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| ID | Type | Description | Link |
|---|---|---|---|
| 5K23MD016950-04 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Minority Health and Health Disparities (NIMHD) | NIH |
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The purpose of this study is to test whether the peer support program is acceptable, possible, and can improve mental health among individuals accessing hormone care. Eligible participants will be enrolled and randomized to the support program or enhanced usual care arm. Participants will take part in this study for 6 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Peer support group | Experimental | Participants in the peer support group will be contacted by the peer coordinator to be connected with a peer mentor and will have access to peer support options, namely, one-one one meetings with a peer mentor, group meetings with mentors and other participants, and medical appointment buddy. |
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| Enhanced Usual Care (EUC) | Other | EUC Documents will be disseminated with hormone care information and resources to share with patients relevant to the participants specific hormone condition or type of hormone care. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Peer support group | Behavioral | A peer mentor will be matched to mentees with participant input. The first meeting is intended to establish contact and expectations. Sessions will be scheduled according to the participant's preferences, with a suggested frequency of once a month with more as necessary and feasible. Participants in the peer support group will have access to peer support options that include: one-one one meetings with a peer mentor; group meetings with mentors and other participants; and medical appointment buddy. Participants are not required to use every option each month. Study visits will be completed baseline-6 months. |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility assessed by Acceptability based on the average total Abbreviated Acceptability Rating Profile (AARP) score at 6 months | The 9-item AARP is adapted to specifically address this peer support intervention for individuals seeking hormone care. Participants will respond to a 6-point Likert scale rating participants agreement with each acceptability statement. Total scores range from 9-54 with a higher score indicating greater acceptability. | 6 months |
| Feasibility based on the number of participants that agreed to participate on the study out of total number of individuals approached for study participation. | Up to 6 months (recruitment period) | |
| Feasibility assessed by Practicality based on the total number of one-on-one in-person sessions vs one-on-one virtual sessions | This is defined as the total number of one-on-one in-person sessions vs one-on-one virtual sessions. | 6 months |
| Feasibility assessed by Practicality based on the total the number participants engaged with group sessions in-person vs. number of participants engaged virtually | This is defined as the total number of participants engaged with group sessions in-person vs. number of participants engaged virtually. | 6 months |
| Safety based on the number of related adverse events | Related events included will be definitely, probably, and possibly related events (defined per protocol). The grading scale that will be used for these events include:
| 6 months |
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Inclusion Criteria:
Patients with hormone condition aged 18 years or older and English speaking
Initiating or receiving hormone care in Michigan
Report mild depression or anxiety symptoms, as determined by:
Interest or willingness to participate in peer support group meetings either in-person or virtually
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Daphna Stroumsa, MD, MPH, MSc | University of Michigan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
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| University of Michigan | Ann Arbor | Michigan | 48109 | United States |
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| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| ID | Term |
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| D001523 | Mental Disorders |
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Random assignment will be completed using 1:1 computer randomization. Randomization will be stratified by indication and regimen. Randomization will occur prior to the participant's hormone initiation visit to ensure participants assigned to the intervention have standardized access to the peer support components.
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| Enhanced Usual Care (EUC) | Other | Participants randomized to the usual care group will not have access to the peer support options but will complete the study visits (baseline-6 months). All participants will be given a resource document with community resources. |
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