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OpenTrials
Completed

NCT Number: NCT02827773

Improving Medication Adherence: A 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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Talking Pill Bottle

Other

Made by Talking Rx

Primary outcomes

  1. Change from Baseline Systolic Blood Pressure at 3 months

    Time frame: 90 days

    Measured by electronic blood pressure cuff at 90 days

Secondary outcomes

  1. Change from Baseline Self Efficacy in Medication Self Administration at 3 months

    Time frame: 90 days

    Measured by using the survey instrument of same name at 90 days

  2. Change from Baseline Medication Adherence at 3 months

    Time frame: 90 days

    Measured by using the survey instrument Morisky Medication Adherence Scale and also calculating Cumulative Medication Gap at 90 days based on pill counts.

  3. Change from Baseline Medication Knowledge at 3 months

    Time frame: 90 days

    Measured by administering internally created survey instrument at 90 days.

Sponsors and collaborators

Lead sponsor

University of Washington

Other

Collaborators

  • Dana-Farber Cancer Institute
  • University of California, Los Angeles

Registry information

Official study title

Improving Medication Adherence: A Pilot Study With Talking Pill Bottles

Acronym: TPB

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Jul 11, 2016
Registry last updated
Jul 11, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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