Any Condition in N73.0 Specified as ChronicNCT01614353
Medication-taking Preferences & Practices of Patients With Chronic Conditions
An observational study of Any Condition in N73.0 Specified as Chronic and Adult Disease, run by Washington State University at 2 sites in United States.
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). Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Any Condition in N73.0 Specified as Chronic, Adult Disease, Pharmacological Action
- What is being tested?
- Electronic Diaries and Hermeneutic Interviews
- How many people
- 30 participants
- Where
- 2 sitesUnited States
- Study dates
- Oct 2012to Nov 2013
- Phase
- Observational
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Any individual that does not meet the 5 inclusion criteria listed above
Trial locations and contacts
2 sites in 1 country.
United States2 sites, 2 recruiting
- Recruiting
Providence Medical Research Center
Spokane, Washington, 99201-4813
Katherine Tuttle, MD
Gail Burton, RN
- Recruiting
Washington State University
Spokane, Washington, 99210-1495
Joshua J Neumiller, PharmD, 509-368-6756, jneumiller@wsu.edu
Roxanne Vandermause, PhD
About this study
"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.
- Being tested
- Electronic Diaries, Hermeneutic Interviews
- Keywords
- Multiple Chronic Conditions, Older Adults, New Prescription
- Medical subject headings
- Disease, Multiple Chronic Conditions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electronic DiariesOther
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 InterviewsOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Electronic Diaries; Other: Hermeneutic Interviews |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Daily electronic diaries for a duration of 30 days
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.
Measured: 2 Interviews: 1 at enrollment and 1 at 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2012 (estimated)
- Study startOct 2012
- Primary completionOct 2013 (estimated)
- Study completionNov 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Any Condition in N73.0 Specified as ChronicStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Washington State University
- Sponsor type
- University, hospital or other
- Collaborators
- Providence Medical Research Center
- Responsible party
- Principal investigator, Roxanne Vandermause, Washington State University
- Investigators
- Joshua Neumiller, PharmD, Principal investigator, Washington State UniversityRoxanne Vandermause, PhD, Principal investigator, Washington State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01614353
- Sponsor's protocol ID
- PI-12-001
- Status last verified
- Dec 2012
- First submitted
- 1 Jun 2012
- Last updated
- 21 Dec 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Medication-taking Preferences & Practices of Patients With Chronic Conditions
- ClinicalTrials.gov ID
- NCT01614353
- Acronym / sponsor ID
- PI-12-001
- Keywords
- Multiple Chronic Conditions, Older Adults, New Prescription
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Washington State UniversityUniversity, hospital or other
- Collaborators
- Providence Medical Research Center
- Study start
- Oct 2012
- Primary completion
- Oct 2013 (estimated)
- Study completion
- Nov 2013 (estimated)
- First posted
- 7 Jun 2012 (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.
"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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study Cohort | – | Other: Electronic Diaries, Other: Hermeneutic InterviewsAll 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. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- Any individual that does not meet the 5 inclusion criteria listed above
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 |
|---|---|---|
| Electronic DiariesParticipants (N=30) will maintain electronic diaries to record spontaneous thoughts and perceptions regarding the use of a newly prescribed drug over 30 days. | Other | Study Cohort |
| Hermeneutic InterviewsHalf 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. | Other | Study Cohort |
Primary outcome
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.
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2012.
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.
Joshua Neumiller, PharmD principal investigator
Washington State University
Roxanne Vandermause, PhD principal investigator
Washington State University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Any Condition in N73.0 Specified as Chronic and Adult Disease, run by Washington State University at 2 sites in United States.
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 5 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 21 Dec 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Roxanne K Vandermause, PhD (509-324-7281, rvandermause@wsu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Dec 2012.