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CompletedNCT03650777Updated Jan 15, 2019

Impact of Telehealth Warfarin Education on Patient Retention

An interventional study of Warfarin Telehealth Education in Educational Problems and Medication Adherence, sponsored by Baylor Research Institute. Completed. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-01-15.

Sponsored by Baylor Research Institute · Not applicable, Interventional, and Other

From the registry’s dates

  • Registered 2 years 5 months after the study started (first participant enrolled Feb 2016, registered Aug 2018).
Phase
Not applicable
Study type
Interventional
Enrollment
18
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

The objective of this study is to evaluate the effectiveness of telehealth warfarin education in a charity outpatient clinic. The purpose is to increase patient knowledge with regard to their warfarin therapy and to measure knowledge retention

Read the detailed description

2. This study is conducted in outpatient ambulatory care clinics at the Baylor Family Medicine Worth Street clinic and the Irving Interfaith clinic. The average census for warfarin patients Friday clinic is 10. The anticoagulation clinic consists of an interdisciplinary team including physicians, medical assistants, nurse practitioners, and pharmacists. Patients initially visit with the provider and subsequent follow up INR checks are performed by the pharmacists or medical assistants. Currently, pharmacists manage the anticoagulation clinic on Fridays and medical assistants manage the clinic on Monday through Thursday. All providers provide patient education through written brochures.

3. Study Design

a. This study is a prospective, single-centered, randomized controlled quality improvement pilot study.

4. Warfarin Education Procedures

  1. Each Friday morning, the pharmacist will identify the patients with appointments for INR checks.
  2. As each patient checks in for their appointment, the pharmacist will ask the patient for consent to be a part of the study
  3. If the patient says yes, the pharmacist will have the patient complete a warfarin questionnaire and health literacy test to see the patient's baseline knowledge on their warfarin therapy
  4. Intervention patients (iPAD® video)

    1. The patient will then watch a warfarin education video on the iPAD®
    2. After the video the patient will receive point of care INR check and have their warfarin dose adjusted
    3. Patient will then complete the same warfarin questionnaire
    4. After completion, answers to the questionnaire will be presented to the patient. A written brochure will be given.
    5. A satisfaction survey will be given
    6. 30-60 days days later the pharmacist will follow up with the patient to repeat the warfarin questionnaire

    5. Description of iPAD video

a. Setting: a pharmacy b. Description: A pharmacist will provide education about warfarin using not only verbal instructions but also provide illustrations of directions. Please refer to Appendix for dialogue.

6. Control group

a. Patients' INR will be taken and warfarin education will be given verbally similar to Monday-Thursday clinic. A written brochure will be given.

02

Conditions studied

  • Educational Problems
  • Medication Adherence

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03

In context

Medication Adherence

240 studies on the registry are indexed under Medication Adherence; 111 are open to participants now.

This study's enrollment of 18 is below the median of 120 across 203 interventional studies indexed under Medication Adherence.

Browse Medication Adherence studies →

Lead sponsor

Baylor Research Institute is the lead sponsor of 223 studies on the registry; 49 are open to participants now.

Of its 23 completed or terminated interventional studies of FDA-regulated products, 9 (39%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Age > 18 years
  2. English as a first language
  3. Currently taking warfarin for an approved indication
  4. Having the ability to see, read, and hear for verbal, written, and iPad® warfarin education

Exclusion criteria

Exclusion Criteria:

  1. Age \< 18 years
  2. Unwilling to receive iPad counseling
  3. Cognitive dysfunction and impairments that prevents patient from fully comprehending warfarin education
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
18 participants (actual)

Interventions

  • OtherWarfarin Telehealth Education

    Patients received education on warfarin through a video on an iPad, and were assessed on knowledge pre and post video, and at follow up visit

06

What researchers measure

Primary outcomes

  1. Knowledge Retention of Warfarin Education post video watching

    Difference in pre warfarin education video and post video test for warfarin education in patients receiving warfarin education via iPad

    Time frame: pre and post video test(20 minutes)

  2. Long Term Knowledge Retention of warfarin education post video watching

    Difference in pre video test and follow up retention test for warfarin education in patients receiving warfarin education via iPad

    Time frame: initial and follow up visit (max 30 days)

Secondary outcomes

  1. Self Reported Adherence to Warfarin therapy during duration of study

    Descriptive results of patient self reported adherence (yes/no response) related to warfarin between initial and follow up visit

    Time frame: Between initial and follow up visit ( max 30 days)

  2. Satisfaction Survey

    A satisfaction survey (designed by pharmacy resident) with 4 questions based on Likert scale (0-5), and one free response question patient completes on follow up visit. Name of Scale used for 4 questions: Likert. (Range 1-5, 1= highly disagree, 2= disagree, 3-neutral, 4-agree, 5-highly agree). There was no total of scoring, each response was individual of each other.

    Time frame: Max 30 days

  3. Adverse Events

    Descriptive results of patient self reported adverse events related to warfarin between initial and follow up visit

    Time frame: Between initial and follow up visit ( max 30 days)

  4. Time of Warfarin in Therapeutic Range for Duration of Study

    Time patient was within therapeutic range for their INR goal between initial and follow up visit

    Time frame: Between initial and follow up visit ( max 30 days)

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • Heinrich K, Sanchez K, Hui C, Talabi K, Perry M, Qin H, Nguyen H, Tatachar A. Impact of an electronic medium delivery of warfarin education in a low income, minority outpatient population: a pilot intervention study. BMC Public Health. 2019 Aug 5;19(1):1050. doi: 10.1186/s12889-019-7370-4. PubMed 31382942 ↗

Individual participant data

Plan to share: Undecided

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 15, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03650777
Responsible party
Sponsor
First posted
Aug 29, 2018
Start date
Feb 18, 2016
Primary completion
Jul 31, 2017
Completion
Jul 31, 2017
Last update
Jan 15, 2019

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jan 2019. You cannot join it, but the record below documents what was studied.

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