Opiate Dependency Relapse Clinical Trial
Official title:
Using mHealth to Aid Opioid Medication Adherence Focus Groups
Verified date | November 2013 |
Source | Care Team Solutions |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Federal Government |
Study type | Observational |
The purpose of the proposed study is perform focus groups to identify and prioritize
features of the SubAID application (APP). The SubAID APP is smartphone APP being created to
support patients self-managing buprenorphine/naloxone (bup/nal) medication. Many people have
difficulty in managing bup/nal in the prescribed manner. Not taking medicines in their
prescribed manner can cause negative health outcomes.
Focus group participants will be asked to elaborate on medication-taking patterns that work
best for them, pitfalls associated with poor adherence and offer opinions upon what
features/functions the SubAID APP should perform to be most helpful to them. The focus group
is designed to remain open-ended and allow free discussion regarding each particular topic
that the moderator will bring up.
Status | Completed |
Enrollment | 11 |
Est. completion date | October 2013 |
Est. primary completion date | October 2013 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 21 Years and older |
Eligibility |
Inclusion Criteria: - At least 21 years of age - Physician diagnosis of opioid dependence (OD) - Prescribed buprenorphine/naloxone (bup/nal) and acclimated to the medication - Able to speak and read English - Willing to provide written informed consent prior to study entry - Able to understand the study - Ownership of an Android or iPhone smartphone Exclusion Criteria: - Having any concurrent medical or psychiatric condition that, in the investigator's opinion, may preclude participation in this study; or - Cognitive or other impairment (e.g., visual) that would interfere with completing a self-administered questionnaire and with participating in a group discussion. |
Observational Model: Cohort, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
United States | Care Team Solutions | Lexington | Kentucky |
Lead Sponsor | Collaborator |
---|---|
Care Team Solutions |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Attitudes, beliefs and perceptions | Content analysis will be used to evaluate the information gathered during the focus groups. The analysis will be based on recall, notes taken by the co-facilitator, and transcripts from session recordings. The evaluation process will include the following: 1) generation of key words, phrases, and quotes concerning symptoms, concerns or fears about their ability to effectively manage maintenance medications, and 2) identification of additional, emergent themes in each of the SubAID features that would be helpful and relevant to the impact of managing maintenance therapy medications. To be considered credible, themes included in the final analysis will be features or concerns that were raised by more than one participant in a single group, and, ideally, by participants in more than one group. | Up to 8 weeks | No |