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The Medication Experience Study

Primary Purpose

Hypertension, Elevated Cholesterol, Diabetes

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Internet Survey
Sponsored by
Wake Forest University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Hypertension focused on measuring prescriptions, hypertension, high cholesterol, diabetes, depression, adherence

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Any male or female 18 years or older, filling prescriptions for oral medications for hypertension, high cholesterol, diabetes, or depression at the Downtown Health Plaza, Piedmont Plaza, or Cancer Center Pharmacies.

Exclusion Criteria:

  • Inability to complete Internet surveys due to inadequate Internet access, not understanding a survey written in English, or lack of computer skills.
  • Patient does not intend to continue using the same WFBMC-affiliated pharmacy for the next 12 months.

Sites / Locations

  • Wake Forest University Health Sciences

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

No Intervention

Experimental

Experimental

Experimental

Arm Label

Control

Intervention Group A

Intervention Group B

Intervention Group C

Arm Description

Randomization occurs after enrollment survey has been completed. This group will not receive the internet intervention for the twelve months. They will be asked to complete the final survey.

Randomization occurs after enrollment survey has been completed. Upon secondary randomization at week eight, this group will continue to receive weekly internet surveys for the entire twelve months. They will be asked to complete the final survey.

Randomization occurs after enrollment survey has been completed. This group will complete weekly internet surveys for eight weeks. Upon secondary randomization at week eight, this group will begin to receive monthly internet surveys. They will be asked to complete the final survey.

Randomization occurs after enrollment survey has been completed. This group will complete weekly internet surveys for eight weeks. Upon secondary randomization at week eight, the group will not receive any more internet surveys. They will be asked to complete the final survey.

Outcomes

Primary Outcome Measures

The primary measure will be adherence as measured by pharmacy refills in each group.

Secondary Outcome Measures

Full Information

First Posted
October 4, 2012
Last Updated
September 25, 2023
Sponsor
Wake Forest University
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1. Study Identification

Unique Protocol Identification Number
NCT01702883
Brief Title
The Medication Experience Study
Official Title
Using an Internet Survey to Improve Patient Adherence in Chronic Disease
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
October 2012 (undefined)
Primary Completion Date
July 31, 2015 (Actual)
Study Completion Date
November 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wake Forest University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to evaluate whether participation in an Internet-based intervention helps improve medication use.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension, Elevated Cholesterol, Diabetes, Depression
Keywords
prescriptions, hypertension, high cholesterol, diabetes, depression, adherence

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
186 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
No Intervention
Arm Description
Randomization occurs after enrollment survey has been completed. This group will not receive the internet intervention for the twelve months. They will be asked to complete the final survey.
Arm Title
Intervention Group A
Arm Type
Experimental
Arm Description
Randomization occurs after enrollment survey has been completed. Upon secondary randomization at week eight, this group will continue to receive weekly internet surveys for the entire twelve months. They will be asked to complete the final survey.
Arm Title
Intervention Group B
Arm Type
Experimental
Arm Description
Randomization occurs after enrollment survey has been completed. This group will complete weekly internet surveys for eight weeks. Upon secondary randomization at week eight, this group will begin to receive monthly internet surveys. They will be asked to complete the final survey.
Arm Title
Intervention Group C
Arm Type
Experimental
Arm Description
Randomization occurs after enrollment survey has been completed. This group will complete weekly internet surveys for eight weeks. Upon secondary randomization at week eight, the group will not receive any more internet surveys. They will be asked to complete the final survey.
Intervention Type
Other
Intervention Name(s)
Internet Survey
Other Intervention Name(s)
internet surveys
Intervention Description
prompt to complete internet survey
Primary Outcome Measure Information:
Title
The primary measure will be adherence as measured by pharmacy refills in each group.
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Any male or female 18 years or older, filling prescriptions for oral medications for hypertension, high cholesterol, diabetes, or depression at the Downtown Health Plaza, Piedmont Plaza, or Cancer Center Pharmacies. Exclusion Criteria: Inability to complete Internet surveys due to inadequate Internet access, not understanding a survey written in English, or lack of computer skills. Patient does not intend to continue using the same WFBMC-affiliated pharmacy for the next 12 months.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steve R Feldman, MD, PhD
Organizational Affiliation
Wake Forest University Health Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wake Forest University Health Sciences
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States

12. IPD Sharing Statement

Learn more about this trial

The Medication Experience Study

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