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Improving Medication Adherence: A Study With Talking Pill Bottles

Improving Medication Adherence: A Pilot Study With Talking Pill Bottles

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02827773
Acronym
TPB
Enrollment
138
Registered
2016-07-11
Start date
2009-03-31
Completion date
2010-10-31
Last updated
2016-07-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Medication Adherence

Keywords

Literacy

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

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.

Interventions

OTHERTalking Pill Bottle

Made by Talking Rx

Sponsors

Dana-Farber Cancer Institute
CollaboratorOTHER
University of California, Los Angeles
CollaboratorOTHER
University of Washington
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Age
21 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change from Baseline Systolic Blood Pressure at 3 months90 daysMeasured by electronic blood pressure cuff at 90 days

Secondary

MeasureTime frameDescription
Change from Baseline Self Efficacy in Medication Self Administration at 3 months90 daysMeasured by using the survey instrument of same name at 90 days
Change from Baseline Medication Adherence at 3 months90 daysMeasured by using the survey instrument Morisky Medication Adherence Scale and also calculating Cumulative Medication Gap at 90 days based on pill counts.
Change from Baseline Medication Knowledge at 3 months90 daysMeasured by administering internally created survey instrument at 90 days.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026