Diabetes MellitusNCT03021746
Fostering Sustainability Through Diabetes Self-Management Support
A study testing Diabetes Self Management Support (DSMS) in people with Diabetes Mellitus, run by University of Michigan at 1 site in United States.
Trial summary
To understand the effectiveness of three approaches to address diabetes self-management support compared to enhanced usual care in church-based settings. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- Diabetes Self Management Support (DSMS)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 358 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2016to 31 Aug 2021
- 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
- Have Type 2 diabetes for at least 6 months
- Be Black/African American
- Be a resident of metro-Detroit, Toledo, or Flint
- Be at least 21 years old
- Be under the care of a physician for diabetes
- Have transportation to attend the program
Who cannot join
- Have Type 2 diabetes for less than 6 months
- Under 21 years of age
- Not under care of physician
- Lack of transportation to attend the program
Trial locations and contacts
1 site in 1 country.
About this study
To understand the effectiveness of three approaches to address diabetes self-management support compared to enhanced usual care in church-based settings.
Read the detailed description
To understand the effectiveness of three approaches to address diabetes self-management support compared to enhanced usual care in church-based settings.
- Conditions
- Diabetes Mellitus
- Being tested
- Diabetes Self Management Support (DSMS)
- Keywords
- African-American
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diabetes Self Management Support (DSMS)Behavioural
| Study group | Role | What they receive |
|---|---|---|
| Parish Nurse plus Peer Leader | Experimental | The focus of this approach is for Peer Leaders (PL) to provide Diabetes Self Management Support (DSMS) with the oversight of Parish Nurses (PN). The first component starts with group-based Diabetes Self Management Education (DSME) provided by Certified Diabetes Educators (CDE), co-facilitated by PN and PL and held at the church. PL will also facilitate activities including behavioral goal setting, monthly phone contacts, and preparation for a diabetes-related health care visit, with oversight of PN. As the study progresses, PL and PN will have progressive leadership responsibilities. Following DSME, participants will be invited to attend 12 months of monthly DSMS support groups led by the PL, with oversight from the PN. This approach allows for PN to provide direct supervision to PL in areas of clinical content, educational methods, and group facilitation and communication skills. Receives: Behavioral: Diabetes Self Management Support (DSMS) |
| Peer Leader Only | Experimental | This approach will contain the same elements as the PN plus PL approach, except that a PN will not be used. Rather, PL will provide all aspects of DSMS, including behavioral goal setting, monthly phone contacts, and preparation for a diabetes-related health care visit. This approach will be delivered in a group setting. DSME will be provided by CDEs and co-facilitated by a PL to ensure consistency in the DSME content. Following DSME, participants will be invited to attend 12 monthly DSMS groups led by PL. Following the group sessions, participants will transition into a period of ongoing support. During this time, participants and PL will be encouraged to foster DSMS through programs and initiatives that are meaningful to them, utilizing the existing church infrastructure. If needed, PL may contact the CDE for additional information Receives: Behavioral: Diabetes Self Management Support (DSMS) |
| Parish Nurse Only | Experimental | The main focus of this approach will contain all of the same elements as the PN plus PL approach, except that PL will not be used. Rather, the PN will provide all aspects of Diabetes Self Management Support (DSMS), including facilitation of goal setting, monthly phone contacts, and preparation for a diabetes-related health care visit. Diabetes Self Management Education (DSME) will be provided by CDEs and co-facilitated by a PN to ensure consistency in the DSME content. Following DSME, participants will be invited to attend 12 months of monthly, DSMS support groups led by the PN. Following support sessions, participants will transition into a period of ongoing support, where the participants and PN will be encouraged to continue to foster DSMS through programs and initiatives that are meaningful to them, utilizing the existing church infrastructure. The PN may answer clinical questions and may contact the CDE for additional information if needed. Receives: Behavioral: Diabetes Self Management Support (DSMS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in A1C Blood Glucose level
An A1C test is a blood test that reflects one's average blood glucose levels over the previous 3 months.
Measured: During this study, A1c will be measured at five time points; baseline, 6 months, 9 months, 21 months, and 33 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2017 (estimated)
- Study startMar 2016
- Primary completion31 Aug 2021
- Study completion31 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by University of MichiganThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 358 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gretchen Piatt, University of Michigan
- Investigators
- Gretchen Piatt, MPH, PhD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03021746
- Sponsor's protocol ID
- HUM00104965
- Status last verified
- Dec 2021
- First submitted
- 12 Jan 2017
- Last updated
- 16 Dec 2021
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fostering Sustainability Through Diabetes Self-Management Support
- ClinicalTrials.gov ID
- NCT03021746
- Acronym / sponsor ID
- HUM00104965
- Conditions
- Diabetes Mellitus
- Keywords
- African-American
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 358 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- Mar 2016
- Primary completion
- 31 Aug 2021 (actual)
- Study completion
- 31 Aug 2021 (actual)
- First posted
- 16 Jan 2017 (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.
To understand the effectiveness of three approaches to address diabetes self-management support compared to enhanced usual care in church-based settings.
Detailed description
To understand the effectiveness of three approaches to address diabetes self-management support compared to enhanced usual care in church-based settings.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Parish Nurse plus Peer Leader | Experimental | Behavioral: Diabetes Self Management Support (DSMS)The focus of this approach is for Peer Leaders (PL) to provide Diabetes Self Management Support (DSMS) with the oversight of Parish Nurses (PN). The first component starts with group-based Diabetes Self Management Education (DSME) provided by Certified Diabetes Educators (CDE), co-facilitated by PN and PL and held at the church. PL will also facilitate activities including behavioral goal setting, monthly phone contacts, and preparation for a diabetes-related health care visit, with oversight of PN. As the study progresses, PL and PN will have progressive leadership responsibilities. Following DSME, participants will be invited to attend 12 months of monthly DSMS support groups led by the PL, with oversight from the PN. This approach allows for PN to provide direct supervision to PL in areas of clinical content, educational methods, and group facilitation and communication skills. |
| Peer Leader Only | Experimental | Behavioral: Diabetes Self Management Support (DSMS)This approach will contain the same elements as the PN plus PL approach, except that a PN will not be used. Rather, PL will provide all aspects of DSMS, including behavioral goal setting, monthly phone contacts, and preparation for a diabetes-related health care visit. This approach will be delivered in a group setting. DSME will be provided by CDEs and co-facilitated by a PL to ensure consistency in the DSME content. Following DSME, participants will be invited to attend 12 monthly DSMS groups led by PL. Following the group sessions, participants will transition into a period of ongoing support. During this time, participants and PL will be encouraged to foster DSMS through programs and initiatives that are meaningful to them, utilizing the existing church infrastructure. If needed, PL may contact the CDE for additional information |
| Parish Nurse Only | Experimental | Behavioral: Diabetes Self Management Support (DSMS)The main focus of this approach will contain all of the same elements as the PN plus PL approach, except that PL will not be used. Rather, the PN will provide all aspects of Diabetes Self Management Support (DSMS), including facilitation of goal setting, monthly phone contacts, and preparation for a diabetes-related health care visit. Diabetes Self Management Education (DSME) will be provided by CDEs and co-facilitated by a PN to ensure consistency in the DSME content. Following DSME, participants will be invited to attend 12 months of monthly, DSMS support groups led by the PN. Following support sessions, participants will transition into a period of ongoing support, where the participants and PN will be encouraged to continue to foster DSMS through programs and initiatives that are meaningful to them, utilizing the existing church infrastructure. The PN may answer clinical questions and may contact the CDE for additional information if needed. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Have Type 2 diabetes for at least 6 months
- Be Black/African American
- Be a resident of metro-Detroit, Toledo, or Flint
- Be at least 21 years old
- Be under the care of a physician for diabetes
Key exclusion criteria (4 listed)
- Have Type 2 diabetes for less than 6 months
- Under 21 years of age
- Not under care of physician
- Lack of transportation to attend the program
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 |
|---|---|---|
| Diabetes Self Management Support (DSMS) | Behavioural | Parish Nurse Only, Parish Nurse plus Peer Leader, Peer Leader Only |
Primary outcome
Change in A1C Blood Glucose level
Time frame: During this study, A1c will be measured at five time points; baseline, 6 months, 9 months, 21 months, and 33 months.
An A1C test is a blood test that reflects one's average blood glucose levels over the previous 3 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 16 Dec 2021.
- 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.
Gretchen Piatt, MPH, PhD principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diabetes Self Management Support (DSMS) in people with Diabetes Mellitus, run by University of Michigan 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 6 inclusion and 4 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 16 Dec 2021. 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?
Change in A1C Blood Glucose level (time frame: During this study, A1c will be measured at five time points; baseline, 6 months, 9 months, 21 months, and 33 months.). 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 16 Dec 2021.