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Trial record 68 of 333 for:    DABIGATRAN

Dabigatran Adherence Pilot Intervention for Patients With Atrial Fibrillation

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ClinicalTrials.gov Identifier: NCT01578044
Recruitment Status : Completed
First Posted : April 16, 2012
Results First Posted : June 15, 2015
Last Update Posted : October 10, 2018
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Health Services Research
Condition Atrial Fibrillation
Interventions Behavioral: Intervention
Other: Control
Enrollment 12
Recruitment Details Patients who are new starts on dabigatran, apixaban, and rivaroxaban and have completed the initial 3-month pharmacy follow-up will be approached by a pharmacist to inquire about their interest in participating in our study. Patients interested will verbally consent to participate and will then be randomized to the intervention or control group.
Pre-assignment Details  
Arm/Group Title Intervention Group Usual Care
Hide Arm/Group Description

Intervention patients will receive the following:

  1. Patient education: All patients will receive information on their oral anticoagulant, including risks, benefits, and potential side effects. Intervention patients will receive additional materials at the beginning of the study through the mail.
  2. Tele-monitoring: IVR technology will be used to send patients automated reminders to refill their dabigatran, rivaroxaban, and apixaban prescriptions. This call will be delivered on day 20 following each anticoagulant prescription.
  3. Pharmacists follow-up: If dabigatran, rivaroxaban, and apixaban has not been refilled, the pharmacy staff will contact the patient to assess reasons that the patient has not refilled the medication.

Usual care patients will receive information on dabigatran, apixaban, and rivaroxaban including risks, benefits and potential side effects.

Following the end of the study, the usual care patients will receive the additional educational materials the intervention group received during the study.

Period Title: Overall Study
Started 6 6
Completed 6 6
Not Completed 0 0
Arm/Group Title Intervention Group Usual Care Group Total
Hide Arm/Group Description

Patients who are randomized to the intervention group will receive the following:

  1. Patient education: Patients will receive information on dabigatran, apixaban, and rivaroxaban, including risks, benefits and potential side effects. This information will be re-enforced during the study on a monthly basis during the IVR calls and during the pharmacy service calls to patients.
  2. Tele-monitoring: IVR technology will be used to send patients automated reminders to refill their dabigatran, rivaroxaban, and apixaban prescriptions. This call will be delivered on day 20 following each anticoagulant prescription.
  3. Pharmacy follow-up: If the anticoagulant has not been refilled, the pharmacy staff will contact the patient to assess reasons the patient has not refilled the medication.

Usual care

Usual care patients will receive information on dabigatran, apixaban, and rivaroxaban including risks, benefits and potential side effects.

Following the end of the study, the usual care patients will receive the additional educational materials the intervention group received during the study.

Total of all reporting groups
Overall Number of Baseline Participants 6 6 12
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 6 participants 12 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
0
   0.0%
0
   0.0%
0
   0.0%
>=65 years
6
 100.0%
6
 100.0%
12
 100.0%
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 6 participants 6 participants 12 participants
70.5
(67 to 78)
69.3
(63 to 84)
69.9
(63 to 84)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 6 participants 12 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
Male
6
 100.0%
6
 100.0%
12
 100.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 6 participants 6 participants 12 participants
6 6 12
1.Primary Outcome
Title Gaps Days Between Prescription Refills for Dabigatran, Rivaroxaban, and Apixaban
Hide Description The investigators will calculate the # of gap days between refills for dabigatran/rivaroxaban/apixaban for each3 and 6 months of the pilot intervention. This will be based on pharmacy refill data and calculated using the date dabigatran/rivaroxaban/apixaban was dispensed and the # of days supplied for that prescription. We will add the # of gap days for each 3 and 6 months of the pilot for each patient, and compare the total # of gaps days between intervention and usual care patients. The gap days between refills is a validated measure of adherence and identifies patients with sub-optimal adherence.A negative gap day value indicates that participants received the refill prior to completion of the previous prescription.
Time Frame 3 and 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Intervention Group Usual Care Group
Hide Arm/Group Description:
  1. Patient education: Patients will receive information on dabigatran, including risks, benefits and potential side effects. This information will be re-enforced during the study on a monthly basis during the IVR calls and during the pharmacy service calls to patients.
  2. Tele-monitoring: We will use IVR technology to send patients an automated reminder to refill their dabigatran, rivaroxaban, and apixaban prescriptions. This call will be delivered on day 20 following each dabigatran, rivaroxaban, and apixaban prescription.
  3. Pharmacists follow-up: If dabigatran, rivaroxaban, and apixaban has not been refilled, the pharmacy staff will contact the patient to assess reasons that the patient has not refilled the medication.
All usual care patients will receive information on dabigatran, rivaroxaban, and apixaban, including risks, benefits, and potential side effects. Additionally, following their time in the study, the usual care patients will receive the additional educational materials the usual care received.
Overall Number of Participants Analyzed 6 6
Measure Type: Number
Unit of Measure: days
# of Patient gap days for 3-months of intervention 43 51
# of Patient gap days for 6-months of intervention 41 -5
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Intervention Group Usual Care Group
Hide Arm/Group Description
  1. Patient education: Patients will receive information on dabigatran, including risks, benefits and potential side effects. This information will be re-enforced during the study on a monthly basis during the IVR calls and during the pharmacy service calls to patients.
  2. Tele-monitoring: We will use IVR technology to send patients an automated reminder to refill their dabigatran, rivaroxaban, and apixaban prescriptions. This call will be delivered on day 20 following each dabigatran, rivaroxaban, and apixaban prescription.
  3. Pharmacists follow-up: If dabigatran, rivaroxaban, and apixaban has not been refilled, the pharmacy staff will contact the patient to assess reasons that the patient has not refilled the medication.

Usual care

All patients will receive information on dabigatran, rivaroxaban, and apixaban, including risks, benefits, and potential side effects. Also, following their enrollment in the study will receive the additional educational materials given to the intervention group during their time in the study.

All-Cause Mortality
Intervention Group Usual Care Group
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Intervention Group Usual Care Group
Affected / at Risk (%) Affected / at Risk (%)
Total   0/6 (0.00%)   0/6 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Intervention Group Usual Care Group
Affected / at Risk (%) Affected / at Risk (%)
Total   0/6 (0.00%)   0/6 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: P. Michael Ho
Organization: VA Eastern Colorado Health Care System
Phone: 720-857-2115
EMail: michael.ho@va.gov
Publications of Results:
Shore S, Carey E, Turakhia M, Jackevicius CA, Cunningham F, Pilote L, Baron A, Grunwald G, Bradley SM, Maddox TM, Rumsfeld JS, Varosy PD, Ho M. Patterns of Adherence to Dabigatran and its Association with Outcomes. [Abstract]. Circulation. 2013 Nov 26; 128(22 Suppl):A16864.
Layout table for additonal information
Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT01578044     History of Changes
Other Study ID Numbers: RRP 11-424
First Submitted: April 3, 2012
First Posted: April 16, 2012
Results First Submitted: April 27, 2015
Results First Posted: June 15, 2015
Last Update Posted: October 10, 2018