Diabetic Nephropathy Type 2 - UncontrolledNCT05692388
Mixed Methods Study of Health-Related Social Needs in African American Adults With Chronic Kidney Disease and Type 2 Diabetes Mellitus
An observational study of Diabetic Nephropathy Type 2 - Uncontrolled and Diabetes Mellitus, Type 2, run by Medical College of Wisconsin at 1 site in United States.
Trial summary
The overarching goal of this study is to understand facilitators and barriers to self-care, develop and refine a culturally tailored intervention to improve clinical outcomes, quality of life (QOL), and self-care behaviors in African American adults with diabetic kidney disease (DKD) experiencing health-related social… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Nephropathy Type 2 - Uncontrolled, Diabetes Mellitus, Type 2, Chronic Kidney Diseases
- What is being tested?
- Patient and Community Stakeholder Interviews, Cross-sectional Study Participants and Focus Groups and Intervention Mapping
- How many people
- 330 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Jan 2023to 31 Mar 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants will include African American adults with diagnosed diabetic kidney and reporting multiple social risk factors.
Who may be able to join
- self- report as AA/Black
- age ≥18
- screen positive for 1 or more adversities using the Centers for Medicare and Medicaid Services Accountable Health Communities Health-Related Social Needs Screening tool
- self-reported type 2 diabetes and self-report or screen positive for chronic kidney disease (CKD)
- able to communicate in English.
Who cannot join
- cognitive impairment at screening visit
- active psychosis
- active alcohol or drug abuse/dependency
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
Mukoso N Ozieh, MD, MSCR, 4149558839, mozieh@mcw.edu
About this study
The overarching goal of this study is to understand facilitators and barriers to self-care, develop and refine a culturally tailored intervention to improve clinical outcomes, quality of life (QOL), and self-care behaviors in African American adults with diabetic kidney disease (DKD) experiencing health-related social needs (HRSN).
Read the detailed description
Health-related social needs (HRSN) including loss of employment, housing instability, food insecurity, transportation needs, utility needs, interpersonal safety, and financial strain impacts the complex self-management of DKD such as self-monitoring and behavior modification. This study utilizes a convergent parallel mixed methods study design to understand facilitators and barriers to care and develop a culturally tailored intervention to improve clinical outcomes, quality of life, and self-care behaviors in African American adults with DKD experiencing HRSN.
Aim 1 (Qualitative): Identify facilitators and barriers to care in African American adults with DKD experiencing HRSN using in-depth patient and stakeholder interviews.
Aim 2 (Quantitative): Examine the effect of increasing burden of HRSN on clinical outcomes (hemoglobin A1c, blood pressure, lipids), quality of life, and self-care behaviors (diet, exercise, and medication adherence) in a sample of 300 African American adults with DKD experiencing HRSN.
Aim 3 (Integrative): Integrate findings from Aims 1 and 2 and develop a culturally tailored intervention to improve clinical outcomes, quality of life, and self-care behaviors in African American adults with DKD experiencing HRSN.
- Conditions
- Diabetic Nephropathy Type 2 - Uncontrolled, Diabetes Mellitus, Type 2, Chronic Kidney Diseases
- Being tested
- Patient and Community Stakeholder Interviews, Cross-sectional Study Participants, Focus Groups and Intervention Mapping
- Keywords
- Social risk factors
- Medical subject headings
- Diabetes Mellitus, Type 2, Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient and Community Stakeholder InterviewsOther
Thirty in-depth face-to-face patient interviews, and ten in-depth structured stakeholder interviews will be conducted to explore and identify facilitators and barriers to self-care in African American adults with DKD experiencing HRSN.
Cross-sectional Study ParticipantsOther
Three hundred African American adults with DKD experiencing HRSN will be recruited to participate in a cross-sectional study. All participants will complete a one-time survey, and blood samples and blood pressure readings will be obtained to assess clinical outcomes.
Focus Groups and Intervention MappingOther
A subsample of patient interview/cross-sectional study participants will be invited back to participate in four focus groups (five participants/group) to review components of the intervention, give feedback on appropriateness, feasibility, acceptability, and likelihood of having an impact based on their lived experiences.
| Study group | Role | What they receive |
|---|---|---|
| Aim 1 | Qualitative Aim Receives: Other: Patient and Community Stakeholder Interviews | |
| Aim 2 | Quantitative Aim Receives: Other: Cross-sectional Study Participants | |
| Aim 3 | Integrative Aim Receives: Other: Focus Groups and Intervention Mapping |
What is being measured
The primary outcome is the main question the study is designed to answer.
Systolic blood pressure (SBP)
Blood pressure readings will be obtained using automated BP monitors
Measured: Baseline
Hemoglobin A1c (HbA1c)
Blood sample will be drawn by a trained phlebotomist and sent to the laboratory for HbA1c.
Measured: Baseline
LDL cholesterol
Blood sample will be drawn by a trained phlebotomist and sent to the laboratory for LDL cholesterol.
Measured: Baseline
Quality of Life (QOL)
Quality of Life will be assessed using SF-12, a valid and reliable instrument to measure functional status. This 12-item scale is a valid and reliable instrument of functional status and provides a summary physical health-related quality of life (PCS) and mental health-related quality of life (MCS). Scores for each of the PCS and MCS range from 0 to 100, with higher scores indicating better physical and mental health-related quality of life, respectively.
Measured: Baseline
Self-Care Behavior
Self-Care Behavior will be assessed with the Summary of Diabetes Self-Care Activities scale. This is an 11-item self-reported questionnaire including items assessing diet, exercise, blood glucose test, foot care, and smoking status. Higher scores indicate more engagement in self-care behaviors.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2023
- Study start23 Jan 2023
- Primary completion31 Mar 2027 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Nephropathy Type 2 - UncontrolledStudies of the same condition, open and under way.
- More trials run by Medical College of WisconsinThe 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
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 330 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical College of Wisconsin
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Responsible party
- Principal investigator, Mukoso N. Ozieh, Medical College of Wisconsin
- Investigators
- Mukoso N Ozieh, MD, MSCR, Principal investigator, Medical College of Wisconsin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05692388
- Sponsor's protocol ID
- PRO00043301
- Other IDs
- 1K23MD016448-01A1
- Status last verified
- Oct 2025
- First submitted
- 11 Jan 2023
- Last updated
- 1 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mixed Methods Study of Health-Related Social Needs in African American Adults With Chronic Kidney Disease and Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT05692388
- Acronym / sponsor ID
- PRO00043301
- Conditions
- Diabetic Nephropathy Type 2 - Uncontrolled, Diabetes Mellitus, Type 2, Chronic Kidney Diseases
- Keywords
- Social risk factors
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 330 participants (estimated)
- Lead sponsor
- Medical College of WisconsinUniversity, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Study start
- 23 Jan 2023 (actual)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 20 Jan 2023 (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 overarching goal of this study is to understand facilitators and barriers to self-care, develop and refine a culturally tailored intervention to improve clinical outcomes, quality of life (QOL), and self-care behaviors in African American adults with diabetic kidney disease (DKD) experiencing health-related social needs (HRSN).
Detailed description
Health-related social needs (HRSN) including loss of employment, housing instability, food insecurity, transportation needs, utility needs, interpersonal safety, and financial strain impacts the complex self-management of DKD such as self-monitoring and behavior modification. This study utilizes a convergent parallel mixed methods study design to understand facilitators and barriers to care and develop a culturally tailored intervention to improve clinical outcomes, quality of life, and self-care behaviors in African American adults with DKD experiencing HRSN.
Aim 1 (Qualitative): Identify facilitators and barriers to care in African American adults with DKD experiencing HRSN using in-depth patient and stakeholder interviews.
Aim 2 (Quantitative): Examine the effect of increasing burden of HRSN on clinical outcomes (hemoglobin A1c, blood pressure, lipids), quality of life, and self-care behaviors (diet, exercise, and medication adherence) in a sample of 300 African American adults with DKD experiencing HRSN.
Aim 3 (Integrative): Integrate findings from Aims 1 and 2 and develop a culturally tailored intervention to improve clinical outcomes, quality of life, and self-care behaviors in African American adults with DKD experiencing HRSN.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Aim 1 | – | Other: Patient and Community Stakeholder InterviewsQualitative Aim |
| Aim 2 | – | Other: Cross-sectional Study ParticipantsQuantitative Aim |
| Aim 3 | – | Other: Focus Groups and Intervention MappingIntegrative Aim |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants will include African American adults with diagnosed diabetic kidney and reporting multiple social risk factors.
Key inclusion criteria (5 listed)
- self- report as AA/Black
- age ≥18
- screen positive for 1 or more adversities using the Centers for Medicare and Medicaid Services Accountable Health Communities Health-Related Social Needs Screening tool
- self-reported type 2 diabetes and self-report or screen positive for chronic kidney disease (CKD)
- able to communicate in English.
Key exclusion criteria (3 listed)
- cognitive impairment at screening visit
- active psychosis
- active alcohol or drug abuse/dependency
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 |
|---|---|---|
| Patient and Community Stakeholder InterviewsThirty in-depth face-to-face patient interviews, and ten in-depth structured stakeholder interviews will be conducted to explore and identify facilitators and barriers to self-care in African American adults with DKD experiencing HRSN. | Other | Aim 1 |
| Cross-sectional Study ParticipantsThree hundred African American adults with DKD experiencing HRSN will be recruited to participate in a cross-sectional study. All participants will complete a one-time survey, and blood samples and blood pressure readings will be obtained to assess clinical outcomes. | Other | Aim 2 |
| Focus Groups and Intervention MappingA subsample of patient interview/cross-sectional study participants will be invited back to participate in four focus groups (five participants/group) to review components of the intervention, give feedback on appropriateness, feasibility, acceptability, and likelihood of having an impact based on their lived experiences. | Other | Aim 3 |
Primary outcome
Systolic blood pressure (SBP)
Time frame: Baseline
Blood pressure readings will be obtained using automated BP monitors
Hemoglobin A1c (HbA1c)
Time frame: Baseline
Blood sample will be drawn by a trained phlebotomist and sent to the laboratory for HbA1c.
LDL cholesterol
Time frame: Baseline
Blood sample will be drawn by a trained phlebotomist and sent to the laboratory for LDL cholesterol.
Quality of Life (QOL)
Time frame: Baseline
Quality of Life will be assessed using SF-12, a valid and reliable instrument to measure functional status. This 12-item scale is a valid and reliable instrument of functional status and provides a summary physical health-related quality of life (PCS) and mental health-related quality of life (MCS). Scores for each of the PCS and MCS range from 0 to 100, with higher scores indicating better physical and mental health-related quality of life, respectively.
Self-Care Behavior
Time frame: Baseline
Self-Care Behavior will be assessed with the Summary of Diabetes Self-Care Activities scale. This is an 11-item self-reported questionnaire including items assessing diet, exercise, blood glucose test, foot care, and smoking status. Higher scores indicate more engagement in self-care behaviors.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2026.
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.
Mukoso N Ozieh, MD, MSCR principal investigator
Medical College of Wisconsin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetic Nephropathy Type 2 - Uncontrolled and Diabetes Mellitus, Type 2, run by Medical College of Wisconsin 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 5 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: looking for participants now, as of the sponsor's last update on 1 May 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mukoso N Ozieh, MD, MSCR (414-955-8839, mozieh@mcw.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Systolic blood pressure (SBP) (time frame: Baseline). The study lists 5 primary outcomes in all. 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 1 May 2026.