Medication AdherenceTPBNCT02827773
Improving Medication Adherence: A Study With Talking Pill Bottles
A study testing Talking Pill Bottle in people with Medication Adherence, run by University of Washington.
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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Medication Adherence
- What is being tested?
- Talking Pill Bottle
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 138 participants
- Where
- No sites listed yet
- Study dates
- Mar 2009to Oct 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 21 years or older
- Filling a prescription for hypertension treatment
- Able to understand spoken English.
Who cannot join
- Cannot understand English;
- Hearing impaired when not using hearing assistive devices
- Cognitively impaired.
- Unable to read labels with corrected vision
About this study
Official title: 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:
- feasibility of the procedures,
- utility of the equipment,
- medication adherence,
- self efficacy in medication self management, and
- blood pressure control.
Read the 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.
- Conditions
- Medication Adherence
- Being tested
- Talking Pill Bottle
- Keywords
- Literacy
- Medical subject headings
- Medication Adherence, Literacy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Talking Pill BottleOther
Made by Talking Rx
| Study group | Role | What they receive |
|---|---|---|
| Received Talking Pill Bottles | Experimental | Patients received anti-hypertensives over 90 day period in Talking Pill Bottle which contained summary of pharmacy counselling session. Receives: Other: Talking Pill Bottle |
| Usual Care | No intervention | Patients received oral summary of pharmacy counselling session. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline Systolic Blood Pressure at 3 months
Measured by electronic blood pressure cuff at 90 days
Measured: 90 days
Secondary outcomes (3)
Change from Baseline Self Efficacy in Medication Self Administration at 3 months
Measured by using the survey instrument of same name at 90 days
Measured: 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.
Measured: 90 days
Change from Baseline Medication Knowledge at 3 months
Measured by administering internally created survey instrument at 90 days.
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2016 (estimated)
- Study startMar 2009
- Primary completionJun 2010
- Study completionOct 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Medication AdherenceStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 138 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Seth Wolpin, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02827773
- Sponsor's protocol ID
- 35077-G
- Acronym
- TPB
- Status last verified
- Jul 2016
- First submitted
- 15 Jun 2016
- Last updated
- 11 Jul 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
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.
PubMed 21896452
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Medication Adherence: A Pilot Study With Talking Pill Bottles
- ClinicalTrials.gov ID
- NCT02827773
- Acronym / sponsor ID
- TPB / 35077-G
- Conditions
- Medication Adherence
- Keywords
- Literacy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 138 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- Dana-Farber Cancer Institute, University of California, Los Angeles
- Study start
- Mar 2009
- Primary completion
- Jun 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 11 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- feasibility of the procedures,
- utility of the equipment,
- medication adherence,
- self efficacy in medication self management, and
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Received Talking Pill Bottles | Experimental | Other: Talking Pill BottlePatients received anti-hypertensives over 90 day period in Talking Pill Bottle which contained summary of pharmacy counselling session. |
| Usual Care | No intervention | –Patients received oral summary of pharmacy counselling session. |
Who may qualify
- Ages
- 21 years and older
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 21 years or older
- Filling a prescription for hypertension treatment
- Able to understand spoken English.
Key exclusion criteria (4 listed)
- Cannot understand English;
- Hearing impaired when not using hearing assistive devices
- Cognitively impaired.
- Unable to read labels with corrected vision
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Talking Pill BottleMade by Talking Rx | Other | Received Talking Pill Bottles |
Primary outcome
Change from Baseline Systolic Blood Pressure at 3 months
Time frame: 90 days
Measured by electronic blood pressure cuff at 90 days
3 secondary outcomes
Change from Baseline Self Efficacy in Medication Self Administration at 3 months
Time frame: 90 days
Change from Baseline Medication Adherence at 3 months
Time frame: 90 days
Change from Baseline Medication Knowledge at 3 months
Time frame: 90 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2016.
- Background: PubMed 21896452Lam 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Talking Pill Bottle in people with Medication Adherence, run by University of Washington.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline Systolic Blood Pressure at 3 months (time frame: 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02827773, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2016.