Clinical trial NCT02375737: Evaluating CVD Medication Adherence Program in Low SES
Official title: Evaluating CVD Medication Adherence Program in Low SES
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Disease
Hypertension
Diabetes
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: PhRMA Foundation
First posted: 2015-03-03
Enrollment: 100
Sex: ALL
Minimum age (years): 21
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: 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.

Detailed description: 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).

Eligibility criteria: Inclusion Criteria:

1. Medicaid recipient (preferred); however the investigators will include those patients with other types of insurance or those who are uninsured
2. Enrolled in Duke Outpatient Clinic for at least one year
3. Outpatient diagnostic code for hypertension and/or hypercholesterolemia and/or diabetes
4. Poorly controlled BP levels (\>140/90) and/or LDL-C (\>130mg/dl) and/or HbA1c of \>8 within last 6 months

Exclusion Criteria:

1. No access to cell phone
2. Not proficient in English
3. Nursing home/long-term care facility resident or receiving home health care
4. Impaired hearing/ speech/ vision
5. Participating in another trial (pharmaceutical or behavioral)
6. Planning to leave the area in the next 12 months
7. Pregnancy (or planning)
8. Diagnosis of life-threatening disease with death probable within 1 year
9. Active Diagnosis of psychosis or dementia (has been hospitalized in the last 30 days)
10. Diagnosis of ESRD

Primary outcomes:
measure: Adherence to the program's intervention
timeFrame: 6 months
Secondary outcomes:
measure: Clinical effectiveness/impact of the program to pill refill adherence
timeFrame: 6 months
measure: Clinical effectiveness/impact on BP
timeFrame: 6 months
measure: Clinical effectiveness/impact on A1C
timeFrame: 6 months
measure: Clinical effectiveness/impact on cholesterol
timeFrame: 6 months
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Health System Clinic
state: North Carolina
Study officials:
affiliation: Duke University
name: Hayden Bosworth, PhD
role: PRINCIPAL_INVESTIGATOR
References: