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Clinical Trials/NCT00201201
NCT00201201
Completed
Not Applicable

Reducing Adverse Self-Medication Behaviors in Older Adults With Hypertension

University of Connecticut1 site in 1 country160 target enrollmentSeptember 2007

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cardiovascular Diseases
Sponsor
University of Connecticut
Enrollment
160
Locations
1
Primary Endpoint
Behaviors Risk Score
Status
Completed
Last Updated
12 years ago

Overview

Brief Summary

The purpose of this study is to reduce adverse self-medication practices in older adults with hypertension.

Detailed Description

BACKGROUND: Failure of older adults to take medications properly is estimated to be a factor in more than a quarter of emergency room visits and 10 percent of nursing home admissions, with a total cost of over $25 billion annually. It has been estimated that 10 percent of adverse drug events may be attributed to communication failure between the provider and patient. Lack of adherence to prescription medication protocols and adverse self-medication practices can result in drug interactions that can be fatal. In a health environment that promotes polypharmacy for older adults, a group that is less well able to see, hear, and understand medical information than the general population, a need exists to educate both older adults and their providers about the dangers of adverse drug interactions arising from self-medication. DESIGN NARRATIVE: The goal is to reduce adverse self-medication practices in older adults with hypertension. A computer program developed for older adults (Personal Education Program or PEP) will be modified as the next generation PEP, (PEP-NG), to include an interface to allow clients to enter self-medication behavior data independently on a wireless, touch screen tablet computer. Data entered on the PEP-NG will be analyzed via a secure server (ProHealth) and program content tailored to the specific adverse self-medication behaviors will be delivered. Summaries of the reported behaviors with corrective strategies will be printed for both patient and provider so the advanced practice registered nurse (APRN) has a good idea of the client's self-medication practices before beginning the face-to-face interview. Thus, the PEP-NG will make optimal use of the client's waiting time and the APRN's clinical time. Specific aims are at three levels. 1) To design an interface for the PEP-NG with: a) desirable characteristics for both older adults and primary care providers; and b) minimal user burden. 2) To show that APRNs will increase: a) knowledge concerning potential drug interactions arising from older adults' self-medication practices; b) self-efficacy for teaching older adults about potential drug interactions; c) self-efficacy for communicating with older adults about self-medication; and to d) demonstrate satisfaction using the PEP-NG with clients. 3) To show that older adults using the PEP-NG will: a) increase knowledge concerning potential drug interactions arising from self-medication practices; b) increase self-efficacy as to how to avoid potential drug interactions arising from self-medication practice; c) reduce self-reported adverse behaviors associated with potential drug interactions; 4) improve prescription medication adherence; d) achieve target blood pressure readings; and demonstrate e) satisfaction with the PEP-NG and f) the APRN provider relationship. User-sensitive inclusive design methods will be used to develop and test the patient data interface. After beta-testing the PEP-NG in the primary care laboratory, the PEP-NG will be piloted by 10 APRNs affiliated with ProHealth primary care practices. Repeated Measures Analysis of Variance (RM ANOVA) with one within subjects factor (TIME) will be performed on APRNs' outcome measures at time 0, immediate post-instruction, and 3 and 6 months later. APRNs will each recruit 24 clients (240 total) meeting study criteria. The PEP-NG software will randomly assign each APRN's clients to either control (data collection only) and experimental (data collection plus educational intervention with targeted messages). Client outcome will be assessed at 0, 4, 8, 12, and 52 weeks and analyzed as a mixed ANOVA with NURSE and GROUP as between-subjects factors and TIME as a repeated-measures factor. Healthcare utilization will be compared between the 2 groups after 52 weeks and a cost-benefit analysis conducted.

Registry
clinicaltrials.gov
Start Date
September 2007
End Date
July 2010
Last Updated
12 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Behaviors Risk Score

Time Frame: Measured at 0, 4, 8, and 12 weeks on visit 1, 2, 3 and 4

Using a five-point scale from 1, "very unlikely" to 5, "very likely," a five-member expert panel rated a list of adverse self-medication behaviors. The weight of each behavior was the mean of the expert ratings. Adverse self-medication behaviors were identified from questions that address use of medications (in the past month) to treat high blood pressure as well as use of OTC agents and alcohol for common problems that were self-treated with non-prescription agents. Participants were also asked if they drank alcoholic beverages, smoked or used nicotine, or took any vitamin or mineral supplements (including what, when and how frequently each was taken). The Adverse Self-Medication Behavior Risk Score is the sum (range 3 - 60) of the scores for the adverse behaviors identified. The higher the score, the higher the risk is for adverse self-medication behaviors.

Blood Pressure (BP) Readings: Systolic Blood Pressure

Time Frame: Measured at weeks 0, 4, 8 and 12 on visit 1, 2, 3 and 4

BP measurements were taken by the APRN at each of 4 visits - at the beginning of PEP-NG use on visit 1, and post-PEP-NG use on subsequent visits.

Secondary Outcomes

  • Satisfaction With the PEP-NG(Measured at 12 weeks)
  • Satisfaction With the APRN Provider Relationship(Measured at 0, 12 weeks on visit 1 and 4)
  • Self-efficacy for Avoiding Adverse Self-medication Behaviors(Measured at 0, 4, 8 and 12 weeks on visit 1, 2, 3 and 4)
  • Prescription/Over the Counter (Rx-OTC) Knowledge(Measured at 0, 4, 8, 12 weeks on visits 1, 2, 3 and 4)

Study Sites (1)

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