NCT02452788

Brief Summary

The purpose of this study is to evaluate the effectiveness of pharmaceutical care, compared to usual care, in improving medication adherence behaviour of ambulatory hemodialysis patients.

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2015

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

May 19, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 25, 2015

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
Last Updated

May 25, 2015

Status Verified

May 1, 2015

Enrollment Period

2 months

First QC Date

May 19, 2015

Last Update Submit

May 20, 2015

Conditions

Medication AdherenceChronic Renal DiseasesRenal Failure Chronic Requiring Hemodialysis

Outcome Measures

Primary Outcomes (1)

  • Medication adherence

    High adherence according to the Brief Medication Questionnaire

    one month

Secondary Outcomes (1)

  • Quality of life

    one month

Study Arms (2)

Intervention

OTHER

Pharmaceutical care with educational intervention provided by a pharmacist to ambulatory hemodialysis patients

Other: Pharmaceutical care

Usual Care

NO INTERVENTION

Usual Care

Interventions

Pharmaceutical careOTHER

Pharmacist-provided education on medication adherence in hemodialysis patients.

Intervention

Eligibility Criteria

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

You may qualify if:

  • Aged 18 years or more
  • Chronic renal patients undergoing regular hemodialysis
  • Receiving their scheduled medications (at least one drug)

You may not qualify if:

  • Unable to answer the questionnaire or to sign the informed consent form
  • Inability to obtain prescription drugs

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Moinhos de Vento

Porto Alegre, Rio Grande do Sul, 90035-001, Brazil

Location

MeSH Terms

Conditions

Medication AdherenceRenal Insufficiency, Chronic

Interventions

Pharmaceutical Services

Condition Hierarchy (Ancestors)

Patient CompliancePatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehaviorRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Health ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Lisiane F Leal, MBA

    Hospital Moinhos de Vento

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Maicon Falavigna, PhD

CONTACT

+555133143600maicon.falavigna@hmv.org.br

Study Design

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

Study Record Dates

First Submitted

May 19, 2015

First Posted

May 25, 2015

Study Start

May 1, 2015

Primary Completion

July 1, 2015

Last Updated

May 25, 2015

Record last verified: 2015-05

Locations

BR(1)