AzTrials
AzTrials

Bipolar DisorderPhase 3SMAHRTNCT00499096

Self-Management Addressing Heart Disease Risk Trial

A Phase 3 study testing Chronic care model for Bipolar Disorder in people with Bipolar Disorder and Cardiovascular Disease, run by US Department of Veterans Affairs at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The purpose of this research study is to learn whether or not people with bipolar disorder can reduce their risk of heart disease and related conditions by having a Care Manager provide self management and care management. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Bipolar Disorder, Cardiovascular Disease
What is being tested?
Chronic care model for Bipolar Disorder
Could I receive a placebo?
No, everyone receives an active treatment
How many people
118 participants
Where
1 siteUnited States
Study dates
May 2008to Nov 2012
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Diagnosis of bipolar disorder (I, II, not otherwise specified, or schizoaffective-bipolar subtype)
  • Have a diagnosis or be at risk for arteriosclerotic cardiovascular disease (ASCVD).
  • We define this as a patient having a current diagnosis of or receiving treatment for at least one of the following medical conditions:
  • hyperlipidemia or dyslipidemia (documented diagnosis or low-density lipoprotein >=160, or receiving statin or other treatment)
  • hypertension (documented diagnosis or blood pressure of >=140/90 on 2 occasions)
  • diabetes mellitus (documented diagnosis or HbA1C >=7%, or receiving treatment)
  • obesity (documented diagnosis or BMI >30), based on medical record review of current problems
  • current ASCVD diagnosis

Who cannot join

  • Have unresolved substance intoxication or withdrawal, such as appearing to be intoxicated (e.g., incoherent, slurred speech), or experiencing withdrawal symptoms from substance abuse at the time of enrollment.
  • Are already enrolled in a mental health program with a mobile outreach component in which clinical caregivers deliver services to the patient in the community (e.g., assertive community treatment or intensive case management). These patients may be receiving similar services to those offered in the intervention.
  • Are unwilling or unable to provide informed consent or comply with study requirements at the time of enrollment (e.g., unable to complete forms or attend scheduled sessions due to serious illness or substantial functional limitations).

Trial locations and contacts

1 site in 1 country.

United States1 site

  • VA Ann Arbor Healthcare System

    Ann Arbor, Michigan, 48113

Other trials in United States

About this study

Official title: Cardiovascular Risk Factors in Veterans With Bipolar Disorder

The purpose of this research study is to learn whether or not people with bipolar disorder can reduce their risk of heart disease and related conditions by having a Care Manager provide self management and care management.

Read the detailed description

Background: Bipolar disorder is associated with significant personal and societal costs, and represents a substantial burden to the VA. Medical conditions, notably cardiovascular disease (CVD), are substantial contributors to increased morbidity and mortality in patients with bipolar disorder, in part because of behavioral and treatment factors. Despite the existence of effective medications for managing CVD-related risk factors (e.g., hypertension, hyperlipidemia, diabetes, obesity), outcomes for these conditions remain suboptimal among patients with bipolar disorder.

Objectives: The immediate objective of this study is to determine whether a manual-based Chronic Care Model (CCM) intervention compared to usual VA care improves control of intermediate physiological measures that represent risk factors of CVD for veterans with bipolar disorder. We hypothesize that, within 12 months of the intervention initiation, patients receiving the CCM intervention will be more likely to demonstrate improved control of CVD-related risk factors (blood pressure, fasting cholesterol) and report improved physical health-related quality of life.

Methods: This is a prospective, randomized, controlled, single-blind, single-site behavioral intervention trial of adult patients with a diagnosis of bipolar disorder receiving care in the VA Ann Arbor Healthcare System. Up to 300 subjects will be enrolled, of which 150 will be randomized to receive the intervention and 150 will receive usual VA care. All subjects will complete a baseline clinical assessment and then subsequent follow-up assessments at 3, 6, 12, and 24 months. The intervention's three core components will be implemented by a nurse Care Manager and include: 1) self-management behavioral sessions for patients addressing the reduction of CVD risk factors through symptom control and behavior change based on Social Cognitive Theory, 2) care management to promote patient behavior change and coordinate care, and 3) implementation of practice guidelines for providers on management of CVD risk factors in patients with bipolar disorder. Medical and psychiatric care, including medications, will continue to be provided by the patient's usual providers. Usual VA care will be enhanced and consist of guideline implementation and general patient education (attention control), but will not include self-management sessions or Care Manager contacts. Primary clinical outcomes include changes in cholesterol, and health-related quality of life (SF-12 physical health summary score). Linear regression models will be used to determine the effect of the intervention on each outcome. Mediators of treatment effect including symptoms and health behaviors will also be assessed.

Being tested
Chronic care model for Bipolar Disorder
Keywords
Chronic Illness, Disease management, Health Behaviors, Mood Disorders-Bipolar
Medical subject headings
Bipolar Disorder, Cardiovascular Diseases, Chronic Disease, Health Behavior

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Chronic care model for Bipolar DisorderBehavioural

    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.

Study groups in NCT00499096
Study groupRoleWhat they receive
Chronic Care Model for Bipolar DisorderExperimentalAn 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. This is the chronic care model for bipolar disorder
Receives: Behavioral: Chronic care model for Bipolar Disorder
Enhanced Usual CareNo interventionA 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Systolic and Diastolic Blood Pressure (SBP, DBP)

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

    Measured: 24 months

  2. Total Cholesterol

    Total cholesterol in mg/dl- lower is better

    Measured: 24 months

  3. Physical Health-related Quality of Life Score

    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

    Measured: 24 months

Secondary outcomes (4)

  1. Manic Symptoms

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

    Measured: 24 months

  2. Depressive Symptom Score

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

    Measured: 24 months

  3. Disability Based on WHO-DAS Score

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

    Measured: 24 months

  4. Body Mass Index (BMI)

    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

    Measured: 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Jul 2007 (estimated)
  2. Study startMay 2008
  3. Primary completionMay 2012
  4. Study completionNov 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
118 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00499096
Sponsor's protocol ID
MHBA-018-06F
Acronym
SMAHRT
Status last verified
Nov 2014
First submitted
9 Jul 2007
Last updated
20 Nov 2014
Data monitoring committee
No

Publications

  • Kilbourne AM, Goodrich DE, Lai Z, Post EP, Schumacher K, Nord KM, Bramlet M, Chermack S, Bialy D, Bauer MS. Randomized controlled trial to assess reduction of cardiovascular disease risk in patients with bipolar disorder: the Self-Management Addressing Heart Risk Trial (SMAHRT). J Clin Psychiatry. 2013 Jul;74(7):e655-62. doi: 10.4088/JCP.12m08082.

    PubMed 23945460

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Chronic care model for Bipolar Disorder in people with Bipolar Disorder and Cardiovascular Disease, run by US Department of Veterans Affairs at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 20 Nov 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Systolic and Diastolic Blood Pressure (SBP, DBP) (time frame: 24 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00499096, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2014.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in
Self-Management Addressing Heart Disease Risk Trial | AzTrials