Pharmaceutical Care in Ambulatory Hemodialysis Patients | NCT02452788

Studies
Pharmaceutical Care in Ambulatory Hemodialysis Patients

NCT02452788

Sponsor

Hospital Moinhos de Vento

Status

Unknown status

Last Update Posted

May 25, 2015Estimated

Enrollment

40Estimated

Phase

Not Applicable

Conditions

Medication Adherence
Chronic Renal Diseases
Renal Failure Chronic Requiring Hemodialysis

Interventions

Pharmaceutical care

Countries

Brazil

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2015

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2015

Primary Completion Date

Jul 2015Estimated

Completion Date

Not provided

First Submitted Date

May 19, 2015

First Submission Date that Met QC Criteria

May 20, 2015

First Posted Date

May 25, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 20, 2015

Last Update Posted Date

May 25, 2015Estimated

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Pharmaceutical care	Other	Pharmacist-provided education on medication adherence in hemodialysis patients.	Intervention

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Medication adherence	High adherence according to the Brief Medication Questionnaire	one month

Secondary Outcomes

Measure	Description	Time Frame
Quality of life	Quality of life will be evaluated with EQ-5D questionnaire	one month

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Maicon Falavigna, PhD	Contact	+555133143600		maicon.falavigna@hmv.org.br

Overall Officials

Name	Affiliation	Role
Lisiane F Leal, MBA	Hospital Moinhos de Vento	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hospital Moinhos de Vento		Porto Alegre	Rio Grande do Sul	90035-001	Brazil

Condition Browse Module

MeSH Terms

ID	Term
D055118	Medication Adherence
D051436	Renal Insufficiency, Chronic

Ancestor Terms

ID	Term
D010349	Patient Compliance
D010342	Patient Acceptance of Health Care
D000074822	Treatment Adherence and Compliance
D015438	Health Behavior

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D010593	Pharmaceutical Services

Ancestor Terms

ID	Term
D006296	Health Services
D005159	Health Care Facilities Workforce and Services

Browse Leaves

Not provided

Browse Branches

Not provided