NCT01750255

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

Effect of Pharmaceutical Care in Patients With Bipolar I Disorder at St John of God Clinic. Randomized Trial.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 92 (actual)
• Sponsor: Universidad de Antioquia · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Bipolar Disorder

Interventions

Type	Name	Description
OTHER	Pharmaceutical Care	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 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 and Mania Rating Scale, Clinical Global Assessment Scale, Quality of life and adherence to treatment
OTHER	Education	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 (Sf - 36 test), adherence to treatment, the severity of depressive symptoms in individuals, Symptoms of Mania, the psychiatrist rated patient impairment.

Timeline

• Start date: 2011-11-01
• Primary completion: 2013-05-01
• Completion: 2014-06-01
• First posted: 2012-12-17
• Last updated: 2016-09-16
• Results posted: 2016-09-16

Locations

1 site across 1 country: Colombia