- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01614353
Medication-taking Preferences & Practices of Patients With Chronic Conditions
December 19, 2012 updated by: Roxanne Vandermause, Washington State University
"Patients can easily be overwhelmed, confused and many times don't fully understand their need for new medications, or when the dosages are to be administered" (patient research partner quote).
The long-term goal of this study is to refine medication science by developing patient-centered assessment, monitoring and management guidelines for patients and health professionals.
The objective is to advance knowledge about the medication-taking perspectives, experiences, and behaviors of older adults with multiple chronic medical conditions (MCMC) to inform future research related to patient-centered medication prescribing, monitoring and management.
This pilot study addresses the following PCORI interest area: "evaluating methods that can be used to assess the patient perspective when researching behaviors and choices within the patient's control that may influence outcomes."
The rationale that underlies the proposed study is that medication-taking practices are wholly within patients' control, and are foundational to reducing complications and improving outcomes for those with MCMC.
To meet the overall objective of this application, the following specific aims will be pursued: 1) identify perceptions and behaviors surrounding the medication-taking process of older adults with MCMC; and 2) generate an interpretation of the meaning of medication-taking among older adults with MCMC.
To achieve these aims, data will be obtained in "real time" from patients (N=30) receiving a new prescription using smart phone technology.
The smart phones will include prompts to help participants record thoughts about medication use throughout the day for 30 days.
Findings from electronic diaries will be logged, analyzed and qualitatively analyzed.
Some patients (n=15) will provide in-depth hermeneutic interviews to provide rich descriptions and interpretive commentary about the experience of receiving a new medication prescription.
The objective is to uncover previously unidentified areas of common experience in older persons with multiple chronic conditions who have received a new prescription.
Common experiences and patterns of influences, that are often surprising or unexpected, will be categorized and assessed.
The expected outcomes of this pilot study are improved knowledge of medication-taking perceptions, experiences, and practices of older adults with MCMC-knowledge that is critical to advance patient-centered medication science.
Study Overview
Status
Unknown
Intervention / Treatment
Study Type
Observational
Enrollment (Anticipated)
30
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Roxanne K Vandermause, PhD
- Phone Number: 509-324-7281
- Email: rvandermause@wsu.edu
Study Locations
-
-
Washington
-
Spokane, Washington, United States, 99201-4813
- Recruiting
- Providence Medical Research Center
-
Sub-Investigator:
- Katherine Tuttle, MD
-
Sub-Investigator:
- Gail Burton, RN
-
Sub-Investigator:
- Duane Sunwold
-
Spokane, Washington, United States, 99210-1495
- Recruiting
- Washington State University
-
Contact:
- Joshua J Neumiller, PharmD
- Phone Number: 509-368-6756
- Email: jneumiller@wsu.edu
-
Principal Investigator:
- Roxanne Vandermause, PhD
-
Sub-Investigator:
- Cynthia F Corbett, RN, PhD
-
Principal Investigator:
- Joshua J Neumiller, PharmD
-
Sub-Investigator:
- Prabu David, PhD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
60 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Persons seen at the Providence Kidney Disease and Hypertension Clinic, aged 60 years or older, with 3 chronic conditions, taking 5 or more medications, and who receive a prescription for a NEW medication will be invited to participate in the 30 day study.
Description
Inclusion Criteria:
- 60 years of age or older
- Diagnosis of at least 3 chronic medical conditions
- Receiving 5 or more medications
- Receipt of a new prescription medication at enrollment
- Ability to speak English
Exclusion Criteria:
- Any individual that does not meet the 5 inclusion criteria listed above
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Study Cohort
All participants (N=30) will be asked to identify perceptions and behaviors surrounding the medication-taking process using technology-assisted prompts and recordings.
Half (n=15) of the participants will participate in two hermeneutic interviews using an interpretive phenomenological approach to generate an interpretation of the meaning of medication taking.
|
Participants (N=30) will maintain electronic diaries to record spontaneous thoughts and perceptions regarding the use of a newly prescribed drug over 30 days.
Half of the enrolled participants (n=15) will participate in 2 hermeneutic interviews conducted in an interpretive phenomonological approach to generate an interpretation of the meaning of medication taking.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Identify perceptions and behaviors surrounding the medication-taking process of older adults with MCMC.
Time Frame: Daily electronic diaries for a duration of 30 days
|
Data will be obtained in "real time" in that patients will audio record thoughts as they arise in the course of each day using an electronic device, over 30 consecutive days, and will answer questions related to medication use.
Findings from end of day prompts will be logged using tables that compare participant demographic characteristics, whether or not the new medication or all prescribed medication was taken, and self-assessed level of wellness.
|
Daily electronic diaries for a duration of 30 days
|
Generate an interpretation of the meaning of medication taking among older adults with MCMC.
Time Frame: 2 Interviews: 1 at enrollment and 1 at 30 days
|
In-depth hermeneutic interviews and interpretive phenomenological analyses will be conducted for 15 of the 30 enrolled participants.
Patterns and themes that capture common experiences revealed in these data provide language for further investigation and new discussion in areas that have been studied traditionally.
Such findings are the characteristic "phenomenological contribution" of qualitative research.
Interpretive commentary in the context of social and cultural evidence and extant literature on medication use will be generated.
|
2 Interviews: 1 at enrollment and 1 at 30 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Joshua Neumiller, PharmD, Washington State University
- Principal Investigator: Roxanne Vandermause, PhD, Washington State University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2012
Primary Completion (Anticipated)
October 1, 2013
Study Completion (Anticipated)
November 1, 2013
Study Registration Dates
First Submitted
June 1, 2012
First Submitted That Met QC Criteria
June 6, 2012
First Posted (Estimate)
June 7, 2012
Study Record Updates
Last Update Posted (Estimate)
December 21, 2012
Last Update Submitted That Met QC Criteria
December 19, 2012
Last Verified
December 1, 2012
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PI-12-001
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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