Type 2 DiabetesNCT05527847
Peers EXCEL Trial to Improve Glycemic Control
A study testing Peers LEAD and HLWD in people with Type 2 Diabetes, run by University of Wisconsin, Madison at 1 site in United States.
Trial summary
The purpose of the study is to gather input about the value of adding a newly developed diabetes self-management program to an existing diabetes self-management program. Participants will self-identify as African-American/Black with type 2 diabetes, and prescribed a diabetes medication. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Peers LEAD and HLWD
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Feb 2023to 14 Nov 2023
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Between 18-90 years old
- Self-identify as African-American
- Diagnosis of Type 2 diabetes
- Able to speak/read English
- Self-report having a primary care provider who prescribes one diabetes medication
- Diagnosed with diabetes for ≥1 year at point of care
Show all 9Show fewer
- Will reside in the geographical area throughout the study period
- Self-reported nonadherence on the DOSE-nonadherence survey
- ≥7.5% A1C
Who cannot join
- Self-reported bipolar or personality disorders, schizophrenia, Alcohol and Other Drug Abuse (AODA), dementia
- Older adults who have a history of severe hypoglycemia requiring medical assistance or glucagon administration
- Participating in another lifestyle or medication adherence program
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pilot Randomized Clinical Trial (RCT) to Examine the Benefits of a Culturally Adapted Peer Support and Self-Management Intervention to Improve Glycemic Control in African Americans
The purpose of the study is to gather input about the value of adding a newly developed diabetes self-management program to an existing diabetes self-management program. Participants will self-identify as African-American/Black with type 2 diabetes, and prescribed a diabetes medication. Participants can expect to be in the study for 6 months.
Read the detailed description
Both programs utilized in this study focus on topics such as diet, exercise, and stress. Both programs offer ideas to manage diabetes symptoms, discuss appropriate exercises, provide guidance on healthy eating, review the use of medicine, and offer tips on communicating with healthcare providers and voicing concerns to family members.
The new program is culturally-tailored for African Americans and focuses on helping patients take their medicines as prescribed.
The purpose of this research study is to evaluate this newly developed combined diabetes self-management program.
- Conditions
- Type 2 Diabetes
- Being tested
- Peers LEAD, HLWD
- Keywords
- African-American, medication adherence, diabetes self-management
- Medical subject headings
- Diabetes Mellitus, Type 2, Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peers LEADBehavioural
Two group session focusing on beliefs about medicines and diabetes, discrimination/mistrust, and communication with providers, and 2 peer-based phone calls from Ambassadors to occur weekly for weeks 3-8, then bi-weekly for weeks 9-12.
HLWDBehavioural
Weekly group sessions for two months. Sessions will last up to 2.5 hours and focus on a different diabetes self-management topic.
| Study group | Role | What they receive |
|---|---|---|
| Healthy Living with Diabetes (HLWD) | Active comparator | Participants will have a 6-week self-management program, followed by the option to work with a Community Health Worker for the remaining 4 months. Receives: Behavioral: HLWD |
| Peers EXCEL | Experimental | Participants will have an 8-week self-management program, and will participate in phone calls with a peer for the remaining 4 months. Receives: Behavioral: Peers LEAD; Behavioral: HLWD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in blood glucose (hemoglobin A1C)
The hypothesis is that there will be a more significant change in mean A1C, which is clinically meaningful, for participants in Peers EXCEL as compared to those in HLWD.
Measured: Baseline, 2 months, 6 months
Secondary outcomes (4)
Medication adherence
The hypothesis is that there will be higher medication adherence for participants in Peers EXCEL as compared to those in HLWD. Self-reported medication adherence is measured using the 3-item Extent of Nonadherence domain in the Domains of Subjective Extent of Nonadherence (DOSE-Nonadherence) survey. This measure screens for nonadherence and is calculated by computing the mean of the 3 items (range of score is 1-5). Mean scores of 3 (i.e., scoring "1" on each of the 3 items) will be classified as nonadherent, while all mean scores >3 will be classified as adherent.
Measured: Baseline, 2 months, 6 months
Feasibility of intervention
Participants will complete validated surveys to assess diabetes-health beliefs, patient self-efficacy/activation, and patient-provider communication quality.
Measured: Baseline, 2 months, 6 months
Acceptability of intervention
Interviews and focus groups will be conducted with participants, ambassadors and HLWD leaders respectively to get feedback on their intervention experiences.
Measured: Baseline, 2 months, 6 months
Adherence to Refills and Medicines Scale for Diabetes (ARMS-D) Score
The ARMS-D has a total possible range of scores from 11-44, with higher scores indicating increased problems with medication adherence.
Measured: Baseline, 2 months, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2022
- Study start13 Feb 2023
- Primary completion2 Oct 2023
- Study completion14 Nov 2023
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 Wisconsin, MadisonThe 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
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Olayinka Shiyanbola, MD, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05527847
- Sponsor's protocol ID
- 2022-0879
- Other IDs
- A561000, PHARM/PHARMACY, Protocol Version 02/20/2023
- Status last verified
- Nov 2023
- First submitted
- 1 Sep 2022
- Last updated
- 18 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Randomized Clinical Trial (RCT) to Examine the Benefits of a Culturally Adapted Peer Support and Self-Management Intervention to Improve Glycemic Control in African Americans
- ClinicalTrials.gov ID
- NCT05527847
- Acronym / sponsor ID
- 2022-0879
- Conditions
- Type 2 Diabetes
- Keywords
- African-American, medication adherence, diabetes self-management
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Study start
- 13 Feb 2023 (actual)
- Primary completion
- 2 Oct 2023 (actual)
- Study completion
- 14 Nov 2023 (actual)
- First posted
- 6 Sep 2022 (actual)
- 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 the study is to gather input about the value of adding a newly developed diabetes self-management program to an existing diabetes self-management program. Participants will self-identify as African-American/Black with type 2 diabetes, and prescribed a diabetes medication. Participants can expect to be in the study for 6 months.
Detailed description
Both programs utilized in this study focus on topics such as diet, exercise, and stress. Both programs offer ideas to manage diabetes symptoms, discuss appropriate exercises, provide guidance on healthy eating, review the use of medicine, and offer tips on communicating with healthcare providers and voicing concerns to family members.
The new program is culturally-tailored for African Americans and focuses on helping patients take their medicines as prescribed.
The purpose of this research study is to evaluate this newly developed combined diabetes self-management program.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy Living with Diabetes (HLWD) | Active comparator | Behavioral: HLWDParticipants will have a 6-week self-management program, followed by the option to work with a Community Health Worker for the remaining 4 months. |
| Peers EXCEL | Experimental | Behavioral: Peers LEAD, Behavioral: HLWDParticipants will have an 8-week self-management program, and will participate in phone calls with a peer for the remaining 4 months. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Between 18-90 years old
- Self-identify as African-American
- Diagnosis of Type 2 diabetes
- Able to speak/read English
- Self-report having a primary care provider who prescribes one diabetes medication
Key exclusion criteria (3 listed)
- Self-reported bipolar or personality disorders, schizophrenia, Alcohol and Other Drug Abuse (AODA), dementia
- Older adults who have a history of severe hypoglycemia requiring medical assistance or glucagon administration
- Participating in another lifestyle or medication adherence 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 |
|---|---|---|
| Peers LEADTwo group session focusing on beliefs about medicines and diabetes, discrimination/mistrust, and communication with providers, and 2 peer-based phone calls from Ambassadors to occur weekly for weeks 3-8, then bi-weekly for weeks 9-12. | Behavioural | Peers EXCEL |
| HLWDWeekly group sessions for two months. Sessions will last up to 2.5 hours and focus on a different diabetes self-management topic. | Behavioural | Healthy Living with Diabetes (HLWD), Peers EXCEL |
Primary outcome
Change in blood glucose (hemoglobin A1C)
Time frame: Baseline, 2 months, 6 months
The hypothesis is that there will be a more significant change in mean A1C, which is clinically meaningful, for participants in Peers EXCEL as compared to those in HLWD.
4 secondary outcomes
Medication adherence
Time frame: Baseline, 2 months, 6 months
Feasibility of intervention
Time frame: Baseline, 2 months, 6 months
Acceptability of intervention
Time frame: Baseline, 2 months, 6 months
Adherence to Refills and Medicines Scale for Diabetes (ARMS-D) Score
Time frame: Baseline, 2 months, 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 18 Nov 2023.
- 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.
Olayinka Shiyanbola, MD principal investigator
University of Wisconsin, Madison
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Peers LEAD and HLWD in people with Type 2 Diabetes, run by University of Wisconsin, Madison 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 9 inclusion and 3 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 18 Nov 2023. 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 blood glucose (hemoglobin A1C) (time frame: Baseline, 2 months, 6 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 18 Nov 2023.