N/A
Completed N=270
Evaluation of a Patient Portal Intervention for Diabetes: A Pilot Randomized Controlled Trial
Source: ClinicalTrials.gov NCT03947333 ↗Enrolled (actual)
270
Serious AEs
0.0%
Results posted
Mar 2022
Primary outcomePrimary: Change in Patient Activation at 6 Months — 4.3; 2.7 units on a scale — p=0.221
Summary
The purpose of this study is to conduct a two-arm, parallel-design, pragmatic randomized controlled trial of a patient portal intervention for diabetes, My Diabetes Care, to evaluate its effect on patient activation and secondary cognitive, behavioral, and clinical outcomes.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Patient Activation at 6 Months |
4.3; 2.7 | 0.221 |
| PRIMARY Change in Patient Activation at 3 Months |
3.1; 3.3 | 0.532 |
| SECONDARY Change in Diabetes Self-Efficacy |
1.0; 0.3; 0.7; 0.8 | 0.086 |
| SECONDARY Change in Diabetes Knowledge |
0.7; -0.1; 2.0; 1.3 | 0.270 |
| SECONDARY Change in Diabetes Self-Care (General Diet Adherence) |
0.3; 0.1; 0.5; 0.1 | 0.093 |
| SECONDARY Change in Diabetes Self-Care (Specific Diet) |
0.2; 0; 0.3; -0.1 | 0.116 |
| SECONDARY Change in Diabetes Self-Care (Exercise Adherence) |
0.2; -0.1; 0; 0.1 | 0.188 |
| SECONDARY Change in Diabetes Self-Care (Self-Monitoring of Blood Glucose Adherence) |
0.3; 0.1; 0.3; 0.1 | 0.182 |
| SECONDARY Change in Diabetes Self-Care (Diabetes Medication Adherence) |
-0.3; 0.2; -0.3; -0.1 | 0.970 |
| SECONDARY Change in Diabetes Distress |
-0.2; -0.2; -0.4; -0.2 | 0.478 |
| SECONDARY Change in Blood Glucose Control |
0.1; 0.1 | 0.654 |
| SECONDARY Change in Blood Pressure Control |
-0.2; -0.2 | 0.485 |
| SECONDARY Change in Flu Vaccination Status for 2019-20 Flu Season |
42; 38; 93; 97; 40; 33 | 0.480 |
| SECONDARY Change in Low Density Lipoprotein |
-3.0; -3.8 | 0.542 |
| SECONDARY Satisfaction/Usability of My Health at Vanderbilt (for Control Group) |
79.0; 82.4; 83.2 | — |
| SECONDARY Satisfaction/Usability of My Diabetes Care (for Intervention Group) |
73.7; 71.7 | — |
| SECONDARY System Usage Data for My Diabetes Care - Total Sessions (Intervention Group Only) |
12; 60; 39; 9; 9; 6 | — |
| SECONDARY System Usage Data for My Diabetes Care - Total Duration of Visits (Intervention Group Only) |
22; 37; 21; 22; 15; 18 | — |
| SECONDARY System Usage Data for My Diabetes Care - Utilization of Embedded Features and Functionality (Intervention Group Only) |
67; 62; 98; 31; 119; 10 | — |
Eligibility Criteria
Inclusion Criteria
- Type 2 Diabetes Mellitus
- Currently being treated with at least one antihyperglycemic medication
- Able to speak and read in English
- Reliable access to a computer (desktop or laptop) with internet capabilities
- Active VUMC patient web portal (known as My Health At Vanderbilt) account
Exclusion Criteria
- Residing in a long term care facility
- Medical condition that affects my memory or ability to think.
- Severe visual impairment
- Currently participating in another diabetes-related research study
Data sourced from ClinicalTrials.gov (NCT03947333). 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.