Trial Outcomes & Findings for Reducing Adverse Self-Medication Behaviors in Older Adults With Hypertension (NCT NCT00201201)
NCT ID: NCT00201201
Last Updated: 2014-02-03
Results Overview
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.
COMPLETED
NA
160 participants
Measured at 0, 4, 8, and 12 weeks on visit 1, 2, 3 and 4
2014-02-03
Participant Flow
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.
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.
Participant milestones
| Measure |
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.
|
|---|---|---|
|
Overall Study
STARTED
|
87
|
73
|
|
Overall Study
COMPLETED
|
82
|
66
|
|
Overall Study
NOT COMPLETED
|
5
|
7
|
Reasons for withdrawal
| Measure |
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.
|
|---|---|---|
|
Overall Study
Death
|
0
|
2
|
|
Overall Study
Withdrawal by Subject
|
5
|
5
|
Baseline Characteristics
Reducing Adverse Self-Medication Behaviors in Older Adults With Hypertension
Baseline characteristics by cohort
| Measure |
Education Intervention
n=87 Participants
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
n=73 Participants
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
n=160 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=85 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=39 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
26 Participants
n=85 Participants
|
21 Participants
n=18 Participants
|
47 Participants
n=39 Participants
|
|
Age, Categorical
>=65 years
|
61 Participants
n=85 Participants
|
52 Participants
n=18 Participants
|
113 Participants
n=39 Participants
|
|
Age, Continuous
|
67.8 years
STANDARD_DEVIATION 9.5 • n=85 Participants
|
69.6 years
STANDARD_DEVIATION 7.7 • n=18 Participants
|
68.6 years
STANDARD_DEVIATION 8.7 • n=39 Participants
|
|
Sex: Female, Male
Female
|
65 Participants
n=85 Participants
|
60 Participants
n=18 Participants
|
125 Participants
n=39 Participants
|
|
Sex: Female, Male
Male
|
22 Participants
n=85 Participants
|
13 Participants
n=18 Participants
|
35 Participants
n=39 Participants
|
|
Region of Enrollment
United States
|
87 participants
n=85 Participants
|
73 participants
n=18 Participants
|
160 participants
n=39 Participants
|
PRIMARY outcome
Timeframe: Measured at 0, 4, 8, and 12 weeks on visit 1, 2, 3 and 4Using 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.
Outcome measures
| Measure |
Education Intervention
n=82 Participants
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
n=66 Participants
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.
|
|---|---|---|
|
Behaviors Risk Score
Visit 4 (12 weeks)
|
13.4 units on a scale
Standard Deviation 11.2
|
14.2 units on a scale
Standard Deviation 13.5
|
|
Behaviors Risk Score
Visit 1 (0 weeks)
|
17.9 units on a scale
Standard Deviation 15.4
|
16.6 units on a scale
Standard Deviation 15.9
|
|
Behaviors Risk Score
Visit 2 (4 weeks)
|
16.4 units on a scale
Standard Deviation 13.4
|
12.6 units on a scale
Standard Deviation 12.6
|
|
Behaviors Risk Score
Visit 3 (8 weeks)
|
15.9 units on a scale
Standard Deviation 12.9
|
14.1 units on a scale
Standard Deviation 13.3
|
PRIMARY outcome
Timeframe: Measured at weeks 0, 4, 8 and 12 on visit 1, 2, 3 and 4BP 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.
Outcome measures
| Measure |
Education Intervention
n=82 Participants
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
n=66 Participants
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.
|
|---|---|---|
|
Blood Pressure (BP) Readings: Systolic Blood Pressure
Visit 1 (0 weeks)
|
129.1 mm Hg
Standard Deviation 15.5
|
127.4 mm Hg
Standard Deviation 13.4
|
|
Blood Pressure (BP) Readings: Systolic Blood Pressure
Visit 2 (4 weeks)
|
128.6 mm Hg
Standard Deviation 15.2
|
128.8 mm Hg
Standard Deviation 13.3
|
|
Blood Pressure (BP) Readings: Systolic Blood Pressure
Visit 3 (8 weeks)
|
125.8 mm Hg
Standard Deviation 13.2
|
128.6 mm Hg
Standard Deviation 15.6
|
|
Blood Pressure (BP) Readings: Systolic Blood Pressure
Visit 4 (12 weeks)
|
126.5 mm Hg
Standard Deviation 13.5
|
128.5 mm Hg
Standard Deviation 13.6
|
SECONDARY outcome
Timeframe: Measured at 0, 4, 8 and 12 weeks on visit 1, 2, 3 and 4The Self-efficacy scale is a 12-item instrument with statements reflecting patient confidence in selecting appropriate OTC agents and supplements, aside from avoiding adverse effects arising from self-medication behaviors. This scale has 5-point self-report response categories (ranging from 1, "Not Sure" to 5, "Totally Sure"). Responses were summed and divided by the number of items answered, so that the overall score would not be affected by omitted items and was reported based on the original 5-point metric. The higher the score on the instrument, the higher the degree of self-efficacy for avoiding adverse self-medication behaviors.
Outcome measures
| Measure |
Education Intervention
n=82 Participants
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
n=66 Participants
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.
|
|---|---|---|
|
Self-efficacy for Avoiding Adverse Self-medication Behaviors
Visit 1 (0 weeks)
|
2.5 units on a scale
Standard Deviation 0.9
|
2.3 units on a scale
Standard Deviation 0.9
|
|
Self-efficacy for Avoiding Adverse Self-medication Behaviors
Visit 2 (4 weeks)
|
2.7 units on a scale
Standard Deviation 0.9
|
2.4 units on a scale
Standard Deviation 0.8
|
|
Self-efficacy for Avoiding Adverse Self-medication Behaviors
Visit 3 (8 weeks)
|
3.0 units on a scale
Standard Deviation 0.8
|
2.6 units on a scale
Standard Deviation 0.8
|
|
Self-efficacy for Avoiding Adverse Self-medication Behaviors
Visit 4 (12 weeks)
|
3.3 units on a scale
Standard Deviation 0.7
|
2.5 units on a scale
Standard Deviation 0.8
|
SECONDARY outcome
Timeframe: Measured at 0, 4, 8, 12 weeks on visits 1, 2, 3 and 4The OTC-Rx Knowledge scale has 14 multiple-choice items and the score is the percent of the items with correct response (range: 0-100%; these items test both knowledge and application concerning potential adverse effects of self-medication with OTC agents, supplements, or alcohol in persons with hypertension. The higher the score, the higher the knowledge of the potential adverse effects from self-medication.
Outcome measures
| Measure |
Education Intervention
n=82 Participants
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
n=66 Participants
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.
|
|---|---|---|
|
Prescription/Over the Counter (Rx-OTC) Knowledge
Visit 1 (0 weeks)
|
45.2 percentage of questions correct
Standard Deviation 16.4
|
45.6 percentage of questions correct
Standard Deviation 14.6
|
|
Prescription/Over the Counter (Rx-OTC) Knowledge
Visit 2 (4 weeks)
|
51.0 percentage of questions correct
Standard Deviation 16.5
|
44.8 percentage of questions correct
Standard Deviation 17.0
|
|
Prescription/Over the Counter (Rx-OTC) Knowledge
Visit 3 (8 weeks)
|
57.0 percentage of questions correct
Standard Deviation 15.3
|
46.4 percentage of questions correct
Standard Deviation 16.5
|
|
Prescription/Over the Counter (Rx-OTC) Knowledge
Visit 4 (12 weeks)
|
59.4 percentage of questions correct
Standard Deviation 16.4
|
45.1 percentage of questions correct
Standard Deviation 16.2
|
SECONDARY outcome
Timeframe: Measured at 12 weeksThe PEP-NG user Satisfaction scale is a 14-item instrument - with eight items addressing the ease of program use, program content, and suitability of program content - and another six items addressing the intent to change behavior following program use. Ratings reflected by the 5-point Likert-type scale (ranging from 1, "strongly disagree" to 5, "strongly agree") were summed and divided by the number of items answered to ensure that the overall Satisfaction scale was not affected by omitted items and was cast in the original 5-point metric. The higher the score on the instrument, the higher the degree of satisfaction with the PEP-NG.
Outcome measures
| Measure |
Education Intervention
n=71 Participants
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
n=64 Participants
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.
|
|---|---|---|
|
Satisfaction With the PEP-NG
|
4.2 units on a scale
Standard Deviation 0.5
|
4.0 units on a scale
Standard Deviation 0.4
|
SECONDARY outcome
Timeframe: Measured at 0, 12 weeks on visit 1 and 4Population: There 69 participants in the control group and 82 participants in the education intervention group who chose to complete the satisfaction with the APRN provider on visit one and 65 in the control group and 75 in the education intervention group who chose to complete the survey on visit 4.
The Healthcare Relationships Scale assesses the perceived communication relationship with a provider. The 5-item instrument, based on two qualitative studies addresses patient-provider communication (2 questions), trust, decision-making related to care, and satisfaction with care. The scale was modified for use with older adults by changing the visual analog 10 cm response format to 5-point Likert-type responses with two extremes (e.g., 1:"not at all easy" to 5: "very easy").
Outcome measures
| Measure |
Education Intervention
n=82 Participants
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
n=69 Participants
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.
|
|---|---|---|
|
Satisfaction With the APRN Provider Relationship
Satisfaction with APRN Visit 1 (0 weeks)
|
4.40 units on a scale of 1-5
Standard Deviation 0.68
|
4.46 units on a scale of 1-5
Standard Deviation 0.83
|
|
Satisfaction With the APRN Provider Relationship
Satisfaction with APRN Visit 4 (12 weeks)
|
4.34 units on a scale of 1-5
Standard Deviation 0.60
|
4.42 units on a scale of 1-5
Standard Deviation 0.63
|
Adverse Events
Education
Control
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place