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Completed

NCT Number: NCT04839406

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

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.

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Key information

Conditions

Caregiver Stress Syndrome

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Oslo University Hospital

Oslo, 0424, Norway

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Structured support of caregivers at the ICU

Behavioral

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

Primary outcomes

  1. Post traumatic stress

    Time frame: Group differences at f-up month 3

    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.

  2. Post traumatic stress

    Time frame: Group differences at f-up month 6

    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.

  3. Post traumatic stress

    Time frame: Group differences at f-up month 12

    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.

  4. Anxiety and Depression

    Time frame: Change from baseline to f-up month 3

    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).

  5. Anxiety and Depression

    Time frame: Change from baseline to f-up month 6

    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).

  6. Anxiety and Depression

    Time frame: Change from baseline to f-up month 12

    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).

  7. Quality Adjusted Life Years (QUALYs)

    Time frame: Group differences at f-up month 12

    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).

Secondary outcomes

  1. Health related quality of life

    Time frame: Change from baseline to f-up month 3

    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).

  2. Health related quality of life

    Time frame: Change from baseline to f-up month 6

    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).

  3. Health related quality of life

    Time frame: Change from baseline to f-up month 12

    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).

  4. Hope

    Time frame: Change from baseline to f-up month 3

    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.

  5. Hope

    Time frame: Change from baseline to f-up month 6

    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.

  6. Hope

    Time frame: Change from baseline to f-up month 12

    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.

  7. Self-Efficacy.

    Time frame: Change from baseline to f-up month 3

    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.

  8. Self-Efficacy.

    Time frame: Change from baseline to f-up month 6

    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.

  9. Self-Efficacy.

    Time frame: Change from baseline to f-up month 12

    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.

  10. Caregiver satisfaction.

    Time frame: Group differences at f-up month 3

    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.

  11. Caregivers burden

    Time frame: Group differences at f-up month 12

    The Caregiver Reaction Assessment (CRA). Summary score range between 5 and 120. A higher score indicates a higher level of burden.

  12. Complicated grief

    Time frame: Group differences at f-up month 12

    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.

Sponsors and collaborators

Lead sponsor

Oslo University Hospital

Other

Collaborators

  • The Dam Foundation

Registry information

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Apr 9, 2021
Registry last updated
May 31, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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