Chronic Kidney Diseases, Diabetes Mellitus, Type 2, Diabetic Nephropathies, Healthy Lifestyle
Conditions
Keywords
Social risk factors, Social determinants of health
Brief 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. 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).
Interventions
BEHAVIORALIndividualized basic need navigation and lifestyle coaching and skills training
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.
BEHAVIORALEnhanced usual care
During each session participants will receive DKD education only.
Sponsors
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Medical College of Wisconsin
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. self- report as Black/African American 2. age ≥18 3. screen positive for 1 or more adversities using the Centers for Medicare and Medicaid Services Accountable Health Communities Health-Related Social Needs Screening tool 4. diagnosed type 2 diabetes (T2DM) with HbA1c≥8 5. chronic kidney disease (CKD) 6. able to communicate in English.
Exclusion criteria
1. does not identify as Black/African American 2. age \<18 3. no diagnosis of T2DM and CKD 4. cognitive impairment at screening visit 5. active psychosis 6. active alcohol or drug abuse/dependency 7. life expectancy \<12 months 8. participation in other diabetes/CKD trials 9. unable to communicate in English.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of the basic needs navigation intervention | At 6 months post intervention follow-up | Feasibility of the basic needs navigation intervention as measured by recruitment, session attendance and retention |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Basic Needs | At 6 months post intervention follow-up | Frequency of basic needs will be assessed using the Centers for Medicare and Medicaid Services Accountable Health Communities Health-Related Social Needs Screening tool |
| Hemoglobin A1c (Hb A1c) | Change in baseline Hb A1c at 6 months post intervention follow-up | Blood will be drawn by trained phlebotomist for HbA1c |
| Systolic blood pressure (SBP) | Change in baseline SBP at 6 months post intervention follow-up | Blood pressure readings will be obtained using automated BP monitors (OMRON IntelliSenseTM HEM-907XL) |
| LDL cholesterol | Change in baseline LDL at 6 months post intervention follow-up | Blood sample will be drawn by a trained phlebotomist and sent to the laboratory for LDL cholesterol. |
Countries
United States
Outcome results
None listed