Trial Outcomes & Findings for Life Goals Collaborative Care to Improve Health Outcomes in Mental Disorders (NCT NCT01487668)

Results Overview

The outcome is measures by changes in the Veterans short form 12-item (VR-12) survey, which includes a physical and mental health component score (PCS and MCS, respectively). Each component score (PCS and MCS) has a range of 0-100, with a higher score on the PCS and MCS indicating better outcome, or better physical or mental health-related quality of life, respectively.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

304 participants

Primary outcome timeframe

12 months

Results posted on

2016-01-22

Participant Flow

Overall, 287 subjects completed baseline assessments, and 245 completed both baseline and 12-month follow-up assessments, and the 245 are included in final analyses, with 124 in the treatment (LGCC) group and 121 in the control (usual care) group.

304 participants enrolled in the project, but only 287 completed baseline assessments, so those will be the participants included in the baseline analysis.

Participant milestones

Participant milestones
Measure	Arm 1 (Usual Care) Usual care will include standard mental health and medical care available in the VA clinics but with no active management by the LGCC health specialist.	Arm 2 (Life Goals Collaborative Care) Life Goals Collaborative Care: LGCC consists of 1) 10 self-management sessions that cover personal goal-setting and mental health symptom management reinforced through healthy lifestyles; 2) medical care management that includes identification of patient medical risk factors, monitoring of patient symptoms and medical needs via a registry over time; and 3) support for provider guidelines and community linkages.
Overall Study STARTED	146	141
Overall Study COMPLETED	121	124
Overall Study NOT COMPLETED	25	17

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Life Goals Collaborative Care to Improve Health Outcomes in Mental Disorders

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Arm 1 (Usual Care) n=146 Participants Usual care will include standard mental health and medical care available in the VA clinics but with no active management by the LGCC health specialist.	Arm 2 (Life Goals Collaborative Care) n=141 Participants Life Goals Collaborative Care: LGCC consists of 1) 10 self-management sessions that cover personal goal-setting and mental health symptom management reinforced through healthy lifestyles; 2) medical care management that includes identification of patient medical risk factors, monitoring of patient symptoms and medical needs via a registry over time; and 3) support for provider guidelines and community linkages.	Total n=287 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	126 Participants n=5 Participants	120 Participants n=7 Participants	246 Participants n=5 Participants
Age, Categorical >=65 years	20 Participants n=5 Participants	21 Participants n=7 Participants	41 Participants n=5 Participants
Age, Continuous	55.4 years STANDARD_DEVIATION 11.0 • n=5 Participants	55.3 years STANDARD_DEVIATION 10.7 • n=7 Participants	55.3 years STANDARD_DEVIATION 10.8 • n=5 Participants
Sex: Female, Male Female	21 Participants n=5 Participants	20 Participants n=7 Participants	41 Participants n=5 Participants
Sex: Female, Male Male	125 Participants n=5 Participants	121 Participants n=7 Participants	246 Participants n=5 Participants
Region of Enrollment United States	146 participants n=5 Participants	141 participants n=7 Participants	287 participants n=5 Participants

PRIMARY outcome

Timeframe: 12 months

The outcome is measures by changes in the Veterans short form 12-item (VR-12) survey, which includes a physical and mental health component score (PCS and MCS, respectively). Each component score (PCS and MCS) has a range of 0-100, with a higher score on the PCS and MCS indicating better outcome, or better physical or mental health-related quality of life, respectively.

Outcome measures

Outcome measures
Measure	Arm 1 (Usual Care) n=121 Participants Usual care will include standard mental health and medical care available in the VA clinics but with no active management by the LGCC health specialist.	Arm 2 (Life Goals Collaborative Care) n=124 Participants Life Goals Collaborative Care: LGCC consists of 1) 10 self-management sessions that cover personal goal-setting and mental health symptom management reinforced through healthy lifestyles; 2) medical care management that includes identification of patient medical risk factors, monitoring of patient symptoms and medical needs via a registry over time; and 3) support for provider guidelines and community linkages.
Physical Health-related Quality of Life	34.00 units on a scale Standard Deviation 11.49	33.61 units on a scale Standard Deviation 11.36

SECONDARY outcome

Timeframe: 12 months

Change in SF-12 mental health scores from baseline to 12 months. The outcome is measures by changes in the Veterans short form 12-item (VR-12) survey, which includes a physical and mental health component score (PCS and MCS, respectively). Each component score (PCS and MCS) has a range of 0-100, with a higher score on the PCS and MCS indicating better outcome, or better physical or mental health-related quality of life, respectively.

Outcome measures

Outcome measures
Measure	Arm 1 (Usual Care) n=121 Participants Usual care will include standard mental health and medical care available in the VA clinics but with no active management by the LGCC health specialist.	Arm 2 (Life Goals Collaborative Care) n=124 Participants Life Goals Collaborative Care: LGCC consists of 1) 10 self-management sessions that cover personal goal-setting and mental health symptom management reinforced through healthy lifestyles; 2) medical care management that includes identification of patient medical risk factors, monitoring of patient symptoms and medical needs via a registry over time; and 3) support for provider guidelines and community linkages.
Improved Mental Health-related Quality of Life	36.36 units on a scale Standard Deviation 12.11	38.13 units on a scale Standard Deviation 12.41

Adverse Events

Arm 1 (Usual Care)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Arm 2 (Life Goals Collaborative Care)

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

Amy M. Kilbourne, PhD, MPH

Department of Veterans Affairs, VA Ann Arbor Healthcare System

Phone: 734-845-3452

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place