Phase 2
Completed N=166
TExT-MED + FANS Full Trial
Source: ClinicalTrials.gov NCT03178773 ↗Enrolled (actual)
166
Serious AEs
24.1%
Results posted
Aug 2021
Primary outcomePrimary: Change in HBA1c From Baseline — 1.42; 1.34 %mmHg/dL
Summary
This is an intervention to study incorporating social support into mHealth interventions for low-income, ED patients with diabetes
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in HBA1c From Baseline |
1.42; 1.34 | — |
| SECONDARY Change in HBA1c From 6 Months to 12 Months |
-.36; .28 | — |
| SECONDARY Change in BMI From Baseline |
-7.91; -3.84; -5.96 | — |
| SECONDARY Change in BMI From 6 Months to 12 Months |
-3.38; 4.02; -0.04 | — |
| SECONDARY Change in Abdominal Circumference From Baseline |
1.58; 2.73; 2.11 | — |
| SECONDARY Change From Abdominal Circumference From 6 Months to 12 Months |
0.99; 0.85; 0.93 | — |
| SECONDARY Change in Systolic Blood Pressure From Baseline |
-9.11; -13.07; -11.00 | — |
| SECONDARY Change in Systolic Blood Pressure From 6 Months to 12 Months |
-4.95; 2.09; -1.71 | — |
| SECONDARY Change in Diastolic Blood Pressure From Baseline |
-0.27; -2.56; -1.36 | — |
| SECONDARY Change in Diastolic Blood Pressure From 6 Months to 12 Months |
-0.82; 5.20; 1.95 | — |
| SECONDARY Change in Summary of Diabetes Self-care Activities From Baseline |
-1.55; -1.17; -1.37; -0.42; -0.78; -0.59 | — |
| SECONDARY Change in Summary of Diabetes Self-care Activities From 6 Months to 12 Months |
0.23; 0.96; 0.57; 0.29; 0.45; 0.36 | — |
| SECONDARY Change in Wilson 3 Item Scale From Baseline |
-15.73; -12.39; -14.16 | — |
| SECONDARY Change in Wilson 3 Item Scale From 6 Months to 12 Months |
1.74; 3.22; 2.43 | — |
| SECONDARY Change in Healthcare Utilization From Baseline |
1.47; .88; 1.18; 0.24; .13; .19 | — |
| SECONDARY Change in Healthcare Utilization From 6 Months to 12 Months |
0.07; .05; .06; -.02; 0; -.01 | — |
| SECONDARY Change in Diabetes Empowerment Scale Short Form From Baseline |
-0.17; -0.05; -0.11 | — |
| SECONDARY Change in Diabetes Empowerment Scale Short Form From 6 Months to 12 Months |
0.13; -0.03; 0.05 | — |
| SECONDARY Change in Diabetes Distress Scale From Baseline |
0.65; 0.60; 0.63 | — |
| SECONDARY Change in Diabetes Distress Scale From 6 Months to 12 Months |
0.06; -0.01; 0.03 | — |
| SECONDARY Change in Patient Health Questionnaire 9 From Baseline |
3.86; 2.33; 3.13 | — |
| SECONDARY Change in Patient Health Questionnaire 9 From 6 Months to 12 Months |
-0.18; -0.13; -0.15 | — |
| SECONDARY Change in Fatalism From Baseline |
-1.44; 0.58; -0.47 | — |
| SECONDARY Change in Fatalism From 6 Months to 12 Months |
-1.30; -1.20; -1.26 | — |
| SECONDARY Change in WHO Quality of Life From Baseline |
-9.69; -4.96; -7.47 | — |
| SECONDARY Change in WHO Quality of Life From 6 Months to 12 Months |
0.09; 6.30; 2.94 | — |
| SECONDARY Change in Diabetes Family Behavior Checklist - Supportive From Baseline |
.58; .12; .36 | — |
| SECONDARY Change in Diabetes Family Behavior Checklist Supportive From 6 Months to 12 Months |
-.70; -.98; -.83 | — |
| SECONDARY Change in Diabetes Family Behavior Checklist - Nonsupportive From Baseline |
.58; .56; .57 | — |
| SECONDARY Change in Diabetes Family Behavior Checklist Nonsupportive From 6 Months to 12 Months |
-.85; -1.13; -.98 | — |
| SECONDARY Change in Diabetes Care Profile Support From Baseline |
4.44; 5.80; 5.08; -0.08; -3.65; -1.76 | — |
| SECONDARY Change in Diabetes Care Profile Support From 6 Months to 12 Months |
-0.38; 0.40; -0.02; -1.38; 2.70; 0.49 | — |
| SECONDARY Change in Norbeck Social Support Questionnaire From Baseline |
0.64; -0.22; 0.24; 0.06; -0.29; -0.10 | — |
| SECONDARY Change in Norbeck Social Support Questionnaire From 6 Months to 12 Months |
-0.48; 0.69; 0.06; -0.36; 0.48; 0.02 | — |
| SECONDARY Change in Partner Distress Scale From Baseline |
.45; .13; .37 | — |
Eligibility Criteria
Inclusion Criteria
- Age >18
- HbA1c>8.5
- Social support person identified and contacted
Exclusion Criteria
- unable to consent
- does not speak/read English or Spanish
Data sourced from ClinicalTrials.gov (NCT03178773). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.