N/A
N=92
Effect of Pharmaceutical Care in Patients With Bipolar I Disorder (BD I)
Bipolar Disorder
Bottom Line
View on ClinicalTrials.gov: NCT01750255 ↗Enrolled (actual)
92
Serious AEs
0.0%
Results posted
Sep 2016
Primary outcome: Primary: To Reduce the Use of Health Care Services by Quantifying the Number of Hospitalizations — 12; 1 Hospitalizations
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Pharmaceutical Care (Other); Education (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Universidad de Antioquia
- Primary completion
- May 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY To Reduce the Use of Health Care Services by Quantifying the Number of Hospitalizations |
12; 1 | — |
| PRIMARY To Reduce the Use of Health Care Services by Quantifying the Number of Emergency Service Consultations |
23; 4 | — |
| PRIMARY To Reduce the Use of Health Care Services by Quantifying the Number of Unscheduled Outpatient Visits |
3; 12 | — |
| SECONDARY Quality of Life |
83; 89.7 | — |
| SECONDARY Adherence to Treatment |
74.4; 86.8 | — |
| SECONDARY Clinical Global Impression for Bipolar Modified, CGI-BP-M. |
1.6; 1.3 | — |
| SECONDARY Mania |
— | — |
| SECONDARY Depression |
— | — |
| SECONDARY Necessity, Effectiveness and Security Problems Associated With Pharmacotherapy |
— | — |
| SECONDARY Preventable Causes of Problems of Effectiveness and Safety of Pharmacotherapy |
— | — |
Summary
This project aims, through pharmaceutical care in patients with Bipolar I Disorder, improve compliance and adherence rate, associated with greater effectiveness and safety of drug therapy to help achieve therapeutic goals, and finally to improving the quality of life of patients.
Eligibility Criteria
Inclusion Criteria
- Patients diagnosed with Bipolar I Disorder
- Have been discharged from the Clinic of Saint John of God -La Ceja-
- Have been resulting from external consultation (outpatient) of the Clinic of Saint John of God -La Ceja-
- Male and female patients aged between 18 and 65 years
- Living in Medellin or any of the following eastern municipalities in the department of Antioquia.
Exclusion Criteria
- Patients with first episode of manic type, schizoaffective disorder, bipolar disorder II, cyclothymia and other bipolar spectrum disorders, personality disorders that seem bipolar disorder, sociopathic disorder.
- Epilepsy
- Patients unable to comply with the protocol requirements, including severe alcohol and drug use.
- Patients with diagnostic uncertainty.
- Pregnancy or breastfeeding
- Infection with the human immunodeficiency virus (HIV).
- Chronic decompensate disease (no significant diseases): blood pressure values above 180/110 mmHg, total cholesterol above 300 mg / dL, low density cholesterol greater than 160 mmHg, hemoglobin A1c greater than 9%, lower oxygen saturation 90%.
- Mental retardation, presence of any cognitive impairment that prevents understands and signs informed consent.
- Refusal to sign informed consent (Consent must be obtained before any study-related procedures are conducted).
- Illiteracy.
- Patients in electroconvulsive therapy.
Data sourced from ClinicalTrials.gov (NCT01750255). 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.