Phase 3
Completed N=118
Self-Management Addressing Heart Disease Risk Trial
Source: ClinicalTrials.gov NCT00499096 ↗Enrolled (actual)
118
Serious AEs
0.0%
Results posted
Nov 2014
Primary outcomePrimary: Systolic and Diastolic Blood Pressure (SBP, DBP) — 127.2; 130.4; 75.9; 78.5 mm/Hg — p=<.05
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Systolic and Diastolic Blood Pressure (SBP, DBP) |
127.2; 130.4; 75.9; 78.5 | <.05 sig |
| PRIMARY Total Cholesterol |
178.9; 175.9 | — |
| PRIMARY Physical Health-related Quality of Life Score |
36.8; 35.3 | — |
| SECONDARY Manic Symptoms |
148.9; 173.4 | — |
| SECONDARY Depressive Symptom Score |
50.6; 60.3 | — |
| SECONDARY Disability Based on WHO-DAS Score |
15.0; 16.5 | — |
| SECONDARY Body Mass Index (BMI) |
31.3; 33.4 | — |
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- 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).
Data sourced from ClinicalTrials.gov (NCT00499096). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.