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| Name | Class |
|---|---|
| American Academy of Family Physicians | OTHER |
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The goal of this observational study is to evaluate the feasibility and acceptability of a 12-week intervention utilizing a Fitbit and artificial intelligence (AI)-delivered diabetes self-management education and support (DSMES) with tailored text messages.
The main question it aims to answer is:
Does providing a wearable fitness and activity tracker plus AI-tailored and DSMES improve clinical outcomes for patients with type 2 diabetes?
Participants will complete a baseline visit, wear a Fitbit and answer text messages for 12-weeks, and complete by a final visit.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental: Fitbit and AI Chatbot | Participants will wear their Fitbit devices daily and receive personalized messages from the AI Chatbot weekly with setting a new exercise goal based on their previous week's activity level. Additionally, they can engage with the AI Chatbot through text message for further support, education, and goal setting. Participants will interact throughout the week on completing their goal or where they might improve. |
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| Active Comparator: Controls | The control group will be established through a rigorous retrospective chart review of patients with type 2 diabetes who meet the study's inclusion criteria but have not participated in the intervention. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fitbit and AI Chatbot | Behavioral | Participants will wear their Fitbit devices daily for 12-weeks and will receive personalized messages from the AI Chatbot every week with a new exercise recommendation based on their previous week's activity level. Additionally, they can engage with the AI Chatbot through text message for further support and education. |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility - Recruitment | Recruitment of 36 adults within 6 months. | 6 months |
| Feasibility - Retainment | Retainment of 85% of participants for post-assessments. | 6 months |
| Feasibility - Fitbit wear | Fitbit wear ≥ 5 days/week > 12 hours per day, wear at night > 3 nights/week. | 12 Weeks |
| Feasibility - Text message responses | Responding to 80% of text messages when prompted. | 12 Weeks |
| Feasibility - Technical issues | Participation with ≤10% technical issues (battery life, data sync between device and app/dashboard, device failure). | 12 Weeks |
| Acceptability - Participant Experience and Satisfaction | Obtaining > 60% satisfaction from participants via a satisfaction survey. | 12 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in HbA1c | Change in HbA1c from baseline to post-intervention. | 12 Weeks |
| Change in Body Mass Index | Change in Body Mass Index (BMI) from baseline to post-intervention. |
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Inclusion Criteria:
Exclusion Criteria:
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Primary care adult patients diagnosed with type 2 diabetes who do not meet ADA guidelines for physical activity (< 150 minutes of aerobic exercise per week defined as any activity where the participant can talk but not sing).
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jessica Parascando, MPH | Contact | 303-724-9525 | jessica.parascando@cuanschutz.edu | |
| Elizabeth Westfeldt, BSN, RN | Contact | elizabeth.westfeldt@cuanschutz.edu |
| Name | Affiliation | Role |
|---|---|---|
| Seth Kramer, DO, MPH | University of Colorado Anschutz Medical School | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Colorado, Anschutz | Recruiting | Aurora | Colorado | 80045 | United States |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| Routine Care | Other | The control group will consist of patients with type 2 diabetes who meet the study's inclusion criteria but have not participated in the intervention. |
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| 12 Weeks |
| Change in lipid panel | Change in lipid panel from baseline to post-intervention. | 12 Weeks |
| Change in weight | Change in weight from baseline to post-intervention. | 12 Weeks |
| Change in blood pressure | Change in blood pressure from baseline to post-intervention. | 12 Weeks |
| Change in diabetes distress | Change in diabetes distress as measured by the T2-DDAS: The Type 2 Diabetes Distress Assessment System from baseline to post-intervention. | 12 Weeks |
| Experience with technology | Patient experience with technology as measured via the System Usability Scale (SUS). | 12 Weeks |
| Experience with technology | Patient experience with technology as measured via the FACETS Comfort with Technology assessment. | 12 Weeks |
| Cost | Cost of delivering remote patient monitoring intervention as measured via time-diaries and patient logs. | Weekly, 12 weeks |
| Revenue | Revenue modeling from practice perspective of remote patient monitoring intervention as measured via staff and patient time logs. | Weekly, 12 weeks |
| D004700 | Endocrine System Diseases |
| D001519 | Behavior |