Trial Outcomes & Findings for Improving Psychological Distress Among Critical Illness Survivors and Their Caregivers (NCT NCT01983254)
NCT ID: NCT01983254
Last Updated: 2020-01-21
Results Overview
Hospital Anxiety and Depression Scale (HADS) questionnaire: The HADS is a fourteen item scale. Seven of the items relate to anxiety and seven relate to depression. The anxiety and depression subscales each range from 0 to 21, with higher scores indicating higher anxiety/depression complains. Patients were defined as having anxiety or depression or both if the score was 8 or more in the corresponding subscale. The 3 month measure is primary outcome timing, though changes at 6 months will be tested as well
COMPLETED
NA
417 participants
3 & 6 months post-randomization
2020-01-21
Participant Flow
417 participants were enrolled (277 patients and 140 informal caregivers). 261 participants were randomized (175 patients and 86 caregivers).
Participant milestones
| Measure |
Coping Skills Training
6 sessions of weekly telephone-based coping skills training delivered by trained interventionist
coping skills training: 6-session coping skills training program delivered by telephone w/ web augmentation
|
Education Program
6 week access to a web-based, critical illness-specific education program
education program: web-based, ICU-specific education program
|
|---|---|---|
|
Overall Study
STARTED
|
125
|
136
|
|
Overall Study
Interview 1
|
125
|
136
|
|
Overall Study
Interview 2
|
95
|
110
|
|
Overall Study
Interview 3
|
91
|
106
|
|
Overall Study
COMPLETED
|
91
|
106
|
|
Overall Study
NOT COMPLETED
|
34
|
30
|
Reasons for withdrawal
| Measure |
Coping Skills Training
6 sessions of weekly telephone-based coping skills training delivered by trained interventionist
coping skills training: 6-session coping skills training program delivered by telephone w/ web augmentation
|
Education Program
6 week access to a web-based, critical illness-specific education program
education program: web-based, ICU-specific education program
|
|---|---|---|
|
Overall Study
Death
|
6
|
6
|
|
Overall Study
Lost to Follow-up
|
17
|
16
|
|
Overall Study
too ill
|
11
|
8
|
Baseline Characteristics
Separate tables are shown for patients (n=175) and family members (n=86).
Baseline characteristics by cohort
| Measure |
Coping Skills Training
n=125 Participants
6 sessions of weekly telephone-based coping skills training delivered by trained interventionist
coping skills training: 6-session coping skills training program delivered by telephone w/ web augmentation
|
Education Program
n=136 Participants
6 week access to a web-based, critical illness-specific education program
education program: web-based, ICU-specific education program
|
Total
n=261 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=125 Participants
|
0 Participants
n=136 Participants
|
0 Participants
n=261 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
105 Participants
n=125 Participants
|
110 Participants
n=136 Participants
|
215 Participants
n=261 Participants
|
|
Age, Categorical
>=65 years
|
20 Participants
n=125 Participants
|
26 Participants
n=136 Participants
|
46 Participants
n=261 Participants
|
|
Age, Continuous
Patients
|
49.7 years
STANDARD_DEVIATION 13.8 • n=86 Participants • Separate tables are shown for patients (n=175) and family members (n=86).
|
53.7 years
STANDARD_DEVIATION 13.5 • n=89 Participants • Separate tables are shown for patients (n=175) and family members (n=86).
|
51.7 years
STANDARD_DEVIATION 13.8 • n=175 Participants • Separate tables are shown for patients (n=175) and family members (n=86).
|
|
Age, Continuous
Caregivers
|
50.0 years
STANDARD_DEVIATION 14.9 • n=39 Participants • Separate tables are shown for patients (n=175) and family members (n=86).
|
52.9 years
STANDARD_DEVIATION 15.2 • n=47 Participants • Separate tables are shown for patients (n=175) and family members (n=86).
|
51.4 years
STANDARD_DEVIATION 15.0 • n=86 Participants • Separate tables are shown for patients (n=175) and family members (n=86).
|
|
Sex: Female, Male
Female
|
71 Participants
n=125 Participants
|
73 Participants
n=136 Participants
|
144 Participants
n=261 Participants
|
|
Sex: Female, Male
Male
|
54 Participants
n=125 Participants
|
63 Participants
n=136 Participants
|
117 Participants
n=261 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=125 Participants
|
3 Participants
n=136 Participants
|
3 Participants
n=261 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
125 Participants
n=125 Participants
|
133 Participants
n=136 Participants
|
258 Participants
n=261 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=125 Participants
|
0 Participants
n=136 Participants
|
0 Participants
n=261 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=125 Participants
|
3 Participants
n=136 Participants
|
3 Participants
n=261 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=125 Participants
|
0 Participants
n=136 Participants
|
2 Participants
n=261 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=125 Participants
|
0 Participants
n=136 Participants
|
1 Participants
n=261 Participants
|
|
Race (NIH/OMB)
Black or African American
|
25 Participants
n=125 Participants
|
25 Participants
n=136 Participants
|
50 Participants
n=261 Participants
|
|
Race (NIH/OMB)
White
|
95 Participants
n=125 Participants
|
102 Participants
n=136 Participants
|
197 Participants
n=261 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=125 Participants
|
5 Participants
n=136 Participants
|
6 Participants
n=261 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=125 Participants
|
1 Participants
n=136 Participants
|
2 Participants
n=261 Participants
|
|
Region of Enrollment
United States
|
125 participants
n=125 Participants
|
136 participants
n=136 Participants
|
261 participants
n=261 Participants
|
PRIMARY outcome
Timeframe: 3 & 6 months post-randomizationPopulation: Patients who completed the HADS scale at 3 \& 6 months post-randomization.
Hospital Anxiety and Depression Scale (HADS) questionnaire: The HADS is a fourteen item scale. Seven of the items relate to anxiety and seven relate to depression. The anxiety and depression subscales each range from 0 to 21, with higher scores indicating higher anxiety/depression complains. Patients were defined as having anxiety or depression or both if the score was 8 or more in the corresponding subscale. The 3 month measure is primary outcome timing, though changes at 6 months will be tested as well
Outcome measures
| Measure |
Coping Skills Training
n=65 Participants
6 sessions of weekly telephone-based coping skills training delivered by trained interventionist
coping skills training: 6-session coping skills training program delivered by telephone w/ web augmentation
|
Education Program
n=71 Participants
6 week access to a web-based, critical illness-specific education program
education program: web-based, ICU-specific education program
|
|---|---|---|
|
Hospital Anxiety and Depression Scale Score
3 months
|
16.6 units on a scale (HADS summary score)
Standard Error 0.9
|
15.3 units on a scale (HADS summary score)
Standard Error 0.9
|
|
Hospital Anxiety and Depression Scale Score
6 months
|
15.6 units on a scale (HADS summary score)
Standard Error 1.0
|
15.9 units on a scale (HADS summary score)
Standard Error 1.0
|
SECONDARY outcome
Timeframe: 3 & 6 months post-randomizationPopulation: Patients who completed the IES-R scale at 3 \& 6 months post-randomization.
The IES-R evaluates subjective distress caused by traumatic events and assesses manifestations of post-traumatic stress disorder (PTSD) or acute stress disorder. It is not diagnostic but possesses excellent reliability and validity for manifestations of PTSD. The IES-R has three subscales (eight items on intrusion, eight items on avoidance, and six items on hyperarousal). Each item is scored on a four point scale: 0 = "not at all," 1 = "a little bit," 2 = "moderately often," 3 = "quite a bit," and 4 = "extremely often." The total score of each subscale may be averaged and a cumulative score of 30 is indicative of the presence of PTSD. The maximum score for each subscale is 32 for intrusion, 32 for avoidance, and 24 for hyperarousal. The minimum cumulative score is 0 and the maximum cumulative score possible is 88.3 months post-randomization is main time point while The 3 month IES-R score will be the primary analysis, though 6 month changes will be tested as well.
Outcome measures
| Measure |
Coping Skills Training
n=65 Participants
6 sessions of weekly telephone-based coping skills training delivered by trained interventionist
coping skills training: 6-session coping skills training program delivered by telephone w/ web augmentation
|
Education Program
n=71 Participants
6 week access to a web-based, critical illness-specific education program
education program: web-based, ICU-specific education program
|
|---|---|---|
|
Impact of Events Scale-revised (IES-R) Score
3 months
|
31.0 units on a scale (IES-R)
Standard Error 2.6
|
27.9 units on a scale (IES-R)
Standard Error 2.6
|
|
Impact of Events Scale-revised (IES-R) Score
6 months
|
29.4 units on a scale (IES-R)
Standard Error 2.9
|
25.8 units on a scale (IES-R)
Standard Error 2.9
|
OTHER_PRE_SPECIFIED outcome
Timeframe: over 6 months follow upPopulation: patients
here reported as weeks (instead of days) not at home for simplicity
Outcome measures
| Measure |
Coping Skills Training
n=24 weeks
6 sessions of weekly telephone-based coping skills training delivered by trained interventionist
coping skills training: 6-session coping skills training program delivered by telephone w/ web augmentation
|
Education Program
n=24 weeks
6 week access to a web-based, critical illness-specific education program
education program: web-based, ICU-specific education program
|
|---|---|---|
|
Total Weeks at Home Post-randomization
|
1.3 weeks not at home during follow up
Standard Deviation 3.0
|
1.6 weeks not at home during follow up
Standard Deviation 3.5
|
Adverse Events
Coping Skills Training
Education Program
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place