Patient Reported Outcome Measure for Disease

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Stanley Street Resources and Treatment, Fall River, MA
Disease+4 More
Patient Reported Outcome Measure - Other
Eligibility
18+
All Sexes
What conditions do you have?
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Study Summary

This trial will test a new patient-reported outcome measure to see if it is useful and acceptable to patients and clinicians, and if it leads to improved outcomes for people with substance use disorders. The Patient Reported Outcome Measure will be used to treat the Disease in this trial, and no patients will receive a placebo. The Patient Reported Outcome Measure has previously been approved by the FDA for a different condition.

Eligible Conditions

  • Disease
  • Substance Use Disorders (SUD)
  • Opioid Use Disorder (OUD)

Treatment Effectiveness

Study Objectives

5 Primary · 2 Secondary · Reporting Duration: 3 months after baseline, 6 months after baseline

Month 6
Change in number of days mental/physical health were not good (in past 30 days), assessed via CDC HRQOL questionnaire
Change in number of days mental/physical health were not good (in past 30 days), assessed via CDC HRQOL questionnaire.
Change in patient-clinician alliance, assessed via WAI-SR
Change in reported health related quality of life (4-point scale), assessed via CDC HRQOL questionnaire
Change in reported self-efficacy for managing chronic conditions, assessed via PROMIS Self-Efficacy measure
Social determinants of health, assessed via PRAPARE
Substance use past 30 days, assessed via modified ASI Alcohol and Drug module
6 months after baseline
Satisfaction with Recovery PROM

Trial Safety

Trial Design

1 Treatment Group

Recovery PROM
1 of 1
Experimental Treatment

100 Total Participants · 1 Treatment Group

Primary Treatment: Patient Reported Outcome Measure · No Placebo Group · N/A

Recovery PROM
Other
Experimental Group · 1 Intervention: Patient Reported Outcome Measure · Intervention Types: Other

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 3 months after baseline, 6 months after baseline
Closest Location: Stanley Street Resources and Treatment · Fall River, MA
Photo of massachusetts 1Photo of massachusetts 2Photo of massachusetts 3
N/AFirst Recorded Clinical Trial
1 TrialsResearching Disease
0 CompletedClinical Trials

Who is running the clinical trial?

Brandeis UniversityLead Sponsor
18 Previous Clinical Trials
10,689 Total Patients Enrolled
Stanley Street Treatment and Resources (SSTAR)UNKNOWN
1 Previous Clinical Trials
417 Total Patients Enrolled
National Institute on Drug Abuse (NIDA)NIH
2,207 Previous Clinical Trials
5,610,708 Total Patients Enrolled
200 Trials studying Disease
1,019,144 Patients Enrolled for Disease
Constance M Horgan, ScDPrincipal InvestigatorBrandeis University
Sharon Reif, PhDPrincipal InvestigatorBrandeis University

Eligibility Criteria

Age 18+ · All Participants · 4 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You are able to read English, to provide informed consent and complete study instruments.
You are able to use a smart phone to complete study instruments.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.