Diabetes Mellitus, Insulin Dependent
Conditions
Keywords
diabetes, regimen adherence, metabolic control, adolescents, family therapy
Brief summary
The study is a randomized clinical trial testing the effectiveness of Multisystemic Therapy (MST) for improving the treatment adherence, metabolic control and quality of life of urban adolescents with poorly controlled insulin dependent diabetes.
Detailed description
The deterioration in regimen adherence and metabolic control associated with the adolescent developmental period is well-documented. However, a subset of high-risk adolescents with diabetes demonstrate much more serious adherence problems, as evidenced by chronically poor metabolic control (CPMC) and post-diagnostic admissions for diabetic ketoacidosis (DKA). Adolescents in CPMC represent a group at high risk for both short and long term diabetes complications and are therefore heavy users of medical resources and health care dollars. Minority and low-income children are over-represented among adolescents with CPMC. The design for the proposed study is a randomized, controlled trial with a repeated measures design using a sample of 170 adolescents, 85 of whom will receive MST and 85 of whom will receive a telephone intervention to test the effect of increased attention (control condition). Subjects must have a current hemoglobin A1C (HbA1c) of \>8% and an average HbA1c of \>8% during the past year, must be diagnosed with insulin dependent diabetes for at least one year, be 10-17 years of age and reside in the metro Detroit tri-county area. Exclusion criteria are severe mental impairment/thought disorder, non-English speaking patient/parent or a co-morbid major medical condition such as cystic fibrosis. Families who are randomized to MST receive intensive, home-based family therapy for approximately six months. MST is a community based treatment originally designed for use with adolescents presenting with serious mental health problems, but which is adapted in the present study for use with chronically ill youth and serious adherence difficulties. Therapists meet with families two to three times per week at the beginning of treatment with a decreasing number of sessions at the end of treatment.
Interventions
BEHAVIORALIntensive Home-Based Family Therapy
Multisystemic Therapy (MST): Adolescents receiving MST will receive home-based, family psychotherapy sessions 2-3 times a week, lasting 60 minutes in duration from a pediatric mental health worker for six months. The purpose of the therapy sessions are to improve the youths' ability to complete their dilay diabetes illness management tasks, reduce average blood glucose levels and improve metabolic control.
BEHAVIORALSupportive Telephone Calls
Telephone Support Calls: Adolescents receiving TS will receive weekly 30 minute phone calls from a pediatric mental health worker for six months. The purpose of the call is to provide emotional support regarding the adolescent's chronic medical condition, assess adherence to the prescribed regimen and to help the adolescent brainstorm solutions to any barriers they identify to completion of diabetes care.
Sponsors
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Wayne State University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
10 Years to 17 Years
Healthy volunteers
No
Inclusion criteria
* insulin dependent Type 1 or Type 2 diabetes * diagnosed with diabetes ≥ 1 year * current HbA1c ≥ 8% * average HbA1c ≥ 8% over the past year * aged 10 -17 * patient of Children's Hospital of Michigan Diabetes Clinic * lives within 30 miles of Children's Hospital of Michigan
Exclusion criteria
* moderate to severe mental retardation (unable to complete study measures) * psychosis or current suicidal intent * any medical diagnosis that alters standard diabetes care
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Metabolic Control: Hemoglobin A1c (HbA1c) | treatment termination, 6-month follow up | Retrospective measure of blood glucose control, encompasses the previous 2-3 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Diabetes-Specific Family Functioning | treatment termination, 6-month follow up | Diabetes Family Responsibility Questionnaire (DFRQ), Parental Monitoring of Adolescent Diabetes Care (PMADC), Diabetes Social Support Questionnaire-Family (DSSQ-Family) |
| DKA admissions and emergency room (ER) Visits: hospital information systems data extraction, Service Utilization Questionnaire (SUQ) | treatment termination, 6-month follow up | The number of patient visits to acute care settings represents a significant health care cost in this high-risk population. |
| BMI percentile | treatment termination, 6-month follow up | Body mass index (BMI) a value derived from the mass and height of an individual |
| Regimen Adherence: Diabetes Management Scale (DMS), Twenty-Four Hour Recall Interview, Glucose Meter Downloads | treatment termination, 6-month follow up | The DMS assesses a broad range of management behaviors, such as insulin management, dietary management, blood glucose monitoring, symptom response, and parent assistance/supervision. Glucose meters only assess blood glucose monitoring, but are empirically linked to metabolic control. |
Countries
United States
Outcome results
None listed