Type 2 DiabetesNCT02066155
Ongoing Diabetes Self-Management Support in Church-Based Settings
A study testing Parish nurse and Peer Support in people with Type 2 Diabetes, run by University of Michigan at 1 site in United States.
Trial summary
African Americans are twice as likely to have diabetes compared to their White counterparts and experience higher rates of diabetes-related complications. Diabetes-related health disparities underscore the need for effective, culturally tailored approaches to promote and sustain diabetes self-management over time. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Parish nurse and Peer Support
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 94 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2013to 31 Dec 2016
- 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
- Registered nurse in Michigan
- Identified as a parish nurse in the participating church
- Member of the Detroit Parish Nurse Network
- Willing to serve as a parish nurse for the research study
- Have diabetes ≥ one year
- Be a resident of metro-Detroit
Show all 17Show fewer
- -≥21 years old and ≥ 8th grade education
- Have transportation to attend training
- Be willing to commit to 3 months of training
- Actively working on his/her own self management goals and
- Willing to serve as a peer leader
- Have diabetes ≥ 6 months
- Resident of metro-Detroit
- -≥ 21years old
- Be under the care of a physician for diabetes
- Have transportation to attend the program
- Be a member or regularly attend the participating church
Who cannot join
- Not a registered nurse
- Not a parish nurse in the church
- Not a member of the DPNN
- Unwilling to serve as a parish nurse for the research studyExclusion Criteria for Participants:
- Non ambulatory or serious health conditions or psychiatric illness (severity requiring hospitalization)
- Serious diabetes complications (e.g. blindness) that would impede meaningful participation
- Non ambulatory or serious health conditions or psychiatric illness (severity requiring hospitalization)
- Serious diabetes complications (e.g. blindness) that would impede meaningful participation
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Michigan Medical School
Ann Arbor, Michigan, 48109
About this study
African Americans are twice as likely to have diabetes compared to their White counterparts and experience higher rates of diabetes-related complications. Diabetes-related health disparities underscore the need for effective, culturally tailored approaches to promote and sustain diabetes self-management over time. Diabetes self-management education (DSME) is effective in improving diabetes outcomes in the short-term. However, many adults with diabetes cannot sustain achieved improvements without continued follow-up and support. The 2012 revisions of both the National Standards for Diabetes Care 6 and the National Standards for DSME and Support emphasize the importance of providing both initial DSME and on-going diabetes self-management support (DSMS) to assist people with diabetes in maintaining effective self-management throughout a lifetime. While a great deal is understood about how to provide effective, initial DSME, less is known about who, where, when, and how to provide effective, sustained DSMS. One significant challenge is that DSME is a covered benefit in the healthcare system, while DSMS is not. This ultimately limits access and availability of DSMS programs, especially for low-income African Americans. Accordingly, there is critical need to develop, evaluate, and understand effective DSMS models that are ongoing, patient-driven, and embedded in the community.
Read the detailed description
The long-term goal of our research is to determine the most effective, practical, and sustainable approaches to provide ongoing DSMS in the context of the communities in which people live. In the African American community, the church plays a central role in community life and can serve as a powerful channel to deliver health promotion programs. Churches in the community are thus ideal venues to intervene to help people with diabetes achieve their self-management related goals. The objective of this proposal is to examine the relative effectiveness of three approaches to address DSMS compared to enhanced usual care within the context of the church-based setting. To accomplish this objective, a cluster randomized, modified stepped wedge, practical behavioral trial with three parallel DSMS approaches will be implemented. Twenty-one African American churches (23 African American participants per church) in metro-Detroit will be randomized to one of three DSMS approaches. Fourteen parish nurses who are volunteers at the churches, and 21 peer leaders will be trained to deliver DSMS. Measures will be collected at baseline, 6, 9, 15 and 27-month follow-up. The primary outcome will be changes in A1c at 9, 15 and 27-month follow-up. Secondary outcomes include changes in weight, blood pressure, quality of life, and diabetes related distress at 9,15 and 27-month follow-up. We hypothesize that 1) participants in both Parish Nurse DSMS and Peer Leader DSMS will have improved outcomes over enhanced usual care, and that 2) participants in Parish Nurse + Peer Leader DSMS will sustain improvements in outcomes achieved following DSME at significantly higher levels than participants in Parish Nurse DSMS and Peer Leader DSMS
- Conditions
- Type 2 Diabetes
- Being tested
- Parish nurse, Peer Support
- Keywords
- diabetes self-management support, diabetes-related distress, parish nurses, peer support
- 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.
Parish nurseBehavioural
On-going support following diabetes self-management education provided by Parish Nurse
Peer SupportBehavioural
On-going support following diabetes self-management education provided by a trained person with diabetes
| Study group | Role | What they receive |
|---|---|---|
| Parish nurse | Experimental | On-going support provided by parish nurse Receives: Behavioral: Parish nurse |
| Peer support | Experimental | On-going support provided by a person with diabetes Receives: Behavioral: Peer Support |
| Control group | No intervention | No on-going support provided |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemoglobin A1C
Measure of long-term glucose control
Measured: Baseline, 3, 9, 15, 27 months
Secondary outcomes (1)
BMI
Measure of weight loss
Measured: Baseline, 3, 9, 15, 27 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2014 (estimated)
- Study startJan 2013
- Primary completion31 Dec 2016
- Study completion31 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 94 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 A Piatt, PhD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02066155
- Sponsor's protocol ID
- 14-PAF00455 PAF
- Other IDs
- DSMS
- Status last verified
- Aug 2019
- First submitted
- 16 Feb 2014
- Last updated
- 6 Aug 2019
- 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 6 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ongoing Diabetes Self-Management Support in Church-Based Settings
- ClinicalTrials.gov ID
- NCT02066155
- Acronym / sponsor ID
- 14-PAF00455 PAF
- Conditions
- Type 2 Diabetes
- Keywords
- diabetes self-management support, diabetes-related distress, parish nurses, peer support
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 94 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Study start
- Jan 2013 (actual)
- Primary completion
- 31 Dec 2016 (actual)
- Study completion
- 31 Dec 2016 (actual)
- First posted
- 19 Feb 2014 (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.
African Americans are twice as likely to have diabetes compared to their White counterparts and experience higher rates of diabetes-related complications. Diabetes-related health disparities underscore the need for effective, culturally tailored approaches to promote and sustain diabetes self-management over time. Diabetes self-management education (DSME) is effective in improving diabetes outcomes in the short-term. However, many adults with diabetes cannot sustain achieved improvements without continued follow-up and support. The 2012 revisions of both the National Standards for Diabetes Care 6 and the National Standards for DSME and Support emphasize the importance of providing both initial DSME and on-going diabetes self-management support (DSMS) to assist people with diabetes in maintaining effective self-management throughout a lifetime. While a great deal is understood about how to provide effective, initial DSME, less is known about who, where, when, and how to provide effective, sustained DSMS. One significant challenge is that DSME is a covered benefit in the healthcare system, while DSMS is not. This ultimately limits access and availability of DSMS programs, especially for low-income African Americans. Accordingly, there is critical need to develop, evaluate, and understand effective DSMS models that are ongoing, patient-driven, and embedded in the community.
Detailed description
The long-term goal of our research is to determine the most effective, practical, and sustainable approaches to provide ongoing DSMS in the context of the communities in which people live. In the African American community, the church plays a central role in community life and can serve as a powerful channel to deliver health promotion programs. Churches in the community are thus ideal venues to intervene to help people with diabetes achieve their self-management related goals. The objective of this proposal is to examine the relative effectiveness of three approaches to address DSMS compared to enhanced usual care within the context of the church-based setting. To accomplish this objective, a cluster randomized, modified stepped wedge, practical behavioral trial with three parallel DSMS approaches will be implemented. Twenty-one African American churches (23 African American participants per church) in metro-Detroit will be randomized to one of three DSMS approaches. Fourteen parish nurses who are volunteers at the churches, and 21 peer leaders will be trained to deliver DSMS. Measures will be collected at baseline, 6, 9, 15 and 27-month follow-up. The primary outcome will be changes in A1c at 9, 15 and 27-month follow-up. Secondary outcomes include changes in weight, blood pressure, quality of life, and diabetes related distress at 9,15 and 27-month follow-up. We hypothesize that 1) participants in both Parish Nurse DSMS and Peer Leader DSMS will have improved outcomes over enhanced usual care, and that 2) participants in Parish Nurse + Peer Leader DSMS will sustain improvements in outcomes achieved following DSME at significantly higher levels than participants in Parish Nurse DSMS and Peer Leader DSMS
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Parish nurse | Experimental | Behavioral: Parish nurseOn-going support provided by parish nurse |
| Peer support | Experimental | Behavioral: Peer SupportOn-going support provided by a person with diabetes |
| Control group | No intervention | –No on-going support provided |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Registered nurse in Michigan
- Identified as a parish nurse in the participating church
- Member of the Detroit Parish Nurse Network
- Willing to serve as a parish nurse for the research study
- Have diabetes ≥ one year
Key exclusion criteria (8 listed)
- Not a registered nurse
- Not a parish nurse in the church
- Not a member of the DPNN
- Unwilling to serve as a parish nurse for the research studyExclusion Criteria for Participants:
- Non ambulatory or serious health conditions or psychiatric illness (severity requiring hospitalization)
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 |
|---|---|---|
| Parish nurseOn-going support following diabetes self-management education provided by Parish Nurse | Behavioural | Parish nurse |
| Peer SupportOn-going support following diabetes self-management education provided by a trained person with diabetes | Behavioural | Peer support |
Primary outcome
Hemoglobin A1C
Time frame: Baseline, 3, 9, 15, 27 months
Measure of long-term glucose control
1 secondary outcome
BMI
Time frame: Baseline, 3, 9, 15, 27 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 6 Aug 2019.
- 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 A Piatt, 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 Parish nurse and Peer Support in people with Type 2 Diabetes, 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 17 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 Aug 2019. 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: Baseline, 3, 9, 15, 27 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 6 Aug 2019.