Reducing Adverse Self-Medication Behaviors in Older Adults With Hypertension

NCT00201201 | Completed Results DMC

• 2 other identifiers: H02-602R01HL084208
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Cardiovascular Diseases; Heart Diseases; Hypertension

Keywords

Older Adults; Primary Care; Hypertension; Adherence

Outcome Measures

Primary Outcomes (2)

• Behaviors Risk Score

  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.

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

• Blood Pressure (BP) Readings: Systolic Blood Pressure

  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.

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

Secondary Outcomes (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

• 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

Study Arms (2)

Education

EXPERIMENTAL

PEP-NG targeted and tailored education intervention

Other: Education Intervention

Control

OTHER

Control, intervention is care as usual.

Other: Control

Interventions

Education Intervention OTHER

Adults aged 60 and over with hypertension were randomized to usual care and intervention groups. Both groups entered medication taking behaviors on the PEP-NG and answer questions related to knowledge and self-efficacy regarding adverse self-medication behaviors. The education intervention group received a tailored education program.

Also known as: Personal Education Program - Next Generation (PEP-NG)

Education

Control OTHER

Control group receiving care as usual after interfacing with the surveys on the PEP-NG

Also known as: Control group for PEP-NG

Control

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Older adult diagnosed with hypertension
• Health literacy score (REALM) of 44 or greater
• Independent physical and cognitive functioning
• Visual acuity of at least 20/100, with corrective lenses

You may not qualify if:

• less than age 60
• health literacy score below 44 (6th grade)
• not currently prescribed antihypertensive medication
• visual acuity of less than 20/100 (with corrective lenses, if needed)
• inability to meet independent-living and cognitive-functioning ability.
• Affiliated with ProHealth Physicians, Inc. practice site in CT and/or
• Affiliated with APRN practice sites in CT
• Not affiliated with primary care practice sites in CT

Sponsors & Collaborators

• University of Connecticut: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

University of Connecticut

Storrs, Connecticut, 06269, United States

Location

Related Publications (9)

• Alicea-Planas, J., Neafsey, P.J., & Anderson, E. (2012). Using an e-health intervention to enhance patient visits for hypertension; The nurse practitioner perspective. Journal of Communication in Healthcare, 5(4), 239-249.

  BACKGROUND

• Lin CA, Neafsey PJ, Anderson E. Advanced practice registered nurse usability testing of a tailored computer-mediated health communication program. Comput Inform Nurs. 2010 Jan-Feb;28(1):32-41. doi: 10.1097/NCN.0b013e3181c0484e.

  PMID: 19940619 BACKGROUND

• Neafsey PJ, Anderson E, Coleman C, Lin CA, M'lan CE, Walsh S. Reducing adverse self-medication behaviors in older adults with the Next Generation Personal Education Program (PEP-NG): Design and methodology. Patient Prefer Adherence. 2009 Nov 29;3:323-34. doi: 10.2147/ppa.s7906.

  PMID: 20016796 BACKGROUND

• Lin CA, Neafsey PJ, Strickler Z. Usability testing by older adults of a computer-mediated health communication program. J Health Commun. 2009 Mar;14(2):102-18. doi: 10.1080/10810730802659095.

  PMID: 19283536 BACKGROUND

• Neafsey PJ, Anderson E, Peabody S, Lin CA, Strickler Z, Vaughn K. Beta testing of a network-based health literacy program tailored for older adults with hypertension. Comput Inform Nurs. 2008 Nov-Dec;26(6):311-9. doi: 10.1097/01.NCN.0000336466.17811.e7.

  PMID: 19047879 BACKGROUND

• Neafsey PJ, M'lan CE, Ge M, Walsh SJ, Lin CA, Anderson E. Reducing Adverse Self-Medication Behaviors in Older Adults with Hypertension: Results of an e-health Clinical Efficacy Trial. Ageing Int. 2011 Jun;36(2):159-191. doi: 10.1007/s12126-010-9085-9. Epub 2010 Dec 8.

  PMID: 21654869 RESULT

• Anderson EH, Neafsey PJ, Peabody S. Psychometrics of the computer-based Relationships with Health Care Provider Scale in older adults. J Nurs Meas. 2011;19(1):3-16. doi: 10.1891/1061-3749.19.1.3.

  PMID: 21560897 RESULT

• Alicea-Planas J, Neafsey PJ, Anderson E. A Qualitative Study of Older Adults and Computer Use for Health Education: "It opens people's eyes". J Commun Healthc. 2011 Apr 1;4(1):38-45. doi: 10.1179/175380611X12950033990179.

  PMID: 23243465 RESULT

• Strickler, Z., Lin, C., Rauh, C. & Neafsey, P.J. (2008). Educating older adults to avoid harmful self-medication. Journal of Communication in Healthcare, 1(1), 110-128.

  RESULT

MeSH Terms

Conditions

Cardiovascular Diseases; Heart Diseases; Hypertension

Interventions

Early Intervention, Educational; Control Groups

Condition Hierarchy (Ancestors)

Vascular Diseases

Intervention Hierarchy (Ancestors)

Child Health Services; Community Health Services; Health Services; Health Care Facilities Workforce and Services; Preventive Health Services; Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Results Point of Contact

• Title: Patricia J. Neafsey, PhD
• Organization: University of Connecticut

pjneafsey@actualmeds.com

860-486-0779

Study Officials

• Patricia J. Neafsey, RD, PhD

  University of Connecticut

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 16, 2005
• First Posted: September 20, 2005
• Study Start: September 1, 2007
• Primary Completion: December 1, 2009
• Study Completion: July 1, 2010
• Last Updated: February 3, 2014
• Results First Posted: February 3, 2014

Record last verified: 2013-12

Locations

US (1)