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

Study Overview
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Brief Summary
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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
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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).

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

Conditions
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Bipolar Disorder

Intervention / Treatment
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* Other: Pharmaceutical Care
* Other: Education


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Control<br>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<br>* 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.<br>* Other names: Psycho-education;|
| Active Comparator: Pharmaceutical Care<br>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<br>* 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<br>* Other names: Dader Method for pharmaceutical care;|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Life | 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 | Total percentage of adherence by treatment group | 1 year | 
| Clinical Global Impression for Bipolar Modified, CGI-BP-M. | 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 |  | 1 year | 
| 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 | 1 year | 
| 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. | 1 year | 
| 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] | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pharmaceutical care, Pharmacotherapy follow-up, Bipolar disorder, Pharmacy services