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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01DK100694-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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This study evaluates a mobile phone-delivered intervention, called REACH (Rapid Education/Encouragement And Communications for Health), in supporting adults with type 2 diabetes in their self-management relative to a control group. The goal of this study is to determine if individually tailored content (based on the Information-Motivation-Behavioral Skills Model) delivered to the participant via text messages can improve the participant's glycemic control and adherence to diabetes medications. We will test whether our intervention improves adherence-related information, motivation, and behavioral skills and whether improving these mechanisms drives improvements in adherence and, in turn, glycemic control.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| REACH | Experimental | Participants will receive REACH text messages (individual-focused text messaging tailored to user's individual barriers to adherence and targeted to address other self-care behaviors) for 12 months. All participants will also receive text messages advising how to access their study A1c test results, receive quarterly newsletters on healthy living with diabetes, and have access to a Helpline for study- and diabetes medication-related questions. |
|
| REACH + FAMS | Experimental | In addition to the REACH text messages tailored to user's individual barriers to adherence, participants will receive FAMS components (monthly phone coaching and text messages supporting a goal set in coaching, plus the option to invite a family member/support person to receive text messages) for six months. After six months, participants in this arm will receive REACH text messages only. All participants will also receive text messages advising how to access their study A1c test results, receive quarterly newsletters on healthy living with diabetes, and have access to a Helpline for study- and diabetes medication-related questions. |
|
| Helpline and A1c results | Active Comparator | Participants assigned to the control group will complete measures at each time point and maintain care as usual (i.e., medical treatment and physician monitoring). All participants will receive text messages advising how to access their study A1c test results, receive quarterly newsletters on healthy living with diabetes, and have access to a Helpline for study- and diabetes medication-related questions. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| REACH | Behavioral | The intervention consists of daily text messaging tailored to user's individual barriers to medication adherence, text messages assessing user's adherence with feedback on progress, plus text messaging targeting other self-care behaviors. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Glycemic Control as Indicated by Hemoglobin A1c (HbA1c) | as measured by Hemoglobin A1c (%) with higher values indicating worse glycemic control and an improvement of 0.5% considered clinically meaningful | Baseline, 3 months, 6 months, 12 months, 15 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Self-reported Medication Adherence | as measured by the Summary of Diabetes Self-Care Activities (SDSCA) Medications subscale; response options are days in the last week ranging from 0 to 7, with 7 representing perfect adherence | Baseline, 3 months, 6 months, 12 months, 15 months |
| Change in Self-reported Medication Adherence |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Adherence to Dietary Behavior | as measured by the Personal Diabetes Questionnaire diet subscale "Use of information for decision making"; possible range 1-6, higher indicates more use of dietary information (better) | Baseline, 3 months, 6 months, 12 months, 15 months |
| Change in Adherence to Dietary Behavior |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lindsay S Mayberry, MS, PhD | Vanderbilt University Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Federally Qualified Health Centers and Vanderbilt Primary Care Clinics | Nashville | Tennessee | 37203 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27609738 | Background | Nelson LA, Mayberry LS, Wallston K, Kripalani S, Bergner EM, Osborn CY. Development and Usability of REACH: A Tailored Theory-Based Text Messaging Intervention for Disadvantaged Adults With Type 2 Diabetes. JMIR Hum Factors. 2016 Sep 8;3(2):e23. doi: 10.2196/humanfactors.6029. | |
| 29636319 | Background | Nelson LA, Wallston KA, Kripalani S, Greevy RA Jr, Elasy TA, Bergner EM, Gentry CK, Mayberry LS. Mobile Phone Support for Diabetes Self-Care Among Diverse Adults: Protocol for a Three-Arm Randomized Controlled Trial. JMIR Res Protoc. 2018 Apr 10;7(4):e92. doi: 10.2196/resprot.9443. |
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Individual participant data collected during the trial will be de-identified and made available following publication of the 15-month trial results to researchers who provide a methodologically sound proposal.
Beginning 6 months after final trial results publication. No end date.
Approval of a proposal by the study PI.
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6 participants were administratively withdrawn prior to randomization; 5 were unreachable during a pre-determined run-in period after enrollment, 1 behaved inappropriately with a research assistant during enrollment
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| ID | Title | Description |
|---|---|---|
| FG000 | REACH | Participants will receive REACH text messages (individual-focused text messaging tailored to user's individual barriers to adherence and targeted to address other self-care behaviors) for 12 months. All participants will also receive text messages advising how to access their study A1c test results, receive quarterly newsletters on healthy living with diabetes, and have access to a Helpline for study- and diabetes medication-related questions. REACH: The intervention consists of daily text messaging tailored to user's individual barriers to medication adherence, text messages assessing user's adherence with feedback on progress, plus text messaging targeting other self-care behaviors. Helpline and A1c results: Participants complete study assessments, receive text messages advising how to access study A1c results, receive quarterly newsletters on healthy living with diabetes, and have access to a helpline for study- or diabetes medication-related questions. |
| FG001 | REACH + FAMS | In addition to the REACH text messages tailored to user's individual barriers to adherence, participants will receive FAMS components (monthly phone coaching and text messages supporting a goal set in coaching, plus the option to invite a family member/support person to receive text messages) for six months. After 6 months, participants in this arm will receive REACH text messages only. All participants will also receive text messages advising how to access their study A1c test results, receive quarterly newsletters on healthy living with diabetes, and have access to a Helpline for study- and diabetes medication-related questions. Helpline and A1c results: Participants complete study assessments, receive text messages advising how to access study A1c results, receive quarterly newsletters on healthy living with diabetes, and have access to a helpline for study- or diabetes medication-related questions. REACH + FAMS: The intervention consists of REACH individually-focused text mes |
| FG002 | Helpline and A1c Results | Participants assigned to the control group will complete measures at each time point and maintain care as usual (i.e., medical treatment and physician monitoring). All participants will receive text messages advising how to access their study A1c test results, receive quarterly newsletters on healthy living with diabetes, and have access to a Helpline for study- and diabetes medication-related questions. Helpline and A1c results: Participants complete study assessments, receive text messages advising how to access study A1c results, receive quarterly newsletters on healthy living with diabetes, and have access to a helpline for study- or diabetes medication-related questions. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | REACH | Participants will receive REACH text messages (individual-focused text messaging tailored to user's individual barriers to adherence and targeted to address other self-care behaviors) for 12 months. All participants will also receive text messages advising how to access their study A1c test results, receive quarterly newsletters on healthy living with diabetes, and have access to a Helpline for study- and diabetes medication-related questions. REACH: The intervention consists of daily text messaging tailored to user's individual barriers to medication adherence, text messages assessing user's adherence with feedback on progress, plus text messaging targeting other self-care behaviors. Helpline and A1c results: Participants complete study assessments, receive text messages advising how to access study A1c results, receive quarterly newsletters on healthy living with diabetes, and have access to a helpline for study- or diabetes medication-related questions. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Glycemic Control as Indicated by Hemoglobin A1c (HbA1c) | as measured by Hemoglobin A1c (%) with higher values indicating worse glycemic control and an improvement of 0.5% considered clinically meaningful | We compared participants receiving the REACH intervention (combining REACH and REACH + FAMS) with participants not receiving REACH (in condition Helpline and A1c Results). | Posted | Mean | Standard Deviation | percent | Baseline, 3 months, 6 months, 12 months, 15 months |
|
We followed participants for 15 months of study participation, lasting from recruitment start May 2016 until the last participant completed 15-month follow-up in June 2019.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | REACH | Participants will receive REACH text messages (individual-focused text messaging tailored to user's individual barriers to adherence and targeted to address other self-care behaviors) for 12 months. All participants will also receive text messages advising how to access their study A1c test results, receive quarterly newsletters on healthy living with diabetes, and have access to a Helpline for study- and diabetes medication-related questions. REACH: The intervention consists of daily text messaging tailored to user's individual barriers to medication adherence, text messages assessing user's adherence with feedback on progress, plus text messaging targeting other self-care behaviors. Helpline and A1c results: Participants complete study assessments, receive text messages advising how to access study A1c results, receive quarterly newsletters on healthy living with diabetes, and have access to a helpline for study- or diabetes medication-related questions. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Lindsay S. Mayberry, PhD, MS | Vanderbilt University Medical Center | 615-875-5821 | lindsay.mayberry@vumc.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 9, 2018 | Mar 31, 2020 | SAP_000.pdf |
| Prot | Yes | No | No | Study Protocol | Apr 9, 2018 | Apr 23, 2020 | Prot_001.pdf |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| Helpline and A1c results | Behavioral | Participants complete study assessments, receive text messages advising how to access study A1c results, receive quarterly newsletters on healthy living with diabetes, and have access to a helpline for study- or diabetes medication-related questions. |
|
| REACH + FAMS | Behavioral | The intervention consists of REACH individually-focused text messaging, plus family-focused phone coaching session, goal-focused text messaging, and the option to invite a family member/support person to receive text messaging. |
|
|
as measured by the Adherence to Refills and Medications Scale for Diabetes (ARMS-D); reverse coded such that higher scores indicate better adherence on a scale from 11 to 44 |
| Baseline, 3 months, 6 months, 12 months, 15 months |
Personal Diabetes Questionnaire diet subscale "Problem eating behavior"; possible range 1-6 with higher indicating more problem eating behavior (worse) |
| Baseline, 3 months, 6 months, 12 months, 15 months |
| Change in Physical Activity | as measured by International Physical Activity Questionnaire-Short form [metabolic equivalent minutes (MET-minutes) per week] where more MET-minutes per week indicates more physical activity | Baseline, 3 months, 6 months, 12 months, 15 months |
| Change in Glycemic Control - REACH Only vs. Control & REACH+FAMS vs. Control | as measured by hemoglobin A1c (HbA1c, %) We may be under-powered to for these comparative analyses. | Baseline, 3 months, 6 months, 12 months, 15 months |
| 35948873 | Derived | Roddy MK, Mayberry LS, Nair D, Cavanaugh KL. Exploring mHealth potential to improve kidney function: secondary analysis of a randomized trial of diabetes self-care in diverse adults. BMC Nephrol. 2022 Aug 10;23(1):280. doi: 10.1186/s12882-022-02885-6. |
| 31403688 | Derived | Mayberry LS, Bergner EM, Harper KJ, Laing S, Berg CA. Text messaging to engage friends/family in diabetes self-management support: acceptability and potential to address disparities. J Am Med Inform Assoc. 2019 Oct 1;26(10):1099-1108. doi: 10.1093/jamia/ocz091. |
| BG001 | REACH + FAMS | In addition to the REACH text messages tailored to user's individual barriers to adherence, participants will receive FAMS components (monthly phone coaching and text messages supporting a goal set in coaching, plus the option to invite a family member/support person to receive text messages) for 6 months. After six months, participants in this arm will receive REACH text messages only. All participants will also receive text messages advising how to access their study A1c test results, receive quarterly newsletters on healthy living with diabetes, and have access to a Helpline for study- and diabetes medication-related questions. Helpline and A1c results: Participants complete study assessments, receive text messages advising how to access study A1c results, receive quarterly newsletters on healthy living with diabetes, and have access to a helpline for study- or diabetes medication-related questions. REACH + FAMS: The intervention consists of REACH individually-focused text mes |
| BG002 | Helpline and A1c Results | Participants assigned to the control group will complete measures at each time point and maintain care as usual (i.e., medical treatment and physician monitoring). All participants will receive text messages advising how to access their study A1c test results, receive quarterly newsletters on healthy living with diabetes, and have access to a Helpline for study- and diabetes medication-related questions. Helpline and A1c results: Participants complete study assessments, receive text messages advising how to access study A1c results, receive quarterly newsletters on healthy living with diabetes, and have access to a helpline for study- or diabetes medication-related questions. |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Hemoglobin A1c (%) | Mean | Standard Deviation | percent |
|
| Medication Adherence - Summary of Diabetes Self-Care Activities medication subscale | as measured by the Summary of Diabetes Self-Care Activities (SDSCA) Medications subscale; response options are days in the last week ranging from 0 to 7, with 7 representing perfect adherence | Mean | Standard Deviation | days in a week |
|
| Medication Adherence - Adherence to Refills and Medications Scale for Diabetes | as measured by the Adherence to Refills and Medications Scale for Diabetes (ARMS-D); reverse coded such that higher scores indicate better adherence on a scale from 11 to 44 | Mean | Standard Deviation | score on a scale |
|
| Use of dietary information - Personal Diabetes Questionnaire | as measured by the Personal Diabetes Questionnaire diet subscale "Use of information for decision making"; possible range 1-6, higher indicates more use of dietary information (better) | Mean | Standard Deviation | score on a scale |
|
| Problem eating behaviors - Personal Diabetes Questionnaire | Personal Diabetes Questionnaire diet subscale "Problem eating behavior"; possible range 1-6 with higher indicating more problem eating behavior (worse) | Mean | Standard Deviation | score on a scale |
|
| MET-minutes per week - International Physical Activity Questionnaire-short form | as measured by International Physical Activity Questionnaire-Short form [metabolic equivalent minutes (MET-minutes) per week] where more MET-minutes per week indicates more physical activity | Mean | Standard Deviation | MET-minutes per week |
|
| OG001 | Helpline and A1c Results | Participants assigned to the control group will complete measures at each time point and maintain care as usual (i.e., medical treatment and physician monitoring). All participants will receive text messages advising how to access their study A1c test results, receive quarterly newsletters on healthy living with diabetes, and have access to a Helpline for study- and diabetes medication-related questions. Helpline and A1c results: Participants complete study assessments, receive text messages advising how to access study A1c results, receive quarterly newsletters on healthy living with diabetes, and have access to a helpline for study- or diabetes medication-related questions. |
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| Secondary | Change in Self-reported Medication Adherence | as measured by the Summary of Diabetes Self-Care Activities (SDSCA) Medications subscale; response options are days in the last week ranging from 0 to 7, with 7 representing perfect adherence | We compared participants receiving the REACH intervention (combining REACH and REACH + FAMS) with participants not receiving REACH (in condition Helpline and A1c Results). | Posted | Mean | Standard Deviation | days per week | Baseline, 3 months, 6 months, 12 months, 15 months |
|
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|
|
| Secondary | Change in Self-reported Medication Adherence | as measured by the Adherence to Refills and Medications Scale for Diabetes (ARMS-D); reverse coded such that higher scores indicate better adherence on a scale from 11 to 44 | We compared participants receiving the REACH intervention (combining REACH and REACH + FAMS) with participants not receiving REACH (in condition Helpline and A1c Results). | Posted | Mean | Standard Deviation | score on a scale | Baseline, 3 months, 6 months, 12 months, 15 months |
|
|
|
|
| Other Pre-specified | Change in Adherence to Dietary Behavior | as measured by the Personal Diabetes Questionnaire diet subscale "Use of information for decision making"; possible range 1-6, higher indicates more use of dietary information (better) | We compared participants receiving the REACH intervention (combining REACH and REACH + FAMS) with participants not receiving REACH (in condition Helpline and A1c Results). | Posted | Mean | Standard Deviation | score on a scale | Baseline, 3 months, 6 months, 12 months, 15 months |
|
|
|
|
| Other Pre-specified | Change in Adherence to Dietary Behavior | Personal Diabetes Questionnaire diet subscale "Problem eating behavior"; possible range 1-6 with higher indicating more problem eating behavior (worse) | We compared participants receiving the REACH intervention (combining REACH and REACH + FAMS) with participants not receiving REACH (in condition Helpline and A1c Results). | Posted | Mean | Standard Deviation | score on a scale | Baseline, 3 months, 6 months, 12 months, 15 months |
|
|
|
|
| Other Pre-specified | Change in Physical Activity | as measured by International Physical Activity Questionnaire-Short form [metabolic equivalent minutes (MET-minutes) per week] where more MET-minutes per week indicates more physical activity | We compared participants receiving the REACH intervention (combining REACH and REACH + FAMS) with participants not receiving REACH (in condition Helpline and A1c Results). | Posted | Mean | Standard Deviation | MET-minutes per week | Baseline, 3 months, 6 months, 12 months, 15 months |
|
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|
|
| Other Pre-specified | Change in Glycemic Control - REACH Only vs. Control & REACH+FAMS vs. Control | as measured by hemoglobin A1c (HbA1c, %) We may be under-powered to for these comparative analyses. | We compared participants receiving the REACH intervention only with those receiving REACH + FAMS and with participants not receiving REACH (in condition Helpline and A1c Results). This analysis was subsetted to participants with baseline HbA1c greater than or equal to 8.5% with the goal of improved power. | Posted | Mean | Standard Deviation | percent | Baseline, 3 months, 6 months, 12 months, 15 months |
|
|
|
|
| 3 |
| 127 |
| 0 |
| 127 |
| 0 |
| 127 |
| EG001 | REACH + FAMS | In addition to the REACH text messages tailored to user's individual barriers to adherence, participants will receive FAMS components (monthly phone coaching and text messages supporting a goal set in coaching, plus the option to invite a family member/support person to receive text messages) for 6 months. After six months, participants in this arm will receive REACH text messages only. All participants will also receive text messages advising how to access their study A1c test results, receive quarterly newsletters on healthy living with diabetes, and have access to a Helpline for study- and diabetes medication-related questions. Helpline and A1c results: Participants complete study assessments, receive text messages advising how to access study A1c results, receive quarterly newsletters on healthy living with diabetes, and have access to a helpline for study- or diabetes medication-related questions. REACH + FAMS: The intervention consists of REACH individually-focused text mes | 2 | 126 | 0 | 126 | 0 | 126 |
| EG002 | Helpline and A1c Results | Participants assigned to the control group will complete measures at each time point and maintain care as usual (i.e., medical treatment and physician monitoring). All participants will receive text messages advising how to access their study A1c test results, receive quarterly newsletters on healthy living with diabetes, and have access to a Helpline for study- and diabetes medication-related questions. Helpline and A1c results: Participants complete study assessments, receive text messages advising how to access study A1c results, receive quarterly newsletters on healthy living with diabetes, and have access to a helpline for study- or diabetes medication-related questions. | 3 | 253 | 0 | 253 | 0 | 253 |
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| D004700 | Endocrine System Diseases |
| 12 months |
|
| 15 months |
|
We performed an omnibus test of the treatment effect at 3 and 6 months using a robust variance-covariance based Wald statistic. We used ordinary least squares linear regression with Huber-White heteroscedasticity-consistent standard errors to obtain point estimates and 95% CIs for the intervention effect at each time. |
| Any REACH vs. Helpline and A1c results. We used generalized estimating equations (GEE) with a working-exchangeable correlation structure and identity link, adjusting for baseline and allowing a time-treatment interaction. For the HbA1c model, we allowed for a three-way interaction between time, treatment group, and baseline HbA1c because there was descriptive evidence that the effect was modified by baseline HbA1c values. Multiply imputed data (m=1,000) using chained equations. | GEE, Wald test | Adjusted for baseline values with cubic splines (3 knots). | 0.003 | A priori threshold p<.05. | Predicted mean difference | 0.210 | 2-Sided | 95 | -0.031 | 0.450 | 15-month point estimate | Superiority | We performed an omnibus test of the treatment effect at 3, 6, 12, and 15 months using a robust variance-covariance based Wald statistic. We used ordinary least squares linear regression with Huber-White heteroscedasticity-consistent standard errors to obtain point estimates and 95% CIs for the intervention effect at each time. |
| 12 months |
|
| 15 months |
|
We performed an omnibus test of the treatment effect at 3 and 6 months using a robust variance-covariance based Wald statistic. We used ordinary least squares linear regression with Huber-White heteroscedasticity-consistent standard errors to obtain point estimates and 95% CIs for the intervention effect at each time. |
| Any REACH vs. Helpline and A1c results. We used generalized estimating equations (GEE) with a working-exchangeable correlation structure and identity link, adjusting for baseline and allowing a time-treatment interaction. Multiply imputed data (m=1,000) using chained equations. | GEE, Wald test | Adjusted for baseline values with cubic splines (3 knots). | 0.434 | A priori threshold p<.05. | Predicted mean difference | 0.278 | 2-Sided | 95 | -0.319 | 0.875 | 15-month point estimate | Superiority | We performed an omnibus test of the treatment effect at 3, 6, 12, and 15 months using a robust variance-covariance based Wald statistic. We used ordinary least squares linear regression with Huber-White heteroscedasticity-consistent standard errors to obtain point estimates and 95% CIs for the intervention effect at each time. |
| 12 months |
|
| 15 months |
|
We performed an omnibus test of the treatment effect at 3 and 6 months using a robust variance-covariance based Wald statistic. We used ordinary least squares linear regression with Huber-White heteroscedasticity-consistent standard errors to obtain point estimates and 95% CIs for the intervention effect at each time. |
| Any REACH vs. Helpline and A1c results. We used generalized estimating equations (GEE) with a working-exchangeable correlation structure and identity link, adjusting for baseline and allowing a time-treatment interaction. Multiply imputed data (m=1,000) using chained equations. | GEE, Wald test | Adjusted for baseline values with cubic splines (3 knots). | 0.003 | A priori threshold p<.05. | Predicted mean difference | 0.152 | 2-Sided | 95 | -0.121 | 0.426 | 15-month point estimate | Superiority | We performed an omnibus test of the treatment effect at 3, 6, 12, and 15 months using a robust variance-covariance based Wald statistic. We used ordinary least squares linear regression with Huber-White heteroscedasticity-consistent standard errors to obtain point estimates and 95% CIs for the intervention effect at each time. |
| 12 months |
|
| 15 months |
|
We performed an omnibus test of the treatment effect at 3 and 6 months using a robust variance-covariance based Wald statistic. We used ordinary least squares linear regression with Huber-White heteroscedasticity-consistent standard errors to obtain point estimates and 95% CIs for the intervention effect at each time. |
| Any REACH vs. Helpline and A1c results. We used generalized estimating equations (GEE) with a working-exchangeable correlation structure and identity link, adjusting for baseline and allowing a time-treatment interaction. Multiply imputed data (m=1,000) using chained equations. | GEE, Wald test | Adjusted for baseline values with cubic splines (3 knots). | 0.572 | A priori threshold p<.05. | Predicted mean difference | 0.005 | 2-Sided | 95 | -0.202 | 1.100 | 15-month point estimate | Superiority | We performed an omnibus test of the treatment effect at 3, 6, 12, and 15 months using a robust variance-covariance based Wald statistic. We used ordinary least squares linear regression with Huber-White heteroscedasticity-consistent standard errors to obtain point estimates and 95% CIs for the intervention effect at each time. |
| 12 months |
|
| 15 months |
|
We performed an omnibus test of the treatment effect at 3 and 6 months using a robust variance-covariance based Wald statistic. We used ordinary least squares linear regression with Huber-White heteroscedasticity-consistent standard errors to obtain point estimates and 95% CIs for the intervention effect at each time. |
| Any REACH vs. Helpline and A1c results. We used generalized estimating equations (GEE) with a working-exchangeable correlation structure and identity link, adjusting for baseline and allowing a time-treatment interaction. Multiply imputed data (m=1,000) using chained equations. | GEE, Wald test | Adjusted for baseline values with cubic splines (3 knots). | 0.465 | A priori threshold p<.05. | Predicted mean difference | 26 | 2-Sided | 95 | -459 | 511 | 15-month point estimate | Superiority | We performed an omnibus test of the treatment effect at 3, 6, 12, and 15 months using a robust variance-covariance based Wald statistic. We used ordinary least squares linear regression with Huber-White heteroscedasticity-consistent standard errors to obtain point estimates and 95% CIs for the intervention effect at each time. |
|
| 12 months |
|
| 15 months |
|
Testing superiority of REACH only relative to control. We used ordinary least squares linear regression with Huber-White heteroscedasticity-consistent standard errors to obtain point estimates and 95% CIs for the intervention effect at each time.
| To evaluate if REACH only and REACH+FAMS had similar effects on HbA1c relative to control, we subsetted to participants with baseline HbA1c greater than or equal to 8.5% to maximize our power for these analyses. We used generalized estimating equations (GEE) with a working-exchangeable correlation structure and identity link, adjusting for baseline and allowing a time-treatment interaction. Multiply imputed data (m=1,000) using chained equations. | Predicted mean difference | -0.31 | 2-Sided | 95 | -1.00 | 0.39 | 12-month point estimate | Superiority | Testing superiority of REACH only relative to control. We used ordinary least squares linear regression with Huber-White heteroscedasticity-consistent standard errors to obtain point estimates and 95% CIs for the intervention effect at each time. |
| To evaluate if REACH only and REACH+FAMS had similar effects on HbA1c relative to control, we subsetted to participants with baseline HbA1c greater than or equal to 8.5% to maximize our power for these analyses. We used generalized estimating equations (GEE) with a working-exchangeable correlation structure and identity link, adjusting for baseline and allowing a time-treatment interaction. Multiply imputed data (m=1,000) using chained equations. | Predicted mean difference | -0.65 | 2-Sided | 95 | -1.26 | -0.05 | 6-month point estimate | Superiority | Testing superiority of REACH_FAMS relative to control. We used ordinary least squares linear regression with Huber-White heteroscedasticity-consistent standard errors to obtain point estimates and 95% CIs for the intervention effect at each time. |
| To evaluate if REACH only and REACH+FAMS had similar effects on HbA1c relative to control, we subsetted to participants with baseline HbA1c greater than or equal to 8.5% to maximize our power for these analyses. We used generalized estimating equations (GEE) with a working-exchangeable correlation structure and identity link, adjusting for baseline and allowing a time-treatment interaction. Multiply imputed data (m=1,000) using chained equations. | Predicted mean difference | -0.31 | 2-Sided | 95 | -0.96 | 0.51 | 12-month point estimate | Superiority | Testing superiority of REACH+FAMS relative to control. We used ordinary least squares linear regression with Huber-White heteroscedasticity-consistent standard errors to obtain point estimates and 95% CIs for the intervention effect at each time. |