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| ID | Type | Description | Link |
|---|---|---|---|
| 1R61DA061326-01A1 | U.S. NIH Grant/Contract | View source | |
| UWMSN | COE | Industrial and S | Other Identifier | UW Madison | |
| Protocol Version 2/16/26 | Other Identifier | UW Madison |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
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The purpose of this clinical trial is to develop and test whether a text- and web-based tool called FamilyCHESS - designed for individuals with opioid use disorder (OUD) and a concerned significant other (CSO) - can help the identified patient (IP) begin and stay on medication for opioid use disorder (MOUD).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FamilyCHESS (Family Comprehensive Health Enhancement Support System) | Experimental | Participant dyads will receive FamilyCHESS |
|
| Control | Active Comparator | Participant dyads will receive standard of care treatment for MOUD |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FamilyCHESS | Behavioral | Participants will have access to the FamilyCHESS system on their personal smartphone. FamilyCHESS incorporates Invitation to Change (ITC), a combination of Community Reinforcement and Family Training (CRAFT), Acceptance and Commitment Therapy (ACT), and Motivational Interviewing (MI) training principles and components for a CSO (e.g., parent, spouse/romantic partner, adult child, other family member or friend) to encourage and support the patient to engage in treatment. |
| Measure | Description | Time Frame |
|---|---|---|
| Initiation of MOUD | Number of days between study start date and MOUD initiation date. | 12 months |
| Continuity on MOUD | Collected through self-report. Percentage of days IPs in the intervention arm are on MOUD compared to control arm. | 4, 8, and 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in IP Quality of Life | Quality of life (QOL) is measured using the SF-12 Health Survey, which is a 12-item questionnaire. It is scored on a variable Likert scale. Scores range from 12 to 47 where higher scores indicate greater quality of life. | Baseline, 4, 8, and 12 months |
| Change in number of opioid overdoses |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Klaren Pe-Romashko, MS | Contact | kspe@wisc.edu | ||
| Gina Landucci, BS | Contact | gina.landucci@wisc.edu |
| Name | Affiliation | Role |
|---|---|---|
| Todd Molfenter, PhD | University of Wisconsin, Madison | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northwestern University Feinberg School of Medicine | Chicago | Illinois | 60187 | United States | ||
| University of Wisonsin-Madison |
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| ID | Term |
|---|---|
| D009293 | Opioid-Related Disorders |
| D008224 | Lymphoma, Follicular |
| ID | Term |
|---|---|
| D000079524 | Narcotic-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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Two arms consisting of dyads (IP + CSO) will complete the study.
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| Standard of Care | Behavioral | Participants will receive links to Substance Abuse and Mental Health Services Administration (SAMHSA) resources for MOUD |
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IPs will self-report whether, and how many, overdoses they experienced in the previous 30 days. An opioid overdose occurs when someone turns blue, has little or no breathing, or passes out and cannot be woken up without help after using opioids. |
| Baseline, 4, 8, and 12 months |
| Change in number of emergency room visits | Baseline to 12 months |
| Change in percentage of days of opioid use | IPs will self-report the number of days they used any illegal/street drugs, abuse any prescription medications, or drink alcohol over the previous 30 days. It will be reported as a percentage of overall days of use | Baseline, 4, 8, and 12 months |
| Change in McMaster Family Functioning Scale (FAD-GF) | FAD-GF is a 12 item questionnaire using a 4-point Likert scale. 1 = strongly agree and 4 = strongly disagree. Odd items are reverse scored. Once the odd items have been reverse scored the participant's family functioning score is the sum of the 12 items, which ranges from 12-48, where higher scores indicate better family functioning. | Baseline, 4, 8, and 12 months |
| Change in CSO coping styles | CSOs will complete a 30-item survey about coping strategies. It is scored on a 3-point Likert scale where no = 0 and often = 3. Scores range from 0-90, where higher scores indicate better coping strategies. | Baseline, 4, 8, and 12 months |
| Change in CSO perceptions of social support | Using the Alcohol, Drugs and the Family Support Scale, CSOs will rate their perception of social support. The scale is a 25 item survey which uses a 3-point Likert scale where 0 = never and 3 = often (some items are reverse scored). Scores range from 0-75. Higher scores indicate greater sense of support. | Baseline, 4, 8, and 12 months |
| Change in CSO Quality of Life | QOL is measured using the SF-12 Health Survey, which is a 12-item questionnaire. It is scored on a variable Likert scale. Scores range from 12 to 47 where higher scores indicate greater quality of life. | Baseline, 4, 8, and 12 months |
| Madison |
| Wisconsin |
| 53706 |
| United States |
|
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |