Ignite Creation Date:
2024-05-06 @ 2:09 AM
Last Modification Date:
2024-10-26 @ 11:14 AM
Study NCT ID:
NCT01983254
Status:
COMPLETED
Last Update Posted:
2020-01-21
First Post:
2013-11-01
Brief Title:
Improving Psychological Distress Among Critical Illness Survivors and Their Caregivers
Sponsor:
Duke University
Organization:
Duke University
Study Overview
Official Title:
Improving Psychological Distress Among Critical Illness Survivors and Their Caregivers
Status:
COMPLETED
Status Verified Date:
2020-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Patients who receive life support in intensive care units commonly suffer from persistent depression anxiety and post-traumatic stress disorder PTSD symptoms after discharge We are trying to learn which is a better way to manage this distress a telephone-based adaptive coping skills training program or an educational program
Detailed Description:
Public Summary of Research Project Why is this important Nearly 800000 Americans receive mechanical ventilation for acute respiratory failure in the ICU each year Afterward over half of both patients and their family caregivers suffer from psychological distress depression anxiety and post-traumatic stress PTSD for over 1 year after discharge Patients and families told us that they need help with their distress because it worsens their quality of life More specifically patients said that learning how to adapt that is how to cope with the physical and emotional changes of critical illness would be helpful In fact most ICU survivors use coping skills infrequently which worsens psychological distress But patients also told us that they wanted more information about critical illness recovery and what to expect A lack of information increases PTSD symptoms However there are few treatments for this distress that can overcome ICU survivors physical disability great distance from expert medical centers and concerns about how much treatments would cost Therefore we developed two treatments to address coping and lack of information
What is the main goal We aim to compare which of two treatments are more effective in reducing psychological distress and improving quality of life One is a coping skills training CST program provided by telephone The other is an education program about critical illness that is accessed primarily online Also we will determine if unique groups of people with special characteristics have especially good improvement-and if so what personal factors explain this response
How will we know which treatment is better We will determine which treatment is most helpful by comparing participants levels of psychological distress and quality of life with surveys taken over 6 months Well also record patients own descriptions of how the treatments impacted their daily lives The study will take 3 years and would be performed at 5 medical centers across the US that treat patients with diverse backgrounds and illnesses 200 ICU survivor-family member pairs will be randomly assigned like a coin flip to receive either the CST program or the education program Treatments consist of 6 weekly telephone calls with a trained staff member web-based modules and handouts
How will this help others in the future This research is important because it aims to improve long-term recovery for entire families by focusing on a devastating common yet inadequately addressed problem These treatments were developed with the direct input of patients and families These treatments represent a new direction in treating critical illness because they can be delivered inexpensively by phone easily adapted to future technologies overcome barriers to care common to ICU survivors and shared easily by phone or computer with others in need across the world
What is the main goal We aim to compare which of two treatments are more effective in reducing psychological distress and improving quality of life One is a coping skills training CST program provided by telephone The other is an education program about critical illness that is accessed primarily online Also we will determine if unique groups of people with special characteristics have especially good improvement-and if so what personal factors explain this response
How will we know which treatment is better We will determine which treatment is most helpful by comparing participants levels of psychological distress and quality of life with surveys taken over 6 months Well also record patients own descriptions of how the treatments impacted their daily lives The study will take 3 years and would be performed at 5 medical centers across the US that treat patients with diverse backgrounds and illnesses 200 ICU survivor-family member pairs will be randomly assigned like a coin flip to receive either the CST program or the education program Treatments consist of 6 weekly telephone calls with a trained staff member web-based modules and handouts
How will this help others in the future This research is important because it aims to improve long-term recovery for entire families by focusing on a devastating common yet inadequately addressed problem These treatments were developed with the direct input of patients and families These treatments represent a new direction in treating critical illness because they can be delivered inexpensively by phone easily adapted to future technologies overcome barriers to care common to ICU survivors and shared easily by phone or computer with others in need across the world
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| PCORI PFA 195 | OTHER_GRANT | PCORI PFA 195 | None |