Skip to content

Reducing Adverse Self-Medication Behaviors in Older Adults With Hypertension

Reducing Adverse Self-Medication Behaviors in Older Adults With Hypertension

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00201201
Enrollment
160
Registered
2005-09-20
Start date
2007-09-30
Completion date
2010-07-31
Last updated
2014-02-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiovascular Diseases, Heart Diseases, Hypertension

Keywords

Older Adults, Primary Care, Hypertension, Adherence

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.

Interventions

OTHEREducation Intervention

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.

OTHERControl

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

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)
CollaboratorNIH
University of Connecticut
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No

Inclusion criteria

for Older Adults: * 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

Exclusion criteria

for Older Adults: * 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. Inclusion Criteria for APRNs: * Affiliated with ProHealth Physicians, Inc. practice site in CT and/or * Affiliated with APRN practice sites in CT

Design outcomes

Primary

MeasureTime frameDescription
Behaviors Risk ScoreMeasured 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.
Blood Pressure (BP) Readings: Systolic Blood PressureMeasured 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.

Secondary

MeasureTime frameDescription
Self-efficacy for Avoiding Adverse Self-medication BehaviorsMeasured 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.
Prescription/Over the Counter (Rx-OTC) KnowledgeMeasured 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.
Satisfaction With the PEP-NGMeasured 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.
Satisfaction With the APRN Provider RelationshipMeasured at 0, 12 weeks on visit 1 and 4The 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).

Countries

United States

Participant flow

Recruitment details

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

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.

Participants by arm

ArmCount
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.
87
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.
73
Total160

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyDeath02
Overall StudyWithdrawal by Subject55

Baseline characteristics

CharacteristicControlEducation InterventionTotal
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
52 Participants61 Participants113 Participants
Age, Categorical
Between 18 and 65 years
21 Participants26 Participants47 Participants
Age, Continuous69.6 years
STANDARD_DEVIATION 7.7
67.8 years
STANDARD_DEVIATION 9.5
68.6 years
STANDARD_DEVIATION 8.7
Region of Enrollment
United States
73 participants87 participants160 participants
Sex: Female, Male
Female
60 Participants65 Participants125 Participants
Sex: Female, Male
Male
13 Participants22 Participants35 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
0 / 870 / 73
serious
Total, serious adverse events
0 / 870 / 73

Outcome results

Primary

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.

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

ArmMeasureGroupValue (MEAN)Dispersion
Education InterventionBehaviors Risk ScoreVisit 1 (0 weeks)17.9 units on a scaleStandard Deviation 15.4
Education InterventionBehaviors Risk ScoreVisit 2 (4 weeks)16.4 units on a scaleStandard Deviation 13.4
Education InterventionBehaviors Risk ScoreVisit 3 (8 weeks)15.9 units on a scaleStandard Deviation 12.9
Education InterventionBehaviors Risk ScoreVisit 4 (12 weeks)13.4 units on a scaleStandard Deviation 11.2
ControlBehaviors Risk ScoreVisit 4 (12 weeks)14.2 units on a scaleStandard Deviation 13.5
ControlBehaviors Risk ScoreVisit 1 (0 weeks)16.6 units on a scaleStandard Deviation 15.9
ControlBehaviors Risk ScoreVisit 3 (8 weeks)14.1 units on a scaleStandard Deviation 13.3
ControlBehaviors Risk ScoreVisit 2 (4 weeks)12.6 units on a scaleStandard Deviation 12.6
Comparison: Repeated measures linear-mixed model ANOVA methodology was employed as each participant was measured on 4 visits and the 4 repeated measures are likely dependent. We used study group (intervention vs. control) and visit as categorical variables and controlled for gender, age, APRN, income, education, computer use. Non-parametric tests (Cochran-Mantel-Haenszel statistic), based on rank scores, controlling for participant code were used for the transformed behavior risk scores within groups.p-value: 0.035Cochran-Mantel-Haenszel
Primary

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.

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

ArmMeasureGroupValue (MEAN)Dispersion
Education InterventionBlood Pressure (BP) Readings: Systolic Blood PressureVisit 1 (0 weeks)129.1 mm HgStandard Deviation 15.5
Education InterventionBlood Pressure (BP) Readings: Systolic Blood PressureVisit 2 (4 weeks)128.6 mm HgStandard Deviation 15.2
Education InterventionBlood Pressure (BP) Readings: Systolic Blood PressureVisit 3 (8 weeks)125.8 mm HgStandard Deviation 13.2
Education InterventionBlood Pressure (BP) Readings: Systolic Blood PressureVisit 4 (12 weeks)126.5 mm HgStandard Deviation 13.5
ControlBlood Pressure (BP) Readings: Systolic Blood PressureVisit 4 (12 weeks)128.5 mm HgStandard Deviation 13.6
ControlBlood Pressure (BP) Readings: Systolic Blood PressureVisit 1 (0 weeks)127.4 mm HgStandard Deviation 13.4
ControlBlood Pressure (BP) Readings: Systolic Blood PressureVisit 3 (8 weeks)128.6 mm HgStandard Deviation 15.6
ControlBlood Pressure (BP) Readings: Systolic Blood PressureVisit 2 (4 weeks)128.8 mm HgStandard Deviation 13.3
Comparison: Repeated measures linear-mixed model ANOVA methodology was employed as each participant was measured on 4 visits and the 4 repeated measures are likely dependent. We used study group (intervention vs. control) and visit as categorical variables and controlled for gender, age, APRN, income, education, computer use.p-value: 0.0204ANOVA
Secondary

Prescription/Over the Counter (Rx-OTC) Knowledge

The 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.

Time frame: Measured at 0, 4, 8, 12 weeks on visits 1, 2, 3 and 4

ArmMeasureGroupValue (MEAN)Dispersion
Education InterventionPrescription/Over the Counter (Rx-OTC) KnowledgeVisit 1 (0 weeks)45.2 percentage of questions correctStandard Deviation 16.4
Education InterventionPrescription/Over the Counter (Rx-OTC) KnowledgeVisit 2 (4 weeks)51.0 percentage of questions correctStandard Deviation 16.5
Education InterventionPrescription/Over the Counter (Rx-OTC) KnowledgeVisit 3 (8 weeks)57.0 percentage of questions correctStandard Deviation 15.3
Education InterventionPrescription/Over the Counter (Rx-OTC) KnowledgeVisit 4 (12 weeks)59.4 percentage of questions correctStandard Deviation 16.4
ControlPrescription/Over the Counter (Rx-OTC) KnowledgeVisit 4 (12 weeks)45.1 percentage of questions correctStandard Deviation 16.2
ControlPrescription/Over the Counter (Rx-OTC) KnowledgeVisit 1 (0 weeks)45.6 percentage of questions correctStandard Deviation 14.6
ControlPrescription/Over the Counter (Rx-OTC) KnowledgeVisit 3 (8 weeks)46.4 percentage of questions correctStandard Deviation 16.5
ControlPrescription/Over the Counter (Rx-OTC) KnowledgeVisit 2 (4 weeks)44.8 percentage of questions correctStandard Deviation 17
Comparison: Repeated measures linear-mixed model ANOVA methodology was employed as each participant was measured on 4 visits and the 4 repeated measures are likely dependent. We used study group (intervention vs. control) and visit as categorical variables and controlled for gender, age, APRN, income, education, computer use.p-value: 0.0001ANOVA
Secondary

Satisfaction With the APRN Provider Relationship

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).

Time frame: Measured at 0, 12 weeks on visit 1 and 4

Population: 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.

ArmMeasureGroupValue (MEAN)Dispersion
Education InterventionSatisfaction With the APRN Provider RelationshipSatisfaction with APRN Visit 1 (0 weeks)4.40 units on a scale of 1-5Standard Deviation 0.68
Education InterventionSatisfaction With the APRN Provider RelationshipSatisfaction with APRN Visit 4 (12 weeks)4.34 units on a scale of 1-5Standard Deviation 0.6
ControlSatisfaction With the APRN Provider RelationshipSatisfaction with APRN Visit 1 (0 weeks)4.46 units on a scale of 1-5Standard Deviation 0.83
ControlSatisfaction With the APRN Provider RelationshipSatisfaction with APRN Visit 4 (12 weeks)4.42 units on a scale of 1-5Standard Deviation 0.63
Comparison: Analyzed at 0 and 12 weeks.p-value: <0.1t-test, 2 sided
Secondary

Satisfaction With the PEP-NG

The 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.

Time frame: Measured at 12 weeks

ArmMeasureValue (MEAN)Dispersion
Education InterventionSatisfaction With the PEP-NG4.2 units on a scaleStandard Deviation 0.5
ControlSatisfaction With the PEP-NG4.0 units on a scaleStandard Deviation 0.4
p-value: 0.0431t-test, 2 sided
Secondary

Self-efficacy for Avoiding Adverse Self-medication Behaviors

The 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.

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

ArmMeasureGroupValue (MEAN)Dispersion
Education InterventionSelf-efficacy for Avoiding Adverse Self-medication BehaviorsVisit 1 (0 weeks)2.5 units on a scaleStandard Deviation 0.9
Education InterventionSelf-efficacy for Avoiding Adverse Self-medication BehaviorsVisit 3 (8 weeks)3.0 units on a scaleStandard Deviation 0.8
Education InterventionSelf-efficacy for Avoiding Adverse Self-medication BehaviorsVisit 2 (4 weeks)2.7 units on a scaleStandard Deviation 0.9
Education InterventionSelf-efficacy for Avoiding Adverse Self-medication BehaviorsVisit 4 (12 weeks)3.3 units on a scaleStandard Deviation 0.7
ControlSelf-efficacy for Avoiding Adverse Self-medication BehaviorsVisit 4 (12 weeks)2.5 units on a scaleStandard Deviation 0.8
ControlSelf-efficacy for Avoiding Adverse Self-medication BehaviorsVisit 1 (0 weeks)2.3 units on a scaleStandard Deviation 0.9
ControlSelf-efficacy for Avoiding Adverse Self-medication BehaviorsVisit 2 (4 weeks)2.4 units on a scaleStandard Deviation 0.8
ControlSelf-efficacy for Avoiding Adverse Self-medication BehaviorsVisit 3 (8 weeks)2.6 units on a scaleStandard Deviation 0.8
Comparison: Repeated measures linear-mixed model ANOVA methodology was employed as each participant was measured on 4 visits and the 4 repeated measures are likely dependent. We used study group (intervention vs. control) and visit as categorical variables and controlled for gender, age, APRN, income, education, computer use.p-value: 0.0001ANOVA

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026