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

July 27, 2016 updated by: Pedro Amariles, Universidad de Antioquia

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Actual)

92

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Colombia
    • Antioquia
      • La Ceja, Antioquia, Colombia, 574
        • Clínica San Juan de Dios

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Control
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:
  • Promotion of health
  • Disease prevention
  • Psycho-education
Active Comparator: 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 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
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To Reduce the Use of Health Care Services by Quantifying the Number of Hospitalizations
Time Frame: 1 year
1 year
To Reduce the Use of Health Care Services by Quantifying the Number of Emergency Service Consultations
Time Frame: 1 year
1 year
To Reduce the Use of Health Care Services by Quantifying the Number of Unscheduled Outpatient Visits
Time Frame: 1 year
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of Life
Time Frame: 1 year
The Short Form-36 Health Survey (SF-36): It is a questionnaire to measure quality of life, exploring the physical and mental health. Contains 36 topics that explore 8 dimensions of health: physical function; social function; limitations of the role: physical problems; limitations of the role: emotional problems; mental health; vitality; pain and general health perception. Each of the 8 dimensions of the SF-36 scores range between 0 and 100 values. 100 being a result indicating optimal health and 0 would reflect in a very bad state of health. The questionnaire allows the calculation of 2 scores summary, physical component summary (PCS) and mental (MCS), by combining each dimension scores
1 year
Adherence to Treatment
Time Frame: 1 year
Total percentage of adherence by treatment group
1 year
Clinical Global Impression for Bipolar Modified, CGI-BP-M.
Time Frame: 1 year
The modified version of the Clinical Global Impression for Bipolar Disorder (CGI-BP-M) a condensed version of the CGI-BP, which is also an adaptation of the CGI for bipolar patients. The CGI-BP-M, is a scale for the assessment of manic, hypomanic, depressive or mixed symptoms, and long-term outcome of bipolar disorder. Assesses the current gravity, the short and long term of the disease course. It consists of three subscales, composed of a single item, evaluating the severity of the acute symptoms of depression, mania and disease in general (refers to the longitudinal disease severity). It has a Likert intensity scale of 7 degrees of freedom ( 1 normal, 7 very severe).
1 year
Mania
Time Frame: 1 year
1 year
Depression
Time Frame: 1 year
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
1 year
Necessity, Effectiveness and Security Problems Associated With Pharmacotherapy
Time Frame: 1 year
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.
1 year
Preventable Causes of Problems of Effectiveness and Safety of Pharmacotherapy
Time Frame: 1 year
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]
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidad de Antioquia

Collaborators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2011

Primary Completion (Actual)

May 1, 2013

Study Completion (Actual)

June 1, 2014

Study Registration Dates

First Submitted

August 6, 2012

First Submitted That Met QC Criteria

December 12, 2012

First Posted (Estimate)

December 17, 2012

Study Record Updates

Last Update Posted (Estimate)

September 16, 2016

Last Update Submitted That Met QC Criteria

July 27, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EMDADER-TABI-20111108

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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