Effect of Pharmaceutical Care in Patients With Bipolar I Disorder (BD I) (EMDADER-TABI)

Universidad de Antioquia

Status: Completed

Conditions: Bipolar Disorder

Treatments: Other: Education; Other: Pharmaceutical Care

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01750255

EMDADER-TABI-20111108

Details and patient eligibility

About

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.

Full 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).

Enrollment: 92 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

92 participants in 2 patient groups, including a placebo group

Control

Placebo Comparator group

Description:

The control group will receive the usual care and verbal and written information and education about mental health and bipolar disorder for patients and their families. The written material is a brochure designed for this purpose, which focused on the goals and importance of adherence with pharmacological and nonpharmacological interventions to achieve treatment goals. Patients met again with the pharmacist every three months during one year. At each appointment will assess of parameters of efficacy and safety. Quality of life, adherence to treatment, the severity of depressive symptoms in individuals, Symptoms of Mania, the psychiatrist rated patient impairment.

Treatment:

Other: Education

Pharmaceutical Care

Active Comparator group

Description:

Pharmaceutical care will be provided according to Dader Method for pharmaceutical care and will be carried out in collaboration with patients and physicians.The time between admission to the group and 20 days,the pharmacist will enhance the information related to treatment adherence and investigate by certain criteria to make an approach to the effectiveness and safety of treatment, through phone calls(weeks 1,3, 4-6) and a home visit(week 2). Pharmacist will call the patient weekly in order to increase adherence. At each appointment will assess of parameters of efficacy (Depression- Mania Rating Scale, Clinical Global Assessment Scale,Quality of life, adherence to treatment.

Treatment:

Other: Pharmaceutical Care