NCT01978925

Brief Summary

The purpose of this study is to evaluate the effectiveness of pharmaceutical care, compared to usual care, in patient discharge in an emergency department in patients with hypertension and/or diabetes mellitus type 2.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
380

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2013

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

First Submitted

Initial submission to the registry

November 1, 2013

Completed
Same day until next milestone

Study Start

First participant enrolled

November 1, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 8, 2013

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

May 20, 2015

Status Verified

May 1, 2015

Enrollment Period

1.1 years

First QC Date

November 1, 2013

Last Update Submit

May 19, 2015

Conditions

Medication AdherenceHypertensionDiabetes Mellitus

Keywords

Pharmaceutical careMedication AdherenceBlood PressureDiabetesEmergency

Outcome Measures

Primary Outcomes (1)

  • Medication Adherence

    Outcome of interest: High Adherence According to the Brief Medication Questionnaire and Morisky-Green Test

    Two months

Secondary Outcomes (3)

  • Blood Pressure Control

    Two months

  • Glycated hemoglobin (HbA1C) for diabetic patients

    two months

  • Quality of Life

    Two months

Other Outcomes (1)

  • Fasting plasma glucose for diabetic patients

    Two months

Study Arms (2)

Pharmaceutical care

EXPERIMENTAL

In the ED, immediately after discharge, participants randomized to the pharmaceutical care group will receive intervention coordinated by the study pharmacist.

Other: Pharmaceutical care

Usual care

NO INTERVENTION

In addition to counseling provided by a physician and by the nursing staff during their stay in the ED (usual care), patients randomized to the control group will receive the same printed material information on hypertension and/or diabetes medications and lifestyle interventions in order to keep patients masked.

Interventions

Pharmaceutical careOTHER

The clinical pharmacist will provide a structured 30-minute intervention for enhancing their medication adherence. The recommendations include: discussion on hypertension and/or diabetes, risk of complications, prescribed drug therapy, correct use of medications and proper dosage, possible adverse effects, route of administration, schedule of administration and correct storage. The pharmacist will also emphasize the importance of lifestyle modifications. Printed educational material, with information on hypertension and/ or diabetes medications, including suggested lifestyle interventions was prepared to assist in the intervention and will be handed to patients in the end of the session.

Pharmaceutical care

Eligibility Criteria

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

You may qualify if:

  • Blood pressure inadequate control (systolic blood pressure ≥ 160 or diastolic blood pressure ≥ 100 mmHg) or
  • Diabetes mellitus inadequate Control( ≥ 200 mg/dL) or hypoglycemia moderate or severe
  • Be referred to clinical care.

You may not qualify if:

  • \< 18 years
  • Not resident of Porto Alegre
  • Diabetes mellitus type I
  • Unable to answer the questionnaire or to sign the informed consent form
  • Hospital admission
  • Death

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Emergency Department - Hospital Moinhos de Vento

Porto Alegre, Rio Grande do Sul, 900350-001, Brazil

Location

Related Publications (1)

  • Kuhmmer R, Lima KM, Ribeiro RA, Hammes LS, Bastos GA, Cotta de Souza MC, Polanczyk CA, Soares Rollin GA, Caon S, Guterres CM, Araujo Leite LE, Delabary TS, Falavigna M. Effectiveness of pharmaceutical care at discharge in the emergency department: study protocol of a randomized controlled trial. Trials. 2015 Feb 25;16:60. doi: 10.1186/s13063-015-0579-3.

    PMID: 25888343DERIVED

MeSH Terms

Conditions

Medication AdherenceHypertensionDiabetes MellitusEmergencies

Interventions

Pharmaceutical Services

Condition Hierarchy (Ancestors)

Patient CompliancePatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehaviorVascular DiseasesCardiovascular DiseasesGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Health ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Rodrigo A Ribeiro, PhD

    Hospital Moinhos de Vento

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 1, 2013

First Posted

November 8, 2013

Study Start

November 1, 2013

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

May 20, 2015

Record last verified: 2015-05

Locations

BR(1)