Bipolar Disorder
Conditions
Brief summary
The CAG Bipolar study is a large-scale pragmatic randomized controlled trial aiming to investigate whether specialized and more centralized treatment (into a clinical academic group (CAG)) improves lives and outcomes for patients with bipolar disorder (N= 1000 patients).
Detailed description
Bipolar disorder is a complex illness with a complex treatment that differs during manic, depressed and remitted states, frequently leaving patients with decreased quality of life and impaired psychosocial function. Traditionally, psychiatry has been sparsely subspecialized in Denmark as well as internationally during the last four decades leaving patients in generalized psychiatric settings. At the same time, demands to clinical skills, research and education have increased, and IT solutions have emerged as a possible way to optimize treatment. Effects of organizational changes and digital health interventions are rarely investigated scientifically in health care services. This is a randomized controlled trial conducted in the entire Mental Health Services, Capital Region of Denmark including all psychiatric centers in the region. The CAG Bipolar study is a large-scale pragmatic randomized controlled trial aiming to investigate whether specialized and more centralized treatment (into a clinical academic group (CAG)) improves lives and outcomes for patients with bipolar disorder (N= 1000 patients). Findings from the study will have great impact on future organization and optimization of treatment within psychiatry in Denmark as well as internationally.
Interventions
OTHERCAG Bipolar
See description of CAG Bipolar
Sponsors
Maria Faurholt-Jepsen, MD, DMSc
The Mental Health Services in the Capital Region of Denmark
Mental Health Services in the Capital Region, Denmark
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* All patients with a main diagnosis of bipolar disorder in the five largest psychiatric centers in the Mental Health Services, Capital Region of Denmark (Psychiatric Center Copenhagen, Psychiatric Center Hillerød, Psychiatric Center Amager, Psychiatric Center Glostrup and Psychiatric Center Ballerup) will be asked for participation
Exclusion criteria
* None
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Risk of psychiatric hospitalization | During the entire study period of 12 months pr participant | Data on hospitalization according to data from the population-based Danish Psychiatric Central Research Register will be collected and analyzed with survival statistics. Assessed blinded for the intervention status |
| Cumulated duration of hospitalization according to data from the population-based Danish Psychiatric Central Research Register | During the entire study period of 12 months pr participant | Data on cumulated duration of hospitalization according to data from the population-based Danish Psychiatric Central Research Register will be collected and analyzed with survival statistics. Assessed blinded for the intervention status |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Satisfaction with care according to scores on the Verona Satisfaction Scale-Affective Disorder | Baseline, 6 months and 12 months | Patient evaluated. Higher scores indicate higher satisfaction with treatment. |
| Satisfaction with care according to scores on the Danish nation-wide patient satisfaction questionnaire | Baseline, 6 months and 12 months | Patient evaluated. Higher scores indicate higher satisfaction with treatment. |
| Adherence to the Danish national guidelines of medical treatment of bipolar disorder according to use of the three main maintenance mood stabilizers for bipolar disorder: lithium, lamotrigine or quetiapine | During the entire study period of 12 months per participant | Data collected from electronic patient records. |
| Clinicians' satisfaction with their work at start and end of the RCT | Baseline and 12 months | Clinician evaluated using the Medical Personnel Job Satisfaction Questionnaire |
| Patient-reported depressive symptoms according to the major depressive Inventory (MDI) | Baseline, 6 months and 12 months | Patient-evaluated. Higher scores indicate higher level of depressive symptoms. |
| Patient-reported manic symptoms according to the Altman Self-rating Scale for Mania (ASRM) | Baseline, 6 months and 12 months | Patient-evaluated. Higher scores indicate higher level of manic symptoms. |
| Proportion of patients starting group-based psychoeducation | During the entire study period of 12 months per centre | Proportion of patients in clinics starting in group-based psychoeducation |
| Quality of life according to WHO Quality of Life-BREF (WHOQoL) | Baseline, 6 months and 12 months | Scored between 0-100. Higher scores indicate higher quality of life. Patient evaluated |
| Perceived stress according to Cohen's Perceived stress scale | Baseline, 6 months and 12 months | Patient evaluated. Scores between 0-40. Higher score indicate higher perceived stress. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Long-term register-based outcome measures: psychosocial measures (sickdays) | 3, 5 and 10 years follow-up | Danish registry data with data available on number of days away form work |
| Long-term register-based outcome measures: somatic comorbidity | 3, 5 and 10 years follow-up | Danish registry data with data available on somatic diagnoses |
| Long-term register-based outcome measures: rate of suicide and death | 3, 5 and 10 years follow-up | Danish registry data with the data available |
| Long-term register-based outcome measures: prescribed medication | 3, 5 and 10 years follow-up | Danish registry data with data available on the medicine prescribed |
| Long-term register-based outcome measures: duration of hospitalization | 3, 5 and 10 years follow-up | Danish registry data with data available on number of longt-term days during hospitalizations |
| Long-term register-based outcome measures: risk of hospitalization | 3, 5 and 10 years follow-up | Danish registry data with data available on number of longt-term hospitalizations |
Countries
Denmark
Contacts
Primary ContactLars Vedel Kessing, Prof., MD, DMSc
Backup ContactMaria Faurholt-Jepsen, MD, DMSc
Outcome results
None listed