NCT02375737

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

January 16, 2015

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 3, 2015

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
Last Updated

August 12, 2016

Status Verified

January 1, 2016

Enrollment Period

1.4 years

First QC Date

January 16, 2015

Last Update Submit

August 11, 2016

Conditions

Cardiovascular DiseaseHypertensionDiabetes

Outcome Measures

Primary Outcomes (1)

  • 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).

    6 months

Secondary Outcomes (4)

  • Clinical effectiveness/impact of the program to pill refill adherence

    6 months

  • Clinical effectiveness/impact on BP

    6 months

  • Clinical effectiveness/impact on A1C

    6 months

  • Clinical effectiveness/impact on cholesterol

    6 months

Study Arms (1)

m-health

EXPERIMENTAL

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

Behavioral: m-health

Interventions

m-healthBEHAVIORAL

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.

m-health

Eligibility Criteria

Age21 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Duke University Health System Clinic

Durham, North Carolina, 27705, United States

Location

MeSH Terms

Conditions

Cardiovascular DiseasesHypertensionDiabetes Mellitus

Interventions

American Recovery and Reinvestment Act

Condition Hierarchy (Ancestors)

Vascular DiseasesGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Legislation as TopicSocial Control, FormalHealth Care Economics and Organizations

Study Officials

  • Hayden Bosworth, PhD

    Duke University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 16, 2015

First Posted

March 3, 2015

Study Start

January 1, 2015

Primary Completion

June 1, 2016

Study Completion

August 1, 2016

Last Updated

August 12, 2016

Record last verified: 2016-01

Locations

US(1)