NCT01770314

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
176

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Sep 2012

Shorter than P25 for phase_2

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2012

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 11, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 17, 2013

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2013

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2013

Completed
9 months until next milestone

Results Posted

Study results publicly available

May 19, 2014

Completed
Last Updated

May 19, 2014

Status Verified

April 1, 2014

Enrollment Period

7 months

First QC Date

January 11, 2013

Results QC Date

September 30, 2013

Last Update Submit

April 21, 2014

Conditions

Medication Adherence

Keywords

Opioid Pain MedicationMedication SafetyCorrect storageCorrect disposalCorrect Use

Outcome Measures

Primary Outcomes (1)

  • Self-efficacy - 8 Item Measure Taps Into Key Concepts Associated With Confidence for Managing Opioid Medications

    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.

    Baseline - Day 1, Posttest - Day 16 (intervention took 15 days), One month Followup - at 1 month post-intervention

Secondary Outcomes (1)

  • Satisfaction With the Program

    One-month followup assessment

Study Arms (2)

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

Control

NO INTERVENTION

The control group is a waitlist control. Participants will be given access to painACTION after the intervention period and follow up assessments are completed.

Interventions

ExperimentalBEHAVIORAL

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.

Also known as: painACTION website
Experimental

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Previously visited painACTION

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Inflexxion Inc

Newton, Massachusetts, 02464, United States

Location

MeSH Terms

Conditions

Medication Adherence

Condition Hierarchy (Ancestors)

Patient CompliancePatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Results Point of Contact

Title
Emil Chiauzzi
Organization
Inflexxion
echiauzzi@inflexxion.com
617-614-0429

Study Officials

  • Elizabeth Donovan, Ph. D.

    Inflexxion, Inc.

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 11, 2013

First Posted

January 17, 2013

Study Start

September 1, 2012

Primary Completion

April 1, 2013

Study Completion

September 1, 2013

Last Updated

May 19, 2014

Results First Posted

May 19, 2014

Record last verified: 2014-04

Locations

US(1)