Improving Medication Adherence: A Study With Talking Pill Bottles (TPB)

Improving Medication Adherence: A Pilot Study With Talking Pill Bottles

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

Study Overview

• Status: Completed
• Conditions: Medication Adherence
• Intervention / Treatment: Other: Talking Pill Bottle

Detailed Description

Introduction: Across the healthcare continuum, patients with low functional health literacy may have worse outcomes due to difficulties in following prescribed medication regimens. While reasons for non-adherence can be drawn from the intra-personal, interpersonal, and systemic perspectives; one starting point is the difficulty that patients have reading and understanding medication instructions on a prescription bottle labels. Labels can provide a vital reminder and decision support aid for patients and healthcare proxies. Yet, skills must be available for reading and understanding the labels. The investigators will utilize "Talking Pill Bottles" to record prescription medication instructions so that patients can re-play the instructions as needed in their homes. Purpose: 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: a. feasibility of the procedures, b. utility of the equipment, c. medication adherence, d. self efficacy in medication self management, and e. blood pressure control. Design: This novel intervention will be tested within the context of a retail pharmacy in the Pacific Northwest. The pilot test will use a randomized trial design with two research arms. Analysis: Within-group change scores on a self efficacy measure and blood pressures will be examined with the paired t-test; between group measures will also be examined between the two treatment arms. The investigators will also track medication complexity as a potential confounder and conduct semi-structured exit interviews. Conclusion: Results will help establish the feasibility and utility of providing this technology to patients who have low functional health literacy in a retail pharmacy. The investigators will gather preliminary descriptive data along with variance and effect size measures for power estimations in a future multi-site, randomized controlled trial.

• Study Type: Interventional
• Enrollment (Actual): 138
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Received Talking Pill Bottles; Patients received anti-hypertensives over 90 day period in Talking Pill Bottle which contained summary of pharmacy counselling session.	Other: Talking Pill Bottle; Made by Talking Rx
NO_INTERVENTION: Usual Care; Patients received oral summary of pharmacy counselling session.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Baseline Systolic Blood Pressure at 3 months	Measured by electronic blood pressure cuff at 90 days	90 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Baseline Self Efficacy in Medication Self Administration at 3 months	Measured by using the survey instrument of same name at 90 days	90 days
Change from Baseline Medication Adherence at 3 months	Measured by using the survey instrument Morisky Medication Adherence Scale and also calculating Cumulative Medication Gap at 90 days based on pill counts.	90 days
Change from Baseline Medication Knowledge at 3 months	Measured by administering internally created survey instrument at 90 days.	90 days

Collaborators and Investigators

• Sponsor: University of Washington
• Collaborators: University of California, Los Angeles; Dana-Farber Cancer Institute

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: March 1, 2009
• Primary Completion (ACTUAL): June 1, 2010
• Study Completion (ACTUAL): October 1, 2010

Study Registration Dates

• First Submitted: June 15, 2016
• First Submitted That Met QC Criteria: July 5, 2016
• First Posted (ESTIMATE): July 11, 2016

Study Record Updates

• Last Update Posted (ESTIMATE): July 11, 2016
• Last Update Submitted That Met QC Criteria: July 5, 2016
• Last Verified: July 1, 2016

More Information

Terms related to this study

• Keywords: Literacy
• Other Study ID Numbers: 35077-G

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO