NCT01720121

Brief Summary

This study is randomized clinical trial to verify the effect of nursing guidelines for patients undergoing left cardiac catheterization on an outpatient basis. Comparing three approaches to direct guidelines about the procedure:

  • printed,
  • digital video disc (DVD)
  • conventional guidelines provide by nursing team

Trial Health

100
On Track

Trial Health Score

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

Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2009

Shorter than P25 for not_applicable

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

April 1, 2009

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2009

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2009

Completed
3 years until next milestone

First Submitted

Initial submission to the registry

October 3, 2012

Completed
1 month until next milestone

First Posted

Study publicly available on registry

November 2, 2012

Completed
Last Updated

November 2, 2012

Status Verified

October 1, 2012

Enrollment Period

3 months

First QC Date

October 3, 2012

Last Update Submit

October 31, 2012

Conditions

Outcome Measures

Primary Outcomes (1)

  • improvement of knowledge about the procedure after orientation

    four months

Study Arms (3)

Control group

NO INTERVENTION

The control group received the guidelines orientation provide by nursing team

Guidelines printed group

EXPERIMENTAL

The patient received the informative material in details about the cardiac catheterization provide by the researchers

Other: Printed, digital video disc

Guidelines digital video disc group

EXPERIMENTAL

Guidelines digital video disc group: The patient received the informative provide by digital video disc in details about the cardiac catheterization

Other: Printed, digital video disc

Interventions

The three groups of patient received: 1)informative material in details about the cardiac catheterization provide by the researchers; 2)informative provide by a digital video disc; 3)the control group received the conventional informative provide by the nursing team.

Guidelines digital video disc groupGuidelines printed group

Eligibility Criteria

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

You may qualify if:

  • Patients undergoing the procedure were included, with age equal or superior to 18 years

You may not qualify if:

  • patients who had already undergone previous procedures similar severe comorbidities, illiterate and who came to the facility to urgently

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Health Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Eneida R Rabelo da Silva, Professor

    Federal University of Rio Grande do Sul

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

October 3, 2012

First Posted

November 2, 2012

Study Start

April 1, 2009

Primary Completion

July 1, 2009

Study Completion

October 1, 2009

Last Updated

November 2, 2012

Record last verified: 2012-10