NCT02757482

Brief Summary

The purpose of this study is to examine the effects of patient training about the safety of warfarin therapy on related knowledge levels and on International Normalized Ratio (INR) control.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
63

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2014

Shorter than P25 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2014

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

April 24, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 2, 2016

Completed
Last Updated

May 2, 2016

Status Verified

April 1, 2016

Enrollment Period

6 months

First QC Date

April 24, 2016

Last Update Submit

April 28, 2016

Conditions

Warfarin Knowledge LevelInternational Normalized Ratio ControlPatient Training

Keywords

Patient trainingWarfarinInternational Normalized RatioNursing

Outcome Measures

Primary Outcomes (1)

  • Warfarin Knowledge Level Measurement

    Warfarin knowledge level was measured by The Warfarin Knowledge Assessment Form. This form consisted of 30 questions. These questions covered basic information for drug treatment such as the drug dose, the duration of drug use, adverse effects of the drug, drug-drug and drug-food interaction, drug use in pregnancy, dental care and treatment, laboratory monitoring, exercise and diet. Each correct answer scored 1, and each wrong answer or a 'don't know' response scored 0. The last two questions in the last section on drug use related to pregnancy and nursing a child, and so these were answered only by women. Patients' raw information scores were between 0 and 30. Those scoring 0-15 were accepted as having a low level of information, those scoring 16-21 a moderate level, and those scoring 22-30 a high level of information.

    2 months

Secondary Outcomes (1)

  • International Normalized Ratio Measurements

    6 months

Study Arms (2)

intervention

EXPERIMENTAL

Patient training

Other: training

control

NO INTERVENTION

no patient training

Interventions

trainingOTHER
intervention

Eligibility Criteria

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

You may qualify if:

  • Using warfarin for at least two months,
  • Between 18 and 65 years old,
  • Were literate,
  • Not have a structured education about warfarin

You may not qualify if:

  • Have structured education about warfarin,
  • Have a seeing or hearing disability,
  • Have a cognitive or sensory disorder,
  • Have a disability affecting oral communication

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CELAL BAYAR UNIVERSITY Ö.Y.P. (Teaching Staff Training Program) OFFICE

Manisa, Muradiye, 45140, Turkey (Türkiye)

Location

Study Officials

  • TULAY SAGKAL MIDILLI, Phd, RN

    Assistant professor

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Asistant Professor

Study Record Dates

First Submitted

April 24, 2016

First Posted

May 2, 2016

Study Start

September 1, 2014

Primary Completion

March 1, 2015

Study Completion

June 1, 2015

Last Updated

May 2, 2016

Record last verified: 2016-04

Locations

TU(1)