Trial Outcomes & Findings for Project SERVE: Post Deployment Functioning (NCT NCT01123642)

NCT ID: NCT01123642

Last Updated: 2018-08-20

Results Overview

Participants complete the WHODAS II at baseline, 4 months, 8 months, and 12 months. The WHODAS II measures general disability related to multiple domains (i.e., understanding and communicating, getting around, self care, getting along with people, life activities, work/school, participation in society). Total scores range from 1 (no disability) to 5 (extreme/cannot do), with higher scores indicating more impairment.

• Recruitment status: COMPLETED
• Target enrollment: 345 participants
• Primary outcome timeframe: one year
• Results posted on: 2018-08-20

Participant Flow

A total of 345 participants were consented into the study, after which final eligibility was determined during the baseline assessment (see inclusion/exclusion criteria). Of the 345 enrolled, 309 met inclusion criteria and were deemed eligible for follow-up in the longitudinal study.

Participant milestones

Measure	OEF/OIF/OND Veterans Operations Enduring Freedom, Iraqi Freedom and New Dawn Veterans
Overall Study STARTED	345
Overall Study COMPLETED	277
Overall Study NOT COMPLETED	68

Reasons for withdrawal

Measure	OEF/OIF/OND Veterans Operations Enduring Freedom, Iraqi Freedom and New Dawn Veterans
Overall Study Lost to Follow-up	23
Overall Study Withdrawal by Subject	9
Overall Study ineligible at baseline assessment	36

Baseline Characteristics

Project SERVE: Post Deployment Functioning

Baseline characteristics by cohort

Measure	OEF/OIF/OND Veterans n=309 Participants Operations Enduring Freedom, Iraqi Freedom and New Dawn Veterans
Age, Continuous	38.81 years STANDARD_DEVIATION 9.81 • n=5 Participants
Sex: Female, Male Female	100 Participants n=5 Participants
Sex: Female, Male Male	209 Participants n=5 Participants

PRIMARY outcome

Timeframe: one year

Population: A total of 345 participants were enrolled, of which 309 were deemed eligible. Analyses are conducted with the total sample N = 309, followed over time. Sample sizes vary over time due to attrition and missing data.

Participants complete the WHODAS II at baseline, 4 months, 8 months, and 12 months. The WHODAS II measures general disability related to multiple domains (i.e., understanding and communicating, getting around, self care, getting along with people, life activities, work/school, participation in society). Total scores range from 1 (no disability) to 5 (extreme/cannot do), with higher scores indicating more impairment.

Outcome measures

Measure	OEF/OIF/OND Veterans n=309 Participants Operations Enduring Freedom, Iraqi Freedom and New Dawn Veterans
World Health Organization Disability Assessment Schedule II (WHODAS II) Baseline	1.87 units on a scale Standard Deviation .69
World Health Organization Disability Assessment Schedule II (WHODAS II) 4 months	2.03 units on a scale Standard Deviation .77
World Health Organization Disability Assessment Schedule II (WHODAS II) 8 months	2.07 units on a scale Standard Deviation .78
World Health Organization Disability Assessment Schedule II (WHODAS II) 12 months	1.88 units on a scale Standard Deviation .73

SECONDARY outcome

Timeframe: one year

Population: Sample sizes differ due to attrition and missing data.

80-item self-report measure of psychosocial functioning across multiple domains (e.g., family, social, day-to-day activities). Items are rated on a 7-point scale ranging from 0 ("never") to 6 ("always"). Lower scores indicate more positive outcomes.

Outcome measures

Measure	OEF/OIF/OND Veterans n=305 Participants Operations Enduring Freedom, Iraqi Freedom and New Dawn Veterans
Inventory of Psychosocial Functioning (IPF) Baseline	2.51 score on a scale Standard Deviation 1.25
Inventory of Psychosocial Functioning (IPF) 12 months	2.33 score on a scale Standard Deviation 1.19

SECONDARY outcome

Timeframe: one year

Population: Sample sizes differ due to attrition and missing data.

Quality of life measure of functioning scored on a 1 (delighted) to 7 (terrible) scale. Scores are summed with higher scores indicating lower quality of life. Total scores range from 16 - 112.

Outcome measures

Measure	OEF/OIF/OND Veterans n=303 Participants Operations Enduring Freedom, Iraqi Freedom and New Dawn Veterans
Quality of Life Scale (QLS) Baseline	76.33 score on a scale Standard Deviation 17.46
Quality of Life Scale (QLS) 4 months	73.04 score on a scale Standard Deviation 20.20
Quality of Life Scale (QLS) 8 months	72.38 score on a scale Standard Deviation 20.60
Quality of Life Scale (QLS) 12 months	77.59 score on a scale Standard Deviation 18.31

SECONDARY outcome

Timeframe: one year

Population: Sample sizes differ across time points due to attrition and missing data.

Total scores reflecting PTSD symptom severity. Scores ranging from 0-136 (higher score = more severe).

Outcome measures

Measure	OEF/OIF/OND Veterans n=309 Participants Operations Enduring Freedom, Iraqi Freedom and New Dawn Veterans
Clinician Administered PTSD Scale (CAPS-5) Baseline	29.71 score on a scale Standard Deviation 27.49
Clinician Administered PTSD Scale (CAPS-5) 12 months	34.29 score on a scale Standard Deviation 30.94

Adverse Events

OEF/OIF/OND Veterans

Serious events: 28 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Measure	OEF/OIF/OND Veterans n=309 participants at risk Operations Enduring Freedom, Iraqi Freedom and New Dawn Veterans
Psychiatric disorders hospitalized for suicidal ideation/attempt	1.9% 6/309 • Adverse event data were collected for a one year period (baseline to final assessment at 12 months). A total of 345 were enrolled, of which 309 were determined to be eligible. No adverse events occurred at the baseline assessment. Adverse events were reported with respect to the 309 eligible participants followed over time.
Psychiatric disorders hospitalized for homicidal ideation	0.32% 1/309 • Adverse event data were collected for a one year period (baseline to final assessment at 12 months). A total of 345 were enrolled, of which 309 were determined to be eligible. No adverse events occurred at the baseline assessment. Adverse events were reported with respect to the 309 eligible participants followed over time.
Psychiatric disorders Hospitalized for mental health	0.97% 3/309 • Adverse event data were collected for a one year period (baseline to final assessment at 12 months). A total of 345 were enrolled, of which 309 were determined to be eligible. No adverse events occurred at the baseline assessment. Adverse events were reported with respect to the 309 eligible participants followed over time.
General disorders Hospitalized for physical condition	3.6% 11/309 • Adverse event data were collected for a one year period (baseline to final assessment at 12 months). A total of 345 were enrolled, of which 309 were determined to be eligible. No adverse events occurred at the baseline assessment. Adverse events were reported with respect to the 309 eligible participants followed over time.
General disorders ER for physical condition	2.3% 7/309 • Adverse event data were collected for a one year period (baseline to final assessment at 12 months). A total of 345 were enrolled, of which 309 were determined to be eligible. No adverse events occurred at the baseline assessment. Adverse events were reported with respect to the 309 eligible participants followed over time.

Other adverse events

Measure	OEF/OIF/OND Veterans n=309 participants at risk Operations Enduring Freedom, Iraqi Freedom and New Dawn Veterans
Gastrointestinal disorders Visit to ER for chest pain	0.32% 1/309 • Adverse event data were collected for a one year period (baseline to final assessment at 12 months). A total of 345 were enrolled, of which 309 were determined to be eligible. No adverse events occurred at the baseline assessment. Adverse events were reported with respect to the 309 eligible participants followed over time.
Social circumstances Detained in jail	0.32% 1/309 • Adverse event data were collected for a one year period (baseline to final assessment at 12 months). A total of 345 were enrolled, of which 309 were determined to be eligible. No adverse events occurred at the baseline assessment. Adverse events were reported with respect to the 309 eligible participants followed over time.

Additional Information

Sandra B. Morissette, Ph.D.

VISN 17 Center of Excellence for Research on Returning War Veterans

Phone: 254-297-5170

Email: sandra.morissette@va.gov

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place