An interventional study of m-health in Cardiovascular Disease, Hypertension and Diabetes, sponsored by Duke University. Completed at 1 site in United States. Open to participants aged 21 Years to 85 Years. Per ClinicalTrials.gov, last updated 2016-08-12.
Sponsored by Duke University · Not applicable and Interventional
The investigators propose to evaluate the implementation of an efficacious medication adherence program in a group at high risk for CVD. The program involves patients receiving/responding to e-reminders to take CVD medications via patient-selected technology [mobile/web-based applications, short message service (SMS; text messaging), interactive voice response (IVR), or e-mail] supported by a tailored, monthly, self-management program administered by either research staff or a case manager staff member from the Duke Outpatient Clinic via the telephone. This is a hybrid type II implementation science study.
The investigators propose to evaluate the implementation of a medication adherence program among patients who attend Duke Outpatient Clinic (DOC). It is anticipated that, among the providers' patient panels, at least 100 and up to 300 with CVD risk and poor CVD medication adherence (\<0.08 medication possession ratio) will consent to the program.
Using procedures from the investigators previous studies, the investigators will identify potential patients from the EHR, and will identify a pool of potential patients using electronic health records, with the goal of administering the program to at least 100 patients. Patients will be mailed letters, signed by their own provider or medical director of DOC, requesting their participation in the programs. The RA will contact patients via telephone to explain the study, screen for eligibility, and determine what mode of administration individuals prefer to receive the program (SMS, IVR, or email).
The primary outcome will be that the effectiveness/impact of the proposed adherence program will be a 10% improvement in MPR and CVD outcomes (anticipate reducing SBP by 5 mmHg, Hgb a1c by 0.5%, LDL-C by 20 mg/dl).
5,025 studies on the registry are indexed under Cardiovascular Diseases; 930 are open to participants now.
This study's enrollment of 100 is close to the median of 100 across 2,801 interventional studies indexed under Cardiovascular Diseases.
Browse Cardiovascular Diseases studies →Duke University is the lead sponsor of 2,058 studies on the registry; 274 are open to participants now.
Of its 204 completed or terminated interventional studies of FDA-regulated products, 165 (81%) have results posted.
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Exclusion Criteria:
Patients will receive text message, emails, and monthly phone calls
Behavioral: m-health
Patients will receive e-reminders via text message and email. A message library that allows us to disseminate constant and reliable information has been created. Messages will contain not only medication reminders, but information about issues related to self-management and medication adherence for CVD risk including messages on side-effects, risks/benefits of medication treatment, and barriers to medication adherence. In addition to these messages, patients will also receive tailored information via telephone by trained research staff.
Adherence to the program's intervention
It is measured as the proportion of technology or interventionist contacts responded to by a patient out of those received over the course of the intervention period. This will be summarized descriptively by type of contact (technology vs. interventionist call) and subdivided by technology (SMS, email).
Time frame: 6 months
Clinical effectiveness/impact of the program to pill refill adherence
This will be measured by pulling pill refill records of those patients who are enrolled. The investigators anticipate an improvement of 10% on pill refill adherence.
Time frame: 6 months
Clinical effectiveness/impact on BP
This will be measured by assessing systolic BP values. The investigators anticipate reducing SBP by 5 mmHg.
Time frame: 6 months
Clinical effectiveness/impact on A1C
This will be measured by assessing A1C values. The investigators anticipate reducing Hgb A1c by 0.5%.
Time frame: 6 months
Clinical effectiveness/impact on cholesterol
This will be measured by assessing LDL-C levels in patients. The goal is to reduce LDL-C levels by 20 mg/dl.
Time frame: 6 months
The record gives a start of Jan 2015, a primary completion of Jun 2016 and a completion of Aug 2016. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in Jan 2016. You cannot join it, but the record below documents what was studied.
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