NCT02060981

Brief Summary

Investigators will conduct a randomized trial with patients, through one-on-one interviews, to evaluate their understanding of and willingness to use a decision support tool and to determine if receiving and discussing the decision support tool improves the likelihood that a patient is adherent to a new antihypertensive medication.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
140

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2014

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

February 1, 2014

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

February 10, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 12, 2014

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2015

Completed
Last Updated

February 18, 2015

Status Verified

February 1, 2015

Enrollment Period

1.1 years

First QC Date

February 10, 2014

Last Update Submit

February 16, 2015

Conditions

Medication AdherenceHypertensionDecision Making, SharedPatient-Centered Outcomes Research

Keywords

Randomized controlled trialPrimary medication adherenceDecision-support toolPatient-centered outcomes researchAntihypertensive medicationsOne-on-one patient interviews

Outcome Measures

Primary Outcomes (1)

  • Cumulative incidence of antihypertensive medication fills

    The proportion of patients in each group who picked up a prescription for an antihypertensive medication in any class during the follow-up period. Investigators will calculate cumulative incidences among all patients, whether or not they successfully completed the interview or returned the paper-based survey (Intention to Treat) and among only those patients who did complete the interview or returned the paper-based survey (As Treated).

    6 months

Secondary Outcomes (1)

  • Patient Interviews

    5 months

Study Arms (3)

Interview only

ACTIVE COMPARATOR

Patients will be asked to participate in an interview regarding their views on hypertension and taking medications to treat hypertension.

Behavioral: Interview Only

Control

PLACEBO COMPARATOR

Control group patients will then be mailed an American Heart Association brochure regarding hypertension and a brief, 5-question, paper-based survey. These patients will be asked to review the brochure, complete the survey, and mail it back to the research team using a self-addressed stamped envelope.

Behavioral: Control

Interview plus decision support tool

EXPERIMENTAL

Patients will be asked to participate in an interview regarding their views on hypertension and taking medications to treat hypertension, and to provide feedback regarding a new tool for helping patients learn more about their medications. Interview plus patients' index date for follow-up is the date of the scheduled interview.

Behavioral: Interview plus decision support tool

Interventions

ControlBEHAVIORAL

Control group patients will then be mailed an American Heart Association brochure regarding hypertension and a brief, 5-question, paper-based survey.

Control
Interview OnlyBEHAVIORAL

Patients will be asked to participate in an interview regarding their views on hypertension and taking medications to treat hypertension.

Interview only
Interview plus decision support toolBEHAVIORAL

Patients will be asked to participate in an interview regarding their views on hypertension and taking medications to treat hypertension and to provide feedback regarding a new decision support tool for helping patients learn more about their medications.

Interview plus decision support tool

Eligibility Criteria

Age25 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • does not pick up a prescription for a new antihypertensive medication within 14 days as identified by CVS pharmacy, their retail pharmacy provider.
  • High blood pressure diagnosis

You may not qualify if:

  • under age 25.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Medication AdherenceHypertension

Interventions

Interviews as Topic

Condition Hierarchy (Ancestors)

Patient CompliancePatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehaviorVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Jennifer Polinski, Sc.D.

    Brigham and Women's Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor and Epidemiologist

Study Record Dates

First Submitted

February 10, 2014

First Posted

February 12, 2014

Study Start

February 1, 2014

Primary Completion

March 1, 2015

Study Completion

April 1, 2015

Last Updated

February 18, 2015

Record last verified: 2015-02

Locations

US(1)