Trial Outcomes & Findings for Comparison of E-health vs. In-person Multi-Family Group (MFG) (NCT NCT02032680)
NCT ID: NCT02032680
Last Updated: 2020-10-20
Results Overview
At baseline, each participant developed a goal that she or he would work on to achieve as part of involvement in the study. Indicators of the 5 levels (0-4) of achievement, on the Goal Attainment Scale, were developed for each individual participant's goal, with each individual participant. The minimum was 0 (zero), the maximum was 4, and higher scores were better.
COMPLETED
NA
40 participants
Outcome is assessed at 3, 6, and 12 months
2020-10-20
Participant Flow
Of 96 veterans screened, 78 met eligibility criteria.
Of the 78 who were screened and met eligibility criteria, 40 consented to participate in the study. 10 of the 40 dropped out before being assigned to an intervention arm. 30 were assigned to an intervention arm.
Participant milestones
| Measure |
Web-based Family Psycho-education Treatment
The e-health/web-based intervention provides: three therapist facilitated group forums; a function to send facilitators questions; a library of previously answered questions; and a library of educational materials.
Web-based multi-family psychoeducational treatment: This intervention uses a website to provide multi-family psychoeducational treatment to Veterans and their family members or other supporters.
|
In-persons Multi-family Psycho-educational Treatment
This arm provides the evidence based multi-family psychoeducational treatment, termed Multi-Family Group (MFG) that is the standard of care in the VA.
In-persons multi-family psycho-educational treatment: This intervention will provide the VA's evidence-based, in-person delivered, multi-family psychoeducational treatment, termed Multi-Family group (MFG). This intervention is delivered to Veterans and their families or other supporters using an in-person format.
|
|---|---|---|
|
Overall Study
STARTED
|
22
|
8
|
|
Overall Study
COMPLETED
|
16
|
7
|
|
Overall Study
NOT COMPLETED
|
6
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Comparison of E-health vs. In-person Multi-Family Group (MFG)
Baseline characteristics by cohort
| Measure |
Web-based Family Psycho-education Treatment
n=22 Participants
The e-health/web-based intervention provides: three therapist facilitated on-line group forums; a function to send facilitators questions; a library of previously answered questions; and a library of educational materials.
Web-based multi-family psychoeducational treatment: This intervention uses a website to provide multi-family psychoeducational treatment to Veterans and their family members or other supporters.
|
In-persons Multi-family Psycho-educational Treatment
n=8 Participants
This arm provides the evidence based multi-family psychoeducational treatment, termed Multi-Family Group (MFG) that is the standard of care in the VA.
In-persons multi-family psycho-educational treatment: This intervention will provide the VA's evidence-based, in-person delivered, multi-family psychoeducational treatment, termed Multi-Family group (MFG). This intervention is delivered to Veterans and their families or other supporters using an in-person format.
|
Total
n=30 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
58.8 Years
STANDARD_DEVIATION 10.9 • n=5 Participants
|
51.4 Years
STANDARD_DEVIATION 11.8 • n=7 Participants
|
56.8 Years
STANDARD_DEVIATION 11.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
10 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
12 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
22 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Participant Goal Attainment Scale
|
0 units on a scale
STANDARD_DEVIATION 0 • n=5 Participants
|
0 units on a scale
STANDARD_DEVIATION 0 • n=7 Participants
|
0 units on a scale
STANDARD_DEVIATION 0 • n=5 Participants
|
PRIMARY outcome
Timeframe: Outcome is assessed at 3, 6, and 12 monthsPopulation: The analyses assessed the highest level that participants achieved on their goal, using the 5 point scale 0, 1, 2, 3, 4, with 4 being the highest achievement level The reported outcomes data indicates the highest level that a participant achieved on their goal during the study, regardless of which timepoint (3, 6, or 12 months) that this occurred.
At baseline, each participant developed a goal that she or he would work on to achieve as part of involvement in the study. Indicators of the 5 levels (0-4) of achievement, on the Goal Attainment Scale, were developed for each individual participant's goal, with each individual participant. The minimum was 0 (zero), the maximum was 4, and higher scores were better.
Outcome measures
| Measure |
Web-based Family Psycho-education Treatment
n=16 Participants
The e-health/web-based intervention provides: three therapist facilitated group forums; a function to send facilitators questions; a library of previously answered questions; and a library of educational materials.
Web-based multi-family psychoeducational treatment: This intervention uses a website to provide multi-family psychoeducational treatment to Veterans and their family members or other supporters.
|
In-persons Multi-family Psycho-educational Treatment
n=7 Participants
This arm provides the evidence based multi-family psychoeducational treatment, termed Multi-Family Group (MFG) that is the standard of care in the VA.
In-persons multi-family psycho-educational treatment: This intervention will provide the VA's evidence-based, in-person delivered, multi-family psychoeducational treatment, termed Multi-Family group (MFG). This intervention is delivered to Veterans and their families or other supporters using an in-person format.
|
|---|---|---|
|
Goal Attainment Scale
Highest level achieved was 1
|
6.25 percentage of participats
|
14.29 percentage of participats
|
|
Goal Attainment Scale
Highest level achieved was 2
|
37.5 percentage of participats
|
0 percentage of participats
|
|
Goal Attainment Scale
Highest level achieved was 3
|
18.75 percentage of participats
|
28.57 percentage of participats
|
|
Goal Attainment Scale
Highest level achieved was 4
|
37.5 percentage of participats
|
57.14 percentage of participats
|
Adverse Events
Web-based Family Psycho-education Treatment
In-persons Multi-family Psycho-educational Treatment
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