DiabetesCHAMPNCT02681718
Controlling Hyperglycemia Among Minority Population
A study testing Community health worker education and Cell phone text messaging in people with Diabetes, run by Sinai Health System at 1 site in United States.
Trial summary
The purpose of this study is to compare the efficacy of three approaches in diabetes management: (1) community health worker (CHW) education; (2) text messaging; and (3) usual hospital-based care. Read more about this study
- Who is it for?
- Ages 18 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes
- What is being tested?
- Community health worker education and Cell phone text messaging
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 272 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2016to Sep 2017
- 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 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Hyperglycemia with A1C ≥9%
Who cannot join
- Lives greater than 20 miles driving distance from Mount Sinai Hospital
- Pregnant women with gestational diabetes
- Advanced end-organ complications due to diabetes that include: end-stage renal disease, stroke with paresis, Congestive Heart Failure (NYHA class III or IV), or other major end-organ complication of diabetes
- Receiving treatment for a major psychiatric disorder (i.e. schizophrenia)
- Unable to understand and give informed consent in either English or Spanish
- Currently or previously participated in a diabetes research study
Show all 11Show fewer
- Family member currently enrolled in a diabetes research study
- Previously received diabetes care related cell phone text messages
- Unable to receive text messages 3-4 times per week
- Living in a homeless shelter or temporary housing
- Plans to travel outside of the United States for more than 3 months in next year
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Controlling Hyperglycemia Among Minority Population (CHAMP): A Randomized Controlled Trial of Two Diabetes Interventions for Underserved Communities
The purpose of this study is to compare the efficacy of three approaches in diabetes management: (1) community health worker (CHW) education; (2) text messaging; and (3) usual hospital-based care. The goal is to determine the most cost-effective method of diabetes management among an economically-disadvantaged, minority population.
Read the detailed description
The CHAMP study will test the efficacy of two interventions designed to decrease uncontrolled hyperglycemia (defined as Hemoglobin-A1C (A1C) at or above 9%) among adults with diabetes. Patients from a safety-net hospital will be randomized into three groups: 1) a control group, 2) an intervention providing diabetes self-care text messages, or 3) an intervention using community health workers to provide diabetes education and linkage to care. Secondary objectives include increasing diabetes knowledge, improving diabetes self-management, and increasing use of primary care (i.e., make one visit to the physician in 6 months) among the intervention participants. A cost-effectiveness analysis will determine the most appropriate way to reduce the burden of uncontrolled diabetes.
- Conditions
- Diabetes
- Being tested
- Community health worker education, Cell phone text messaging
- Keywords
- A1C≥9%, minorities, economically disadvantaged
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Community health worker educationBehavioural
Diabetes self-management education by community health workers
Cell phone text messagingBehavioural
Diabetes self-management education through cell phone text messaging
| Study group | Role | What they receive |
|---|---|---|
| Community Health Worker education | Experimental | During a six-month intervention period, the CHWs will conduct six home-based visitations and provide individualized diabetes education using an intensive diabetes lifestyle curriculum called Diabetes Learning Circle (DLC), developed and used by the Sinai Diabetes Education Program. At each visit, lasting for approximately one hour, the participants will be motivated to set SMART behavioral goals for diabetes self-management. At each visit after the initial visit, CHWs will follow-up with each participant to check their progress on their behavioral SMART goals. In addition, the CHWs will conduct intermittent phone calls (at least one monthly) and home visits as needed. Receives: Behavioral: Community health worker education |
| Cell phone text messaging | Experimental | The participants in the text messaging group will receive weekly text messages through CareMessage. Each participant will receive 3-4 text messages per week for 6 months. Receives: Behavioral: Cell phone text messaging |
| Control | No intervention | The participants in the control group will receive education as determined by the hospital's diabetes educator, dietitian, physician, or the participant's managed care provider. No additional education will be provided by the research team. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in Hemoglobin A1C (CHW vs. Control)
To assess whether there is a statistically significant difference in HbA1C level between CHW and control groups at 6 months follow-up.
Measured: 6 months
Difference in Hemoglobin A1C (Text Message vs. Control)
To assess whether there is a statistically significant difference in HbA1C level between text message and control groups at 6 months follow-up.
Measured: 6 months
Secondary outcomes (6)
Percentage change in diabetes knowledge test scores
Michigan Diabetes and Research Center Knowledge test
Measured: 6 months
Mean change in diabetes self-efficacy scores
Perceived competence in diabetes scale
Measured: 6 months
Mean change in diabetes distress scores
Problem areas in diabetes (PAID-5) scale
Measured: 6 months
Mean change in participants' beliefs about using insulin scores
Insulin treatment appraisal (ITAS) scale
Measured: 6 months
Mean changes in diabetes self-care activities
Diabetes self-care activities include: diet, physical activity, self-monitoring of blood glucose, foot-care, and smoking
Measured: 6 months
Percentage of participants who visited a physician due to a diabetes related follow-up
Self- reported
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2016 (estimated)
- Study startJan 2016
- Primary completionSep 2017
- Study completionSep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 272 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sinai Health System
- Sponsor type
- University, hospital or other
- Collaborators
- Blue Cross Blue Shield
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02681718
- Sponsor's protocol ID
- MSH15-46
- Acronym
- CHAMP
- Status last verified
- Jan 2018
- First submitted
- 3 Feb 2016
- Last updated
- 26 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Controlling Hyperglycemia Among Minority Population (CHAMP): A Randomized Controlled Trial of Two Diabetes Interventions for Underserved Communities
- ClinicalTrials.gov ID
- NCT02681718
- Acronym / sponsor ID
- CHAMP / MSH15-46
- Conditions
- Diabetes
- Keywords
- A1C≥9%, minorities, economically disadvantaged
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 272 participants (actual)
- Lead sponsor
- Sinai Health SystemUniversity, hospital or other
- Collaborators
- Blue Cross Blue Shield
- Study start
- Jan 2016
- Primary completion
- Sep 2017 (actual)
- Study completion
- Sep 2017 (actual)
- First posted
- 12 Feb 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.
The purpose of this study is to compare the efficacy of three approaches in diabetes management: (1) community health worker (CHW) education; (2) text messaging; and (3) usual hospital-based care. The goal is to determine the most cost-effective method of diabetes management among an economically-disadvantaged, minority population.
Detailed description
The CHAMP study will test the efficacy of two interventions designed to decrease uncontrolled hyperglycemia (defined as Hemoglobin-A1C (A1C) at or above 9%) among adults with diabetes. Patients from a safety-net hospital will be randomized into three groups: 1) a control group, 2) an intervention providing diabetes self-care text messages, or 3) an intervention using community health workers to provide diabetes education and linkage to care. Secondary objectives include increasing diabetes knowledge, improving diabetes self-management, and increasing use of primary care (i.e., make one visit to the physician in 6 months) among the intervention participants. A cost-effectiveness analysis will determine the most appropriate way to reduce the burden of uncontrolled diabetes.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Community Health Worker education | Experimental | Behavioral: Community health worker educationDuring a six-month intervention period, the CHWs will conduct six home-based visitations and provide individualized diabetes education using an intensive diabetes lifestyle curriculum called Diabetes Learning Circle (DLC), developed and used by the Sinai Diabetes Education Program. At each visit, lasting for approximately one hour, the participants will be motivated to set SMART behavioral goals for diabetes self-management. At each visit after the initial visit, CHWs will follow-up with each participant to check their progress on their behavioral SMART goals. In addition, the CHWs will conduct intermittent phone calls (at least one monthly) and home visits as needed. |
| Cell phone text messaging | Experimental | Behavioral: Cell phone text messagingThe participants in the text messaging group will receive weekly text messages through CareMessage. Each participant will receive 3-4 text messages per week for 6 months. |
| Control | No intervention | –The participants in the control group will receive education as determined by the hospital's diabetes educator, dietitian, physician, or the participant's managed care provider. No additional education will be provided by the research team. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Hyperglycemia with A1C ≥9%
Key exclusion criteria (11 listed)
- Lives greater than 20 miles driving distance from Mount Sinai Hospital
- Pregnant women with gestational diabetes
- Advanced end-organ complications due to diabetes that include: end-stage renal disease, stroke with paresis, Congestive Heart Failure (NYHA class III or IV), or other major end-organ complication of diabetes
- Receiving treatment for a major psychiatric disorder (i.e. schizophrenia)
- Unable to understand and give informed consent in either English or Spanish
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 |
|---|---|---|
| Community health worker educationDiabetes self-management education by community health workers | Behavioural | Community Health Worker education |
| Cell phone text messagingDiabetes self-management education through cell phone text messaging | Behavioural | Cell phone text messaging |
Primary outcome
Difference in Hemoglobin A1C (CHW vs. Control)
Time frame: 6 months
To assess whether there is a statistically significant difference in HbA1C level between CHW and control groups at 6 months follow-up.
Difference in Hemoglobin A1C (Text Message vs. Control)
Time frame: 6 months
To assess whether there is a statistically significant difference in HbA1C level between text message and control groups at 6 months follow-up.
6 secondary outcomes
Percentage change in diabetes knowledge test scores
Time frame: 6 months
Mean change in diabetes self-efficacy scores
Time frame: 6 months
Mean change in diabetes distress scores
Time frame: 6 months
Mean change in participants' beliefs about using insulin scores
Time frame: 6 months
Mean changes in diabetes self-care activities
Time frame: 6 months
Percentage of participants who visited a physician due to a diabetes related follow-up
Time frame: 6 months
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 26 Jan 2018.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Community health worker education and Cell phone text messaging in people with Diabetes, run by Sinai Health System 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 1 inclusion and 11 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 26 Jan 2018. 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?
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?
Difference in Hemoglobin A1C (CHW vs. Control) (time frame: 6 months). The study lists 2 primary outcomes in all. 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 26 Jan 2018.