Diabetes Mellitus, Type 2MATCHNCT01067092
MATCH: The Mexican-American Trial of Community Health Workers
A study testing Community Health Worker Intervention and Educational Newsletter in people with Diabetes Mellitus, Type 2, run by Rush University Medical Center at 1 site in United States.
Trial summary
The MATCH study (Mexican-American Trial of Community Health Workers) tests the hypothesis that the use of indigenous Community Health Workers (CHWs), recruited from the target community and trained to provide culturally appropriate diabetes education, can promote pro-active self-management among inner-city dwelling… Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Community Health Worker Intervention and Educational Newsletter
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 144 participants
- Where
- 1 siteUnited States
- Study dates
- May 2005to Dec 2010
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of type 2 diabetes mellitus
- Taking at one oral medication daily to control diabetes
- Self-identified as Mexican or Mexican-American
- Resident in target community within Chicago, Berwyn, or Cicero, Illinois.
Who cannot join
- Diabetes controlled with diet or insulin only
- Advanced end-organ complications, including: end-stage renal disease, stroke with paresis, Congestive Heart Failure (NYHA class 3 or 4), or other major end-organ complication of diabetes
- Receiving treatment for a major psychiatric disorder (i.e. schizophrenia)
- Are unable to understand and give informed consent in either English or Spanish
- Live in a household with someone who is already a randomized study participant or know of family members who are already study participants.
- Have lived in Mexico for more than four months in the past two years, or are anticipating extended travel to Mexico in the next year.
- Are under the age of 18
Trial locations and contacts
1 site in 1 country.
United States1 site
Rush University Medical Center
Chicago, Illinois, 60612
About this study
The MATCH study (Mexican-American Trial of Community Health Workers) tests the hypothesis that the use of indigenous Community Health Workers (CHWs), recruited from the target community and trained to provide culturally appropriate diabetes education, can promote pro-active self-management among inner-city dwelling Mexican-Americans with Type 2 diabetes mellitus. The study aims are to demonstrate that a CHW, compared to an attention control, will: 1) result in improvement in short term physiologic outcomes (Hemoglobin A1c levels and blood pressure), and 2) result in increased frequency of self-management behaviors (daily self blood-glucose monitoring, medication adherence, adherence to diet and physical activity recommendations). The study design is a single site, partially blinded, randomized controlled trial of 144 patients with Type 2 diabetes mellitus.
Eligibility criteria include a diagnosis of Type 2 diabetes, residence in target community areas in the Chicago area, and Mexican or Mexican-American ethnic heritage. Participants are randomized to either an experimental group receiving 36 home visits over a two year period in which a CHW delivered diabetes education and self-management skills training, or to an attention control consisting of 36 bilingual diabetes education newsletters covering the same curriculum as the CHWs. The curriculum covers recommended diabetes self-management behaviors including glucose self-monitoring, responding to abnormal blood glucose levels, working effectively with health care providers, medication adherence, foot care, daily physical activity, and reducing fat content of diet. CHWs also deliver training in behavioral skills of self-monitoring, environmental restructuring, engagement of social support, stress management, and problem-solving skills to facilitate the self-management activities. Consistent delivery of the CHW intervention is documented by audiotapes and Documentation of Intervention worksheets.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Community Health Worker Intervention, Educational Newsletter
- 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.
Community Health Worker InterventionBehavioural
Also called Promotora, Promotora de Salud
A Community Health Worker makes 36 home visits to the person with diabetes over a two year period, providing diabetes education and self-management skills training. The curriculum covers recommended diabetes self-management behaviors including glucose self-monitoring, responding to abnormal blood glucose levels, working effectively with health care providers, medication adherence, foot care, daily physical activity, and reducing fat content of diet. CHWs also deliver training in behavioral skills of self-monitoring, environmental restructuring, engagement of social support, stress management, and problem-solving skills to facilitate the self-management activities.
Educational NewsletterBehavioural
Diabetes education and self-management skills training delivered via 36 bilingual diabetes education newsletters over a 2 year period. The newsletters cover recommended diabetes self-management behaviors including glucose self-monitoring, responding to abnormal blood glucose levels, working effectively with health care providers, medication adherence, foot care, daily physical activity, and reducing fat content of diet. The newsletters also describe behavioral skills of self-monitoring, environmental restructuring, engagement of social support, stress management, and problem-solving skills to facilitate the self-management activities.
| Study group | Role | What they receive |
|---|---|---|
| Community Health Worker Intervention | Experimental | A Community Health Worker makes 36 home visits to the person with diabetes over a two year period, providing diabetes education and self-management skills training. The curriculum covers recommended diabetes self-management behaviors including glucose self-monitoring, responding to abnormal blood glucose levels, working effectively with health care providers, medication adherence, foot care, daily physical activity, and reducing fat content of diet. CHWs also deliver training in behavioral skills of self-monitoring, environmental restructuring, engagement of social support, stress management, and problem-solving skills to facilitate the self-management activities. Receives: Behavioral: Community Health Worker Intervention |
| Educational Newsletter | Active comparator | Diabetes education and self-management skills training delivered via 36 bilingual diabetes education newsletters over a 2 year period. The newsletters cover recommended diabetes self-management behaviors including glucose self-monitoring, responding to abnormal blood glucose levels, working effectively with health care providers, medication adherence, foot care, daily physical activity, and reducing fat content of diet. The newsletters also describe behavioral skills of self-monitoring, environmental restructuring, engagement of social support, stress management, and problem-solving skills to facilitate the self-management activities. Receives: Behavioral: Educational Newsletter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemoglobin A1c
Measured: 2 years
% of persons with blood pressure less than 130/80
Measured: 2 years
Secondary outcomes (3)
Medication adherence
Measured: 2 years
Daily self-blood glucose monitoring
Measured: 2 years
Summary of Diabetes Self-Care Activities
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2010 (estimated)
- Study startMay 2005
- Primary completionDec 2010
- Study completionDec 2010
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.
- More trials run by Rush University Medical CenterThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 144 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rush University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Steven K. Rothschild, MD, Rush University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01067092
- Sponsor's protocol ID
- R01DK061289
- Other IDs
- R01DK061289
- Acronym
- MATCH
- Status last verified
- Nov 2011
- First submitted
- 9 Feb 2010
- Last updated
- 2 Dec 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Swider SM, Martin M, Lynas C, Rothschild S. Project MATCH: training for a promotora intervention. Diabetes Educ. 2010 Jan-Feb;36(1):98-108. doi: 10.1177/0145721709352381. Epub 2009 Dec 11.
PubMed 20008279Martin MA, Swider SM, Olinger T, Avery E, Lynas CM, Carlson K, Rothschild SK. Recruitment of Mexican American adults for an intensive diabetes intervention trial. Ethn Dis. 2011 Winter;21(1):7-12.
PubMed 21462723
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MATCH: The Mexican-American Trial of Community Health Workers
- ClinicalTrials.gov ID
- NCT01067092
- Acronym / sponsor ID
- MATCH / R01DK061289
- Conditions
- Diabetes Mellitus, Type 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 144 participants (actual)
- Lead sponsor
- Rush University Medical CenterUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- May 2005
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 11 Feb 2010 (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 MATCH study (Mexican-American Trial of Community Health Workers) tests the hypothesis that the use of indigenous Community Health Workers (CHWs), recruited from the target community and trained to provide culturally appropriate diabetes education, can promote pro-active self-management among inner-city dwelling Mexican-Americans with Type 2 diabetes mellitus. The study aims are to demonstrate that a CHW, compared to an attention control, will: 1) result in improvement in short term physiologic outcomes (Hemoglobin A1c levels and blood pressure), and 2) result in increased frequency of self-management behaviors (daily self blood-glucose monitoring, medication adherence, adherence to diet and physical activity recommendations). The study design is a single site, partially blinded, randomized controlled trial of 144 patients with Type 2 diabetes mellitus.
Eligibility criteria include a diagnosis of Type 2 diabetes, residence in target community areas in the Chicago area, and Mexican or Mexican-American ethnic heritage. Participants are randomized to either an experimental group receiving 36 home visits over a two year period in which a CHW delivered diabetes education and self-management skills training, or to an attention control consisting of 36 bilingual diabetes education newsletters covering the same curriculum as the CHWs. The curriculum covers recommended diabetes self-management behaviors including glucose self-monitoring, responding to abnormal blood glucose levels, working effectively with health care providers, medication adherence, foot care, daily physical activity, and reducing fat content of diet. CHWs also deliver training in behavioral skills of self-monitoring, environmental restructuring, engagement of social support, stress management, and problem-solving skills to facilitate the self-management activities. Consistent delivery of the CHW intervention is documented by audiotapes and Documentation of Intervention worksheets.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Community Health Worker Intervention | Experimental | Behavioral: Community Health Worker InterventionA Community Health Worker makes 36 home visits to the person with diabetes over a two year period, providing diabetes education and self-management skills training. The curriculum covers recommended diabetes self-management behaviors including glucose self-monitoring, responding to abnormal blood glucose levels, working effectively with health care providers, medication adherence, foot care, daily physical activity, and reducing fat content of diet. CHWs also deliver training in behavioral skills of self-monitoring, environmental restructuring, engagement of social support, stress management, and problem-solving skills to facilitate the self-management activities. |
| Educational Newsletter | Active comparator | Behavioral: Educational NewsletterDiabetes education and self-management skills training delivered via 36 bilingual diabetes education newsletters over a 2 year period. The newsletters cover recommended diabetes self-management behaviors including glucose self-monitoring, responding to abnormal blood glucose levels, working effectively with health care providers, medication adherence, foot care, daily physical activity, and reducing fat content of diet. The newsletters also describe behavioral skills of self-monitoring, environmental restructuring, engagement of social support, stress management, and problem-solving skills to facilitate the self-management activities. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosis of type 2 diabetes mellitus
- Taking at one oral medication daily to control diabetes
- Self-identified as Mexican or Mexican-American
- Resident in target community within Chicago, Berwyn, or Cicero, Illinois.
Key exclusion criteria (7 listed)
- Diabetes controlled with diet or insulin only
- Advanced end-organ complications, including: end-stage renal disease, stroke with paresis, Congestive Heart Failure (NYHA class 3 or 4), or other major end-organ complication of diabetes
- Receiving treatment for a major psychiatric disorder (i.e. schizophrenia)
- Are unable to understand and give informed consent in either English or Spanish
- Live in a household with someone who is already a randomized study participant or know of family members who are already study participants.
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 InterventionAlso: Promotora, Promotora de SaludA Community Health Worker makes 36 home visits to the person with diabetes over a two year period, providing diabetes education and self-management skills training. The curriculum covers recommended diabetes self-management behaviors including glucose self-monitoring, responding to abnormal blood glucose levels, working effectively with health care providers, medication adherence, foot care, daily physical activity, and reducing fat content of diet. CHWs also deliver training in behavioral skills of self-monitoring, environmental restructuring, engagement of social support, stress management, and problem-solving skills to facilitate the self-management activities. | Behavioural | Community Health Worker Intervention |
| Educational NewsletterDiabetes education and self-management skills training delivered via 36 bilingual diabetes education newsletters over a 2 year period. The newsletters cover recommended diabetes self-management behaviors including glucose self-monitoring, responding to abnormal blood glucose levels, working effectively with health care providers, medication adherence, foot care, daily physical activity, and reducing fat content of diet. The newsletters also describe behavioral skills of self-monitoring, environmental restructuring, engagement of social support, stress management, and problem-solving skills to facilitate the self-management activities. | Behavioural | Educational Newsletter |
Primary outcome
Hemoglobin A1c
Time frame: 2 years
% of persons with blood pressure less than 130/80
Time frame: 2 years
3 secondary outcomes
Medication adherence
Time frame: 2 years
Daily self-blood glucose monitoring
Time frame: 2 years
Summary of Diabetes Self-Care Activities
Time frame: 2 years
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 2 Dec 2011.
- Background: PubMed 20008279Swider SM, Martin M, Lynas C, Rothschild S. Project MATCH: training for a promotora intervention. Diabetes Educ. 2010 Jan-Feb;36(1):98-108. doi: 10.1177/0145721709352381. Epub 2009 Dec 11.
- Background: PubMed 21462723Martin MA, Swider SM, Olinger T, Avery E, Lynas CM, Carlson K, Rothschild SK. Recruitment of Mexican American adults for an intensive diabetes intervention trial. Ethn Dis. 2011 Winter;21(1):7-12.
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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 Intervention and Educational Newsletter in people with Diabetes Mellitus, Type 2, run by Rush University Medical Center 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 4 inclusion and 7 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 2 Dec 2011. 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?
Hemoglobin A1c (time frame: 2 years). 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?
On the ClinicalTrials.gov record for NCT01067092, 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 2 Dec 2011.