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| Name | Class |
|---|---|
| Madigan Army Medical Center | FED |
| U.S. Army Medical Research and Development Command | FED |
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Multi-site feasibility study designed to assist type-2 diabetes patients in self-care activities. The study includes Bluetooth-enabled medical devices (i.e. scales, blood pressure cuffs, glucometers, and activity monitors) for both intervention and control groups. Those in the intervention group will have the devices linked too a mobile health care environment that provides key benefits that include: device data trending, reinforcing tailored behavioral messages, and enhanced communication with the clinic.
Multi-site phased study, conducted within the Military Health System that includes a user-centered design phase and a patient centered medical home (PCMH)-based feasibility trial.
In Phase I the investigators will assess both patient and clinician preferences and usability regarding the enhancement of the enabling technology capabilities for Type 2 diabetes chronic self-care management. The data from the experience will be coded and analyzed by the research team and the technology will be adapted accordingly before Phase II.
Phase II research is a single-blinded 12-month feasibility study that seeks to include the enabling technology to support diabetes self-care management with tailored behavioral messaging aimed at reinforcing and encouraging self-care behavior based on patients' readiness. We have included safety thresholds that alert patients and clinical team under certain conditions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | Use of (4) bluetooth-enabled biomedical devices (i.e. scale, blood pressure cuff, activity monitor, glucose monitor), for use in self care activities, integrated with the mobile health care environment (MHCE) system. The MHCE system will provide tailored behavioral messages triggered by clinical values and survey responses. |
|
| Control | No Intervention | Use of (4) bluetooth-enabled biomedical devices (i.e. scale, blood pressure cuff, activity monitor, glucose monitor), for use in self care activities, NOT integrated with the mobile health care environment (MHCE) system. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mobile Health Care Environment (MHCE) | Other | An integrated mobile health system modified to support type 2 diabetes self-care activities. Primary intervention includes visualization and trending of device outcomes AND tailored behavioral messages based on Patient Activation Measure scores. |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Activation Measure (PAM) | PAM is a validated survey measure of patient activation | Every 3 months during the 12-month trial |
| Measure | Description | Time Frame |
|---|---|---|
| Glycosylated hemoglobin (HbA1C) | HbA1c results documented on three occasions | Every 4 months during 12-month trial |
| Low-density Lipoprotein (LDL) | LDL results documented on three occasions |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ronald W. Gimbel | Clemson University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mike O'Callaghan Federal Medical Center | Nellis Air Force Base | Nevada | 89191 | United States | ||
| Madigan Army Medicall Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32329438 | Derived | Gimbel RW, Rennert LM, Crawford P, Little JR, Truong K, Williams JE, Griffin SF, Shi L, Chen L, Zhang L, Moss JB, Marshall RC, Edwards KW, Crawford KJ, Hing M, Schmeltz A, Lumsden B, Ashby M, Haas E, Palazzo K. Enhancing Patient Activation and Self-Management Activities in Patients With Type 2 Diabetes Using the US Department of Defense Mobile Health Care Environment: Feasibility Study. J Med Internet Res. 2020 May 26;22(5):e17968. doi: 10.2196/17968. | |
| 28264792 |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 1, 2017 | Jul 31, 2020 | Prot_SAP_000.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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| Every 4 months during 12-month trial |
| High-density Lipoprotein (HDL) | HDL results documented on three occasions | Every 4 months during 12-month trial |
| Abdominal circumference | Abdominal measures taken on three occasions | Every 4 months during 12-month trial |
| Blood pressure | Collected in clinic and daily by the patient | Every 4 months plus patient self-measurement during 12 -month trial |
| Summary of Diabetes Self-Care Activities (SDSCA) | Validated survey measure of diabetes self-care activities | Every 2 weeks during 12-month trial |
| Tacoma |
| Washington |
| 98431 |
| United States |
| Derived |
| Gimbel R, Shi L, Williams JE, Dye CJ, Chen L, Crawford P, Shry EA, Griffin SF, Jones KO, Sherrill WW, Truong K, Little JR, Edwards KW, Hing M, Moss JB. Enhancing mHealth Technology in the Patient-Centered Medical Home Environment to Activate Patients With Type 2 Diabetes: A Multisite Feasibility Study Protocol. JMIR Res Protoc. 2017 Mar 6;6(3):e38. doi: 10.2196/resprot.6993. |
| D004700 | Endocrine System Diseases |