Back to resultsImproving Medication Adherence in Hypertensive Patients (HTNmobile)
Primary Purpose
Hypertension
Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Electronic Intervention
Sponsored by
About this trial
This is an interventional health services research trial for Hypertension
Eligibility Criteria
Inclusion Criteria:
- Enrolled in the primary care clinic for the past 6 months
- New or existing prescription for hypertension
- Poorly controlled mean systolic blood pressure (SBP) in the last 12 months (>140/90 Hg)
Exclusion Criteria:
- Hospitalized for a stroke, myocardial infarction, coronary artery revascularization in the past 3 months,
- Diagnosis of metastatic cancer;
- Active diagnosis of psychosis or dementia documented in medical record;
- Does not have access to the appropriate technology required
- Is not willing to use said device to receive notifications for the study;
- Does not live independently (assisted living or nursing home residents) or otherwise institutionalized or receiving home health care
- Severely impaired hearing, vision or speech (unless technological aides allow them full functionality)
- Planning to leave the area or change primary care clinics prior to the anticipated end of participation;
- Unable to read and understand spoken English
- Participation in another cardiovascular disease (CVD) study
- Another household member enrolled in study;
- Arm size > 50cm
Sites / Locations
- Duke University Health System Clinic
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Electronic Intervention
Arm Description
Over the three months, participants will receive a technology intervention. This will include text or email encounter notifications associated with appropriate mobile or online self-management information for medication adherence and behavior change.
Outcomes
Primary Outcome Measures
Proportion of Days Covered (PDC)
Proportion of Days Covered (PDC), a Pharmacy Quality Alliance (PQA)-recommended metric for estimation of medication adherence for patients using chronic medications, will be used to identify the percentage of patients taking medications in a particular drug class with high adherence (PDC > 80% for the individual). Participants with a PDC ≤0.8 will be categorized as having "poor" adherence, and those with a PDC >0.8 will be categorized as having "good" adherence. For analyses, the PDC will be dichotomized at 0.8 (PDC >0.8) over the entire 3 month follow-up, yielding a single assessment of pill refill adherence that will be used as the primary outcome.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01826435
Brief Title
Improving Medication Adherence in Hypertensive Patients
Acronym
HTNmobile
Official Title
Improving Medication Adherence in Hypertensive Patients
Study Type
Interventional
2. Study Status
Record Verification Date
January 2014
Overall Recruitment Status
Withdrawn
Why Stopped
Collaborator was not clear on how best to proceed with this project.
Study Start Date
January 2014 (undefined)
Primary Completion Date
August 2014 (Anticipated)
Study Completion Date
May 2015 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The study team is proposing a single arm intervention to test the effect of an electronic intervention on medication use among individuals with a prescription for hypertension/high blood pressure. The investigator proposes that technology like text messaging, email, web applications and mobile apps with proven, nurse intervention scripts, will lead to significant, cost-effective improvements in hypertension medication use.
Detailed Description
The intervention will incorporate a scalable electronic intervention using Email/Web Apps and Short Message Service (SMS)/Mobile Web Apps. The study team will examine the participants' responses to the electronic encounters in the technology-only intervention throughout the 3-month study timeframe.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Electronic Intervention
Arm Type
Experimental
Arm Description
Over the three months, participants will receive a technology intervention. This will include text or email encounter notifications associated with appropriate mobile or online self-management information for medication adherence and behavior change.
Intervention Type
Behavioral
Intervention Name(s)
Electronic Intervention
Intervention Description
Patients will be able to receive the intervention notifications over the electronic/multimedia mode they prefer; selecting either text messaging/mobile web and/or email/online web. Text message or email alerts with an included uniform resource locator (URL) link to the specified mobile or online web site will be utilized to notify patients of a pending encounter available on mobile. Topics that will be addressed in the intervention include medication and side effects, social support, hypertension knowledge, memory and smoking. All intervention encounters that are designed to collect responses from the patient will require the patient to supply credentials before responding to the encounter; thus, ensuring privacy of the patient session, as well as patient-specific tracking of responses.
Primary Outcome Measure Information:
Title
Proportion of Days Covered (PDC)
Description
Proportion of Days Covered (PDC), a Pharmacy Quality Alliance (PQA)-recommended metric for estimation of medication adherence for patients using chronic medications, will be used to identify the percentage of patients taking medications in a particular drug class with high adherence (PDC > 80% for the individual). Participants with a PDC ≤0.8 will be categorized as having "poor" adherence, and those with a PDC >0.8 will be categorized as having "good" adherence. For analyses, the PDC will be dichotomized at 0.8 (PDC >0.8) over the entire 3 month follow-up, yielding a single assessment of pill refill adherence that will be used as the primary outcome.
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Enrolled in the primary care clinic for the past 6 months
New or existing prescription for hypertension
Poorly controlled mean systolic blood pressure (SBP) in the last 12 months (>140/90 Hg)
Exclusion Criteria:
Hospitalized for a stroke, myocardial infarction, coronary artery revascularization in the past 3 months,
Diagnosis of metastatic cancer;
Active diagnosis of psychosis or dementia documented in medical record;
Does not have access to the appropriate technology required
Is not willing to use said device to receive notifications for the study;
Does not live independently (assisted living or nursing home residents) or otherwise institutionalized or receiving home health care
Severely impaired hearing, vision or speech (unless technological aides allow them full functionality)
Planning to leave the area or change primary care clinics prior to the anticipated end of participation;
Unable to read and understand spoken English
Participation in another cardiovascular disease (CVD) study
Another household member enrolled in study;
Arm size > 50cm
Facility Information:
Facility Name
Duke University Health System Clinic
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Improving Medication Adherence in Hypertensive Patients
We'll reach out to this number within 24 hrs