Medication Adherence Clinical Trial
Official title:
Medication Safety Pilot Study
Verified date | April 2014 |
Source | Inflexxion, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 176 |
Est. completion date | September 2013 |
Est. primary completion date | April 2013 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
United States | Inflexxion Inc | Newton | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Inflexxion, Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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? I can recognize side effects that are related to my opioid medicine. 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 | No |
Secondary | Satisfaction With the Program | 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. | One-month followup assessment | No |
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