Diabetes Mellitus, Type 2NCT02949037
Enhancing mHealth Technology to Activate Chronic Care Patients
A study testing Mobile Health Care Environment (MHCE) in people with Diabetes Mellitus, Type 2, run by Clemson University at 2 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Mobile Health Care Environment (MHCE)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 229 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Jul 2017to 4 Oct 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women age 18 years or older,
- Ability to understand and read English,
- Be empanelled to one of the target PCMH sites, and
- Diagnosed with type 2 diabetes.
Who cannot join
- pregnant women,
- non-English speaking patients,
- receiving hospice care,
- active cancer and treatment with chemotherapy or radiation therapy,
- taking Coumadin,
- recipient of gastric bypass or similar procedure,
Show all 14Show fewer
- diagnosis of uncontrolled hypothyroidism,
- known Cushing's syndrome,
- being treated with oral steroids,
- known liver disease,
- current diagnosis of cognitive impairments which would interfere with use of technology,
- congestive heart failure New York Heart Association class 3 or 4,
- inability to use a mobile device due to cognitive or physical impairments, and
- PAM® score = 4 during initial screening.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Mike O'Callaghan Federal Medical Center
Nellis Air Force Base, Nevada, 89191
Madigan Army Medicall Center
Tacoma, Washington, 98431
About this study
Official title: Enhancing mHealth Technology in the PCMH Environment to Activate Chronic Care Patients
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.
Read the detailed description
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.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Mobile Health Care Environment (MHCE)
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mobile Health Care Environment (MHCE)Other
Also called mCare
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Mobile Health Care Environment (MHCE) |
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Activation Measure (PAM)
PAM is a validated survey measure of patient activation
Measured: Every 3 months during the 12-month trial
Secondary outcomes (6)
Glycosylated hemoglobin (HbA1C)
HbA1c results documented on three occasions
Measured: Every 4 months during 12-month trial
Low-density Lipoprotein (LDL)
LDL results documented on three occasions
Measured: Every 4 months during 12-month trial
High-density Lipoprotein (HDL)
HDL results documented on three occasions
Measured: Every 4 months during 12-month trial
Abdominal circumference
Abdominal measures taken on three occasions
Measured: Every 4 months during 12-month trial
Blood pressure
Collected in clinic and daily by the patient
Measured: 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
Measured: Every 2 weeks during 12-month trial
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2016 (estimated)
- Study start1 Jul 2017
- Primary completion30 Apr 2019
- Study completion4 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 229 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clemson University
- Sponsor type
- University, hospital or other
- Collaborators
- Madigan Army Medical Center, U.S. Army Medical Research and Development Command
- Responsible party
- Sponsor
- Investigators
- Ronald W. Gimbel, Principal investigator, Clemson University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02949037
- Sponsor's protocol ID
- IRB2015-234 (PPN 2015000085)
- Status last verified
- Aug 2020
- First submitted
- 30 Sep 2016
- Last updated
- 6 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 32329438Gimbel 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.
PubMed 28264792
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing mHealth Technology in the PCMH Environment to Activate Chronic Care Patients
- ClinicalTrials.gov ID
- NCT02949037
- Acronym / sponsor ID
- IRB2015-234 (PPN 2015000085)
- Conditions
- Diabetes Mellitus, Type 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 229 participants (actual)
- Lead sponsor
- Clemson UniversityUniversity, hospital or other
- Collaborators
- Madigan Army Medical Center, U.S. Army Medical Research and Development Command
- Study start
- 1 Jul 2017 (actual)
- Primary completion
- 30 Apr 2019 (actual)
- Study completion
- 4 Oct 2019 (actual)
- First posted
- 31 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Mobile Health Care Environment (MHCE)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Men and women age 18 years or older,
- Ability to understand and read English,
- Be empanelled to one of the target PCMH sites, and
- Diagnosed with type 2 diabetes.
Key exclusion criteria (14 listed)
- pregnant women,
- non-English speaking patients,
- receiving hospice care,
- active cancer and treatment with chemotherapy or radiation therapy,
- taking Coumadin,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mobile Health Care Environment (MHCE)Also: mCareAn 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. | Other | Intervention |
Primary outcome
Patient Activation Measure (PAM)
Time frame: Every 3 months during the 12-month trial
PAM is a validated survey measure of patient activation
6 secondary outcomes
Glycosylated hemoglobin (HbA1C)
Time frame: Every 4 months during 12-month trial
Low-density Lipoprotein (LDL)
Time frame: Every 4 months during 12-month trial
High-density Lipoprotein (HDL)
Time frame: Every 4 months during 12-month trial
Abdominal circumference
Time frame: Every 4 months during 12-month trial
Blood pressure
Time frame: Every 4 months plus patient self-measurement during 12 -month trial
Summary of Diabetes Self-Care Activities (SDSCA)
Time frame: Every 2 weeks during 12-month trial
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2020.
- Derived from this study: PubMed 32329438Gimbel 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.
- Derived from this study: PubMed 28264792Gimbel 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ronald W. Gimbel principal investigator
Clemson University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mobile Health Care Environment (MHCE) in people with Diabetes Mellitus, Type 2, run by Clemson University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Activation Measure (PAM) (time frame: Every 3 months during the 12-month trial). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02949037, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2020.