Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Reducing Adverse Self-Medication Behaviors in Older Adults With Hypertension

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Connecticut
ClinicalTrials.gov Identifier:
NCT00201201
First received: September 16, 2005
Last updated: December 17, 2013
Last verified: December 2013
Results First Received: August 13, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Open Label
Conditions: Cardiovascular Diseases
Heart Diseases
Hypertension
Interventions: Other: Education Intervention
Other: Control

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Participant recruitment brochures and posters with the advanced practice nurses' (APRNs) names/practice contact information were placed in practice waiting and examination rooms. Older adults self-referred for the study by calling the practice and making an appointment with the APRN. Recruitment was rolling during Sept. 2007 – June 2009.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Exclusion criteria were 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.

Reporting Groups
  Description
Education Intervention

PEP education intervention

Personal Education Program - Next Generation (PEP-NG) : Adults aged 60 and over with hypertension were randomized to usual care and education (intervention)groups. Both groups entered medication taking behaviors on the PEP-NG and answered questions related to knowledge and self-efficacy regarding adverse self-medication behaviors. The education (intervention) group received a tailored education program generated by the PEP-NG software and reinforced by the APRN.

Control

Control:

Adults aged 60 and over with hypertension were randomized to usual care and education (intervention)groups. Both groups entered medication taking behaviors on the PEP-NG and answered questions related to knowledge and self-efficacy regarding adverse self-medication behaviors. The control group met with the APRN after entering their data on the PEP-NG but did not receive a targeted and tailored education intervention.


Participant Flow:   Overall Study
    Education Intervention     Control  
STARTED     87     73  
COMPLETED     82     66  
NOT COMPLETED     5     7  
Death                 0                 2  
Withdrawal by Subject                 5                 5  



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Education Intervention

PEP education intervention

Personal Education Program - Next Generation (PEP-NG) : Adults aged 60 and over with hypertension were randomized to usual care and education (intervention)groups. Both groups entered medication taking behaviors on the PEP-NG and answered questions related to knowledge and self-efficacy regarding adverse self-medication behaviors. The education (intervention) group received a tailored education program.

Control

Control:

Adults aged 60 and over with hypertension were randomized to usual care and education (intervention)groups. Both groups entered medication taking behaviors on the PEP-NG and answered questions related to knowledge and self-efficacy regarding adverse self-medication behaviors. The control group met with the APRN after entering their data on the PEP-NG but did not receive a targeted and tailored education intervention.

Total Total of all reporting groups

Baseline Measures
    Education Intervention     Control     Total  
Number of Participants  
[units: participants]
  87     73     160  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     26     21     47  
>=65 years     61     52     113  
Age  
[units: years]
Mean ± Standard Deviation
  67.8  ± 9.5     69.6  ± 7.7     68.6  ± 8.7  
Gender  
[units: participants]
     
Female     65     60     125  
Male     22     13     35  
Region of Enrollment  
[units: participants]
     
United States     87     73     160  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Behaviors Risk Score   [ Time Frame: Measured at 0, 4, 8, and 12 weeks on visit 1, 2, 3 and 4 ]

2.  Primary:   Blood Pressure (BP) Readings: Systolic Blood Pressure   [ Time Frame: Measured at weeks 0, 4, 8 and 12 on visit 1, 2, 3 and 4 ]

3.  Secondary:   Self-efficacy for Avoiding Adverse Self-medication Behaviors   [ Time Frame: Measured at 0, 4, 8 and 12 weeks on visit 1, 2, 3 and 4 ]

4.  Secondary:   Prescription/Over the Counter (Rx-OTC) Knowledge   [ Time Frame: Measured at 0, 4, 8, 12 weeks on visits 1, 2, 3 and 4 ]

5.  Secondary:   Satisfaction With the PEP-NG   [ Time Frame: Measured at 12 weeks ]

6.  Secondary:   Satisfaction With the APRN Provider Relationship   [ Time Frame: Measured at 0, 12 weeks on visit 1 and 4 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
  Hide More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Patricia J. Neafsey, PhD
Organization: University of Connecticut
phone: 860-486-0779
e-mail: pjneafsey@actualmeds.com


Publications of Results:
Alicea-Planas, J., Neafsey, P.J., & Anderson, E. (2011). A qualitative study of older adults and computer use for health education. Journal of Communication in Healthcare, 4(1), 38-45.

Other Publications:

Responsible Party: University of Connecticut
ClinicalTrials.gov Identifier: NCT00201201     History of Changes
Other Study ID Numbers: H02-602, R01HL084208
Study First Received: September 16, 2005
Results First Received: August 13, 2013
Last Updated: December 17, 2013
Health Authority: United States: Federal Government