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

Bipolar Disorder Clinical Trial

— EMDADER-TABI  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01750255
• Other study ID #: EMDADER-TABI-20111108
• Status: Completed
• Phase: N/A
• First received: August 6, 2012
• Last updated: June 3, 2014
• Start date: November 2011
• Est. completion date: June 2014

Study information

• Verified date: June 2014
• Source: Universidad de Antioquia
• Contact: n/a
• Is FDA regulated: No
• Health authority: Colombia: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: June 2014
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Bipolar Disorder

Intervention

Other:
• Pharmaceutical Care
Patients and their families will be provided with verbal and written information and education about mental health and bipolar disorder. 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
• 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.

Locations

Country	Name	City	State
Colombia	Clínica San Juan de Dios	La Ceja	Antioquia

Sponsors (2)

Lead Sponsor	Collaborator
Universidad de Antioquia	Humax Pharmaceutical

Country where clinical trial is conducted

Colombia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Health care services use	To reduce the use of health care services by quantifying the number of hospitalizations, emergency care and outpatient, in addition to those scheduled	2 years	Yes
Secondary	Quality of Life	To measure the quality of life will be used the Short Form-36 questionnaire. This questionnaire assesses vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning, mental health. Patient wellbeing [Time Frame: At 3, 6, 9 and 12 months]	2 years	No
Secondary	Adherence to treatment	Adherence to treatment, in a direct way (through serum lithium levels, serum valproate levels and carbamazepine-serum level) and indirectly by means of the questionnaire of Morinsky-Green.[Time Frame: At 3, 6, 9 and 12 months]	2 years	No
Secondary	Clinical Global Impression for Bipolar Modified, CGI-BP-M.	The Clinical Global Impressions Scale (CGI) is an scale for use in assessing global illness severity and change in patients with bipolar disorder. [Time Frame: At 3, 6, 9 and 12 months]	2 years	No
Secondary	Mania	To assess manic symptoms, will be used the Young Mania Rating Scale (YMRS). [Time Frame: At 3, 6, 9 and 12 months]	2 years	No
Secondary	Depression	To assess depressive symptoms, will be used the the Hamilton Depression Rating Scale. [Time Frame: At 3, 6, 9 and 12 months]using hamilton depression scale	2 years	No
Secondary	Necessity, effectiveness and security problems associated with pharmacotherapy	Necessity problems of pharmacotherapy are related to the following two questions: 1) The patient has a health problem associated with not receiving a medication you need? 2) The patient has a health problem associated with getting a medicine that does not need. The safety of the pharmacotherapy will be measured by the safety profile of drugs and serum concentrations of drugs. The effectiveness of the pharmacotherapy will be measured by Hamilton Rating Scale for Depression, Clinical Global Impressions (CGI), Young Mania Rating Scale.	2 years	No
Secondary	Preventable causes of problems of effectiveness and safety of pharmacotherapy	Quantify the preventable causes of problems of effectiveness and safety of pharmacotherapy. Quantify the process problems like a drug availability problems, problems in prescribing, dispensing problems, administration and use, quality problem.[Time Frame: At 3, 6, 9 and 12 months]	2 years	No