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Study to Test the Efficacy of Online Education to Increase Safe Use of Opioid Medication.

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01770314
First Posted: January 17, 2013
Last Update Posted: May 19, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Inflexxion, Inc.
  Purpose
The purpose of this project is to test whether an online pain medication intervention is a feasible and effective way to increase opioid pain medication safety.

Condition Intervention Phase
Medication Adherence Behavioral: Experimental Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: Medication Safety Pilot Study

Further study details as provided by Inflexxion, Inc.:

Primary Outcome Measures:
  • Self-efficacy - 8 Item Measure Taps Into Key Concepts Associated With Confidence for Managing Opioid Medications [ Time Frame: Baseline - Day 1, Posttest - Day 16 (intervention took 15 days), One month Followup - at 1 month post-intervention ]

    Responses are measured on a 4-point Likert scale (1= "Not at all confident" and 4= "Extremely confident"). The total Score range:8=least confident, 32=most confident.

    How confident do you feel in your ability to do each of the following activities, today?

    1. I can recognize side effects that are related to my opioid medicine.
    2. I can avoid giving my opioid medicine to someone else. Etc.. 1 - Not at all confident 2 - Somewhat confident 3 - Very confident 4 - Extremely confident Items have been generated from literature. Content validity: assessed by asking two experts if items are important and relevant.

    Internal consistency of the items in the pilot measure will be assessed (Cronbach's alpha).

    Test-retest reliability will be explored by asking 50 participants in the control group to retake the pilot measure within 3-5 days of having taken the measure as part of the pretest.



Secondary Outcome Measures:
  • Satisfaction With the Program [ Time Frame: One-month followup assessment ]
    We tested and analyzed participants' satisfaction with the program by asking the question: "Overall, how satisfied were you with the lessons." They answered on a 4 point Likert scale: 1=Not at all satisfied, 2=Somewhat Satisfied, 3=Satisfied, 4 = Very satisfied. Higher values indicate higher satisfaction.


Enrollment: 176
Study Start Date: September 2012
Study Completion Date: September 2013
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Experimental
Participants will be given instructions via email to review eleven online lessons about opioid medication safety. Instructions will suggest that participants view one lesson per day for eleven consecutive days. Each educational lesson focuses on one or two aspects of medication safety, including how to safely store medication, and the importance of taking medication exactly as prescribed.
Behavioral: Experimental
Participants will be given instructions via email to review eleven online lessons about opioid medication safety. Instructions will suggest that participants view one lesson per day for eleven consecutive days. Each educational lesson focuses on one or two aspects of medication safety, including how to safely store medication, and the importance of taking medication exactly as prescribed.
Other Name: painACTION website
No Intervention: Control
The control group is a waitlist control. Participants will be given access to painACTION after the intervention period and follow up assessments are completed.

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Be willing and able to provide consent
  • Have the ability to read and write English
  • Diagnosis of non-cancer chronic pain
  • Prescribed opioids and taking consistently for 3 months.
  • Over 18 years old

Exclusion Criteria:

  • Previously visited painACTION
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01770314


Locations
United States, Massachusetts
Inflexxion Inc
Newton, Massachusetts, United States, 02464
Sponsors and Collaborators
Inflexxion, Inc.
Investigators
Principal Investigator: Elizabeth Donovan, Ph. D. Inflexxion, Inc.
  More Information

Responsible Party: Inflexxion, Inc.
ClinicalTrials.gov Identifier: NCT01770314     History of Changes
Other Study ID Numbers: MedSafetyStudy
Endo Pharmaceuticals ( Other Identifier: Endo Pharmaceuticals )
First Submitted: January 11, 2013
First Posted: January 17, 2013
Results First Submitted: September 30, 2013
Results First Posted: May 19, 2014
Last Update Posted: May 19, 2014
Last Verified: April 2014

Keywords provided by Inflexxion, Inc.:
Opioid Pain Medication
Medication Safety
Correct storage
Correct disposal
Correct Use

Additional relevant MeSH terms:
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents