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

This study has been completed.
Sponsor:
Collaborator:
Humax Pharmaceutical
Information provided by (Responsible Party):
Pedro Amariles, Universidad de Antioquia
ClinicalTrials.gov Identifier:
NCT01750255
First received: August 6, 2012
Last updated: June 3, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention
Bipolar Disorder
Other: Pharmaceutical Care
Other: Education

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: Effect of Pharmaceutical Care in Patients With Bipolar I Disorder at St John of God Clinic. Randomized Trial.

Resource links provided by NLM:


Further study details as provided by Universidad de Antioquia:

Primary Outcome Measures:
  • Health care services use [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
    To reduce the use of health care services by quantifying the number of hospitalizations, emergency care and outpatient, in addition to those scheduled


Secondary Outcome Measures:
  • Quality of Life [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    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]

  • Adherence to treatment [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    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]

  • Clinical Global Impression for Bipolar Modified, CGI-BP-M. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    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]

  • Mania [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    To assess manic symptoms, will be used the Young Mania Rating Scale (YMRS). [Time Frame: At 3, 6, 9 and 12 months]

  • Depression [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    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

  • Necessity, effectiveness and security problems associated with pharmacotherapy [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    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.

  • Preventable causes of problems of effectiveness and safety of pharmacotherapy [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    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]


Enrollment: 200
Study Start Date: November 2011
Study Completion Date: June 2014
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Control
There is no "placebo" treatment, and after randomization, patients were informed of their group assignments. 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.
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.
Other Names:
  • Education
  • Promotion of health
  • Disease prevention
  • Psycho-education
Active Comparator: Pharmaceutical Care
Patients and 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 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.
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
Other Names:
  • Pharmacotherapy follow-up
  • Dader Method for pharmaceutical care

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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01750255

Locations
Colombia
Clínica San Juan de Dios
La Ceja, Antioquia, Colombia, 574
Sponsors and Collaborators
Universidad de Antioquia
Humax Pharmaceutical
Investigators
Study Chair: Andrea Salazar, cDr. Universidad de Antioquia
Principal Investigator: Pedro J Amariles, Dr. Universidad de Antioquia
Study Chair: Dora M Benjumea, Dr Universidad de Antioquia
Study Chair: Luis F Rodriguez, Dr Clínica San Juan de Dios
Study Chair: Francisco J Gutierrez, Dr Universidad de Antioquia
  More Information

No publications provided by Universidad de Antioquia

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Pedro Amariles, Pharmacy Doctor. Dean of Pharmacy Faculty., Universidad de Antioquia
ClinicalTrials.gov Identifier: NCT01750255     History of Changes
Other Study ID Numbers: EMDADER-TABI-20111108
Study First Received: August 6, 2012
Last Updated: June 3, 2014
Health Authority: Colombia: Institutional Review Board

Keywords provided by Universidad de Antioquia:
Pharmaceutical care
Pharmacotherapy follow-up
Bipolar disorder
Pharmacy services

Additional relevant MeSH terms:
Bipolar Disorder
Disease
Affective Disorders, Psychotic
Mental Disorders
Mood Disorders
Pathologic Processes

ClinicalTrials.gov processed this record on November 24, 2014