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| ID | Type | Description | Link |
|---|---|---|---|
| K23AR078177 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) | NIH |
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The goal of this clinical trial is to pilot test the REACH peer coaching program for fatigue in people with systemic lupus erythematosus. The main questions it aims to answer are:
Researchers will compare the REACH peer coaching program to the REACH mobile health application to see if the REACH program works to reduce fatigue.
Participants will:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| REACH Peer Coaching Program | Experimental | Participants will receive access to the REACH mobile health application and a REACH peer coach with whom they will meet weekly during the 12 weeks of the program. |
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| REACH Mobile Health Application | Active Comparator | Participants will receive access to the REACH mobile health application which they will use during the 12 weeks of the program. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| REACH Peer Coaching Program | Behavioral | The REACH Peer Coaching Program consists of weekly coaching calls conducted over video teleconference. Coaches will use motivational interviewing to help participants formulate and work towards movement goals. |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility | Enrollment rates (subjects enrolled/eligible individuals approached). | 6 months |
| Adherence | Proportions of educational modules, activity logs, and coaching sessions completed. | 12 months |
| Acceptability | Net Promoter Scores for the educational modules, REACH app, and REACH peer coaching intervention. Interviews exploring the acceptability of study procedures (e.g. data collection methods, study assessments, functionality of the mobile app) and engagement with educational modules and peer coaches. | 12 to 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Fatigue | Effect size estimate of change in fatigue using the Fatigue Severity Scale | 12 weeks and 24 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tufts Medical Center | Boston | Massachusetts | 02111 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40548142 | Derived | Gulati N, Singh K, Morrissey E, Calvache P, Rose-Smith J, Gore-Massy M, Chiu F, Trinquart L, Navarro-Millan I, Folta S, Kasturi S. Study protocol for a randomized controlled trial to pilot Restore Energy, Activity Can Help (REACH): an mHealth-enabled peer coaching intervention for fatigue in systemic lupus erythematosus. Contemp Clin Trials Commun. 2025 Jun 7;46:101508. doi: 10.1016/j.conctc.2025.101508. eCollection 2025 Aug. |
| Label | URL |
|---|---|
| Study Landing Page | View source |
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| ID | Term |
|---|---|
| D008180 | Lupus Erythematosus, Systemic |
| D005221 | Fatigue |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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| REACH Mobile Health Application | Behavioral | Participants will use the the REACH mobile health application to set weekly movement goals and log physical activity. |
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| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001519 | Behavior |