The Caregiver Pathway - An Intervention to Support Caregivers of Critically Ill Patients

Caregiver Stress Syndrome Clinical Trial

Official title:

The Caregiver Pathway - An Intervention to Support Caregivers of Critically Ill Patients

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04839406
• Other study ID #: 199446
• Status: Active, not recruiting
• Phase: N/A
• Start date: April 22, 2021
• Est. completion date: October 1, 2024

Study information

• Verified date: February 2024
• Source: Oslo University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of the project is to test the efficacy of a systematic intervention for individual follow-up of caregivers at the intensive care unit during a 12 month randomized controlled trial.

Description:

Caregivers of patients admitted to an intensive care unit (ICU) often experience the situation as traumatic and stressful. Long term consequences such as fatigue, anxiety, depression and symptoms of post-traumatic stress are reported among 30-50 percent of the caregivers of critically ill patients. The need for supportive interventions is called for. The overall goal of this project is to improve the support for caregivers of intensive care patients. A systematic intervention for individual support of caregivers, The Caregiver Pathway Intervention, has been developed with a multidisciplinary approach, based on existing evidence, through interviews with former caregivers, workshops with health care personnel and user input and testing. The intervention consist of mapping of caregivers' prioritized symptoms, needs and preferences with a digital assessment tool, followed by a meeting with a nurse to address these issues, a structured conversation at discharge, and an invitation to a follow-up conversation 4-6 weeks after discharge/patients death. The aim of the project is to test the efficacy of The Caregiver Pathway Intervention among caregivers at the ICU in a randomized controlled trial, using outcome measures such as symptoms of post-traumatic stress, anxiety/depression, cost-utility measures and health-related quality of life. The participants will be randomly assigned to The Caregiver Pathway Intervention or the follow-up as usual group. Both groups will receive outcome measures at baseline and at 3, 6 and 12 months.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 196
• Est. completion date: October 1, 2024
• Est. primary completion date: October 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Caregivers of patients admitted to the intensive care unit that is expected to receive invasive mechanical ventilation for at least 48 hours
• Between 18 and 70 years old
• Able to understand and speak Norwegian

Exclusion Criteria:

• None

Related Conditions & MeSH terms

• Caregiver Stress Syndrome
• Critical Illness

Intervention

Behavioral:
• Structured support of caregivers at the ICU
Structured support of caregivers at the ICU provided by a trained group of 10-15 ICU nurses

Locations

Country	Name	City	State
Norway	Oslo University Hospital	Oslo

Sponsors (2)

Lead Sponsor	Collaborator
Oslo University Hospital	The Dam Foundation

Country where clinical trial is conducted

Norway, 

References & Publications (1)

Watland S, Solberg Nes L, Hanson E, Ekstedt M, Stenberg U, Borosund E. The Caregiver Pathway, a Model for the Systematic and Individualized Follow-up of Family Caregivers at Intensive Care Units: Development Study. JMIR Form Res. 2023 Apr 25;7:e46299. doi: 10.2196/46299. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Post traumatic stress	Post traumatic stress will be measured with the Impact of Event Scale-Revised (IES_R). The total score for the IES_R ranges from 0 to 88. A higher score represents more severe symptoms of post traumatic stress disorder.	Group differences at f-up month 3
Primary	Post traumatic stress	Post traumatic stress will be measured with the Impact of Event Scale-Revised (IES_R). The total score for the IES_R ranges from 0 to 88. A higher score represents more severe symptoms of post traumatic stress disorder.	Group differences at f-up month 6
Primary	Post traumatic stress	Post traumatic stress will be measured with the Impact of Event Scale-Revised (IES_R). The total score for the IES_R ranges from 0 to 88. A higher score represents more severe symptoms of post traumatic stress disorder.	Group differences at f-up month 12
Primary	Anxiety and Depression	Anxiety and Depression will be measured with the Hospital Anxiety and Depression Scale (HADS). HADS consists of 14 items, and two subscales with seven items respectively. Score range is 0-21 for each subcale.; Scores: 0-7= Normal, 8-10= Borderline abnormal (borderline case), 11-21= abnormal (case).	Change from baseline to f-up month 3
Primary	Anxiety and Depression	Anxiety and Depression will be measured with the Hospital Anxiety and Depression Scale (HADS). HADS consists of 14 items, and two subscales with seven items respectively. Score range is 0-21 for each subcale.; Scores: 0-7= Normal, 8-10= Borderline abnormal (borderline case), 11-21= abnormal (case).	Change from baseline to f-up month 6
Primary	Anxiety and Depression	Anxiety and Depression will be measured with the Hospital Anxiety and Depression Scale (HADS). HADS consists of 14 items, and two subscales with seven items respectively. Score range is 0-21 for each subcale.; Scores: 0-7= Normal, 8-10= Borderline abnormal (borderline case), 11-21= abnormal (case).	Change from baseline to f-up month 12
Primary	Quality Adjusted Life Years (QUALYs)	Quality Adjusted Life Years (QUALYs), an economic evaluation of the quality and quantity of life lived, will be derived from the RAND-12 (Short form health survey, developed by the non profit RAND corporation). QUALY scores range from 1 (perfect health) to 0 (death).	Group differences at f-up month 12
Secondary	Health related quality of life	Health related quality of life will be measured with the RAND-12 (short form health survey, developed by the non profit RAND corporation). Units is summary score and sub-scale scores. Score range: 0-100 for all scales. Lower scores indicates more disability (0 = maximum disability, 100 = no disability).	Change from baseline to f-up month 3
Secondary	Health related quality of life	Health related quality of life will be measured with the RAND-12 (short form health survey, developed by the non profit RAND corporation). Units is summary score and sub-scale scores. Score range: 0-100 for all scales. Lower scores indicates more disability (0 = maximum disability, 100 = no disability).	Change from baseline to f-up month 6
Secondary	Health related quality of life	Health related quality of life will be measured with the RAND-12 (short form health survey, developed by the non profit RAND corporation). Units is summary score and sub-scale scores. Score range: 0-100 for all scales. Lower scores indicates more disability (0 = maximum disability, 100 = no disability).	Change from baseline to f-up month 12
Secondary	Hope	Hope will be measured with Herth Hope Index (HHI). The summary score ranges between 12-48, and a higher score indicates a higher level of hope.	Change from baseline to f-up month 3
Secondary	Hope	Hope will be measured with Herth Hope Index (HHI). The summary score ranges between 12-48, and a higher score indicates a higher level of hope.	Change from baseline to f-up month 6
Secondary	Hope	Hope will be measured with Herth Hope Index (HHI). The summary score ranges between 12-48, and a higher score indicates a higher level of hope.	Change from baseline to f-up month 12
Secondary	Self-Efficacy.	Self-efficacy will be measured with the General Self-Efficacy Scale (GSE). The summary score range between 10-40, and a higher score indicates higher perceived self-efficacy.	Change from baseline to f-up month 3
Secondary	Self-Efficacy.	Self-efficacy will be measured with the General Self-Efficacy Scale (GSE). The summary score range between 10-40, and a higher score indicates higher perceived self-efficacy.	Change from baseline to f-up month 6
Secondary	Self-Efficacy.	Self-efficacy will be measured with the General Self-Efficacy Scale (GSE). The summary score range between 10-40, and a higher score indicates higher perceived self-efficacy.	Change from baseline to f-up month 12
Secondary	Caregiver satisfaction.	Caregiver satisfaction will be mesured with the Family satisfaction in the ICU questionnaire (FS-ICU-24). Score range: 0-100, a higher score indicates more satisfaction.	Group differences at f-up month 3
Secondary	Caregivers burden	The Caregiver Reaction Assessment (CRA). Summary score range between 5 and 120. A higher score indicates a higher level of burden.	Group differences at f-up month 12
Secondary	Complicated grief	Complicated grief will be measured with the Inventory of Complicated Grief (ICG). Summary score range between 0-76, and a higher score indicates risk of complicated grief.	Group differences at f-up month 12