Medication Therapy Management With Pharmacogenetic Testing | NCT01970774

Studies
Medication Therapy Management With Pharmacogenetic Testing

NCT01970774

Sponsor

Duke University

Status

Completed

Last Update Posted

Apr 20, 2015Estimated

Enrollment

30Actual

Phase

Not Applicable

Conditions

Pharmacogenetics
Medication Therapy Management

Interventions

MTM with PGx

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2013

Primary Completion Date

Oct 2014Actual

Completion Date

Oct 2014Actual

First Submitted Date

Oct 23, 2013

First Submission Date that Met QC Criteria

Oct 23, 2013

First Posted Date

Oct 28, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 17, 2015

Last Update Posted Date

Apr 20, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This study aims to investigate the benefit and feasibility of providing pharmacogenetic (PGx) testing as part of a standard medication therapy management (MTM) session for patients taking multiple medications, a high-risk population for adverse drug reactions and non-response. Research participants will attend two MTM sessions and undergo PGx testing to inform the MTM plan. Participants will also complete 2 surveys pre and post-MTM/PGx testing. Data analysis will assess the impact of MTM/PGx testing on recommendations for drug dosing, clinical outcomes, patient satisfaction, and feasibility of service delivery. Safety issues are minimal with the primary risks being associated with loss of confidentiality, typical discomfort associated with acquiring blood samples, and genetic discrimination.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
MTM and PGx	Experimental	Participants attend two MTM sessions and have PGx testing	Other: MTM with PGx

Interventions

Name	Type	Description	Arm Group Labels	Other Names
MTM with PGx	Other	Patients will attend MTM sessions and receive PGx testing	MTM and PGx

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Patient satisfaction with MTM and PGx	This will be assessed by a quantitative survey	3 months after completion of MTM2
Change in clinical biomarkers associated with drug therapy	Changes in biomarkers before and after MTM/PGx will be measured. Biomarkers of study group will be compared to chart-review control	baseline and 2 months
Number of recommended drug selection/dosing adjustments	Drug selection/doing changes will be compared between study population and chart-review controls	approximately 9 months

Secondary Outcomes

Measure	Description	Time Frame
Physician time to perform MTM and PGx		end of study, approx. 9 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

currently prescribed 3 medications, one of which must be simvastatin or clopidogrel
18 years of age or older
English speaking
patients of Mahesh Patel or William Kraus at Duke Southpoint Clinic

Exclusion Criteria:

if patient has ever had MTM or PGx

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Susanne Haga, PhD	Duke University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Duke Health Center at Southpoint		Durham	North Carolina	27713	United States

Intervention Browse Module

MeSH Terms

ID	Term
C099588	myotubularin

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided