Diabetes Type 2C4HNCT02093234
Changing the Healthcare Delivery Model
A study testing mobile health care application, CHWs and mobile health care application and Community Health Worker (CHW) in people with Diabetes Type 2, run by George Washington University at 1 site in United States.
Trial summary
This is a randomized controlled trial comparing 3 strategies to improve wellness behaviors and clinical goals for diabetes type 2(DM2) Medicaid patients. A patient interactive cell phone disease management system plus a community health worker (CHW) is superior to either a cell phone system or a CHW alone to activate… Read more about this study
- Who is it for?
- Ages 21 to 75 years
- Conditions the study is for
- Diabetes Type 2
- What is being tested?
- mobile health care application, CHWs and mobile health care application and Community Health Worker (CHW)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 166 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2014to Aug 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 21 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 21 to 75 years old
- Medicaid insurance coverage, Medicare insurance coverage or Affordable Health Care Act insurance coverage
- Fluent in English or Spanish and able to read a text message
- Diagnosed with diabetes mellitus type 2 and A1C is > 8%
- Acceptable values will be either :
- A1c obtained within one month prior to baseline (as long as there were no diabetes changes made during that month) or
- A new A1c measured at the baseline screening visit.
- Meets < 10 of the wellness behaviors and clinical goals if diagnosed with hypertension Meets < 9 of the wellness behaviors and clinical goals if not diagnosed with hypertension
Who cannot join
- Stage 5 chronic kidney disease or end stage renal disease on dialysis
- Terminal illness (expected survival of less than one year)
- Severe dementia or uncontrolled mental illness
- Gestational diabetes mellitus
- Use of an insulin pump
- Inability to use a cellular phone
- Unable to use software application on cellular phone
- Pregnant or planning to get pregnant
Trial locations and contacts
1 site in 1 country.
United States1 site
Medical Faculty Assoc Inc, GWUniv
Washington D.C., District of Columbia, 20037
About this study
Official title: Changing the Healthcare Delivery Model:A Community Health Worker/Mobile Chronic Care Team Strategy
This is a randomized controlled trial comparing 3 strategies to improve wellness behaviors and clinical goals for diabetes type 2(DM2) Medicaid patients. A patient interactive cell phone disease management system plus a community health worker (CHW) is superior to either a cell phone system or a CHW alone to activate DM2 Medicaid patients to improve a composite of 7 Wellness Behaviors and 6 Clinical Goals.
Read the detailed description
This is a randomized controlled trial comparing 3 strategies to improve wellness behaviors and clinical goals for DM2 Medicaid patients with uncontrolled DM.
- Group 1 will be assisted by the Voxiva Care4Life mobile health disease management program (C4L) provided on the patient's cell phone.
- Group 2 will be assisted by CHWs who are members of the outpatient medical home health team.
- Group 3 will be assisted by both the Voxiva Care4Life mHealth disease management system (C4L) and a CHW.
Hypotheses:
- A patient interactive cell phone disease management system plus a community health worker (CHW) is superior to either a cell phone system or a CHW alone to activate DM2 Medicaid patients to improve a composite of 7 Wellness Behaviors and 6 Clinical Goals.
- A patient interactive cell phone disease management system will activate Medicaid patients with type 2 diabetes (DM2) to improve the composite of 7 wellness behaviors and 6 clinical outcomes by 25% or greater compared to baseline
Expected Outcomes:
Primary outcomes:
- Superior improvement over baseline of the composite of Wellness Behaviors and Clinical Outcomes in the CHW plus C4L group compared to the CHW alone and cell phone alone groups.
- Improvement by 25% or greater over baseline of the composite of Wellness Behaviors and Clinical Outcomes for patients using C4L alone.
Secondary outcomes:
Improvement in both clinical and behavior endpoints. Endpoints to be compared across the three treatment arms include:
- mean HbA1c,
- mean LDLc Cholesterol
- average BP if hypertensive
- Patient distress measured with Fisher Brief Diabetes Distress Screening Instrument
- Medication adherence measured with Morisky Medication Adherence Survey 5) Healthcare utilization: ER, acute clinic visits, hospitalizations
Anticipated results and impact on healthcare:
Mobile health has great potential to enhance DM2 patient health behaviors and clinical outcomes both alone and, even better, with assistance of a CHW. mHealth systems can be provided to a wide range of urban and rural DM2 patients resulting in an affordable, a more efficient patient-driven/centered health delivery system.
- Conditions
- Diabetes Type 2
- Being tested
- mobile health care application, CHWs and mobile health care application, Community Health Worker (CHW)
- Keywords
- self care of diabetes type 2 patients, mobile health cell phone application impact on health, community health workers impact on health
- 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 applicationBehavioural
Also called Care 4 Life
mobile health application for cell phones to assist patients in managing their diabetes.
CHWs and mobile health care applicationBehavioural
Also called Care 4 Life and patient navigators
CHWs will assist diabetic patients in managing their health in conjunction with the mobile health care application.
Community Health Worker (CHW)Behavioural
Also called Patient navigators
CHWs assist patients in managing their diabetes in various ways.
| Study group | Role | What they receive |
|---|---|---|
| Mobile health care application | Active comparator | Patients will be assisted with managing their health by a cell phone application used to promote self care for patients with diabetes. Receives: Behavioral: mobile health care application |
| Community Health Worker (CHW) | Active comparator | CHWs assist study patients in managing there health care in various ways. Receives: Behavioral: Community Health Worker (CHW) |
| CHWs and mobile health care application | Experimental | Patients will receive assistance in managing their health from both CHWs and the mobile health cell phone application Receives: Behavioral: CHWs and mobile health care application |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in the Unmet Behaviors/Goals That Were Not Achieved at Year 1
The study staff will determine the status of the 13 behaviors/goals for the year prior to study enrollment. Our primary endpoint will be the mean change after 1 year in number of behaviors/goals met from baseline.
Measured: baseline and 1 year
Secondary outcomes (3)
Change in Distress From Baseline as Measured With Fisher Brief Diabetes Distress Screening Instrument
Participants completed the Fisher Brief Diabetes Screening Instrument at baseline and after 1 year of intervention. The instrument consists of 4 questions regarding how participants feel about dealing with diabetes. They are answered using a scale that goes from 1-6, 1= not a bother and 6=very bothersome. Range 4-24.
Low distress < 12 : moderate / high distress > or = 12.
Measured: Baseline and 1 year
Change in Hemoglobin A1C
Change in HbA1c after 1 year from baseline
Measured: Baseline and 1 year
Change in Medication Adherence
Medication adherence Improvement from baseline after 1 year as measured by the Morisky Medication Adherence Survey. Range 1-4 . 1= least adherent , 4= most adherent
Measured: baseline and 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2014 (estimated)
- Study startApr 2014
- Primary completionAug 2016
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Diabetes 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 166 participants (actual)
Sponsor and investigators
- Lead sponsor
- George Washington University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Richard Katz, MD, Principal investigator, Medical Faculty Assoc. Inc, GWUniv
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02093234
- Sponsor's protocol ID
- PCORI- IH-1304-6797
- Other IDs
- IH-1304-6797
- Acronym
- C4H
- Status last verified
- Sep 2016
- First submitted
- 17 Mar 2014
- Last updated
- 6 Apr 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Yes: De-identified participant data for all primary and secondary outcomes measures will be made available with 6 months of study completion
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changing the Healthcare Delivery Model:A Community Health Worker/Mobile Chronic Care Team Strategy
- ClinicalTrials.gov ID
- NCT02093234
- Acronym / sponsor ID
- C4H / PCORI- IH-1304-6797
- Conditions
- Diabetes Type 2
- Keywords
- self care of diabetes type 2 patients, mobile health cell phone application impact on health, community health workers impact on health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 166 participants (actual)
- Lead sponsor
- George Washington UniversityUniversity, hospital or other
- Study start
- Apr 2014
- Primary completion
- Aug 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 20 Mar 2014 (estimated)
- Results
- Posted 6 Apr 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a randomized controlled trial comparing 3 strategies to improve wellness behaviors and clinical goals for diabetes type 2(DM2) Medicaid patients. A patient interactive cell phone disease management system plus a community health worker (CHW) is superior to either a cell phone system or a CHW alone to activate DM2 Medicaid patients to improve a composite of 7 Wellness Behaviors and 6 Clinical Goals.
Detailed description
This is a randomized controlled trial comparing 3 strategies to improve wellness behaviors and clinical goals for DM2 Medicaid patients with uncontrolled DM.
- Group 1 will be assisted by the Voxiva Care4Life mobile health disease management program (C4L) provided on the patient's cell phone.
- Group 2 will be assisted by CHWs who are members of the outpatient medical home health team.
- Group 3 will be assisted by both the Voxiva Care4Life mHealth disease management system (C4L) and a CHW.
Hypotheses:
- A patient interactive cell phone disease management system plus a community health worker (CHW) is superior to either a cell phone system or a CHW alone to activate DM2 Medicaid patients to improve a composite of 7 Wellness Behaviors and 6 Clinical Goals.
- A patient interactive cell phone disease management system will activate Medicaid patients with type 2 diabetes (DM2) to improve the composite of 7 wellness behaviors and 6 clinical outcomes by 25% or greater compared to baseline
Expected Outcomes:
Primary outcomes:
- Superior improvement over baseline of the composite of Wellness Behaviors and Clinical Outcomes in the CHW plus C4L group compared to the CHW alone and cell phone alone groups.
- Improvement by 25% or greater over baseline of the composite of Wellness Behaviors and Clinical Outcomes for patients using C4L alone.
Secondary outcomes:
Improvement in both clinical and behavior endpoints. Endpoints to be compared across the three treatment arms include:
- mean HbA1c,
- mean LDLc Cholesterol
- average BP if hypertensive
- Patient distress measured with Fisher Brief Diabetes Distress Screening Instrument
- Medication adherence measured with Morisky Medication Adherence Survey 5) Healthcare utilization: ER, acute clinic visits, hospitalizations
Anticipated results and impact on healthcare:
Mobile health has great potential to enhance DM2 patient health behaviors and clinical outcomes both alone and, even better, with assistance of a CHW. mHealth systems can be provided to a wide range of urban and rural DM2 patients resulting in an affordable, a more efficient patient-driven/centered health delivery system.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Mobile health care application | Active comparator | Behavioral: mobile health care applicationPatients will be assisted with managing their health by a cell phone application used to promote self care for patients with diabetes. |
| Community Health Worker (CHW) | Active comparator | Behavioral: Community Health Worker (CHW)CHWs assist study patients in managing there health care in various ways. |
| CHWs and mobile health care application | Experimental | Behavioral: CHWs and mobile health care applicationPatients will receive assistance in managing their health from both CHWs and the mobile health cell phone application |
Who may qualify
- Ages
- 21 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age 21 to 75 years old
- Medicaid insurance coverage, Medicare insurance coverage or Affordable Health Care Act insurance coverage
- Fluent in English or Spanish and able to read a text message
- Diagnosed with diabetes mellitus type 2 and A1C is > 8%
- A1c obtained within one month prior to baseline (as long as there were no diabetes changes made during that month) or
Key exclusion criteria (8 listed)
- Stage 5 chronic kidney disease or end stage renal disease on dialysis
- Terminal illness (expected survival of less than one year)
- Severe dementia or uncontrolled mental illness
- Gestational diabetes mellitus
- Use of an insulin pump
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 applicationAlso: Care 4 Lifemobile health application for cell phones to assist patients in managing their diabetes. | Behavioural | Mobile health care application |
| CHWs and mobile health care applicationAlso: Care 4 Life and patient navigatorsCHWs will assist diabetic patients in managing their health in conjunction with the mobile health care application. | Behavioural | CHWs and mobile health care application |
| Community Health Worker (CHW)Also: Patient navigatorsCHWs assist patients in managing their diabetes in various ways. | Behavioural | Community Health Worker (CHW) |
Primary outcome
Change From Baseline in the Unmet Behaviors/Goals That Were Not Achieved at Year 1
Time frame: baseline and 1 year
The study staff will determine the status of the 13 behaviors/goals for the year prior to study enrollment. Our primary endpoint will be the mean change after 1 year in number of behaviors/goals met from baseline.
3 secondary outcomes
Change in Distress From Baseline as Measured With Fisher Brief Diabetes Distress Screening Instrument
Time frame: Baseline and 1 year
Change in Hemoglobin A1C
Time frame: Baseline and 1 year
Change in Medication Adherence
Time frame: baseline and 1 year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. De-identified participant data for all primary and secondary outcomes measures will be made available with 6 months of study completion
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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.
Richard Katz, MD principal investigator
Medical Faculty Assoc. Inc, GWUniv
1 site 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 application, CHWs and mobile health care application and Community Health Worker (CHW) in people with Diabetes Type 2, run by George Washington University at 1 site 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 8 inclusion and 8 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 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Yes. Results are posted in the registry (first posted 6 Apr 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change From Baseline in the Unmet Behaviors/Goals That Were Not Achieved at Year 1 (time frame: baseline and 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Apr 2017.