Trial Outcomes & Findings for Integrating Caregiver Support Into MS Care (NCT NCT02835677)
NCT ID: NCT02835677
Last Updated: 2019-07-24
Results Overview
Caregiver primary outcome. PHQ-9, range 0-27, lower better
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
25 participants
Primary outcome timeframe
baseline, 6 months
Results posted on
2019-07-24
Participant Flow
Recruitment occurred in the Neurology Service at the Memphis Veterans Affairs Medical Center (VAMC).
Participant milestones
| Measure |
Intervention
Behavioral intervention with caregivers to reduce stress and management of patient concerns, particularly ambulation
Behavioral: Education and skills building, including problem solving, cognitive restructuring, and stress management
|
|---|---|
|
Overall Study
STARTED
|
25
|
|
Overall Study
COMPLETED
|
25
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Lost to followup
Baseline characteristics by cohort
| Measure |
Intervention
n=25 Participants
Behavioral intervention with caregivers to reduce stress and management of patient concerns, particularly ambulation
Behavioral: Education and skills building, including problem solving, cognitive restructuring, and stress management
|
|---|---|
|
Age, Continuous
|
55.9 years
STANDARD_DEVIATION 11.6 • n=25 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=25 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=25 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=25 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
25 Participants
n=25 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=25 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=25 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=25 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=25 Participants
|
|
Race (NIH/OMB)
Black or African American
|
14 Participants
n=25 Participants
|
|
Race (NIH/OMB)
White
|
10 Participants
n=25 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=25 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=25 Participants
|
|
Region of Enrollment
United States
|
25 Participants
n=25 Participants
|
|
Marital status
Married
|
19 Participants
n=25 Participants
|
|
Marital status
Not married
|
6 Participants
n=25 Participants
|
|
Relationship to care recipient
Spouse
|
17 Participants
n=25 Participants
|
|
Relationship to care recipient
Parent
|
3 Participants
n=25 Participants
|
|
Relationship to care recipient
Sibling
|
3 Participants
n=25 Participants
|
|
Relationship to care recipient
Child
|
2 Participants
n=25 Participants
|
|
Anxiety change from baseline to six months
Baseline
|
5.2 units on a scale
STANDARD_DEVIATION 5.3 • n=25 Participants • Lost to followup
|
|
Anxiety change from baseline to six months
Six months
|
4.6 units on a scale
STANDARD_DEVIATION 4.4 • n=23 Participants • Lost to followup
|
|
Depression change from baseline to six months
Baseline
|
5.4 units on a scale
STANDARD_DEVIATION 5.2 • n=25 Participants • Lost to followup
|
|
Depression change from baseline to six months
Six months
|
7.9 units on a scale
STANDARD_DEVIATION 5.8 • n=24 Participants • Missing data
|
|
Burden change from baseline to six months
Baseline
|
6.6 units on a scale
STANDARD_DEVIATION 6.9 • n=25 Participants • Lost to followup
|
|
Burden change from baseline to six months
Six months
|
7.5 units on a scale
STANDARD_DEVIATION 6.2 • n=23 Participants • Lost to followup
|
|
Caregiving tasks change from baseline to six months
Baseline
|
30.7 units on a scale
STANDARD_DEVIATION 19.9 • n=25 Participants • Lost to followup
|
|
Caregiving tasks change from baseline to six months
Six months
|
31.0 units on a scale
STANDARD_DEVIATION 19.2 • n=23 Participants • Lost to followup
|
|
Social support change from baseline to six months
Baseline
|
18.0 units on a scale
STANDARD_DEVIATION 6.6 • n=25 Participants • Lost to followup
|
|
Social support change from baseline to six months
Six months
|
18.9 units on a scale
STANDARD_DEVIATION 5.3 • n=23 Participants • Lost to followup
|
|
Self Care change from baseline to six months
Baseline
|
9.4 units on a scale
STANDARD_DEVIATION 2.0 • n=25 Participants • Lost to followup
|
|
Self Care change from baseline to six months
Six months
|
10.5 units on a scale
STANDARD_DEVIATION 1.9 • n=23 Participants • Lost to followup
|
|
Caregiving frustrations change from baseline to six months
Baseline
|
0.7 units on a scale
STANDARD_DEVIATION 0.7 • n=25 Participants • Lost to followup
|
|
Caregiving frustrations change from baseline to six months
Six months
|
0.6 units on a scale
STANDARD_DEVIATION 0.7 • n=23 Participants • Lost to followup
|
|
Hours on duty change from baseline to six months
Baseline
|
12.3 hours
STANDARD_DEVIATION 8.9 • n=25 Participants • Lost to followup
|
|
Hours on duty change from baseline to six months
Six months
|
12.0 hours
STANDARD_DEVIATION 9.8 • n=23 Participants • Lost to followup
|
|
Hours performing tasks change from baseline to six months
Baseline
|
3.4 hours
STANDARD_DEVIATION 2.5 • n=24 Participants • Missing data, Lost to followup
|
|
Hours performing tasks change from baseline to six months
Six months
|
4.3 hours
STANDARD_DEVIATION 3.7 • n=23 Participants • Missing data, Lost to followup
|
|
Concerning care recipient behaviors change from baseline to six months
Baseline
|
9.5 number of behaviors reported
STANDARD_DEVIATION 4.7 • n=25 Participants • Lost to followup
|
|
Concerning care recipient behaviors change from baseline to six months
Six months
|
8.0 number of behaviors reported
STANDARD_DEVIATION 5.3 • n=23 Participants • Lost to followup
|
|
Number of behaviors that bother change from baseline to six months
Baseline
|
6.1 number of behaviors
STANDARD_DEVIATION 5.5 • n=25 Participants • Lost to followup
|
|
Number of behaviors that bother change from baseline to six months
Six months
|
3.9 number of behaviors
STANDARD_DEVIATION 4.1 • n=23 Participants • Lost to followup
|
|
Timed Up and Go Test change from baseline to six months
Baseline
|
4.2 seconds
STANDARD_DEVIATION 1.6 • n=23 Participants • Missing data
|
|
Timed Up and Go Test change from baseline to six months
Six months
|
4.1 seconds
STANDARD_DEVIATION 2.2 • n=19 Participants • Missing data
|
|
MS Self-efficacy change from baseline to six months
Baseline
|
52.3 units on a scale
STANDARD_DEVIATION 10.8 • n=23 Participants • Missing data
|
|
MS Self-efficacy change from baseline to six months
Six months
|
54.0 units on a scale
STANDARD_DEVIATION 12.6 • n=24 Participants • Missing data
|
|
Disability Scale change from baseline to six months
Baseline · Mild
|
12 Participants
n=24 Participants • Missing data
|
|
Disability Scale change from baseline to six months
Baseline · Moderate
|
4 Participants
n=24 Participants • Missing data
|
|
Disability Scale change from baseline to six months
Baseline · Severe
|
8 Participants
n=24 Participants • Missing data
|
|
Disability Scale change from baseline to six months
Six monts · Mild
|
11 Participants
n=23 Participants • Missing data
|
|
Disability Scale change from baseline to six months
Six monts · Moderate
|
3 Participants
n=23 Participants • Missing data
|
|
Disability Scale change from baseline to six months
Six monts · Severe
|
9 Participants
n=23 Participants • Missing data
|
|
Depression change from baseline to six months
Baselinw
|
7.5 units on a scale
STANDARD_DEVIATION 5.5 • n=25 Participants • Missing data
|
|
Employment, full or part time
|
12 Participants
n=25 Participants
|
PRIMARY outcome
Timeframe: baseline, 6 monthsCaregiver primary outcome. PHQ-9, range 0-27, lower better
Outcome measures
| Measure |
Intervention
n=25 Participants
Behavioral intervention with caregivers to reduce stress and management of patient concerns, particularly ambulation
Behavioral: Education and skills building, including problem solving, cognitive restructuring, and stress management
|
|---|---|
|
Depression Measured With the Patient Health Questionnaire 9 (PHQ-9) Scale
Baseline
|
5.2 units on a scale
Standard Error 1.1
|
|
Depression Measured With the Patient Health Questionnaire 9 (PHQ-9) Scale
Six month
|
4.6 units on a scale
Standard Error 0.9
|
PRIMARY outcome
Timeframe: baseline, 6 monthsCaregiver primary outcome. Zarit Burden Inventory, 12 item, 0-48, lower better
Outcome measures
| Measure |
Intervention
n=25 Participants
Behavioral intervention with caregivers to reduce stress and management of patient concerns, particularly ambulation
Behavioral: Education and skills building, including problem solving, cognitive restructuring, and stress management
|
|---|---|
|
Burden Measured With the Zarit Burden Inventory
Baseline
|
6.6 units on a scale
Standard Error 1.4
|
|
Burden Measured With the Zarit Burden Inventory
Six month
|
7.5 units on a scale
Standard Error 1.3
|
PRIMARY outcome
Timeframe: baseline, 6 monthsCaregiver primary outcome. General Anxiety Disorders Scale - GAD-7, range 0-21, lower better
Outcome measures
| Measure |
Intervention
n=25 Participants
Behavioral intervention with caregivers to reduce stress and management of patient concerns, particularly ambulation
Behavioral: Education and skills building, including problem solving, cognitive restructuring, and stress management
|
|---|---|
|
Anxiety Measured With the Generalized Anxiety Disorders 7 Scale
Baseline
|
5.2 units on a scale
Standard Error 1.1
|
|
Anxiety Measured With the Generalized Anxiety Disorders 7 Scale
Six month
|
4.6 units on a scale
Standard Error 0.9
|
PRIMARY outcome
Timeframe: baseline, 6 monthsCaregiver primary outcome - number of possible troubling patient problems and concerns, range 0-27, lower better
Outcome measures
| Measure |
Intervention
n=25 Participants
Behavioral intervention with caregivers to reduce stress and management of patient concerns, particularly ambulation
Behavioral: Education and skills building, including problem solving, cognitive restructuring, and stress management
|
|---|---|
|
Number of Patient MS Problems
Baseline
|
9.5 units on a scale
Standard Error 0.9
|
|
Number of Patient MS Problems
Six month
|
7.9 units on a scale
Standard Error 1.1
|
PRIMARY outcome
Timeframe: Baseline, 6 monthsNumber of troubling patient problems or concerns that bother the caregiver, range 0-27, lower better
Outcome measures
| Measure |
Intervention
n=25 Participants
Behavioral intervention with caregivers to reduce stress and management of patient concerns, particularly ambulation
Behavioral: Education and skills building, including problem solving, cognitive restructuring, and stress management
|
|---|---|
|
Bother With Patient MS Problems
Baseline
|
6.1 units on a scale
Standard Error 1.1
|
|
Bother With Patient MS Problems
Six months
|
3.9 units on a scale
Standard Error 0.8
|
Adverse Events
Intervention
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Linda Nichols, Co-Director Caregiver Center
VA Medical Center
Phone: 901 523-8990
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place