Diabetic NephropathiesNCT05357742
Basic Needs Navigation Intervention to Address Multidimensional Adversity in African Americans With Diabetic Kidney Disease
A study testing Individualized basic need navigation and lifestyle coaching and skills training in people with Diabetic Nephropathies and Diabetes Mellitus, Type 2, run by Medical College of Wisconsin at 1 site in United States.
Trial summary
The overarching goal of this proposal is to test the feasibility of a basic needs navigation intervention on improving clinical outcomes, self-care behaviors and quality of life in low-income African Americans with diabetic kidney disease (DKD) experiencing multidimensional adversity. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Nephropathies, Diabetes Mellitus, Type 2, Chronic Kidney Diseases
- What is being tested?
- Individualized basic need navigation and lifestyle coaching and skills training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2022to 31 Jul 2025
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- self- report as Black/African American
- 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
- diagnosed type 2 diabetes (T2DM) with HbA1c≥8
- chronic kidney disease (CKD)
- able to communicate in English.
Who cannot join
- does not identify as Black/African American
- age <18
- no diagnosis of T2DM and CKD
- cognitive impairment at screening visit
- active psychosis
- active alcohol or drug abuse/dependency
Show all 9Show fewer
- life expectancy <12 months
- participation in other diabetes/CKD trials
- unable to communicate in English.
Trial locations and contacts
1 site in 1 country.
United States1 site
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
About this study
The overarching goal of this proposal is to test the feasibility of a basic needs navigation intervention on improving clinical outcomes, self-care behaviors and quality of life in low-income African Americans with diabetic kidney disease (DKD) experiencing multidimensional adversity.
The study objective will be achieved with the following aims:
Read more
Aim 1: To determine the feasibility of a basic needs navigation intervention as measured by recruitment, session attendance and retention in low-income Africans Americans with DKD experiencing multidimensional adversity.
Aim 2: To determine the frequency and compounding nature of different basic needs in Africans Americans with DKD experiencing multidimensional adversity to help refine the basic needs navigation intervention.
Aim 3: To evaluate the change and variability in the clinical outcomes (hemoglobin A1c, blood pressure, lipids) at 6 months of follow-up to plan for larger trial.
Read the detailed description
Multidimensional adversity, defined as having three or more social adversities such as housing instability, food insecurity, transportation needs, utility needs, interpersonal safety, and financial strain impacts the complex self-management of DKD and negatively impacts health outcomes. Evidence suggests patient navigation programs may be a promising strategy to improve health outcomes in low-income individuals with chronic disease. However, there is limited evidence on the use of patient navigator programs to address multidimensional adversity in individuals with chronic disease. Therefore, the primary objective of this study is to address this gap in knowledge.
Study overview: This will be accomplished using a two-arm pilot randomized control trial. Fifty (50) African American adults with DKD experiencing multidimensional adversity will be randomized into one of two arms: 1) Intervention arm and 2) Enhanced usual care arm.
Description of intervention: Participants randomized to the intervention arm will receive the manualized study intervention which includes three components 1) DKD education, 2) Individualized basic needs navigation, and 3) Lifestyle coaching and skills training. Participants will be provided a FORA 2-in-1 device with glucose test strips to allow testing at least once a day. The device automatically uploads blood pressure and glucose readings to a secure server in real time and the health educator will have access to this secure server. Readings will be used to guide lifestyle coaching and skills training. All participants will be assessed at baseline, 3- and 6-months for clinical outcomes (hemoglobin A1c, blood pressure, lipids), self-care behaviors (diet, exercise, and medication adherence), and quality of life (SF-12).
Control arm (Enhanced usual care arm): Participants randomized to the control arm will receive the manualized study intervention which incudes only DKD education.
All participants will be assessed at baseline, 3- and 6-months for clinical outcomes (hemoglobin A1c, blood pressure, lipids), self-care behaviors (diet, exercise, and medication adherence), and quality of life (SF-12).
- Conditions
- Diabetic Nephropathies, Diabetes Mellitus, Type 2, Chronic Kidney Diseases, Healthy Lifestyle
- Being tested
- Individualized basic need navigation and lifestyle coaching and skills training, Enhanced usual care
- Keywords
- Social risk factors, Social determinants of health
- Medical subject headings
- Diabetic Nephropathies, 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.
Individualized basic need navigation and lifestyle coaching and skills trainingBehavioural
During each session participants will receive the manualized study intervention which includes 1) DKD education, 2) Individualized basic needs navigation, and 3) Lifestyle coaching and skills training. Participants will be provided a FORA 2-in-1 device with glucose test strips to allow testing at least once a day. The device automatically uploads blood pressure and glucose readings to a secure server in real time and the health educator will have access to this secure server. Readings will be used to guide lifestyle coaching and skills training.
Enhanced usual careBehavioural
During each session participants will receive DKD education only.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Participants randomized to the intervention group will receive the manualized study intervention delivered by a health educator via telephone weekly for 12-weeks, followed by three monthly booster sessions resulting in a total of 6 months intervention. Receives: Behavioral: Individualized basic need navigation and lifestyle coaching and skills training |
| Control group | Active comparator | Participants randomized to the control group will receive the manualized study intervention delivered by a health educator via telephone weekly for 12-weeks, followed by three monthly booster sessions resulting in a total of 6 months intervention. Receives: Behavioral: Enhanced usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of the basic needs navigation intervention
Feasibility of the basic needs navigation intervention as measured by recruitment, session attendance and retention
Measured: At 6 months post intervention follow-up
Secondary outcomes (4)
Basic Needs
Frequency of basic needs will be assessed using the Centers for Medicare and Medicaid Services Accountable Health Communities Health-Related Social Needs Screening tool
Measured: At 6 months post intervention follow-up
Hemoglobin A1c (Hb A1c)
Blood will be drawn by trained phlebotomist for HbA1c
Measured: Change in baseline Hb A1c at 6 months post intervention follow-up
Systolic blood pressure (SBP)
Blood pressure readings will be obtained using automated BP monitors (OMRON IntelliSenseTM HEM-907XL)
Measured: Change in baseline SBP at 6 months post intervention follow-up
LDL cholesterol
Blood sample will be drawn by a trained phlebotomist and sent to the laboratory for LDL cholesterol.
Measured: Change in baseline LDL at 6 months post intervention follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2022
- Study start1 Aug 2022
- Primary completion31 Jul 2025
- Study completion31 Jul 2025
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 Diabetic NephropathiesStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical College of Wisconsin
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mukoso N. Ozieh, Medical College of Wisconsin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05357742
- Sponsor's protocol ID
- PRO00041675
- Other IDs
- R21DK131356
- Status last verified
- Dec 2025
- First submitted
- 27 Apr 2022
- Last updated
- 26 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ozieh MN, Patterson CG, Williams JS, Walker RJ, Egede LE. Basic needs navigation intervention to address multidimensional adversity in African Americans with diabetic kidney disease: A pilot randomized clinical trial protocol. Contemp Clin Trials. 2026 Feb;161:108183. doi: 10.1016/j.cct.2025.108183. Epub 2025 Dec 17.
PubMed 41419054
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Basic Needs Navigation Intervention to Address Multidimensional Adversity in African Americans With Diabetic Kidney Disease
- ClinicalTrials.gov ID
- NCT05357742
- Acronym / sponsor ID
- PRO00041675
- Conditions
- Diabetic Nephropathies, Diabetes Mellitus, Type 2, Chronic Kidney Diseases, Healthy Lifestyle
- Keywords
- Social risk factors, Social determinants of health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Medical College of WisconsinUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- 31 Jul 2025 (actual)
- Study completion
- 31 Jul 2025 (actual)
- First posted
- 3 May 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 overarching goal of this proposal is to test the feasibility of a basic needs navigation intervention on improving clinical outcomes, self-care behaviors and quality of life in low-income African Americans with diabetic kidney disease (DKD) experiencing multidimensional adversity.
The study objective will be achieved with the following aims:
Aim 1: To determine the feasibility of a basic needs navigation intervention as measured by recruitment, session attendance and retention in low-income Africans Americans with DKD experiencing multidimensional adversity.
Aim 2: To determine the frequency and compounding nature of different basic needs in Africans Americans with DKD experiencing multidimensional adversity to help refine the basic needs navigation intervention.
Aim 3: To evaluate the change and variability in the clinical outcomes (hemoglobin A1c, blood pressure, lipids) at 6 months of follow-up to plan for larger trial.
Detailed description
Multidimensional adversity, defined as having three or more social adversities such as housing instability, food insecurity, transportation needs, utility needs, interpersonal safety, and financial strain impacts the complex self-management of DKD and negatively impacts health outcomes. Evidence suggests patient navigation programs may be a promising strategy to improve health outcomes in low-income individuals with chronic disease. However, there is limited evidence on the use of patient navigator programs to address multidimensional adversity in individuals with chronic disease. Therefore, the primary objective of this study is to address this gap in knowledge.
Study overview: This will be accomplished using a two-arm pilot randomized control trial. Fifty (50) African American adults with DKD experiencing multidimensional adversity will be randomized into one of two arms: 1) Intervention arm and 2) Enhanced usual care arm.
Description of intervention: Participants randomized to the intervention arm will receive the manualized study intervention which includes three components 1) DKD education, 2) Individualized basic needs navigation, and 3) Lifestyle coaching and skills training. Participants will be provided a FORA 2-in-1 device with glucose test strips to allow testing at least once a day. The device automatically uploads blood pressure and glucose readings to a secure server in real time and the health educator will have access to this secure server. Readings will be used to guide lifestyle coaching and skills training. All participants will be assessed at baseline, 3- and 6-months for clinical outcomes (hemoglobin A1c, blood pressure, lipids), self-care behaviors (diet, exercise, and medication adherence), and quality of life (SF-12).
Control arm (Enhanced usual care arm): Participants randomized to the control arm will receive the manualized study intervention which incudes only DKD education.
All participants will be assessed at baseline, 3- and 6-months for clinical outcomes (hemoglobin A1c, blood pressure, lipids), self-care behaviors (diet, exercise, and medication adherence), and quality of life (SF-12).
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Behavioral: Individualized basic need navigation and lifestyle coaching and skills trainingParticipants randomized to the intervention group will receive the manualized study intervention delivered by a health educator via telephone weekly for 12-weeks, followed by three monthly booster sessions resulting in a total of 6 months intervention. |
| Control group | Active comparator | Behavioral: Enhanced usual careParticipants randomized to the control group will receive the manualized study intervention delivered by a health educator via telephone weekly for 12-weeks, followed by three monthly booster sessions resulting in a total of 6 months intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- self- report as Black/African American
- 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
- diagnosed type 2 diabetes (T2DM) with HbA1c≥8
- chronic kidney disease (CKD)
Key exclusion criteria (9 listed)
- does not identify as Black/African American
- age <18
- no diagnosis of T2DM and CKD
- cognitive impairment at screening visit
- active psychosis
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 |
|---|---|---|
| Individualized basic need navigation and lifestyle coaching and skills trainingDuring each session participants will receive the manualized study intervention which includes 1) DKD education, 2) Individualized basic needs navigation, and 3) Lifestyle coaching and skills training. Participants will be provided a FORA 2-in-1 device with glucose test strips to allow testing at least once a day. The device automatically uploads blood pressure and glucose readings to a secure server in real time and the health educator will have access to this secure server. Readings will be used to guide lifestyle coaching and skills training. | Behavioural | Intervention Group |
| Enhanced usual careDuring each session participants will receive DKD education only. | Behavioural | Control group |
Primary outcome
Feasibility of the basic needs navigation intervention
Time frame: At 6 months post intervention follow-up
Feasibility of the basic needs navigation intervention as measured by recruitment, session attendance and retention
4 secondary outcomes
Basic Needs
Time frame: At 6 months post intervention follow-up
Hemoglobin A1c (Hb A1c)
Time frame: Change in baseline Hb A1c at 6 months post intervention follow-up
Systolic blood pressure (SBP)
Time frame: Change in baseline SBP at 6 months post intervention follow-up
LDL cholesterol
Time frame: Change in baseline LDL at 6 months post intervention follow-up
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 26 Dec 2025.
- Derived from this study: PubMed 41419054Ozieh MN, Patterson CG, Williams JS, Walker RJ, Egede LE. Basic needs navigation intervention to address multidimensional adversity in African Americans with diabetic kidney disease: A pilot randomized clinical trial protocol. Contemp Clin Trials. 2026 Feb;161:108183. doi: 10.1016/j.cct.2025.108183. Epub 2025 Dec 17.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Individualized basic need navigation and lifestyle coaching and skills training in people with Diabetic Nephropathies 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 6 inclusion and 9 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 26 Dec 2025. 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?
Feasibility of the basic needs navigation intervention (time frame: At 6 months post intervention follow-up). 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 NCT05357742, 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 26 Dec 2025.