Trial Outcomes & Findings for Self-Management Addressing Heart Disease Risk Trial (NCT NCT00499096)

NCT ID: NCT00499096

Last Updated: 2014-11-20

Results Overview

24-month systolic and diastolic blood pressure (mm/Hg): lower is better

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 118 participants
• Primary outcome timeframe: 24 months
• Results posted on: 2014-11-20

Participant Flow

Participant milestones

Measure	Chronic Care Model for Bipolar Disorder An intervention group of patients with bipolar disorder and 1 or more risk factor for cardiovascular disease; group will receive self-management group sessions, followed by phone contacts by the Care Manager. Chronic care model involving self-management educational sessions, care management for up to 1 year, and guideline dissemination: The behavioral intervention is based on the Chronic Care Model (CCM) where patients receive information on managing bipolar symptoms and health habits in a group self-management session (up to 6 weekly sessions). The Care Manager then follows up with patients via phone contacts for 12 months following the intervention. The providers receive information on guidelines for care.	Enhanced Usual Care A group of patients with bipolar disorder and one or more risk factors for cardiovascular disease will be randomized to receive enhanced usual care. This group will receive usual care, plus mailings on wellness topics (attention control), and their providers will receive information on guideline concordant care.
Overall Study STARTED	58	60
Overall Study COMPLETED	35	40
Overall Study NOT COMPLETED	23	20

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Self-Management Addressing Heart Disease Risk Trial

Baseline characteristics by cohort

Measure	Chronic Care Model for Bipolar Disorder n=58 Participants An intervention group of patients with bipolar disorder and 1 or more risk factor for cardiovascular disease (CVD); group will receive self-management group sessions, followed by phone contacts by the Care Manager. Chronic care model involving self-management educational sessions, care management for up to 1 year, and guideline dissemination: The behavioral intervention is based on the Chronic Care Model (CCM) where patients receive information on managing bipolar symptoms and health habits in a group self-management session (up to 6 weekly sessions). The Care Manager then follows up with patients via phone contacts for 12 months following the intervention. The providers receive information on guidelines for care.	Enhanced Usual Care n=60 Participants A group of patients with bipolar disorder and one or more risk factors for cardiovascular disease (CVD) will be randomized to receive enhanced usual care. This group will receive usual care, plus mailings on wellness topics (attention control), and their providers will receive information on guideline concordant care.	Total n=118 Participants Total of all reporting groups
Age, Continuous	53.1 years STANDARD_DEVIATION 10.6 • n=5 Participants	52.4 years STANDARD_DEVIATION 9.2 • n=7 Participants	52.8 years STANDARD_DEVIATION 9.9 • n=5 Participants
Sex: Female, Male Female	10 Participants n=5 Participants	10 Participants n=7 Participants	20 Participants n=5 Participants
Sex: Female, Male Male	48 Participants n=5 Participants	50 Participants n=7 Participants	98 Participants n=5 Participants
Region of Enrollment United States	58 participants n=5 Participants	60 participants n=7 Participants	118 participants n=5 Participants

PRIMARY outcome

Timeframe: 24 months

24-month systolic and diastolic blood pressure (mm/Hg): lower is better

Outcome measures

Measure	Chronic Care Model for Bipolar Disorder n=58 Participants An intervention group of patients with bipolar disorder and 1 or more risk factor for cardiovascular disease; group will receive self-management group sessions, followed by phone contacts by the Care Manager. Chronic care model involving self-management educational sessions, care management for up to 1 year, and guideline dissemination: The behavioral intervention is based on the Chronic Care Model (CCM) where patients receive information on managing bipolar symptoms and health habits in a group self-management session (up to 6 weekly sessions). The Care Manager then follows up with patients via phone contacts for 12 months following the intervention. The providers receive information on guidelines for care.	Enhanced Usual Care n=60 Participants A group of patients with bipolar disorder and one or more risk factors for cardiovascular disease will be randomized to receive enhanced usual care. This group will receive usual care, plus mailings on wellness topics (attention control), and their providers will receive information on guideline concordant care.
Systolic and Diastolic Blood Pressure (SBP, DBP) 24-month SBP in mm/Hg	127.2 mm/Hg Standard Deviation 15.4	130.4 mm/Hg Standard Deviation 13.6
Systolic and Diastolic Blood Pressure (SBP, DBP) 24-month DBP in mm/Hg	75.9 mm/Hg Standard Deviation 10.4	78.5 mm/Hg Standard Deviation 10.3

PRIMARY outcome

Timeframe: 24 months

Total cholesterol in mg/dl- lower is better

Outcome measures

Measure	Chronic Care Model for Bipolar Disorder n=58 Participants An intervention group of patients with bipolar disorder and 1 or more risk factor for cardiovascular disease; group will receive self-management group sessions, followed by phone contacts by the Care Manager. Chronic care model involving self-management educational sessions, care management for up to 1 year, and guideline dissemination: The behavioral intervention is based on the Chronic Care Model (CCM) where patients receive information on managing bipolar symptoms and health habits in a group self-management session (up to 6 weekly sessions). The Care Manager then follows up with patients via phone contacts for 12 months following the intervention. The providers receive information on guidelines for care.	Enhanced Usual Care n=60 Participants A group of patients with bipolar disorder and one or more risk factors for cardiovascular disease will be randomized to receive enhanced usual care. This group will receive usual care, plus mailings on wellness topics (attention control), and their providers will receive information on guideline concordant care.
Total Cholesterol	178.9 mg/dL Standard Deviation 45.5	175.9 mg/dL Standard Deviation 42.4

PRIMARY outcome

Timeframe: 24 months

Physical health-related quality of life is based on the Short Form (SF)-12 survey physical health component (PCS) score- which ranges from 0 to 50, with higher scores indicating higher quality of life

Outcome measures

Measure	Chronic Care Model for Bipolar Disorder n=58 Participants An intervention group of patients with bipolar disorder and 1 or more risk factor for cardiovascular disease; group will receive self-management group sessions, followed by phone contacts by the Care Manager. Chronic care model involving self-management educational sessions, care management for up to 1 year, and guideline dissemination: The behavioral intervention is based on the Chronic Care Model (CCM) where patients receive information on managing bipolar symptoms and health habits in a group self-management session (up to 6 weekly sessions). The Care Manager then follows up with patients via phone contacts for 12 months following the intervention. The providers receive information on guidelines for care.	Enhanced Usual Care n=60 Participants A group of patients with bipolar disorder and one or more risk factors for cardiovascular disease will be randomized to receive enhanced usual care. This group will receive usual care, plus mailings on wellness topics (attention control), and their providers will receive information on guideline concordant care.
Physical Health-related Quality of Life Score	36.8 units on a scale Standard Deviation 6.6	35.3 units on a scale Standard Deviation 7.0

SECONDARY outcome

Timeframe: 24 months

Manic symptoms based on the Internal State Scale (range is 0-500; higher score indicates more severe symptoms)

Outcome measures

Measure	Chronic Care Model for Bipolar Disorder n=58 Participants An intervention group of patients with bipolar disorder and 1 or more risk factor for cardiovascular disease; group will receive self-management group sessions, followed by phone contacts by the Care Manager. Chronic care model involving self-management educational sessions, care management for up to 1 year, and guideline dissemination: The behavioral intervention is based on the Chronic Care Model (CCM) where patients receive information on managing bipolar symptoms and health habits in a group self-management session (up to 6 weekly sessions). The Care Manager then follows up with patients via phone contacts for 12 months following the intervention. The providers receive information on guidelines for care.	Enhanced Usual Care n=60 Participants A group of patients with bipolar disorder and one or more risk factors for cardiovascular disease will be randomized to receive enhanced usual care. This group will receive usual care, plus mailings on wellness topics (attention control), and their providers will receive information on guideline concordant care.
Manic Symptoms	148.9 units on a scale Standard Deviation 120.9	173.4 units on a scale Standard Deviation 105.8

SECONDARY outcome

Timeframe: 24 months

Depressive symptoms based on the Internal State Scale (Range: 0-200, higher score = more severe symptoms)

Outcome measures

Measure	Chronic Care Model for Bipolar Disorder n=58 Participants An intervention group of patients with bipolar disorder and 1 or more risk factor for cardiovascular disease; group will receive self-management group sessions, followed by phone contacts by the Care Manager. Chronic care model involving self-management educational sessions, care management for up to 1 year, and guideline dissemination: The behavioral intervention is based on the Chronic Care Model (CCM) where patients receive information on managing bipolar symptoms and health habits in a group self-management session (up to 6 weekly sessions). The Care Manager then follows up with patients via phone contacts for 12 months following the intervention. The providers receive information on guidelines for care.	Enhanced Usual Care n=60 Participants A group of patients with bipolar disorder and one or more risk factors for cardiovascular disease will be randomized to receive enhanced usual care. This group will receive usual care, plus mailings on wellness topics (attention control), and their providers will receive information on guideline concordant care.
Depressive Symptom Score	50.6 units on a scale Standard Deviation 46.4	60.3 units on a scale Standard Deviation 55.9

SECONDARY outcome

Timeframe: 24 months

Disability based on the WHO Disability Assessment Scale (WHO-DAS); range = 0-24, higher score equals greater disability

Outcome measures

Measure	Chronic Care Model for Bipolar Disorder n=58 Participants An intervention group of patients with bipolar disorder and 1 or more risk factor for cardiovascular disease; group will receive self-management group sessions, followed by phone contacts by the Care Manager. Chronic care model involving self-management educational sessions, care management for up to 1 year, and guideline dissemination: The behavioral intervention is based on the Chronic Care Model (CCM) where patients receive information on managing bipolar symptoms and health habits in a group self-management session (up to 6 weekly sessions). The Care Manager then follows up with patients via phone contacts for 12 months following the intervention. The providers receive information on guidelines for care.	Enhanced Usual Care n=60 Participants A group of patients with bipolar disorder and one or more risk factors for cardiovascular disease will be randomized to receive enhanced usual care. This group will receive usual care, plus mailings on wellness topics (attention control), and their providers will receive information on guideline concordant care.
Disability Based on WHO-DAS Score	15.0 units on a scale Standard Deviation 10.9	16.5 units on a scale Standard Deviation 10.7

SECONDARY outcome

Timeframe: 24 months

Body mass index (BMI) is reported in kilograms divided by meters squared (kg/m^2) with a normal (healthy) range of 18-24, in which >=25 is considered overweight, and >=30 is the definition of obesity

Outcome measures

Measure	Chronic Care Model for Bipolar Disorder n=58 Participants An intervention group of patients with bipolar disorder and 1 or more risk factor for cardiovascular disease; group will receive self-management group sessions, followed by phone contacts by the Care Manager. Chronic care model involving self-management educational sessions, care management for up to 1 year, and guideline dissemination: The behavioral intervention is based on the Chronic Care Model (CCM) where patients receive information on managing bipolar symptoms and health habits in a group self-management session (up to 6 weekly sessions). The Care Manager then follows up with patients via phone contacts for 12 months following the intervention. The providers receive information on guidelines for care.	Enhanced Usual Care n=60 Participants A group of patients with bipolar disorder and one or more risk factors for cardiovascular disease will be randomized to receive enhanced usual care. This group will receive usual care, plus mailings on wellness topics (attention control), and their providers will receive information on guideline concordant care.
Body Mass Index (BMI)	31.3 kg/m^2 Standard Deviation 5.8	33.4 kg/m^2 Standard Deviation 6.1

Adverse Events

Arm 1

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Arm 2

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. Amy M. Kilbourne, PhD, MPH

Department of Veterans Affairs

Phone: 734-845-3502

Email: Amy.Kilbourne@va.gov

Results disclosure agreements

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