Improving Medication Adherence: A Study With Talking Pill Bottles

Medication Adherence Clinical Trial

— TPB  

Official title:

Improving Medication Adherence: A Pilot Study With Talking Pill Bottles

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02827773
• Other study ID #: 35077-G
• Status: Completed
• Phase: N/A
• First received: June 15, 2016
• Last updated: July 5, 2016
• Start date: March 2009
• Est. completion date: October 2010

Study information

• Verified date: July 2016
• Source: University of Washington
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 138
• Est. completion date: October 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Medication Adherence

Intervention

Other:
• Talking Pill Bottle
Made by Talking Rx

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
University of Washington	Dana-Farber Cancer Institute, University of California, Los Angeles

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline Systolic Blood Pressure at 3 months	Measured by electronic blood pressure cuff at 90 days	90 days	No
Secondary	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	No
Secondary	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	No
Secondary	Change from Baseline Medication Knowledge at 3 months	Measured by administering internally created survey instrument at 90 days.	90 days	No