Trial Outcomes & Findings for Remote Home Prothrombin Time (PT)/International Normalized Ratio (INR) Monitoring and Patient Management System (NCT NCT00978445)

Results Overview

minutes spent measuring coagulation time of blood on standard versus home protocol

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

25 participants

Primary outcome timeframe

Once per week during 12 week study

Results posted on

2013-03-21

Participant Flow

Inrolled 25 patients in two arms of 12 weeks from patient population of Cleveland Clinic Foundation

Clear enrollement criteria were created only real exclusion was if physician did not believe patient could perform protocol and if outside of age criteria.

Participant milestones

Participant milestones
Measure	Home/Standard all participants recieved home and standard protocol, in this ARM the home protocol was a virtual INR and communication using a remote communication device called vMetrics.	Standard/Home all participants recieved home and standard protocol, in this ARM the standard protocol was a in clinic INR and interaction with a care giver, then the Home protocol was as described.
Overall Study STARTED	12	13
Overall Study COMPLETED	10	12
Overall Study NOT COMPLETED	2	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Remote Home Prothrombin Time (PT)/International Normalized Ratio (INR) Monitoring and Patient Management System

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Participants n=25 Participants all participants recieved all interventions during study
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	25 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age Continuous	53.7 years STANDARD_DEVIATION 11.7 • n=5 Participants
Sex: Female, Male Female	10 Participants n=5 Participants
Sex: Female, Male Male	15 Participants n=5 Participants
Region of Enrollment United States	25 participants n=5 Participants

PRIMARY outcome

Timeframe: Once per week during 12 week study

Population: through minimum power study

minutes spent measuring coagulation time of blood on standard versus home protocol

Outcome measures

Outcome measures
Measure	All Participants-Home Protocol n=22 Participants all participants recieved all interventions during study	All Particpants - Standard Protocol n=22 Participants First and second group with vMetrics
Time Spent Per PT/INR Monitoring Encounter	19.4 minutes Standard Deviation 2.3	47 minutes Standard Deviation 2.6

SECONDARY outcome

Timeframe: During study vist number 2 after 12 week study period, repeated after second study 12 week period study visit #3

Population: power analysis

we are interested in the relative measure of quality of life by comparing quality of life measures through use of PSQ-18 and other measures listed. Higher scores indicate a better quality of life.

Outcome measures

Outcome measures
Measure	All Participants-Home Protocol n=22 Participants all participants recieved all interventions during study	All Particpants - Standard Protocol n=22 Participants First and second group with vMetrics
Change in Quality of Life - Based on Quality of Life Scores PSQ-18 (Short Form Patient Satisfaction Questionnaire) Duke Anticoagulation Satisfaction Scale SF-12 (Short Form 12 Version 2) Quality of Life Questionnaire PSQ-18	51.1 scores on a scale Standard Deviation .7	50.8 scores on a scale Standard Deviation .6
Change in Quality of Life - Based on Quality of Life Scores PSQ-18 (Short Form Patient Satisfaction Questionnaire) Duke Anticoagulation Satisfaction Scale SF-12 (Short Form 12 Version 2) Quality of Life Questionnaire DASS	47.5 scores on a scale Standard Deviation 2.6	49.7 scores on a scale Standard Deviation 2.7

Adverse Events

All Participants

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Heather Gornik

Cleveland Clinic Foundation

Phone: 216-445-3689

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place