NCT01750255

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
92

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2011

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2011

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

August 6, 2012

Completed
4 months until next milestone

First Posted

Study publicly available on registry

December 17, 2012

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2013

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
2.3 years until next milestone

Results Posted

Study results publicly available

September 16, 2016

Completed
Last Updated

September 16, 2016

Status Verified

July 1, 2016

Enrollment Period

1.5 years

First QC Date

August 6, 2012

Results QC Date

February 24, 2016

Last Update Submit

July 27, 2016

Conditions

Bipolar Disorder

Keywords

Pharmaceutical carePharmacotherapy follow-upBipolar disorderPharmacy services

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (7)

  • Quality of Life

    1 year

  • Adherence to Treatment

    1 year

  • Clinical Global Impression for Bipolar Modified, CGI-BP-M.

    1 year

  • Mania

    1 year

  • Depression

    1 year

  • +2 more secondary outcomes

Study Arms (2)

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.

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.

Other: Pharmaceutical Care

Interventions

Pharmaceutical CareOTHER

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

Also known as: Pharmacotherapy follow-up, Dader Method for pharmaceutical care
Pharmaceutical Care
EducationOTHER

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.

Also known as: Promotion of health, Disease prevention, Psycho-education
Control

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clínica San Juan de Dios

La Ceja, Antioquia, 574, Colombia

Location

Related Publications (2)

  • 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.

    PMID: 24885673BACKGROUND

  • 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.

    PMID: 28025928DERIVED

MeSH Terms

Conditions

Bipolar Disorder

Interventions

Pharmaceutical ServicesEducational StatusHealth Promotion

Condition Hierarchy (Ancestors)

Bipolar and Related DisordersMood DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Health ServicesHealth Care Facilities Workforce and ServicesSocioeconomic FactorsPopulation CharacteristicsHealth EducationPreventive Health Services

Limitations and Caveats

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).

Results Point of Contact

Title
Pedro Amariles Muñoz
Organization
Universidad de Antioquia
pedro.amariles@udea.edu.co
57 4 2195456

Study Officials

  • Andrea Salazar, cDr.

    Universidad de Antioquia

    STUDY CHAIR

  • Pedro J Amariles, Dr.

    Universidad de Antioquia

    PRINCIPAL INVESTIGATOR

  • 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

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Pharmacy Doctor. Dean of Pharmacy Faculty.

Study Record Dates

First Submitted

August 6, 2012

First Posted

December 17, 2012

Study Start

November 1, 2011

Primary Completion

May 1, 2013

Study Completion

June 1, 2014

Last Updated

September 16, 2016

Results First Posted

September 16, 2016

Record last verified: 2016-07

Locations

CO(1)