Clinical trial NCT02827773: Improving Medication Adherence: A Study With Talking Pill Bottles
Official title: Improving Medication Adherence: A Pilot Study With Talking Pill Bottles
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Medication Adherence
Keywords: Literacy
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: Dana-Farber Cancer Institute
name: University of California, Los Angeles
First posted: 2016-07-11
Enrollment: 138
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change from Baseline Systolic Blood Pressure at 3 months
timeFrame: 90 days
Secondary outcomes:
measure: Change from Baseline Self Efficacy in Medication Self Administration at 3 months
timeFrame: 90 days
measure: Change from Baseline Medication Adherence at 3 months
timeFrame: 90 days
measure: Change from Baseline Medication Knowledge at 3 months
timeFrame: 90 days
Other outcomes:
Locations:
Study officials:
References:
citation: 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.