NCT02827773

Brief Summary

The aim of this research project is to compare the use of "Talking Pill Bottles" to usual care in patients who have low functional health literacy and who purchase medications for primary hypertension at a retail pharmacy with regard to:

  1. 1.feasibility of the procedures,
  2. 2.utility of the equipment,
  3. 3.medication adherence,
  4. 4.self efficacy in medication self management, and
  5. 5.blood pressure control.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
138

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2009

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

Study Start

First participant enrolled

March 1, 2009

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2010

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2010

Completed
5.7 years until next milestone

First Submitted

Initial submission to the registry

June 15, 2016

Completed
26 days until next milestone

First Posted

Study publicly available on registry

July 11, 2016

Completed
Last Updated

July 11, 2016

Status Verified

July 1, 2016

Enrollment Period

1.3 years

First QC Date

June 15, 2016

Last Update Submit

July 5, 2016

Conditions

Medication Adherence

Keywords

Literacy

Outcome Measures

Primary Outcomes (1)

  • Change from Baseline Systolic Blood Pressure at 3 months

    Measured by electronic blood pressure cuff at 90 days

    90 days

Secondary Outcomes (3)

  • Change from Baseline Self Efficacy in Medication Self Administration at 3 months

    90 days

  • Change from Baseline Medication Adherence at 3 months

    90 days

  • Change from Baseline Medication Knowledge at 3 months

    90 days

Study Arms (2)

Received Talking Pill Bottles

EXPERIMENTAL

Patients received anti-hypertensives over 90 day period in Talking Pill Bottle which contained summary of pharmacy counselling session.

Other: Talking Pill Bottle

Usual Care

NO INTERVENTION

Patients received oral summary of pharmacy counselling session.

Interventions

Talking Pill BottleOTHER

Made by Talking Rx

Received Talking Pill Bottles

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years or older
  • Filling a prescription for hypertension treatment
  • Able to understand spoken English.

You may not qualify if:

  • Cannot understand English;
  • Hearing impaired when not using hearing assistive devices
  • Cognitively impaired.
  • Unable to read labels with corrected vision

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Lam A, Wolpin S, Nguyen J, Berry DL, Kurth A, Morisky DE. Is 60 seconds enough? Can talking pill bottles be used in the community pharmacy setting? J Am Pharm Assoc (2003). 2011 Sep-Oct;51(5):569-70. doi: 10.1331/JAPhA.2011.10096. No abstract available.

    PMID: 21896452BACKGROUND

MeSH Terms

Conditions

Medication AdherenceLiteracy

Condition Hierarchy (Ancestors)

Patient CompliancePatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehaviorCommunication

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant Professor

Study Record Dates

First Submitted

June 15, 2016

First Posted

July 11, 2016

Study Start

March 1, 2009

Primary Completion

June 1, 2010

Study Completion

October 1, 2010

Last Updated

July 11, 2016

Record last verified: 2016-07

Data Sharing

IPD Sharing
Will not share