Trial Outcomes & Findings for Addressing Basic Needs to Improve Diabetes Outcomes in Medicaid Beneficiaries (NCT NCT03940209)
NCT ID: NCT03940209
Last Updated: 2026-05-04
Results Overview
Glycated haemoglobin (A1c) values will be abstracted from participants' medical record lab reports
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
473 participants
Primary outcome timeframe
6-12 months
Results posted on
2026-05-04
Participant Flow
Participant milestones
| Measure |
Usual Care
Medicaid beneficiaries in this arm will have all the usual resources available to them through their health plan including access to a physician network, case management resources, and other educational and health-focused resources and activities.
|
Basic Needs Navigation
Medicaid beneficiaries in this arm will have all the usual resources available to them through their health plan (usual care) as well as a navigator for 6 months to address any unmet basic needs, provide instrumental and emotional social support, and improve self-management capabilities.
Basic needs navigation: Navigators will help participants address unmet basic needs for 6 months by telephone. Either party can initiate a call. On every call, navigators will: (1) review unmet needs previously reported (baseline survey for first call) and ask participants to report new needs; (2) jointly prioritize among multiple needs based on severity and resource availability; (3) identify community resources that could help solve the problem; (4) evaluate eligibility for those resources; and (5) prepare participants to interact with service agencies and/or act as an advocate on their behalf. On each subsequent call, navigators will review progress toward resolving those needs, assess emergent needs, and adapt priorities accordingly. Navigators will provide instrumental and emotional social support through regular friendly contact, and will attempt to reduce barriers to needs resolution to improve stability and security for participants longer-term.
|
|---|---|---|
|
Overall Study
STARTED
|
239
|
234
|
|
Overall Study
COMPLETED
|
160
|
152
|
|
Overall Study
NOT COMPLETED
|
79
|
82
|
Reasons for withdrawal
| Measure |
Usual Care
Medicaid beneficiaries in this arm will have all the usual resources available to them through their health plan including access to a physician network, case management resources, and other educational and health-focused resources and activities.
|
Basic Needs Navigation
Medicaid beneficiaries in this arm will have all the usual resources available to them through their health plan (usual care) as well as a navigator for 6 months to address any unmet basic needs, provide instrumental and emotional social support, and improve self-management capabilities.
Basic needs navigation: Navigators will help participants address unmet basic needs for 6 months by telephone. Either party can initiate a call. On every call, navigators will: (1) review unmet needs previously reported (baseline survey for first call) and ask participants to report new needs; (2) jointly prioritize among multiple needs based on severity and resource availability; (3) identify community resources that could help solve the problem; (4) evaluate eligibility for those resources; and (5) prepare participants to interact with service agencies and/or act as an advocate on their behalf. On each subsequent call, navigators will review progress toward resolving those needs, assess emergent needs, and adapt priorities accordingly. Navigators will provide instrumental and emotional social support through regular friendly contact, and will attempt to reduce barriers to needs resolution to improve stability and security for participants longer-term.
|
|---|---|---|
|
Overall Study
Death
|
2
|
2
|
|
Overall Study
Withdrawal by Subject
|
18
|
11
|
|
Overall Study
Lost to Follow-up
|
59
|
68
|
|
Overall Study
Incomplete survey
|
0
|
1
|
Baseline Characteristics
Addressing Basic Needs to Improve Diabetes Outcomes in Medicaid Beneficiaries
Baseline characteristics by cohort
| Measure |
Usual Care
n=239 Participants
Medicaid beneficiaries in this arm will have all the usual resources available to them through their health plan including access to a physician network, case management resources, and other educational and health-focused resources and activities.
|
Basic Needs Navigation
n=234 Participants
Medicaid beneficiaries in this arm will have all the usual resources available to them through their health plan (usual care) as well as a navigator for 6 months to address any unmet basic needs, provide instrumental and emotional social support, and improve self-management capabilities.
Basic needs navigation: Navigators will help participants address unmet basic needs for 6 months by telephone. Either party can initiate a call. On every call, navigators will: (1) review unmet needs previously reported (baseline survey for first call) and ask participants to report new needs; (2) jointly prioritize among multiple needs based on severity and resource availability; (3) identify community resources that could help solve the problem; (4) evaluate eligibility for those resources; and (5) prepare participants to interact with service agencies and/or act as an advocate on their behalf. On each subsequent call, navigators will review progress toward resolving those needs, assess emergent needs, and adapt priorities accordingly. Navigators will provide instrumental and emotional social support through regular friendly contact, and will attempt to reduce barriers to needs resolution to improve stability and security for participants longer-term.
|
Total
n=473 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
51.3 years
STANDARD_DEVIATION 9.7 • n=54 Participants
|
51.8 years
STANDARD_DEVIATION 9.4 • n=60 Participants
|
51.6 years
STANDARD_DEVIATION 9.5 • n=114 Participants
|
|
Sex: Female, Male
Female
|
180 Participants
n=54 Participants
|
180 Participants
n=60 Participants
|
360 Participants
n=114 Participants
|
|
Sex: Female, Male
Male
|
59 Participants
n=54 Participants
|
54 Participants
n=60 Participants
|
113 Participants
n=114 Participants
|
|
Race/Ethnicity, Customized
Non-Hispanic White
|
66 Participants
n=54 Participants
|
65 Participants
n=60 Participants
|
131 Participants
n=114 Participants
|
|
Race/Ethnicity, Customized
Non-Hispanic Black/African American
|
152 Participants
n=54 Participants
|
150 Participants
n=60 Participants
|
302 Participants
n=114 Participants
|
|
Race/Ethnicity, Customized
Hispanic, mixed race, other race
|
17 Participants
n=54 Participants
|
15 Participants
n=60 Participants
|
32 Participants
n=114 Participants
|
|
Region of Enrollment
United States
|
239 Participants
n=54 Participants
|
234 Participants
n=60 Participants
|
473 Participants
n=114 Participants
|
|
Social Needs
|
2.85 units on a scale
STANDARD_DEVIATION 1.67 • n=54 Participants
|
2.94 units on a scale
STANDARD_DEVIATION 1.77 • n=60 Participants
|
2.89 units on a scale
STANDARD_DEVIATION 1.72 • n=114 Participants
|
PRIMARY outcome
Timeframe: 6-12 monthsPopulation: Members for whom lab values could be obtained for HbA1c tests documented in claims data at least 6-12 months post-baseline, with preference given to the earliest one completed after 6 months post-baseline
Glycated haemoglobin (A1c) values will be abstracted from participants' medical record lab reports
Outcome measures
| Measure |
Usual Care
n=94 Participants
Medicaid beneficiaries in this arm will have all the usual resources available to them through their health plan including access to a physician network, case management resources, and other educational and health-focused resources and activities.
|
Basic Needs Navigation
n=69 Participants
Medicaid beneficiaries in this arm will have all the usual resources available to them through their health plan (usual care) as well as a navigator for 6 months to address any unmet basic needs, provide instrumental and emotional social support, and improve self-management capabilities.
Basic needs navigation: Navigators will help participants address unmet basic needs for 6 months by telephone. Either party can initiate a call. On every call, navigators will: (1) review unmet needs previously reported (baseline survey for first call) and ask participants to report new needs; (2) jointly prioritize among multiple needs based on severity and resource availability; (3) identify community resources that could help solve the problem; (4) evaluate eligibility for those resources; and (5) prepare participants to interact with service agencies and/or act as an advocate on their behalf. On each subsequent call, navigators will review progress toward resolving those needs, assess emergent needs, and adapt priorities accordingly. Navigators will provide instrumental and emotional social support through regular friendly contact, and will attempt to reduce barriers to needs resolution to improve stability and security for participants longer-term.
|
|---|---|---|
|
HbA1c
|
8.21 HbA1c percentage
Standard Deviation 1.84
|
8.16 HbA1c percentage
Standard Deviation 1.74
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: Subset of participants who completed outcome measure at 12 months follow up
Physical and mental health aggregate scores from the Short Form-12 item (SF-12) self-report survey instrument were created following standard scoring guides. Standardized scores are reported with a mean of 50 and standard deviation of 10. Higher scores indicate better health status and better health-related quality of life (e.g., Physical health aggregate (1-100; higher=better health) and Mental health aggregate (1-100; higher=better health).
Outcome measures
| Measure |
Usual Care
n=158 Participants
Medicaid beneficiaries in this arm will have all the usual resources available to them through their health plan including access to a physician network, case management resources, and other educational and health-focused resources and activities.
|
Basic Needs Navigation
n=150 Participants
Medicaid beneficiaries in this arm will have all the usual resources available to them through their health plan (usual care) as well as a navigator for 6 months to address any unmet basic needs, provide instrumental and emotional social support, and improve self-management capabilities.
Basic needs navigation: Navigators will help participants address unmet basic needs for 6 months by telephone. Either party can initiate a call. On every call, navigators will: (1) review unmet needs previously reported (baseline survey for first call) and ask participants to report new needs; (2) jointly prioritize among multiple needs based on severity and resource availability; (3) identify community resources that could help solve the problem; (4) evaluate eligibility for those resources; and (5) prepare participants to interact with service agencies and/or act as an advocate on their behalf. On each subsequent call, navigators will review progress toward resolving those needs, assess emergent needs, and adapt priorities accordingly. Navigators will provide instrumental and emotional social support through regular friendly contact, and will attempt to reduce barriers to needs resolution to improve stability and security for participants longer-term.
|
|---|---|---|
|
Health-related Quality of Life
SF12v2 Physical health aggregate (1-100; higher=better health)
|
36.03 units on a scale
Standard Deviation 11.84
|
36.52 units on a scale
Standard Deviation 11.53
|
|
Health-related Quality of Life
SF12v2 Mental health aggregate (1-100; higher=better health)
|
45.14 units on a scale
Standard Deviation 8.04
|
45.32 units on a scale
Standard Deviation 9.02
|
Adverse Events
Usual Care
Serious events: 0 serious events
Other events: 0 other events
Deaths: 2 deaths
Basic Needs Navigation
Serious events: 0 serious events
Other events: 0 other events
Deaths: 2 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place