Diabetes Mellitus, Type 2NCT04857411
Peers LEAD Plus Healthy Living With Diabetes (HLWD)
A study testing Peers LEAD plus HLWD in people with Diabetes Mellitus, Type 2, run by University of Wisconsin, Madison at 1 site in United States.
Trial summary
The specific goal of this project is to decrease diabetes-related morbidity among African Americans (AAs) in Milwaukee through the integration of Peers LEAD, a culturally-appropriate program to increase medication adherence into Healthy Living with Diabetes (HLWD), an existing diabetes self-management program. Read more about this study
- Who is it for?
- Ages 20 to 90 years
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Peers LEAD plus HLWD
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Apr 2021to 22 Nov 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 20 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Self-reported nonadherence on the Adherence to Refills and Medications Scale for Diabetes (ARMS-D) scale
- Most recent A1c is ≥8% based on information collected at point of care A1c testing
- Self-reported adherence on the Adherence to Refills and Medications Scale for Diabetes (ARMS-D) scale
- Most recent A1c is <8% based on point of care A1c test
- Willing to provide support to a Buddy and track phone conversations
- Willing to attend all training sessions and meetings related to being an Ambassador
Show all 9Show fewer
- Shared Exclusion Criteria for Ambassadors and Buddies:
- Diagnosed psychiatric disorder
- Older than 65-years old with a history of severe hypoglycemia requiring medical assistance or glucagon administration
Who cannot join
- Currently participating in another diabetes lifestyle self-management or medication adherence program
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Improving Diabetes Programs for Blacks in Wisconsin: Peers as Coaches in Medicine Use
The specific goal of this project is to decrease diabetes-related morbidity among African Americans (AAs) in Milwaukee through the integration of Peers LEAD, a culturally-appropriate program to increase medication adherence into Healthy Living with Diabetes (HLWD), an existing diabetes self-management program.
Read the detailed description
This project represents the next phase of prior work at the University of Wisconsin School of Pharmacy to create and implement community-based programs for AAs with diabetes that focus on improving medication use and glycemic control. The overall objective is to integrate Peers LEAD into HLWD using a community-engaged approach and an evaluation to document outcomes. This project will produce a culturally-tailored curriculum that can be used broadly across social service and community organizations, faith-based organizations, and federally-qualified health centers committed to improving AAs diabetes self-management. This project will be achieved through the following objectives:
- Objective 1: To gather and incorporate key stakeholders input in the current and future adoption of Peers LEAD+HLWD into community organizations, health system and/or practices. Objective 1 is not a clinical trial.
- Objective 2: To implement and measure the outcomes of Peers LEAD+HLWD to improve medication adherence and hemoglobin A1c. Objective 2 represents the clinical trial aim of this study to be registered in this record.
HLWD is a successful community-based program that offers tools and resources to enhance understanding of what it means to have diabetes, including helping participants to build the confidence to manage diabetes and maintain an active and fulfilling life. HLWD is endorsed by the American Diabetes Association and the Centers for Disease Prevention and Control and proven to reduce emergency department visits by 53%, improve A1c levels, enhance regular treatment and diabetes education, create a community-clinical link in care, provide social benefits for participants, improve self-rated health and communication with physicians, and improve health status, health behavior, and self-efficacy. The investigators chose HLWD as the diabetes self-management education (DSME) program to adapt because it is an effective and widely-disseminated evidence-based DSME program. HLWD has enrolled over 5,000 participants in more than 400 workshops across 52 Wisconsin counties. However, between 2013 and 2016, only 120 AAs (3.1%) participated compared to 1,656 non-Hispanic Whites. In 3 years, only 46% of AAs reported that they took their diabetes pills (HLWD's measure of medication adherence) after the workshop, compared to 55% of non-Hispanic Whites. Despite HLWD's positive outcomes and wide reach, there is limited inclusion of AAs. HLWD does not offer culturally-tailored content for AAs, and lacks one-on-one peer support from an AA who successfully manages diabetes, an important factor influential in improving diabetes outcomes among AAs. There is also insufficient attention to medication adherence. Adding Peers LEAD to HLWD will improve the reach, effectiveness, and impact of diabetes self-management programs among AAs.
Peers LEAD is a culturally-tailored program designed to provide AAs with diabetes and medication beliefs information, behavioral skill-development, and one-on-one peer support to increase medication adherence. Group sessions include discussions of personal discrimination experiences that resulted in provider mistrust, making the most of clinic/pharmacy visits, necessity and concerns about medicines, and enhancing patient-provider communication. Ambassadors are paired with Buddies, and Ambassadors help deliver Peers LEAD content via face-to-face interaction with their Buddies during group sessions and phone follow-ups. Ambassadors address misperceptions of medicines and diabetes, share their experiences managing diabetes and medicines, and discuss building relationships with providers. As well, they are able to provide one-on-one social support.
Peers LEAD+HLWD allows for sufficient attention to medication adherence in a DSME program. For example, HLWD includes only one 20-minute activity on medication use in a 2½ hour session during Week 5. This activity only covers purpose of medicines, medication effects, and remembering to take medicines, but does not address known specific barriers to AAs adherence. In this study, HLWD will be adapted for AAs by adding components of Peers LEAD to overcome key barriers to AAs medication adherence. Core components of Peers LEAD to be incorporated are two group sessions on beliefs about medicines and diabetes, discrimination/mistrust, and provider communication, as well as peer-based phone support from Ambassadors.
The investigators hypothesize that, by implementing Peers LEAD+HLWD, there will be increased reach, engagement, and impact for AAs because psychosocial/sociocultural factors and barriers identified in their work to influence AAs medication adherence (i.e., culturally embedded health beliefs and provider mistrust) will be addressed.
Objective 2 is a pre-post single group design to conduct Peers LEAD+HLWD in Milwaukee. There will be two groups of participants: (1) Ambassadors (who are not consented into the intervention, but help facilitate it) - AAs who have diabetes and are adherent with their medicines and (2) Buddies (consented into the intervention) - who are AAs who have diabetes but are nonadherent with their medicines.
Training of Ambassadors: To prepare to implement Peers LEAD+HLWD, Ambassadors will attend a 6-hour orientation and training meetings, co-facilitated by Wisconsin Network for Research Support (WINRS). This meeting will be an orientation and will prepare the Ambassadors to implement specific elements of Peers LEAD+HLWD, such as the phone calls. WINRS will consult with the research team on all meetings. For >8 years, WINRS staff have been deeply involved in stakeholder engagement, as well as trained, planned and facilitated >250 lay advisory board meetings.
Ambassadors are involved in two group sessions focusing on beliefs about medicines and diabetes, discrimination/mistrust, and communication with providers, and peer-based phone support with buddies to occur weekly for the first 2 weeks, then for 5 weeks after the completion of the 8-week program. Building on the previously piloted version of Peers LEAD, Peers LEAD + HLWD has added phone-based peer support from Ambassadors comprised of bi-weekly calls to monitor progress toward goals (Month 4) and finally monthly calls to support goal adherence (Months 5-6), representing the Maintenance Phase.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Peers LEAD plus HLWD
- Keywords
- Medication adherence
- 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 LEAD plus HLWDBehavioural
Combined Peers LEAD and Healthy Living with Diabetes is a culturally-appropriate program to increase medication adherence
| Study group | Role | What they receive |
|---|---|---|
| Participant 'Buddies' | Experimental | Participants will have an 8-week program initiation phase followed by a maintenance phase through 6-months, supported by Ambassadors. Receives: Behavioral: Peers LEAD plus HLWD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Hemoglobin A1c
Participant buddies will have a hemoglobin A1c greater than 8 percent at baseline. will be measured using the A1cNow+ system, the National Glycohemoglobin Standardization Program Certified, CLIA-waived, system that provides results using a finger stick test.
Measured: baseline
Mean Hemoglobin A1c
Participant buddies will have a hemoglobin A1c greater than 8 percent at baseline. will be measured using the A1cNow+ system, the National Glycohemoglobin Standardization Program Certified, CLIA-waived, system that provides results using a finger stick test.
Measured: 3 months
Mean Hemoglobin A1c
Participant buddies will have a hemoglobin A1c greater than 8 percent at baseline. will be measured using the A1cNow+ system, the National Glycohemoglobin Standardization Program Certified, CLIA-waived, system that provides results using a finger stick test.
Measured: 6 months
Mean Systolic Blood Pressure
Blood pressure readings collected via the Omron Healthcare Inc. 7 Series Upper Arm Blood Pressure Monitor.
Measured: baseline
Mean Systolic Blood Pressure
Blood pressure readings collected via the Omron Healthcare Inc. 7 Series Upper Arm Blood Pressure Monitor.
Measured: 3 months
Mean Systolic Blood Pressure
Blood pressure readings collected via the Omron Healthcare Inc. 7 Series Upper Arm Blood Pressure Monitor.
Measured: 6 months
Change in Diastolic Blood Pressure
Blood pressure readings collected via the Omron Healthcare Inc. 7 Series Upper Arm Blood Pressure Monitor.
Measured: baseline, 3 months, 6 months
Secondary outcomes (9)
Adherence to Refills and Medications Scale for Diabetes (ARMS-D) Score
ARMS-D is a measure of medication adherence. It is an 11-item survey with a total possible range of scores 11-44. Lower scores indicate better medication adherence.
Measured: baseline, 3 months, 6 months
Self-Efficacy for Adherence to Medication Use Scale (SEAMS)
SEAMS is a 16-item questionnaire that assesses peoples' confidence in taking their medications correctly, which can be used to determine medication self-efficacy in a person with diabetes. Current evidence exists demonstrating the reliability and validity of the SEAMS instrument. Respondents are asked to indicate, under a number of different circumstances, their level of confidence about taking medications correctly. Each item is evaluated using a 3-point Likert-type scale (1 = not confident, 2 = somewhat confident, and 3 = very confident). The sum of SEAMS ranges from 13 to 39. Higher scores reflect that respondents have more confidence in being adherent to their medication use.
Measured: baseline, 3 months, 6 months
Patient's Perceived Involvement in Care Scale (PICS)
PICS is a brief, psychometrically-sound, self-report questionnaire about primary care patients' attitudes regarding their illnesses and the management of them. This instrument is designed to examine three relatively distinct factors: (1) doctor facilitation of patient involvement, (2) level of information exchange, and (3) patient participation in decision making.
This instrument evaluates doctor-patient interactions across three relatively distinct factors, including doctor facilitation of patient involvement (5 items), level of information exchange (4 items), and patient participation in decision making (4 items). In total, respondents answer 13 dichotomous items (0 point is given for "no" and 1 point for "yes.") Items scores are summed to generate a total score ranging from 0-13, and higher scores suggest a greater degree of shared decision making for disease self-management.
Measured: baseline, 3 months, 6 months
Diabetes Distress Scale (DDS) 2
The DDS-2 is a 2-item screener version of the reliable and valid 17-item DDS questionnaire, which is constructed for people with type 2 diabetes. The DDS-2 is a simple method to evaluate peoples' feelings about being overwhelmed by the demands of living with diabetes and about the extent that people believe that they are failing with their diabetes routine. Each item is evaluated using a 6-point scale (1 and 2 = not a problem, 3 and 4 = moderate problem, and 5 and 6 = serious problem) for a range of possible scores between 2 and 12. People who rate these two items higher are reporting a greater the degree to which diabetes-related distress is bothering them in their lives.
Measured: baseline, 3 months, 6 months
Patient Health Questionnaire (PHQ-4)
PHQ-4 is an 4-item instrument that is established as a valid diagnostic and severity measure for depressive disorders in large clinical studies, and also serves as a useful measure for the purpose of population-based studies. A score of 10 or greater is considered major depression, 20 or more is severe major depression.
Measured: baseline, 3 months, 6 months
Diabetes Empowerment Scale - Short Form (DES-SF)
The DES-SF is an 8-item short form of the original 37-item Diabetes Empowerment Scale. The DES-SF allows for a brief overall assessment of diabetes-related psychosocial self-efficacy. Investigations have provided preliminary evidence that the DES-SF is a valid and reliable measure of overall diabetes-related psychosocial self-efficacy.
An item checked "strongly agree" receives 5 points; "agree" - 4 points; "neutral" - 3 points; "disagree" - 2 points; and "strongly disagree" receives 1 point. The possible range of scores is 8-40, with higher scores indicating higher diabetes-related psychosocial self-efficacy.
Measured: baseline, 3 months, 6 months
Brief Illness Perception Questionnaire (Brief IPQ)
The Brief IPQ is a 9-item questionnaire designed to rapidly assess cognitive and emotional representations of illness. The Brief IPQ uses a single-item scale approach to assess perception on a 0-10 continuous linear response scale. Overall, the Brief IPQ is a psychometrically sound instrument that provides a rapid assessment of illness perceptions, and can be particularly helpful in ill populations, large-scale studies, and in repeated measures research designs.
To compute the score, reverse score items 3, 4, and 7 and add these to items 1, 2, 5, 6, and 8 for a range of scores from 0-80. A higher score reflects a more threatening view of the illness. Item 9 is qualitative and not scored with the other items. It asks respondents to list in rank-order the three most important factors they believe caused their illness.
Measured: baseline, 3 months, 6 months
Beliefs about Medicines Questionnaire (BMQ)
The BMQ is a tool for evaluating people's beliefs about the necessity of medications and concerns about using those medications. It has been validated for use in patients with chronic illnesses and has been shown to predict adherence to treatment among people with type 2 diabetes.
The BMQ has 10-items and consists of two 5-item subscales: necessity beliefs and concern beliefs. Each item is measured on 5-point Likert-type scales with 'strongly disagree (score = 1)' to 'strongly agree (score = 5)' response options. The scores summed for each subscale range from 5-25, with a higher score meaning stronger necessity or concern beliefs about the medication prescribed for personal use.
Measured: baseline, 3 months, 6 months
Newest Vital Sign (NVS)
The NVS is a 6-item assessment of respondent's health literacy in the following areas: literacy, comprehension, application/function, evaluation, and numeracy skills. Each question is scored "0" for incorrect and "1" for correct yielding a total score ranging from 0 to 6, with higher scores indicating better health literacy. Scores of less than 2 represents high likelihood (50% or more) of limited (inadequate) literacy, 2 to 3 indicates possibility of limited (marginal) literacy, and more than 3 suggests adequate literacy.
Measured: baseline, 3 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 posted23 Apr 2021
- Study start19 Apr 2021
- Primary completion22 Nov 2021
- Study completion22 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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 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
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Olayinka Shiyanbola, PhD, B.Pharm, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04857411
- Sponsor's protocol ID
- 2020-1061
- Other IDs
- A561000, PHARM/PHARMACY, Protocol Version 2/24/2021, Baldwin Grant
- Status last verified
- Feb 2022
- First submitted
- 22 Apr 2021
- Last updated
- 14 Feb 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Shiyanbola OO, Maurer M, Schwerer L, Sarkarati N, Wen MJ, Salihu EY, Nordin J, Xiong P, Egbujor UM, Williams SD. A Culturally Tailored Diabetes Self-Management Intervention Incorporating Race-Congruent Peer Support to Address Beliefs, Medication Adherence and Diabetes Control in African Americans: A Pilot Feasibility Study. Patient Prefer Adherence. 2022 Oct 25;16:2893-2912. doi: 10.2147/PPA.S384974. eCollection 2022.
PubMed 36317056
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Diabetes Programs for Blacks in Wisconsin: Peers as Coaches in Medicine Use
- ClinicalTrials.gov ID
- NCT04857411
- Acronym / sponsor ID
- 2020-1061
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- Medication adherence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Study start
- 19 Apr 2021 (actual)
- Primary completion
- 22 Nov 2021 (actual)
- Study completion
- 22 Nov 2021 (actual)
- First posted
- 23 Apr 2021 (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 specific goal of this project is to decrease diabetes-related morbidity among African Americans (AAs) in Milwaukee through the integration of Peers LEAD, a culturally-appropriate program to increase medication adherence into Healthy Living with Diabetes (HLWD), an existing diabetes self-management program.
Detailed description
This project represents the next phase of prior work at the University of Wisconsin School of Pharmacy to create and implement community-based programs for AAs with diabetes that focus on improving medication use and glycemic control. The overall objective is to integrate Peers LEAD into HLWD using a community-engaged approach and an evaluation to document outcomes. This project will produce a culturally-tailored curriculum that can be used broadly across social service and community organizations, faith-based organizations, and federally-qualified health centers committed to improving AAs diabetes self-management. This project will be achieved through the following objectives:
- Objective 1: To gather and incorporate key stakeholders input in the current and future adoption of Peers LEAD+HLWD into community organizations, health system and/or practices. Objective 1 is not a clinical trial.
- Objective 2: To implement and measure the outcomes of Peers LEAD+HLWD to improve medication adherence and hemoglobin A1c. Objective 2 represents the clinical trial aim of this study to be registered in this record.
HLWD is a successful community-based program that offers tools and resources to enhance understanding of what it means to have diabetes, including helping participants to build the confidence to manage diabetes and maintain an active and fulfilling life. HLWD is endorsed by the American Diabetes Association and the Centers for Disease Prevention and Control and proven to reduce emergency department visits by 53%, improve A1c levels, enhance regular treatment and diabetes education, create a community-clinical link in care, provide social benefits for participants, improve self-rated health and communication with physicians, and improve health status, health behavior, and self-efficacy. The investigators chose HLWD as the diabetes self-management education (DSME) program to adapt because it is an effective and widely-disseminated evidence-based DSME program. HLWD has enrolled over 5,000 participants in more than 400 workshops across 52 Wisconsin counties. However, between 2013 and 2016, only 120 AAs (3.1%) participated compared to 1,656 non-Hispanic Whites. In 3 years, only 46% of AAs reported that they took their diabetes pills (HLWD's measure of medication adherence) after the workshop, compared to 55% of non-Hispanic Whites. Despite HLWD's positive outcomes and wide reach, there is limited inclusion of AAs. HLWD does not offer culturally-tailored content for AAs, and lacks one-on-one peer support from an AA who successfully manages diabetes, an important factor influential in improving diabetes outcomes among AAs. There is also insufficient attention to medication adherence. Adding Peers LEAD to HLWD will improve the reach, effectiveness, and impact of diabetes self-management programs among AAs.
Peers LEAD is a culturally-tailored program designed to provide AAs with diabetes and medication beliefs information, behavioral skill-development, and one-on-one peer support to increase medication adherence. Group sessions include discussions of personal discrimination experiences that resulted in provider mistrust, making the most of clinic/pharmacy visits, necessity and concerns about medicines, and enhancing patient-provider communication. Ambassadors are paired with Buddies, and Ambassadors help deliver Peers LEAD content via face-to-face interaction with their Buddies during group sessions and phone follow-ups. Ambassadors address misperceptions of medicines and diabetes, share their experiences managing diabetes and medicines, and discuss building relationships with providers. As well, they are able to provide one-on-one social support.
Peers LEAD+HLWD allows for sufficient attention to medication adherence in a DSME program. For example, HLWD includes only one 20-minute activity on medication use in a 2½ hour session during Week 5. This activity only covers purpose of medicines, medication effects, and remembering to take medicines, but does not address known specific barriers to AAs adherence. In this study, HLWD will be adapted for AAs by adding components of Peers LEAD to overcome key barriers to AAs medication adherence. Core components of Peers LEAD to be incorporated are two group sessions on beliefs about medicines and diabetes, discrimination/mistrust, and provider communication, as well as peer-based phone support from Ambassadors.
The investigators hypothesize that, by implementing Peers LEAD+HLWD, there will be increased reach, engagement, and impact for AAs because psychosocial/sociocultural factors and barriers identified in their work to influence AAs medication adherence (i.e., culturally embedded health beliefs and provider mistrust) will be addressed.
Objective 2 is a pre-post single group design to conduct Peers LEAD+HLWD in Milwaukee. There will be two groups of participants: (1) Ambassadors (who are not consented into the intervention, but help facilitate it) - AAs who have diabetes and are adherent with their medicines and (2) Buddies (consented into the intervention) - who are AAs who have diabetes but are nonadherent with their medicines.
Training of Ambassadors: To prepare to implement Peers LEAD+HLWD, Ambassadors will attend a 6-hour orientation and training meetings, co-facilitated by Wisconsin Network for Research Support (WINRS). This meeting will be an orientation and will prepare the Ambassadors to implement specific elements of Peers LEAD+HLWD, such as the phone calls. WINRS will consult with the research team on all meetings. For >8 years, WINRS staff have been deeply involved in stakeholder engagement, as well as trained, planned and facilitated >250 lay advisory board meetings.
Ambassadors are involved in two group sessions focusing on beliefs about medicines and diabetes, discrimination/mistrust, and communication with providers, and peer-based phone support with buddies to occur weekly for the first 2 weeks, then for 5 weeks after the completion of the 8-week program. Building on the previously piloted version of Peers LEAD, Peers LEAD + HLWD has added phone-based peer support from Ambassadors comprised of bi-weekly calls to monitor progress toward goals (Month 4) and finally monthly calls to support goal adherence (Months 5-6), representing the Maintenance Phase.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participant 'Buddies' | Experimental | Behavioral: Peers LEAD plus HLWDParticipants will have an 8-week program initiation phase followed by a maintenance phase through 6-months, supported by Ambassadors. |
Who may qualify
- Ages
- 20 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Self-reported nonadherence on the Adherence to Refills and Medications Scale for Diabetes (ARMS-D) scale
- Most recent A1c is ≥8% based on information collected at point of care A1c testing
- Self-reported adherence on the Adherence to Refills and Medications Scale for Diabetes (ARMS-D) scale
- Most recent A1c is <8% based on point of care A1c test
- Willing to provide support to a Buddy and track phone conversations
Key exclusion criteria (1 listed)
- Currently participating in another diabetes lifestyle self-management 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 LEAD plus HLWDCombined Peers LEAD and Healthy Living with Diabetes is a culturally-appropriate program to increase medication adherence | Behavioural | Participant 'Buddies' |
Primary outcome
Mean Hemoglobin A1c
Time frame: baseline
Participant buddies will have a hemoglobin A1c greater than 8 percent at baseline. will be measured using the A1cNow+ system, the National Glycohemoglobin Standardization Program Certified, CLIA-waived, system that provides results using a finger stick test.
Mean Hemoglobin A1c
Time frame: 3 months
Participant buddies will have a hemoglobin A1c greater than 8 percent at baseline. will be measured using the A1cNow+ system, the National Glycohemoglobin Standardization Program Certified, CLIA-waived, system that provides results using a finger stick test.
Mean Hemoglobin A1c
Time frame: 6 months
Participant buddies will have a hemoglobin A1c greater than 8 percent at baseline. will be measured using the A1cNow+ system, the National Glycohemoglobin Standardization Program Certified, CLIA-waived, system that provides results using a finger stick test.
Mean Systolic Blood Pressure
Time frame: baseline
Blood pressure readings collected via the Omron Healthcare Inc. 7 Series Upper Arm Blood Pressure Monitor.
Mean Systolic Blood Pressure
Time frame: 3 months
Blood pressure readings collected via the Omron Healthcare Inc. 7 Series Upper Arm Blood Pressure Monitor.
Mean Systolic Blood Pressure
Time frame: 6 months
Blood pressure readings collected via the Omron Healthcare Inc. 7 Series Upper Arm Blood Pressure Monitor.
Change in Diastolic Blood Pressure
Time frame: baseline, 3 months, 6 months
Blood pressure readings collected via the Omron Healthcare Inc. 7 Series Upper Arm Blood Pressure Monitor.
9 secondary outcomes
Adherence to Refills and Medications Scale for Diabetes (ARMS-D) Score
Time frame: baseline, 3 months, 6 months
Self-Efficacy for Adherence to Medication Use Scale (SEAMS)
Time frame: baseline, 3 months, 6 months
Patient's Perceived Involvement in Care Scale (PICS)
Time frame: baseline, 3 months, 6 months
Diabetes Distress Scale (DDS) 2
Time frame: baseline, 3 months, 6 months
Patient Health Questionnaire (PHQ-4)
Time frame: baseline, 3 months, 6 months
Diabetes Empowerment Scale - Short Form (DES-SF)
Time frame: baseline, 3 months, 6 months
Brief Illness Perception Questionnaire (Brief IPQ)
Time frame: baseline, 3 months, 6 months
Beliefs about Medicines Questionnaire (BMQ)
Time frame: baseline, 3 months, 6 months
Newest Vital Sign (NVS)
Time frame: baseline, 3 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 14 Feb 2022.
- Derived from this study: PubMed 36317056Shiyanbola OO, Maurer M, Schwerer L, Sarkarati N, Wen MJ, Salihu EY, Nordin J, Xiong P, Egbujor UM, Williams SD. A Culturally Tailored Diabetes Self-Management Intervention Incorporating Race-Congruent Peer Support to Address Beliefs, Medication Adherence and Diabetes Control in African Americans: A Pilot Feasibility Study. Patient Prefer Adherence. 2022 Oct 25;16:2893-2912. doi: 10.2147/PPA.S384974. eCollection 2022.
- UniteWILink provided by the sponsor.
- 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, PhD, B.Pharm 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 plus HLWD in people with Diabetes Mellitus, Type 2, 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 1 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 14 Feb 2022. 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?
Mean Hemoglobin A1c (time frame: baseline). The study lists 7 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 NCT04857411, which also lists 1 linked publication.
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 14 Feb 2022.