Nurse-led Case Management for Diabetes and Cardiovascular Disease Patients With Depression
Condition: Depression
MeSH terms: Depression; Depressive Disorder
Study type: Interventional

Summary: 
      This study will evaluate the effectiveness of a nurse-led case management intervention in
      improving disease control and depression symptoms in adults with diabetes and/or heart
      disease who are also depressed.
    

Detailed description: 
      Depression is a serious medical illness that has been associated with increased risk for
      heart disease and diabetes. Depression may negatively impact aspects of self-care that are
      required to effectively manage such long-term diseases. In depressed people who have heart
      disease and/or diabetes, treatment for depression appears to result in only limited
      improvements in depression symptoms and no improvements in heart disease and diabetes
      symptoms. An integrated treatment approach may be more effective in improving all three
      conditions. This study will evaluate the effectiveness of a nurse-led case management
      intervention in improving disease control and depression symptoms in adults with diabetes
      and/or heart disease who are also depressed.

      Participants in this single-blind study will be randomly assigned to take part in the case
      management intervention or receive usual care. All participants will attend 5 in-person study
      evaluation visits and receive 4 follow-up phone calls over 24 months. At each of the study
      visits, measurements of height, weight, waist size, and blood pressure will be taken. At
      study evaluations, blood and urine samples will also be taken. Participants will be asked not
      to eat for 8 hours before providing blood samples at 3 of the visits. During follow-up phone
      calls participants will answer various questions.

      The case management intervention will entail approximately 10 visits with a trained nurse at
      the clinic or by telephone. Participants in this group will receive educational materials
      about how to manage diabetes and/or heart disease and stress or depression. Nurses will also
      provide guidance and support in managing medications, phone calls to check participants'
      progress, and assistance in setting personal goals and in managing physical health problems
      and symptoms of depression or stress. Outcomes will be measured at Months 6, 12, 18, and 24
      months.
    

Intervention name(s): Nurse-led case management; Treatment as usual
Intervention type(s): Behavioral; Behavioral
Intervention description(s): The case management intervention will entail approximately 10 visits with a trained nurse at the clinic or by telephone. Participants in this group will receive educational materials about how to manage diabetes and/or heart disease and stress or depression. Nurses will also provide guidance and support in managing medications, phone calls to check participants' progress, and assistance in setting personal goals and in managing physical health problems and symptoms of depression or stress.; Participants will attend 10 study visits and receive 4 follow-up phone calls over 24 months. During this time, participants will receive usual care.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: major Depressive Disorder; Diabetes; Heart Disease