a depression 7-question subscale. Each subscale includes Likert-scaled questions ranging from 0 to 3. Presence of depression symptoms will be determined when 9 or more points on each subscale.
Measured: 45-60 days after PICU discharge
Incidence of PTSD (Posttraumatic Stress Disorder) in family member from critically ill child.
Proportion of main family member positive for PTSD as measured by PCL-5 (Posttraumatic Stress Disorder Checklist for DSM-V - Diagnostic and Statistical Manual of Mental Disorders - V from Weathers et al), a self-report standardized 20-item questionnaire covering four dimensions of symptoms: intrusions, avoidance, negative alterations in cognitions and mood and alterations in arousal and reactivity. Each subscale includes Likert-scaled questions ranging from 0 (not at all) to 4 (extremely). Presence of PTSD symptoms when 33 or more total points or positivity in each DSM-V dimension.
Measured: 45-60 days after PICU discharge
Secondary outcomes (10)
Evaluate family satisfaction with PICU care as measured by EMpowerment of PArents in THe Intensive Care 30 (EMPATHIC-30) questionnaire.
Quantify family satisfaction with PICU care as measured by EMPATHIC-30 (Latour et al), a self-report standardized 30-item questionnaire covering 5 domains: information, care and treatment, organization, parent participation and professional attitude. Each subscale includes Likert-scaled questions ranging from 1 (certainly no) to 6 (certainly yes). Higher scores, higher family satisfaction with care.
Measured: Until 72 hours after the patient discharge from Pediatric Intensive Care Unit
Evaluate alterations in family quality of life as measured by Short Form 12 (SF-12) questionnaire
Quantify family quality of life as measured by SF-12 (Ware et al), a self-report standardized 12-item questionnaire covering a mental and a physical component, with Likert-scaled questions ranging variedly. Higher scores, better quality of life.
Measured: 45-60 days after PICU discharge
Incidence of Anxiety and Depression in family members of a critically ill child using HADS instrument upon PICU discharge.
Proportion of main family member positive for anxiety and depression as measured by HADS (Zigmond and Snaith), a self-report standardized 14-item questionnaire covering an anxiety 7-question subscale and a depression 7-question subscale. Each subscale includes Likert-scaled questions ranging from 0 to 3. Presence of anxiety or depression symptoms when 9 or more points on each subscale.
Measured: Until 72 hours after the patient discharge from Pediatric Intensive Care Unit
Incidence of New Morbidity in critically ill children at PICU discharge.
Incidence of New Morbidities in critically ill children admitted to a PICU, measured using the Functional Status Scale (FSS) upon admission, at PICU discharge and 60 days after PICU discharge. A raise in 3-points in FSS total score will be described as "New Morbidity", as assigned by Pollack et al.
Measured: Until 72 hours after the patient discharge from Pediatric Intensive Care Unit
Incidence of New Morbidity in critically ill children after PICU discharge.
Incidence of New Morbidities in critically ill children admitted to a PICU, measured using the Functional Status Scale (FSS) upon admission, at PICU discharge and 60 days after PICU discharge. A raise in 3-points in FSS total score will be described as "New Morbidity", as assigned by Pollack et al.
Measured: 45-60 days after PICU discharge
Evaluate alterations in critically ill children Quality of Life as measured by Pediatric Quality of Life Questionnaire (PedsQL).
Quantify critically ill children Quality of Life after PICU discharge as measured by Pediatric Quality of Life Questionnaire (PedsQL).
Measured: 45-60 days after PICU discharge
Prevalence of Burden in the main family member after PICU discharge measured with Zarit Burden Scale.
Prevalence of Burden in the main family member of a critically ill child after PICU discharge measured with Zarit Burden Scale (ZBI). This scale consists of 22 items rated on a 5-point Likert scale that ranges from 0 (never) to 4 (nearly always) with the sum of scores ranging between 0-88. Higher scores indicate greater burden.
Measured: 45-60 days after PICU discharge
Perceptions of health professionals regarding the use of PICU diaries
Perceptions of health professionals regarding the use of PICU diaries using a semi-structured questionnaire specifically developed for this study
Measured: One-month after the intervention period, which ends after the inclusion of 50 patient's family-members.
Perceptions of parents and main family members of a critically ill child regarding the use of PICU diaries
Perceptions of parents and main family members of a critically ill child regarding the use of PICU diaries using a semi-structured questionnaire specifically developed for this study
Measured: 45-60 days after PICU discharge upon intervention period
Evaluate alterations in the three dimensions of the Maslach Burnout Inventory - emotional exhaustion, depersonalization and personal accomplishment - in PICU health professional.
Evaluate alterations in PICU staff Burnout Syndrome scores, measured in the three dimensions of the Maslach Burnout Inventory - emotional exhaustion, depersonalization and personal accomplishment, as a proxy of intervention security for health professionals.
Measured: One month before the beginning of the intervention in the PICU and one-month after the end of intervention period, which ends after the inclusion of 50 patient's family-members.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2021
- Study start20 Dec 2019
- Primary completion16 Dec 2021
- Study completion16 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Post-Intensive Care SyndromeStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- This is a multicentric two-arm two-period crossover study: in the first phase each PICU will be randomized between intervention (PICU with diaries) and control (PICU without diaries), crossing over in the second phase after a washout period.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 431 participants (actual)
Sponsor and investigators
- Lead sponsor
- D'Or Institute for Research and Education
- Sponsor type
- University, hospital or other
- Collaborators
- Rio de Janeiro State Research Supporting Foundation (FAPERJ)
- Responsible party
- Sponsor
- Investigators
- Fernanda Lima-Setta, Principal investigator, D'Or Institute for Research and Education
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04961697
- Sponsor's protocol ID
- FOREVER
- Acronym
- FOREVER
- Status last verified
- Dec 2025
- First submitted
- 22 Jun 2021
- Last updated
- 24 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Harvey MA. The truth about consequences--post-intensive care syndrome in intensive care unit survivors and their families. Crit Care Med. 2012 Aug;40(8):2506-7. doi: 10.1097/CCM.0b013e318258e943. No abstract available.
PubMed 22809925Huggins EL, Bloom SL, Stollings JL, Camp M, Sevin CM, Jackson JC. A Clinic Model: Post-Intensive Care Syndrome and Post-Intensive Care Syndrome-Family. AACN Adv Crit Care. 2016 Apr-Jun;27(2):204-11. doi: 10.4037/aacnacc2016611.
PubMed 27153309Myers EA, Smith DA, Allen SR, Kaplan LJ. Post-ICU syndrome: Rescuing the undiagnosed. JAAPA. 2016 Apr;29(4):34-7. doi: 10.1097/01.JAA.0000481401.21841.32.
PubMed 27023654Svenningsen H, Langhorn L, Agard AS, Dreyer P. Post-ICU symptoms, consequences, and follow-up: an integrative review. Nurs Crit Care. 2017 Jul;22(4):212-220. doi: 10.1111/nicc.12165. Epub 2015 Feb 17.
PubMed 25688675Davidson JE, Aslakson RA, Long AC, Puntillo KA, Kross EK, Hart J, Cox CE, Wunsch H, Wickline MA, Nunnally ME, Netzer G, Kentish-Barnes N, Sprung CL, Hartog CS, Coombs M, Gerritsen RT, Hopkins RO, Franck LS, Skrobik Y, Kon AA, Scruth EA, Harvey MA, Lewis-Newby M, White DB, Swoboda SM, Cooke CR, Levy MM, Azoulay E, Curtis JR. Guidelines for Family-Centered Care in the Neonatal, Pediatric, and Adult ICU. Crit Care Med. 2017 Jan;45(1):103-128. doi: 10.1097/CCM.0000000000002169.
PubMed 27984278Needham DM, Davidson J, Cohen H, Hopkins RO, Weinert C, Wunsch H, Zawistowski C, Bemis-Dougherty A, Berney SC, Bienvenu OJ, Brady SL, Brodsky MB, Denehy L, Elliott D, Flatley C, Harabin AL, Jones C, Louis D, Meltzer W, Muldoon SR, Palmer JB, Perme C, Robinson M, Schmidt DM, Scruth E, Spill GR, Storey CP, Render M, Votto J, Harvey MA. Improving long-term outcomes after discharge from intensive care unit: report from a stakeholders' conference. Crit Care Med. 2012 Feb;40(2):502-9. doi: 10.1097/CCM.0b013e318232da75.
PubMed 21946660Elliott D, Davidson JE, Harvey MA, Bemis-Dougherty A, Hopkins RO, Iwashyna TJ, Wagner J, Weinert C, Wunsch H, Bienvenu OJ, Black G, Brady S, Brodsky MB, Deutschman C, Doepp D, Flatley C, Fosnight S, Gittler M, Gomez BT, Hyzy R, Louis D, Mandel R, Maxwell C, Muldoon SR, Perme CS, Reilly C, Robinson MR, Rubin E, Schmidt DM, Schuller J, Scruth E, Siegal E, Spill GR, Sprenger S, Straumanis JP, Sutton P, Swoboda SM, Twaddle ML, Needham DM. Exploring the scope of post-intensive care syndrome therapy and care: engagement of non-critical care providers and survivors in a second stakeholders meeting. Crit Care Med. 2014 Dec;42(12):2518-26. doi: 10.1097/CCM.0000000000000525.
PubMed 25083984Jezierska N. Psychological reactions in family members of patients hospitalised in intensive care units. Anaesthesiol Intensive Ther. 2014 Jan-Mar;46(1):42-5. doi: 10.5603/AIT.2014.0009.
PubMed 24643927Davidson JE, Jones C, Bienvenu OJ. Family response to critical illness: postintensive care syndrome-family. Crit Care Med. 2012 Feb;40(2):618-24. doi: 10.1097/CCM.0b013e318236ebf9.
PubMed 22080636Goldfarb MJ, Bibas L, Bartlett V, Jones H, Khan N. Outcomes of Patient- and Family-Centered Care Interventions in the ICU: A Systematic Review and Meta-Analysis. Crit Care Med. 2017 Oct;45(10):1751-1761. doi: 10.1097/CCM.0000000000002624.
PubMed 28749855
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Family and Patient Outcomes After Pediatric Intensive Care
- ClinicalTrials.gov ID
- NCT04961697
- Acronym / sponsor ID
- FOREVER / FOREVER
- Conditions
- Post-Intensive Care Syndrome, Anxiety, Depression, Stress Disorders, Post-Traumatic, Quality of Life, Satisfaction, Patient
- Keywords
- Post-Intensive Care Syndrome, Anxiety, Depression, Post-Traumatic Stress Disorder, Health-related Quality of Life, Satisfaction with Care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 431 participants (actual)
- Lead sponsor
- D'Or Institute for Research and EducationUniversity, hospital or other
- Collaborators
- Rio de Janeiro State Research Supporting Foundation (FAPERJ)
- Study start
- 20 Dec 2019 (actual)
- Primary completion
- 16 Dec 2021 (actual)
- Study completion
- 16 Dec 2021 (actual)
- First posted
- 14 Jul 2021 (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.
This study aims to evaluate in the Brazilian context, the impact of the implementation of a diary program on patient and family-centered outcomes after PICU discharge. The intervention investigated will be the use of hospital diaries for the critically ill child in a cross-over study, randomized by clusters in four PICUs of Rio de Janeiro. Family members of children aged 29 days to 12 years, admitted for more than 36 hours will be included and data collection will take place upon admission, at PICU discharge and 60 days after discharge from the PICU.
Family-centered outcomes assessed will be: satisfaction with care, anxiety and depression at discharge, incidence of anxiety, depression, PTSD, burden and quality of life in follow-up. Patient-centered outcomes will be assessed in children at discharge and follow-up - quality of life and incidence of new morbidities will be evaluated. The association of clinical, social and demographic variables with family- and patient-centered outcomes will be investigated on an exploratory basis. Burnout Syndrome in PICU health professionals will be assessed before and after the intervention as a proxy of intervention security for PICU staff.
Detailed description
More than one third of parents and patients admitted to Pediatric Intensive Care Units (PICU) develop Anxiety, Depression and Posttraumatic Stress Disorder (PTSD), with consequent decrease in quality of life and great social impact, known as Pediatric and Family Post-Intensive Care Syndrome (PICS and PICS-F). Strategies that minimize negative outcomes after discharge have been adopted, such as the use of hospital diaries to regularly record the impressions of family members and health professionals about the patient's evolution, hosting parents and encouraging their direct participation in care.
This study aims to evaluate in the Brazilian context, the impact of the implementation of a diary program on patient and family-centered outcomes after discharge. The intervention investigated will be the use of hospital diaries for the critically ill child in a cross-over study, randomized by clusters in four PICUs of Rio de Janeiro, totaling 200 family members in the intervention group and 200 controls. Family members of children aged 29 days to 12 years, admitted for more than 36 hours will be included and data collection will take place upon admission, at discharge and 60 days after discharge from the PICU. Family-centered outcomes assessed will be: satisfaction with care, anxiety and depression at discharge, incidence of anxiety, depression, PTSD, burden and quality of life in follow-up. Quality of life and incidence of new morbidities will be evaluated in children at discharge and follow-up, as well as Burnout Syndrome in the health team. The association of clinical, social and demographic variables with family- and patient-centered outcomes will be investigated on an exploratory basis.
With this study, we aim to contribute to a better knowledge about different family-centered outcomes in intensive care, allowing reduction of health problems and the development of policies that seek to alleviate suffering, to humanize intensive environments and encourage participation of family members in child care during hospitalization.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- This is a multicentric two-arm two-period crossover study: in the first phase each PICU will be randomized between intervention (PICU with diaries) and control (PICU without diaries), crossing over in the second phase after a washout period.
| Arm | Type | Receives |
|---|---|---|
| PICU with diaries | Experimental | Behavioral: Hospital diariesThe main family member of a critically ill child will receive a diary upon PICU admission. Except for the diaries intervention, this group of patients will be submitted to usual PICU routine care. |
| PICU without diaries | No intervention | –This group of critically ill patients and family members will not receive diaries, but will also be submitted to usual PICU routine care. |
Who may qualify
- Ages
- 29 days to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Patients between age limits admitted in PICU for clinical or surgical reasons with 36 or more hours of stay and their main family member.
- Physicians, registered nurses, nurse technicians, physical therapists and other professionals working in participants PICU involved in caring for patients and their families and taking notes in the diaries
Key exclusion criteria (5 listed)
- Patients admitted for monitorization or elective low-complexity surgeries
- Patients readmitted between the first admission and the first follow-up visit
- Patients in palliative care
- Families with linguistic or comprehension barriers
- Families residencies situated outside Rio de Janeiro metropolitan region
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 |
|---|---|---|
| Hospital diariesDiaries will be used by family members, PICU staff or even the patient himself. They will take daily notes expressing feelings and thoughts and describing events that might help chronologically to better understand the course of disease and PICU stay. Photographs and other important PICU memories may also be used in the diary. | Behavioural | PICU with diaries |
Primary outcome
Incidence of anxiety symptoms in family member from critically ill child.
Time frame: 45-60 days after PICU discharge
Proportion of main family member positive for anxiety symptoms as measured by HADS (Hospital Anxiety and Depression Scale from Zigmond and Snaith), a self-report standardized 14-item questionnaire covering an anxiety 7-question subscale and a depression 7-question subscale. Each subscale includes Likert-scaled questions ranging from 0 to 3. Presence of anxiety symptoms will be determined when 9 or more points on each subscale.
Incidence of depression symptoms in family member from critically ill child.
Time frame: 45-60 days after PICU discharge
Proportion of main family member positive for depression symptoms as measured by HADS (Hospital Anxiety and Depression Scale from Zigmond and Snaith), a self-report standardized 14-item questionnaire covering an anxiety 7-question subscale and a depression 7-question subscale. Each subscale includes Likert-scaled questions ranging from 0 to 3. Presence of depression symptoms will be determined when 9 or more points on each subscale.
Incidence of PTSD (Posttraumatic Stress Disorder) in family member from critically ill child.
Time frame: 45-60 days after PICU discharge
Proportion of main family member positive for PTSD as measured by PCL-5 (Posttraumatic Stress Disorder Checklist for DSM-V - Diagnostic and Statistical Manual of Mental Disorders - V from Weathers et al), a self-report standardized 20-item questionnaire covering four dimensions of symptoms: intrusions, avoidance, negative alterations in cognitions and mood and alterations in arousal and reactivity. Each subscale includes Likert-scaled questions ranging from 0 (not at all) to 4 (extremely). Presence of PTSD symptoms when 33 or more total points or positivity in each DSM-V dimension.
10 secondary outcomes
Evaluate family satisfaction with PICU care as measured by EMpowerment of PArents in THe Intensive Care 30 (EMPATHIC-30) questionnaire.
Time frame: Until 72 hours after the patient discharge from Pediatric Intensive Care Unit
Evaluate alterations in family quality of life as measured by Short Form 12 (SF-12) questionnaire
Time frame: 45-60 days after PICU discharge
Incidence of Anxiety and Depression in family members of a critically ill child using HADS instrument upon PICU discharge.
Time frame: Until 72 hours after the patient discharge from Pediatric Intensive Care Unit
Incidence of New Morbidity in critically ill children at PICU discharge.
Time frame: Until 72 hours after the patient discharge from Pediatric Intensive Care Unit
Incidence of New Morbidity in critically ill children after PICU discharge.
Time frame: 45-60 days after PICU discharge
Evaluate alterations in critically ill children Quality of Life as measured by Pediatric Quality of Life Questionnaire (PedsQL).
Time frame: 45-60 days after PICU discharge
Prevalence of Burden in the main family member after PICU discharge measured with Zarit Burden Scale.
Time frame: 45-60 days after PICU discharge
Perceptions of health professionals regarding the use of PICU diaries
Time frame: One-month after the intervention period, which ends after the inclusion of 50 patient's family-members.
Perceptions of parents and main family members of a critically ill child regarding the use of PICU diaries
Time frame: 45-60 days after PICU discharge upon intervention period
Evaluate alterations in the three dimensions of the Maslach Burnout Inventory - emotional exhaustion, depersonalization and personal accomplishment - in PICU health professional.
Time frame: One month before the beginning of the intervention in the PICU and one-month after the end of intervention period, which ends after the inclusion of 50 patient's family-members.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2025.
- Background: PubMed 22809925Harvey MA. The truth about consequences--post-intensive care syndrome in intensive care unit survivors and their families. Crit Care Med. 2012 Aug;40(8):2506-7. doi: 10.1097/CCM.0b013e318258e943. No abstract available.
- Background: PubMed 27153309Huggins EL, Bloom SL, Stollings JL, Camp M, Sevin CM, Jackson JC. A Clinic Model: Post-Intensive Care Syndrome and Post-Intensive Care Syndrome-Family. AACN Adv Crit Care. 2016 Apr-Jun;27(2):204-11. doi: 10.4037/aacnacc2016611.
- Background: PubMed 27023654Myers EA, Smith DA, Allen SR, Kaplan LJ. Post-ICU syndrome: Rescuing the undiagnosed. JAAPA. 2016 Apr;29(4):34-7. doi: 10.1097/01.JAA.0000481401.21841.32.
- Background: PubMed 25688675Svenningsen H, Langhorn L, Agard AS, Dreyer P. Post-ICU symptoms, consequences, and follow-up: an integrative review. Nurs Crit Care. 2017 Jul;22(4):212-220. doi: 10.1111/nicc.12165. Epub 2015 Feb 17.
- Background: PubMed 27984278Davidson JE, Aslakson RA, Long AC, Puntillo KA, Kross EK, Hart J, Cox CE, Wunsch H, Wickline MA, Nunnally ME, Netzer G, Kentish-Barnes N, Sprung CL, Hartog CS, Coombs M, Gerritsen RT, Hopkins RO, Franck LS, Skrobik Y, Kon AA, Scruth EA, Harvey MA, Lewis-Newby M, White DB, Swoboda SM, Cooke CR, Levy MM, Azoulay E, Curtis JR. Guidelines for Family-Centered Care in the Neonatal, Pediatric, and Adult ICU. Crit Care Med. 2017 Jan;45(1):103-128. doi: 10.1097/CCM.0000000000002169.
- Background: PubMed 21946660Needham DM, Davidson J, Cohen H, Hopkins RO, Weinert C, Wunsch H, Zawistowski C, Bemis-Dougherty A, Berney SC, Bienvenu OJ, Brady SL, Brodsky MB, Denehy L, Elliott D, Flatley C, Harabin AL, Jones C, Louis D, Meltzer W, Muldoon SR, Palmer JB, Perme C, Robinson M, Schmidt DM, Scruth E, Spill GR, Storey CP, Render M, Votto J, Harvey MA. Improving long-term outcomes after discharge from intensive care unit: report from a stakeholders' conference. Crit Care Med. 2012 Feb;40(2):502-9. doi: 10.1097/CCM.0b013e318232da75.
- Background: PubMed 25083984Elliott D, Davidson JE, Harvey MA, Bemis-Dougherty A, Hopkins RO, Iwashyna TJ, Wagner J, Weinert C, Wunsch H, Bienvenu OJ, Black G, Brady S, Brodsky MB, Deutschman C, Doepp D, Flatley C, Fosnight S, Gittler M, Gomez BT, Hyzy R, Louis D, Mandel R, Maxwell C, Muldoon SR, Perme CS, Reilly C, Robinson MR, Rubin E, Schmidt DM, Schuller J, Scruth E, Siegal E, Spill GR, Sprenger S, Straumanis JP, Sutton P, Swoboda SM, Twaddle ML, Needham DM. Exploring the scope of post-intensive care syndrome therapy and care: engagement of non-critical care providers and survivors in a second stakeholders meeting. Crit Care Med. 2014 Dec;42(12):2518-26. doi: 10.1097/CCM.0000000000000525.
- Background: PubMed 24643927Jezierska N. Psychological reactions in family members of patients hospitalised in intensive care units. Anaesthesiol Intensive Ther. 2014 Jan-Mar;46(1):42-5. doi: 10.5603/AIT.2014.0009.
- Background: PubMed 22080636Davidson JE, Jones C, Bienvenu OJ. Family response to critical illness: postintensive care syndrome-family. Crit Care Med. 2012 Feb;40(2):618-24. doi: 10.1097/CCM.0b013e318236ebf9.
- Background: PubMed 28749855Goldfarb MJ, Bibas L, Bartlett V, Jones H, Khan N. Outcomes of Patient- and Family-Centered Care Interventions in the ICU: A Systematic Review and Meta-Analysis. Crit Care Med. 2017 Oct;45(10):1751-1761. doi: 10.1097/CCM.0000000000002624.
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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.
Fernanda Lima-Setta principal investigator
D'Or Institute for Research and Education
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hospital diaries in people with Post-Intensive Care Syndrome and Anxiety, run by D'Or Institute for Research and Education at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. 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: finished, as of the sponsor's last update on 24 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of anxiety symptoms in family member from critically ill child. (time frame: 45-60 days after PICU discharge). 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?
On the ClinicalTrials.gov record for NCT04961697, which also lists 10 linked publications.
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 24 Dec 2025.