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Administrative data

NCT number NCT01614353
Other study ID # PI-12-001
Secondary ID
Status Unknown status
Phase N/A
First received June 1, 2012
Last updated December 19, 2012
Start date October 2012
Est. completion date November 2013

Study information

Verified date December 2012
Source Washington State University
Contact Roxanne K Vandermause, PhD
Phone 509-324-7281
Email rvandermause@wsu.edu
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

"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.


Recruitment information / eligibility

Status Unknown status
Enrollment 30
Est. completion date November 2013
Est. primary completion date October 2013
Accepts healthy volunteers No
Gender All
Age group 60 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Electronic Diaries
Participants (N=30) will maintain electronic diaries to record spontaneous thoughts and perceptions regarding the use of a newly prescribed drug over 30 days.
Hermeneutic Interviews
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.

Locations

Country Name City State
United States Providence Medical Research Center Spokane Washington
United States Washington State University Spokane Washington

Sponsors (2)

Lead Sponsor Collaborator
Washington State University Providence Medical Research Center

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Identify perceptions and behaviors surrounding the medication-taking process of older adults with MCMC. 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
Primary Generate an interpretation of the meaning of medication taking among older adults with MCMC. 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
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