Bipolar DisorderEMDADER-TABINCT01750255

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

A study testing Pharmaceutical Care and Education in people with Bipolar Disorder, run by Universidad de Antioquia at 1 site in Colombia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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. Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Bipolar Disorder
What is being tested?: Pharmaceutical Care and Education
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 92 participants
Where: 1 siteColombia
Study dates: Nov 2011to Jun 2014
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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).

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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.

Trial locations and contacts

1 site in 1 country.

Colombia1 site

Clínica San Juan de Dios
La Ceja, Antioquia, 574

Other trials in Colombia

About this study

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

Read the 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).

Conditions: Bipolar Disorder
Being tested: Pharmaceutical Care, Education
Keywords: Pharmaceutical care, Pharmacotherapy follow-up, Bipolar disorder, Pharmacy services
Medical subject headings: Bipolar Disorder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Pharmaceutical CareOther
Also called Pharmacotherapy follow-up, Dader Method for 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
EducationOther
Also called Promotion of health, Disease prevention, Psycho-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.

Study groups in NCT01750255
Study group	Role	What they receive
Control	Placebo comparator	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. Receives: Other: Education
Pharmaceutical Care	Active comparator	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. Receives: Other: Pharmaceutical Care

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (7)

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
Measured: 1 year
Adherence to Treatment
Total percentage of adherence by treatment group
Measured: 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).
Measured: 1 year
Mania
Measured: 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
Measured: 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.
Measured: 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]
Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 2011Jun 2014

First posted17 Dec 2012 (estimated)
Study startNov 2011
Primary completionMay 2013
Study completionJun 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Bipolar DisorderStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 92 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01750255
Sponsor's protocol ID: EMDADER-TABI-20111108
Acronym: EMDADER-TABI
Status last verified: Jul 2016
First submitted: 6 Aug 2012
Last updated: 16 Sep 2016
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: Undecided

Publications

Salazar-Ospina A, Amariles P, Benjumea DM, Gutierrez F, Faus MJ, Rodriguez LF. Effectiveness of the Dader Method for pharmaceutical care in patients with bipolar I disorder: EMDADER-TAB: study protocol for a randomized controlled trial. Trials. 2014 May 20;15:174. doi: 10.1186/1745-6215-15-174.
PubMed 24885673
Salazar-Ospina A, Amariles P, Hincapie-Garcia JA, Gonzalez-Avendano S, Benjumea DM, Faus MJ, Rodriguez LF. Effectiveness of the Dader Method for Pharmaceutical Care on Patients with Bipolar I Disorder: Results from the EMDADER-TAB Study. J Manag Care Spec Pharm. 2017 Jan;23(1):74-84. doi: 10.18553/jmcp.2017.23.1.74.
PubMed 28025928

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Bipolar Disorder trials

Study at a glance

From the registry record, last updated by the sponsor on 16 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effect of Pharmaceutical Care in Patients With Bipolar I Disorder at St John of God Clinic. Randomized Trial.
ClinicalTrials.gov ID: NCT01750255
Acronym / sponsor ID: EMDADER-TABI / EMDADER-TABI-20111108
Conditions: Bipolar Disorder
Keywords: Pharmaceutical care, Pharmacotherapy follow-up, Bipolar disorder, Pharmacy services
Study type: Interventional
Recruitment status: Completed
Enrolment: 92 participants (actual)
Lead sponsor: Universidad de AntioquiaUniversity, hospital or other
Collaborators: Humax Pharmaceutical
Study start: Nov 2011
Primary completion: May 2013 (actual)
Study completion: Jun 2014 (actual)
First posted: 17 Dec 2012 (estimated)
Results: Posted 16 Sep 2016

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Control	Placebo comparator	Other: EducationThe 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.
Pharmaceutical Care	Active comparator	Other: Pharmaceutical CarePharmaceutical 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.

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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.

Key exclusion criteria (11 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Pharmaceutical CareAlso: Pharmacotherapy follow-up, Dader Method for pharmaceutical carePharmaceutical 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	Pharmaceutical Care
EducationAlso: Promotion of health, Disease prevention, Psycho-educationThe 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	Control

Primary outcome

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

7 secondary outcomes

Quality of Life
Time frame: 1 year
Adherence to Treatment
Time frame: 1 year
Clinical Global Impression for Bipolar Modified, CGI-BP-M.
Time frame: 1 year
Mania
Time frame: 1 year
Depression
Time frame: 1 year
Necessity, Effectiveness and Security Problems Associated With Pharmacotherapy
Time frame: 1 year
Preventable Causes of Problems of Effectiveness and Safety of Pharmacotherapy
Time frame: 1 year

Results and safety

Results posted to the registry on 16 Sep 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Control: Usual Care (Routine Dispensing), Verbal and Written	49	43
Intervention Group: the Dader Method for Pharmaceutical Care	43	38

Primary outcome: To Reduce the Use of Health Care Services by Quantifying the Number of Hospitalizations

Time frame: 1 year. Number. Unit: Hospitalizations

Measure	Control n = 49	Pharmaceutical Care n = 43
Value	12	1

Primary outcome: To Reduce the Use of Health Care Services by Quantifying the Number of Emergency Service Consultations

Time frame: 1 year. Number. Unit: Emergency Service Consultations

Measure	Control n = 49	Intervention n = 43
Value	23	4

Primary outcome: To Reduce the Use of Health Care Services by Quantifying the Number of Unscheduled Outpatient Visits

Time frame: 1 year. Number. Unit: Outpatient-unscheduled visits

Measure	Control n = 49	Intervention n = 43
Value	3	12

7 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Control	0 of 49 (0%)	0 of 49 (0%)	Not reported
Pharmaceutical Care	0 of 43 (0%)	0 of 43 (0%)	Not reported

Limitations and caveats (from the sponsor): There was no "placebo" treatment, the study patients were not blinded to treatment assignment and both groups (were seen by the same pharmacist, who was responsible for collecting the measurements).

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 24885673Salazar-Ospina A, Amariles P, Benjumea DM, Gutierrez F, Faus MJ, Rodriguez LF. Effectiveness of the Dader Method for pharmaceutical care in patients with bipolar I disorder: EMDADER-TAB: study protocol for a randomized controlled trial. Trials. 2014 May 20;15:174. doi: 10.1186/1745-6215-15-174.
Derived from this study: PubMed 28025928Salazar-Ospina A, Amariles P, Hincapie-Garcia JA, Gonzalez-Avendano S, Benjumea DM, Faus MJ, Rodriguez LF. Effectiveness of the Dader Method for Pharmaceutical Care on Patients with Bipolar I Disorder: Results from the EMDADER-TAB Study. J Manag Care Spec Pharm. 2017 Jan;23(1):74-84. doi: 10.18553/jmcp.2017.23.1.74.
Individual participant dataSharing planned: Undecided

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Andrea Salazar, cDr. study chair

Universidad de Antioquia

Pedro J Amariles, Dr. principal investigator

Universidad de Antioquia

Dora M Benjumea, Dr study chair

Universidad de Antioquia

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Pharmaceutical Care and Education in people with Bipolar Disorder, run by Universidad de Antioquia at 1 site in Colombia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Colombia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 16 Sep 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

To Reduce the Use of Health Care Services by Quantifying the Number of Hospitalizations (time frame: 1 year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01750255, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2016.