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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01DK124719 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Vanderbilt University Medical Center | OTHER |
| University of California, Merced | OTHER |
| Children's Hospital Los Angeles | OTHER |
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
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The goal of this clinical trial is to evaluate how effective the FAMS-T1D intervention is for improving self-regulation (e.g., setting and meeting goals for type 1 diabetes) and social support for meeting those goals for young adults. The main questions that are examined include 1) whether the intervention improves blood glucose, self-management and diabetes distress across time, 2) whether these improvements occur through better self-regulation and social-regulation, 3) whether the intervention improves outcomes for support persons (a friend or family member invited to participate by the person with diabetes) without increasing support burden and 4) whether the intervention improves for persons with diabetes who are on continuous blood glucose monitor their time in range.
This 12-month intervention is an adaptation and expansion of an intervention originally developed for adults with type 2 diabetes (FAMS; NCT02481596) for young adults with type 1 diabetes. FAMS-T1D includes multiple components:
Participants will be randomized to either the intervention or an active control where individuals receive materials relevant to their type 1 diabetes. We plan to enroll 280 persons with diabetes and support persons (optional for persons with diabetes). Persons with type 1 diabetes and their support person (when enrolled) will be randomized together. The study is powered to detect a .5% reduction in hemoglobin A1c. Analyses will examine effects at 6 months (post intervention) and at 12 months (maintenance of effects). The investigators will impute missing data and individuals will be analyzed as randomized irrespective of whether they withdraw or remain in the study following intention-to-treat principals.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FAMS-T1D | Experimental | Participants will receive FAMS-T1D components (monthly phone coaching and text message support for goals) for 6 months. Support person will receive text messages that are tailored to the goal set by the person with type 1 diabetes. All persons with diabetes will receive text messages regarding how to access their HbA1c results and receive links providing information to assist them in self-care behaviors related to their diabetes. All support persons will also receive materials about type 1 diabetes and how to provide helpful support to the person with diabetes. |
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| Digital resources for diabetes | Placebo Comparator | Persons with type 1 diabetes will receive text messages as to how to access their HbA1c results and digital materials related to self-care behaviors for their diabetes. All support persons will receive digital materials about type 1 diabetes and how to provide helpful support to the person with diabetes. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FAMS-T1D | Behavioral | Behavioral FAMS-T1D FAMS-T1D involves monthly phone coaching that assists individuals in setting specific and time bound diabetes goals with automated text message support to the patient participant and less frequent automated text messages to their support person, if one is enrolled. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in HbA1c (Person with Diabetes) | Higher values indicate values more off target. Hemoglobin A1C assessed by mail-in kits from University of Minnesota ARDL | Baseline and 6, 9, and 12 months post baseline |
| Change in Self-Management (Person with Diabetes) | Self-care inventory revised, higher values indicate better self-management (values range from 1 to 5) | Baseline and 6, 9, and 12 months post baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Diabetes Distress (Person with Diabetes) | The Diabetes Distress Scale for Adults with Type 1 Diabetes, higher values indicate greater distress (values range from X to X) | Baseline and 6, 9, and 12 months post baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Self-Regulation Failures (Person with Diabetes) | Self-regulation failures (outcome and mediator) regarding failures in blood glucose checking ranging from 1 to 5 where higher values indicate greater failures. | Baseline, and 6, 9, and 12 months post baseline |
| Change in Self-Efficacy (Person with Diabetes) |
Inclusion Criteria:
PERSONS WITH DIABETES
SUPPORT PERSON
Exclusion Criteria:
PERSONS WITH DIABETES:
SUPPORT PERSON
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hospital of Los Angeles | Los Angeles | California | 90027-6062 | United States | ||
| University of Utah |
After study results are posted on clinical trials and published, de-identified data will be available upon requests made to the principal investigators
After study results are posted on clinical trials and outcomes published in a peer-reviewed journal.
Contact the principal investigator
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| NIH |
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The investigators use mail-in A1c kits for the primary outcome-hemoglobin A1c-and the lab analyzing these samples is masked to participants' assigned condition.
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| Digital resources for diabetes | Behavioral | Behavioral: Diabetes Resources High quality digital materials about diabetes management will be provided upon enrollment and send to participants quarterly. |
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Self-efficacy (outcomes and mediator), with scores ranging from 1 to 10 where higher numbers indicate greater self-efficacy. |
| Baseline, and 6, 9, and 12 months post baseline |
| Change in Goal planning (Person with Diabetes) | Goal Planning (outcome and mediator) subscale from the Goal Systems Assessment Battery with scores ranging from 1 to 5 where higher values indicate greater planning. | Baseline, and 6, 9, and 12 months post baseline |
| Change in Disclosure (Person with Diabetes) | Disclosure (outcome and mediator) as measured by disclosure subscale with scores ranging from 1 to 5 where higher values indicate greater disclosure to family and friends | Baseline, and 6, 9, and 12 months post baseline |
| Change in Helpful and Harmful Friend and Family Involvement (Person with Diabetes) | Change in Helpful (range 1 to 5, higher scores indicate more helpful involvement) and Harmful friend and family involvement (range 1 to 5, higher scores indicate more harmful involvement) (outcome and mediator) as measured by modified FIAD (Mayberry et al., 2019) for type 1 diabetes management. | Baseline, and 6, 9, and 12 months post baseline |
| Change in emotional support (Person with Diabetes) | Emotional support (outcome and mediator). Scores range from 1 to 5, higher scores indicate greater emotional support. | Baseline, and 6, 9, and 12 months post baseline |
| Time in range (Person with Diabetes) | Time in range (outcome). For individuals on a continuous blood glucose monitor (CGM) we collect time in range from their monitor. Higher scores indicate greater time spent with blood glucose values in the target range of 70-180 mg/dL. | Measured continuously from baseline through 12 months post baseline |
| Change in solicitation of information from patient (support person) | Solicitation of information from patient (outcome and mediator), with higher scores reflecting greater solicitation (range 1 to 5). | Baseline, and 6, 9, and 12 months post baseline |
| Change in support burden (support person) | Support burden (outcome and mediator), scores range from 0 to 4, higher scores indicate greater burden. | Baseline, and 6, 9, and 12 months post baseline |
| Change in Diabetes Distress (support person) | Support Person Diabetes Distress (outcome) with scores ranging from 0 to 4, higher scores indicate greater burden. | Baseline, and 6, 9, and 12 months post baseline |
| Change in Helpful and Harmful Friend and Family Involvement (support person) | Change in helpful (range 1 to 5, higher scores indicate more helpful involvement) and Harmful friend and family involvement (range 1 to 5, higher scores indicate more harmful involvement) (outcome and mediator) as measured by modified FIAD for type 1 diabetes management | Baseline, and 6, 9, and 12 months post baseline. |
| Change in emotional support (support person) | Emotional support (outcome and mediator). Scores range from 1 to 5, higher scores indicate greater emotional support. | Baseline, and 6, 9, and 12 months post baseline |
| Salt Lake City |
| Utah |
| 84112 |
| United States |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |