NCT03848884

Brief Summary

Does monthly adherence monitoring and education by a pharmacy resident impact Kroger star ratings, compared to the current standard?

Trial Health

87
On Track

Trial Health Score

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

Enrollment
34

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2019

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 14, 2019

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 21, 2019

Completed
8 days until next milestone

Study Start

First participant enrolled

March 1, 2019

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 16, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 16, 2019

Completed
Last Updated

October 18, 2019

Status Verified

October 1, 2019

Enrollment Period

8 months

First QC Date

February 14, 2019

Last Update Submit

October 16, 2019

Conditions

Outcome Measures

Primary Outcomes (2)

  • Adherence in oral diabetes medications determined by star ratings

    Determine change in patients who are adherent to oral diabetes medications, determined by pharmacy star ratings in adherence measures; pharmacy analytics determines the star rating measure (on a scale of 1 to 5 stars, with 5 being the highest) before and after the study. A student t-test will be used to determine if there is a difference.

    Baseline to 6 months

  • Adherence in renin-angiotensin system antagonists (RASA) medications determined by star ratings

    Determine change in patients who are adherent to RASA medications, determined by pharmacy star ratings in adherence measures; pharmacy analytics determines the star rating measure (on a scale of 1 to 5 stars, with 5 being the highest) before and after the study. A student t-test will be used to determine if there is a difference.

    Baseline to 6 months

Secondary Outcomes (1)

  • Change in proportion of days covered (PDC)

    Baseline to 6 months

Other Outcomes (1)

  • Satisfaction with education and monitoring service

    6 months

Study Arms (1)

Adherence monitoring and education

EXPERIMENTAL
Behavioral: Adherence monitoring and education

Interventions

Standardized medication counseling and education combined with individual patient customized guidance and counseling - administered monthly.

Adherence monitoring and education

Eligibility Criteria

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

You may qualify if:

  • years or older
  • Patients pre-identified by Kroger analytics in ClinicalQ - Patients with PDC \< 80%
  • Patient taking oral diabetes medications and/or RASA medications (ACE-I, ARB, direct renin inhibitor)

You may not qualify if:

  • Patients who are enrolled in MedSync or Autorefill program
  • Patients who are lost to follow-up
  • Incomplete/missing documentation of an encounter
  • Prisoners, children

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

Location

MeSH Terms

Conditions

Patient Compliance

Interventions

Educational Status

Condition Hierarchy (Ancestors)

Patient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Intervention Hierarchy (Ancestors)

Socioeconomic FactorsPopulation Characteristics

Study Officials

  • Jean-Venable Goode, PharmD

    Virginia Commonwealth University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 14, 2019

First Posted

February 21, 2019

Study Start

March 1, 2019

Primary Completion

October 16, 2019

Study Completion

October 16, 2019

Last Updated

October 18, 2019

Record last verified: 2019-10

Data Sharing

IPD Sharing
Will not share

Locations