Clinical trial NCT01750255: Effect of Pharmaceutical Care in Patients With Bipolar I Disorder (BD I)
Official title: Effect of Pharmaceutical Care in Patients With Bipolar I Disorder at St John of God Clinic. Randomized Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bipolar Disorder
Keywords: Pharmaceutical care
Pharmacotherapy follow-up
Bipolar disorder
Pharmacy services
Lead sponsor: Universidad de Antioquia
Sponsor class: OTHER
Collaborators: name: Humax Pharmaceutical
First posted: 2012-12-17
Enrollment: 92
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief 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.

Detailed description: The objective of the present study was to assess the effectiveness of the Dader Method for pharmaceutical care in the reduction of the use of health care services and the increase in the effectiveness and safety of treatment in patients with Bipolar I Disorder who are discharged or referred for outpatient clinic St John of God-La Ceja. Primary objective: To assess the effectiveness of the Dader method for pharmaceutical care on achieving in reducing the number of hospital readmissions, in the increase of the effectiveness and safety of treatment in patients discharged from the Clinic of Saint John of God -La Ceja - Antioquia with bipolar disorder.

A randomized controlled trial. 200 patients will be randomized to group of control or intervention. Post-randomisation, patients will be required to attend the clinic routinely every 3 months during one year. Every 3 months will be evaluated on the criteria of effectiveness and safety of the treatment. Intervention's group will be following through pharmaceutical care. In the development of the study will be a record of the use of health care services (rehospitalizations, care emergency and outpatient, additional to those scheduled).

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.

Primary outcomes:
measure: To Reduce the Use of Health Care Services by Quantifying the Number of Hospitalizations
timeFrame: 1 year
measure: To Reduce the Use of Health Care Services by Quantifying the Number of Emergency Service Consultations
timeFrame: 1 year
measure: To Reduce the Use of Health Care Services by Quantifying the Number of Unscheduled Outpatient Visits
timeFrame: 1 year
Secondary outcomes:
measure: Quality of Life
timeFrame: 1 year
measure: Adherence to Treatment
timeFrame: 1 year
measure: Clinical Global Impression for Bipolar Modified, CGI-BP-M.
timeFrame: 1 year
measure: Mania
timeFrame: 1 year
measure: Depression
timeFrame: 1 year
measure: Necessity, Effectiveness and Security Problems Associated With Pharmacotherapy
timeFrame: 1 year
measure: Preventable Causes of Problems of Effectiveness and Safety of Pharmacotherapy
timeFrame: 1 year
Other outcomes:
Locations:
city: La Ceja
country: Colombia
facility: Clínica San Juan de Dios
state: Antioquia
Study officials:
affiliation: Universidad de Antioquia
name: Andrea Salazar, cDr.
role: STUDY_CHAIR
affiliation: Universidad de Antioquia
name: Pedro J Amariles, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Universidad de Antioquia
name: Dora M Benjumea, Dr
role: STUDY_CHAIR
affiliation: Clínica San Juan de Dios
name: Luis F Rodriguez, Dr
role: STUDY_CHAIR
affiliation: Universidad de Antioquia
name: Francisco J Gutierrez, Dr
role: STUDY_CHAIR
References:
citation: Salazar-Ospina A, Amariles P, Benjumea DM, Gutierrez F, Faus MJ, Rodriguez LF. Effectiveness of the Dader Method for pharmaceutical care in patients with bipolar I disorder: EMDADER-TAB: study protocol for a randomized controlled trial. Trials. 2014 May 20;15:174. doi: 10.1186/1745-6215-15-174.
citation: Salazar-Ospina A, Amariles P, Hincapie-Garcia JA, Gonzalez-Avendano S, Benjumea DM, Faus MJ, Rodriguez LF. Effectiveness of the Dader Method for Pharmaceutical Care on Patients with Bipolar I Disorder: Results from the EMDADER-TAB Study. J Manag Care Spec Pharm. 2017 Jan;23(1):74-84. doi: 10.18553/jmcp.2017.23.1.74.