Evaluating CVD Medication Adherence Program in Low SES

NCT ID: NCT02375737

Last Updated: 2016-08-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-01-31
• Study Completion Date: 2016-08-31

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).

Conditions

Cardiovascular Disease; Hypertension; Diabetes

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Blinding Strategy: NONE

Study Groups

m-health

Patients will receive text message, emails, and monthly phone calls

Group Type: EXPERIMENTAL

m-health

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

PhRMA Foundation

UNKNOWN

Sponsor Role: collaborator

Duke University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hayden Bosworth, PhD

Role: PRINCIPAL_INVESTIGATOR

Duke University

Locations

Duke University Health System Clinic

Durham, North Carolina, United States

Countries

United States

Other Identifiers

Pro00054572

Identifier Type: -

Identifier Source: org_study_id