Diabetes Mellitus, Type 2
Conditions
Brief summary
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.
Interventions
BEHAVIORALREACH
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.
BEHAVIORALHelpline 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.
BEHAVIORALREACH + FAMS
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.
Sponsors
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Vanderbilt University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adults aged 18 years and older * Individuals who have received a diagnosis for type 2 diabetes mellitus * Enrolled as a patient at a participating community health center * Individuals currently being treated with oral and/or injectable diabetes medications
Exclusion criteria
* Non-English speakers * Individuals who report they do not have a cell phone * Individuals unwilling and/or not able to provide written informed consent * Individuals with unintelligible speech (e.g., dysarthria) * Individuals with a severe hearing or visual impairment * Individuals who report a caregiver administers their diabetes medications Individuals who fail the cognitive screener administered during the baseline survey * Individuals who cannot receive, read, and respond to a text after instruction from a trained research assistant * Individuals whose most recent (within 12 months) HbA1c value was 6.8% or greater
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Glycemic Control as Indicated by Hemoglobin A1c (HbA1c) | Baseline, 3 months, 6 months, 12 months, 15 months | as measured by Hemoglobin A1c (%) with higher values indicating worse glycemic control and an improvement of 0.5% considered clinically meaningful |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Self-reported Medication Adherence | Baseline, 3 months, 6 months, 12 months, 15 months | 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change in Adherence to Dietary Behavior | Baseline, 3 months, 6 months, 12 months, 15 months | 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) |
| Change in Physical Activity | Baseline, 3 months, 6 months, 12 months, 15 months | 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 |
| Change in Glycemic Control - REACH Only vs. Control & REACH+FAMS vs. Control | Baseline, 3 months, 6 months, 12 months, 15 months | as measured by hemoglobin A1c (HbA1c, %) We may be under-powered to for these comparative analyses. |
Countries
United States
Participant flow
Pre-assignment details
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
Participants by arm
| Arm | Count |
|---|---|
| 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. | 127 |
| 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 | 126 |
| 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. | 253 |
| Total | 506 |
Baseline characteristics
| Characteristic | REACH | REACH + FAMS | Helpline and A1c Results | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 18 Participants | 29 Participants | 47 Participants | 94 Participants |
| Age, Categorical Between 18 and 65 years | 109 Participants | 97 Participants | 206 Participants | 412 Participants |
| Age, Continuous | 55.8 years STANDARD_DEVIATION 9.4 | 55.7 years STANDARD_DEVIATION 10.2 | 56.1 years STANDARD_DEVIATION 9.4 | 55.9 years STANDARD_DEVIATION 9.6 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 8 Participants | 8 Participants | 15 Participants | 31 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 116 Participants | 111 Participants | 224 Participants | 451 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 3 Participants | 7 Participants | 14 Participants | 24 Participants |
| Hemoglobin A1c (%) | 8.72 percent STANDARD_DEVIATION 1.79 | 8.56 percent STANDARD_DEVIATION 1.9 | 8.53 percent STANDARD_DEVIATION 1.8 | 8.58 percent STANDARD_DEVIATION 1.82 |
| Medication Adherence - Adherence to Refills and Medications Scale for Diabetes | 39.90 score on a scale STANDARD_DEVIATION 3.74 | 39.66 score on a scale STANDARD_DEVIATION 3.54 | 40.21 score on a scale STANDARD_DEVIATION 3.34 | 39.99 score on a scale STANDARD_DEVIATION 3.54 |
| Medication Adherence - Summary of Diabetes Self-Care Activities medication subscale | 6.25 days in a week STANDARD_DEVIATION 1.37 | 6.37 days in a week STANDARD_DEVIATION 1.09 | 6.41 days in a week STANDARD_DEVIATION 1.16 | 6.36 days in a week STANDARD_DEVIATION 1.2 |
| MET-minutes per week - International Physical Activity Questionnaire-short form | 2565.11 MET-minutes per week STANDARD_DEVIATION 3108.48 | 1836.23 MET-minutes per week STANDARD_DEVIATION 2183.39 | 2348.91 MET-minutes per week STANDARD_DEVIATION 2853.58 | 2274.58 MET-minutes per week STANDARD_DEVIATION 2777.96 |
| Problem eating behaviors - Personal Diabetes Questionnaire | 3.23 score on a scale STANDARD_DEVIATION 1.08 | 3.43 score on a scale STANDARD_DEVIATION 1.04 | 3.35 score on a scale STANDARD_DEVIATION 1.16 | 3.34 score on a scale STANDARD_DEVIATION 1.11 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 1 Participants | 3 Participants | 4 Participants |
| Race (NIH/OMB) Asian | 3 Participants | 2 Participants | 3 Participants | 8 Participants |
| Race (NIH/OMB) Black or African American | 51 Participants | 49 Participants | 98 Participants | 198 Participants |
| Race (NIH/OMB) More than one race | 2 Participants | 5 Participants | 6 Participants | 13 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 6 Participants | 6 Participants | 15 Participants | 27 Participants |
| Race (NIH/OMB) White | 64 Participants | 63 Participants | 128 Participants | 255 Participants |
| Region of Enrollment United States | 127 participants | 126 participants | 253 participants | 506 participants |
| Sex: Female, Male Female | 70 Participants | 69 Participants | 135 Participants | 274 Participants |
| Sex: Female, Male Male | 57 Participants | 57 Participants | 118 Participants | 232 Participants |
| Use of dietary information - Personal Diabetes Questionnaire | 3.09 score on a scale STANDARD_DEVIATION 1.74 | 2.85 score on a scale STANDARD_DEVIATION 1.57 | 2.96 score on a scale STANDARD_DEVIATION 1.7 | 2.97 score on a scale STANDARD_DEVIATION 1.68 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 3 / 127 | 2 / 126 | 3 / 253 |
| other Total, other adverse events | 0 / 127 | 0 / 126 | 0 / 253 |
| serious Total, serious adverse events | 0 / 127 | 0 / 126 | 0 / 253 |
Outcome results
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
Time frame: Baseline, 3 months, 6 months, 12 months, 15 months
Population: We compared participants receiving the REACH intervention (combining REACH and REACH + FAMS) with participants not receiving REACH (in condition Helpline and A1c Results).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| REACH | Change in Glycemic Control as Indicated by Hemoglobin A1c (HbA1c) | 3 months | 8.29 percent | Standard Deviation 1.49 |
| REACH | Change in Glycemic Control as Indicated by Hemoglobin A1c (HbA1c) | 6 months | 8.32 percent | Standard Deviation 1.65 |
| REACH | Change in Glycemic Control as Indicated by Hemoglobin A1c (HbA1c) | 12 months | 8.66 percent | Standard Deviation 1.97 |
| REACH | Change in Glycemic Control as Indicated by Hemoglobin A1c (HbA1c) | 15 months | 8.59 percent | Standard Deviation 1.81 |
| Helpline and A1c Results | Change in Glycemic Control as Indicated by Hemoglobin A1c (HbA1c) | 15 months | 8.61 percent | Standard Deviation 1.95 |
| Helpline and A1c Results | Change in Glycemic Control as Indicated by Hemoglobin A1c (HbA1c) | 3 months | 8.59 percent | Standard Deviation 1.65 |
| Helpline and A1c Results | Change in Glycemic Control as Indicated by Hemoglobin A1c (HbA1c) | 12 months | 8.70 percent | Standard Deviation 2.1 |
| Helpline and A1c Results | Change in Glycemic Control as Indicated by Hemoglobin A1c (HbA1c) | 6 months | 8.57 percent | Standard Deviation 2.15 |
Comparison: 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.p-value: 0.049395% CI: [-0.61, -0.017]GEE, Wald test
Comparison: 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.p-value: 0.2695% CI: [-0.38, 0.24]GEE, Wald test
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
Time frame: Baseline, 3 months, 6 months, 12 months, 15 months
Population: We compared participants receiving the REACH intervention (combining REACH and REACH + FAMS) with participants not receiving REACH (in condition Helpline and A1c Results).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| REACH | Change in Self-reported Medication Adherence | 3 months | 6.59 days per week | Standard Deviation 0.96 |
| REACH | Change in Self-reported Medication Adherence | 6 months | 6.64 days per week | Standard Deviation 0.89 |
| REACH | Change in Self-reported Medication Adherence | 12 months | 6.50 days per week | Standard Deviation 1.09 |
| REACH | Change in Self-reported Medication Adherence | 15 months | 6.36 days per week | Standard Deviation 1.22 |
| Helpline and A1c Results | Change in Self-reported Medication Adherence | 15 months | 6.18 days per week | Standard Deviation 1.45 |
| Helpline and A1c Results | Change in Self-reported Medication Adherence | 3 months | 6.38 days per week | Standard Deviation 1.25 |
| Helpline and A1c Results | Change in Self-reported Medication Adherence | 12 months | 6.27 days per week | Standard Deviation 1.46 |
| Helpline and A1c Results | Change in Self-reported Medication Adherence | 6 months | 6.24 days per week | Standard Deviation 1.51 |
Comparison: Any REACH vs. Helpline and A1c results. We used generalized estimating equations 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.p-value: <0.00195% CI: [0.196, 0.615]Wald statistic
Comparison: 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.p-value: 0.00395% CI: [-0.031, 0.45]GEE, Wald test
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
Time frame: Baseline, 3 months, 6 months, 12 months, 15 months
Population: We compared participants receiving the REACH intervention (combining REACH and REACH + FAMS) with participants not receiving REACH (in condition Helpline and A1c Results).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| REACH | Change in Self-reported Medication Adherence | 3 months | 40.4 score on a scale | Standard Deviation 3.62 |
| REACH | Change in Self-reported Medication Adherence | 6 months | 40.6 score on a scale | Standard Deviation 3.48 |
| REACH | Change in Self-reported Medication Adherence | 12 months | 40.3 score on a scale | Standard Deviation 3.48 |
| REACH | Change in Self-reported Medication Adherence | 15 months | 40.5 score on a scale | Standard Deviation 3.24 |
| Helpline and A1c Results | Change in Self-reported Medication Adherence | 15 months | 40.4 score on a scale | Standard Deviation 3.9 |
| Helpline and A1c Results | Change in Self-reported Medication Adherence | 3 months | 40.4 score on a scale | Standard Deviation 3.45 |
| Helpline and A1c Results | Change in Self-reported Medication Adherence | 12 months | 40.2 score on a scale | Standard Deviation 3.99 |
| Helpline and A1c Results | Change in Self-reported Medication Adherence | 6 months | 40.2 score on a scale | Standard Deviation 3.49 |
Comparison: 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.p-value: 0.37695% CI: [-0.012, 1.09]GEE, Wald test
Comparison: 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.p-value: 0.43495% CI: [-0.319, 0.875]GEE, Wald test
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)
Time frame: Baseline, 3 months, 6 months, 12 months, 15 months
Population: We compared participants receiving the REACH intervention (combining REACH and REACH + FAMS) with participants not receiving REACH (in condition Helpline and A1c Results).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| REACH | Change in Adherence to Dietary Behavior | 3 months | 3.17 score on a scale | Standard Deviation 1.59 |
| REACH | Change in Adherence to Dietary Behavior | 6 months | 3.34 score on a scale | Standard Deviation 1.56 |
| REACH | Change in Adherence to Dietary Behavior | 12 months | 3.22 score on a scale | Standard Deviation 1.58 |
| REACH | Change in Adherence to Dietary Behavior | 15 months | 3.17 score on a scale | Standard Deviation 1.65 |
| Helpline and A1c Results | Change in Adherence to Dietary Behavior | 15 months | 3.01 score on a scale | Standard Deviation 1.77 |
| Helpline and A1c Results | Change in Adherence to Dietary Behavior | 3 months | 2.84 score on a scale | Standard Deviation 1.58 |
| Helpline and A1c Results | Change in Adherence to Dietary Behavior | 12 months | 2.88 score on a scale | Standard Deviation 1.61 |
| Helpline and A1c Results | Change in Adherence to Dietary Behavior | 6 months | 2.93 score on a scale | Standard Deviation 1.62 |
Comparison: 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 equationsp-value: 0.001295% CI: [0.16, 0.637]GEE, Wald test
Comparison: 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.p-value: 0.00395% CI: [-0.121, 0.426]GEE, Wald test
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)
Time frame: Baseline, 3 months, 6 months, 12 months, 15 months
Population: We compared participants receiving the REACH intervention (combining REACH and REACH + FAMS) with participants not receiving REACH (in condition Helpline and A1c Results).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| REACH | Change in Adherence to Dietary Behavior | 3 months | 3.17 score on a scale | Standard Deviation 1.03 |
| REACH | Change in Adherence to Dietary Behavior | 6 months | 3.11 score on a scale | Standard Deviation 0.95 |
| REACH | Change in Adherence to Dietary Behavior | 12 months | 3.09 score on a scale | Standard Deviation 1.07 |
| REACH | Change in Adherence to Dietary Behavior | 15 months | 3.18 score on a scale | Standard Deviation 1.15 |
| Helpline and A1c Results | Change in Adherence to Dietary Behavior | 15 months | 3.18 score on a scale | Standard Deviation 1.11 |
| Helpline and A1c Results | Change in Adherence to Dietary Behavior | 3 months | 3.28 score on a scale | Standard Deviation 1.13 |
| Helpline and A1c Results | Change in Adherence to Dietary Behavior | 12 months | 3.13 score on a scale | Standard Deviation 1.09 |
| Helpline and A1c Results | Change in Adherence to Dietary Behavior | 6 months | 3.18 score on a scale | Standard Deviation 1.06 |
Comparison: 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.p-value: 0.63295% CI: [-0.218, 0.095]GEE, Wald test
Comparison: 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.p-value: 0.57295% CI: [-0.202, 1.1]GEE, Wald test
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.
Time frame: Baseline, 3 months, 6 months, 12 months, 15 months
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| REACH | Change in Glycemic Control - REACH Only vs. Control & REACH+FAMS vs. Control | 3 months | 9.12 percent | Standard Deviation 1.41 |
| REACH | Change in Glycemic Control - REACH Only vs. Control & REACH+FAMS vs. Control | 6 months | 8.88 percent | Standard Deviation 1.64 |
| REACH | Change in Glycemic Control - REACH Only vs. Control & REACH+FAMS vs. Control | 12 months | 9.45 percent | Standard Deviation 1.89 |
| REACH | Change in Glycemic Control - REACH Only vs. Control & REACH+FAMS vs. Control | 15 months | 9.28 percent | Standard Deviation 1.97 |
| Helpline and A1c Results | Change in Glycemic Control - REACH Only vs. Control & REACH+FAMS vs. Control | 15 months | 9.41 percent | Standard Deviation 1.74 |
| Helpline and A1c Results | Change in Glycemic Control - REACH Only vs. Control & REACH+FAMS vs. Control | 3 months | 8.98 percent | Standard Deviation 1.61 |
| Helpline and A1c Results | Change in Glycemic Control - REACH Only vs. Control & REACH+FAMS vs. Control | 12 months | 9.57 percent | Standard Deviation 2.19 |
| Helpline and A1c Results | Change in Glycemic Control - REACH Only vs. Control & REACH+FAMS vs. Control | 6 months | 9.14 percent | Standard Deviation 1.53 |
| Helpline and A1c Results | Change in Glycemic Control - REACH Only vs. Control & REACH+FAMS vs. Control | 15 months | 9.57 percent | Standard Deviation 2.25 |
| Helpline and A1c Results | Change in Glycemic Control - REACH Only vs. Control & REACH+FAMS vs. Control | 6 months | 9.74 percent | Standard Deviation 2.37 |
| Helpline and A1c Results | Change in Glycemic Control - REACH Only vs. Control & REACH+FAMS vs. Control | 12 months | 9.67 percent | Standard Deviation 2.21 |
| Helpline and A1c Results | Change in Glycemic Control - REACH Only vs. Control & REACH+FAMS vs. Control | 3 months | 9.47 percent | Standard Deviation 1.77 |
Comparison: 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.95% CI: [-1.38, -0.12]
Comparison: 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.95% CI: [-1, 0.39]
Comparison: 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.95% CI: [-1.26, -0.05]
Comparison: 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.95% CI: [-0.96, 0.51]
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
Time frame: Baseline, 3 months, 6 months, 12 months, 15 months
Population: We compared participants receiving the REACH intervention (combining REACH and REACH + FAMS) with participants not receiving REACH (in condition Helpline and A1c Results).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| REACH | Change in Physical Activity | 12 months | 2573 MET-minutes per week | Standard Deviation 3329 |
| REACH | Change in Physical Activity | 3 months | 2285 MET-minutes per week | Standard Deviation 2973 |
| REACH | Change in Physical Activity | 15 months | 2221 MET-minutes per week | Standard Deviation 2973 |
| REACH | Change in Physical Activity | 6 months | 2332 MET-minutes per week | Standard Deviation 3168 |
| Helpline and A1c Results | Change in Physical Activity | 15 months | 2239 MET-minutes per week | Standard Deviation 2774 |
| Helpline and A1c Results | Change in Physical Activity | 6 months | 1991 MET-minutes per week | Standard Deviation 2547 |
| Helpline and A1c Results | Change in Physical Activity | 3 months | 2139 MET-minutes per week | Standard Deviation 2501 |
| Helpline and A1c Results | Change in Physical Activity | 12 months | 2273 MET-minutes per week | Standard Deviation 2883 |
Comparison: 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.p-value: 0.70395% CI: [-142, 881]GEE, Wald test
Comparison: 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.p-value: 0.46595% CI: [-459, 511]GEE, Wald test