The Medication Experience Study

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Wake Forest School of Medicine
Sponsor:
Information provided by (Responsible Party):
Steven R. Feldman, Wake Forest School of Medicine
ClinicalTrials.gov Identifier:
NCT01702883
First received: October 4, 2012
Last updated: May 27, 2014
Last verified: May 2014
  Purpose

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


Condition Intervention
Hypertension
Elevated Cholesterol
Diabetes
Depression
Other: Internet Survey

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Investigator)
Official Title: Using an Internet Survey to Improve Patient Adherence in Chronic Disease

Resource links provided by NLM:


Further study details as provided by Wake Forest School of Medicine:

Primary Outcome Measures:
  • The primary measure will be adherence as measured by pharmacy refills in each group. [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 1112
Study Start Date: October 2012
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Control
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.
Experimental: Intervention Group A
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.
Other: Internet Survey
prompt to complete internet survey
Other Name: internet surveys
Experimental: Intervention Group B
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.
Other: Internet Survey
prompt to complete internet survey
Other Name: internet surveys
Experimental: Intervention Group C
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.
Other: Internet Survey
prompt to complete internet survey
Other Name: internet surveys

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01702883

Contacts
Contact: Irma M Richardson, MHA 336-716-2903 irichard@wakehealth.edu

Locations
United States, North Carolina
Wake Forest University Health Sciences Recruiting
Winston Salem, North Carolina, United States, 27157
Contact: Irma M Richardson, MHA    336-716-2903    irichard@wakehealth.edu   
Principal Investigator: Steven Feldman, MD         
Sponsors and Collaborators
Wake Forest School of Medicine
Investigators
Principal Investigator: Steve R Feldman, MD, PhD Wake Forest School of Medicine
  More Information

No publications provided

Responsible Party: Steven R. Feldman, Professor of Dermatology, Wake Forest School of Medicine
ClinicalTrials.gov Identifier: NCT01702883     History of Changes
Other Study ID Numbers: 20789
Study First Received: October 4, 2012
Last Updated: May 27, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Wake Forest School of Medicine:
prescriptions
hypertension
high cholesterol
diabetes
depression
adherence

Additional relevant MeSH terms:
Depression
Depressive Disorder
Diabetes Mellitus
Hypercholesterolemia
Hypertension
Behavioral Symptoms
Mood Disorders
Mental Disorders
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on August 21, 2014