Diabetes Mellitus, Type 2
Conditions
Brief summary
The study is a randomized control trial involving 100 participants (formerly incarcerated Black men with poorly controlled diabetes) to examine the effect of a tailored nurse case manager on glycemic control and other clinical outcomes, self-care behaviors, and quality of life at 6 months post-randomization.
Detailed description
The study is a randomized control trial involving 100 participants (formerly incarcerated Black men with poorly controlled diabetes) to examine the effect of a tailored nurse case manager on glycemic control and other clinical outcomes, self-care behaviors, and quality of life at 6 months post-randomization. Participants assigned to MANAGe-DM will receive the standard diabetes education mailing in addition to a novel nurse case management intervention. Nurse case managers are trained RNs who support patients with T2DM by coordinating services, supporting self-care and implementing disease management strategies (Welch 2010). MANAGe-DM will include NCM services tailored to the health needs of Black men with recent release from incarceration and T2DM. MANAGe-DM will include three components: 1) diabetes education and skills training; 2) healthcare navigation and 3) basic needs navigation. The NCM will serve as an adjunct to the participant's primary care provider; they will not be embedded within a clinic but instead interact with the participant over the phone after study recruitment from a community setting.
Interventions
BEHAVIORALMANAGe-DM - novel nurse case management
Participants assigned to MANAGe-DM will receive the standard diabetes education mailing in addition to a novel nurse case management intervention. Each month of the study period, the NCM will conduct two phone call intervention sessions with individual participants.
BEHAVIORALMonthly Educational Mailing
All participants in the study will receive diabetes education mailers. This includes monthly mailings of diabetes education, based off the American Diabetes Association guidelines for Diabetes Education. Topics covered will include diabetes basics, monitoring and medications, healthy eating and exercise, overview of common comorbidities, basics of foot care, and strategies for overcoming common pitfalls.
Sponsors
Medical College of Wisconsin
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* age ≥18 years * identify as Black or African American * identify as male * formerly incarcerated in a state or federal prison system or county jail * clinical diagnosis of type 2 diabetes with HbA1c ≥8% at the screening visit * able to communicate in English.
Exclusion criteria
* mental confusion on screening interview suggesting significant dementia * current participation in other diabetes clinical trials * active psychosis or acute mental disorder * life expectancy <12 months * awaiting arraignment, trial, sentencing in the criminal legal system * on active surveillance by the criminal legal system, meaning on house arrest or subject to electronic monitoring
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hemoglobin A1C | 6 months post-randomization | Venous draw will be use to obtain HbA1C |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Blood Pressure | 6 months post-randomization | Blood pressure readings (both systolic and diastolic) will be obtained using automated BP monitors programmed to take 3 readings at 2 minute intervals and give average of the 3 readings |
| Quality of Life (Short Form Health Survey, SF-12) | 6 months post-randomization | The Short Form Health Survey (SF-12) version 1, developed by Ware et al. in 1996 is a valid and reliable instrument that will be used to measure quality of life. Scores will be reported in physical health related (PCS) and mental health related (MCS). Scores range from 0 to 100 with higher scores indicating better quality of life. |
Countries
United States
Contacts
Primary ContactLaura Hawks, MD
Outcome results
None listed