N/A
N=19
mHealth for Patient Self-Management of Opioid Use Disorder
Opioid-use Disorder
Bottom Line
View on ClinicalTrials.gov: NCT03633929 ↗Enrolled (actual)
19
Serious AEs
0.0%
Results posted
May 2021
Primary outcome: Primary: Usability Score — 89.5 score on a scale
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- KIOS OUD (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Biomedical Development Corporation
- Primary completion
- Sep 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Usability Score |
89.5 | — |
| SECONDARY Opioid Use |
1 | — |
| SECONDARY Mean Change in Depression Score From Baseline |
-1.00 | — |
| SECONDARY Change in World Health Organization Quality of Life Assessment From Baseline |
0.11; 1.29; 0.36; 0.67 | — |
| SECONDARY Mean Change on Patient-entered Data From KIOS App |
-1.01; -1.20; -1.48; -1.05; -1.08; -1.30 | — |
Summary
Twenty individuals diagnosed with opioid use disorder (OUD) will be recruited to participate in a beta test to demonstrate feasibility of using an online tool to help them better self-manage their recovery.
Eligibility Criteria
Inclusion Criteria
- male or female outpatients 18 years of age or older;
- opioid use disorder as assessed by MINI 6.0;
- currently stable in OUD outpatient treatment for 4 weeks or longer; and
- ability to access KIOS-OUD via computer, smartphone, or tablet.
Exclusion Criteria
- are unwilling or unable to comply with study requirements;
- have a major untreated psychiatric illness (e.g., schizophrenia, bipolar disorder) or suicidality.
Data sourced from ClinicalTrials.gov (NCT03633929). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.