Bipolar Disorder
Conditions
Keywords
Pharmaceutical care, Pharmacotherapy follow-up, Bipolar disorder, Pharmacy services
Brief 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).
Interventions
OTHERPharmaceutical 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
OTHEREducation
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.
Sponsors
Humax Pharmaceutical
Universidad de Antioquia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | 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
| Measure | Time frame | Description |
|---|---|---|
| Mania | 1 year | — |
| Depression | 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 |
| Quality of Life | 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 |
| Preventable Causes of Problems of Effectiveness and Safety of Pharmacotherapy | 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.\[Time Frame: At 3, 6, 9 and 12 months\] |
| Necessity, Effectiveness and Security Problems Associated With Pharmacotherapy | 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. |
| Adherence to Treatment | 1 year | Total percentage of adherence by treatment group |
| Clinical Global Impression for Bipolar Modified, CGI-BP-M. | 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). |
Countries
Colombia
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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.
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. | 49 |
| 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. Pharmaceutical Care: Patients and their families will be provided with verbal and written information and education about mental health and bipolar disorder. | 43 |
| Total | 92 |
Baseline characteristics
| Characteristic | Pharmaceutical Care | Control | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 43 Participants | 49 Participants | 92 Participants |
| Age, Continuous | 41.9 years STANDARD_DEVIATION 9.9 | 43.7 years STANDARD_DEVIATION 11.8 | 42.8 years STANDARD_DEVIATION 10.9 |
| Region of Enrollment Colombia | 43 participants | 49 participants | 92 participants |
| Sex: Female, Male Female | 23 Participants | 29 Participants | 52 Participants |
| Sex: Female, Male Male | 20 Participants | 20 Participants | 40 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 49 | 0 / 43 |
| serious Total, serious adverse events | 0 / 49 | 0 / 43 |
Outcome results
Primary
To Reduce the Use of Health Care Services by Quantifying the Number of Emergency Service Consultations
Time frame: 1 year
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Control | To Reduce the Use of Health Care Services by Quantifying the Number of Emergency Service Consultations | 23 Emergency Service Consultations |
| Pharmaceutical Care | To Reduce the Use of Health Care Services by Quantifying the Number of Emergency Service Consultations | 4 Emergency Service Consultations |
Primary
To Reduce the Use of Health Care Services by Quantifying the Number of Hospitalizations
Time frame: 1 year
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Control | To Reduce the Use of Health Care Services by Quantifying the Number of Hospitalizations | 12 Hospitalizations |
| Pharmaceutical Care | To Reduce the Use of Health Care Services by Quantifying the Number of Hospitalizations | 1 Hospitalizations |
Primary
To Reduce the Use of Health Care Services by Quantifying the Number of Unscheduled Outpatient Visits
Time frame: 1 year
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Control | To Reduce the Use of Health Care Services by Quantifying the Number of Unscheduled Outpatient Visits | 3 Outpatient-unscheduled visits |
| Pharmaceutical Care | To Reduce the Use of Health Care Services by Quantifying the Number of Unscheduled Outpatient Visits | 12 Outpatient-unscheduled visits |
Secondary
Adherence to Treatment
Total percentage of adherence by treatment group
Time frame: 1 year
Population: Total percentage of adherence by treatment group
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Control | Adherence to Treatment | 74.4 Medication adherence percentage |
| Pharmaceutical Care | Adherence to Treatment | 86.8 Medication adherence percentage |
Secondary
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).
Time frame: 1 year
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control | Clinical Global Impression for Bipolar Modified, CGI-BP-M. | 1.6 Clinical Global Impression | Standard Deviation 0.7 |
| Pharmaceutical Care | Clinical Global Impression for Bipolar Modified, CGI-BP-M. | 1.3 Clinical Global Impression | Standard Deviation 0.6 |
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
Time frame: 1 year
Secondary
Mania
Time frame: 1 year
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.
Time frame: 1 year
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.\[Time Frame: At 3, 6, 9 and 12 months\]
Time frame: 1 year
Secondary
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
Time frame: 1 year
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control | Quality of Life | 83 Mental health summary score | Standard Deviation 22.6 |
| Pharmaceutical Care | Quality of Life | 89.7 Mental health summary score | Standard Deviation 16.9 |