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| Name | Class |
|---|---|
| Maria Faurholt-Jepsen, MD, DMSc | UNKNOWN |
| The Mental Health Services in the Capital Region of Denmark | UNKNOWN |
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CAG Bipolar | Experimental |
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| Control group | No Intervention | Standard treatment |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CAG Bipolar | Other | See description of CAG Bipolar |
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| Measure | Description | Time Frame |
|---|---|---|
| Risk of psychiatric hospitalization | 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 | During the entire study period of 12 months pr participant |
| Cumulated duration of hospitalization according to data from the population-based Danish Psychiatric Central Research Register | 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 | During the entire study period of 12 months pr participant |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of life according to WHO Quality of Life-BREF (WHOQoL) | Scored between 0-100. Higher scores indicate higher quality of life. Patient evaluated | Baseline, 6 months and 12 months |
| Perceived stress according to Cohen's Perceived stress scale |
| Measure | Description | Time Frame |
|---|---|---|
| Long-term register-based outcome measures: risk of hospitalization | Danish registry data with data available on number of longt-term hospitalizations | 3, 5 and 10 years follow-up |
| Long-term register-based outcome measures: duration of hospitalization |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lars Vedel Kessing, Prof., MD, DMSc | Contact | +4538647073 | lars.vedel.kessing@regionh.dk | |
| Maria Faurholt-Jepsen, MD, DMSc | Contact | +4538647073 | maria.faurholtjepsen@regionh.dk |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Psychiatric Center Copenhagen | Recruiting | Copenhagen | 2100 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34645661 | Derived | Kessing LV, Kyster NB, Bondo-Kozuch P, Christensen EM, Vejstrup B, Smidt B, Jorgensen AB, Rosenberg R, Mardosas D, Rasmussen LB, Vinberg M, Hageman I, Faurholt-Jepsen M; CAG Bipolar Study group. Effect of specialised versus generalised outpatient treatment for bipolar disorder: the CAG Bipolar trial - study protocol for a randomised controlled trial. BMJ Open. 2021 Oct 13;11(10):e048821. doi: 10.1136/bmjopen-2021-048821. |
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| ID | Term |
|---|---|
| D001714 | Bipolar Disorder |
| ID | Term |
|---|---|
| D000068105 | Bipolar and Related Disorders |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
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Patient evaluated. Scores between 0-40. Higher score indicate higher perceived stress.
| Baseline, 6 months and 12 months |
| Satisfaction with care according to scores on the Verona Satisfaction Scale-Affective Disorder | Patient evaluated. Higher scores indicate higher satisfaction with treatment. | Baseline, 6 months and 12 months |
| Satisfaction with care according to scores on the Danish nation-wide patient satisfaction questionnaire | Patient evaluated. Higher scores indicate higher satisfaction with treatment. | Baseline, 6 months and 12 months |
| 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 | Data collected from electronic patient records. | During the entire study period of 12 months per participant |
| Clinicians' satisfaction with their work at start and end of the RCT | Clinician evaluated using the Medical Personnel Job Satisfaction Questionnaire | Baseline and 12 months |
| Patient-reported depressive symptoms according to the major depressive Inventory (MDI) | Patient-evaluated. Higher scores indicate higher level of depressive symptoms. | Baseline, 6 months and 12 months |
| Patient-reported manic symptoms according to the Altman Self-rating Scale for Mania (ASRM) | Patient-evaluated. Higher scores indicate higher level of manic symptoms. | Baseline, 6 months and 12 months |
| Proportion of patients starting group-based psychoeducation | Proportion of patients in clinics starting in group-based psychoeducation | During the entire study period of 12 months per centre |
Danish registry data with data available on number of longt-term days during hospitalizations
| 3, 5 and 10 years follow-up |
| Long-term register-based outcome measures: prescribed medication | Danish registry data with data available on the medicine prescribed | 3, 5 and 10 years follow-up |
| Long-term register-based outcome measures: psychosocial measures (sickdays) | Danish registry data with data available on number of days away form work | 3, 5 and 10 years follow-up |
| Long-term register-based outcome measures: somatic comorbidity | Danish registry data with data available on somatic diagnoses | 3, 5 and 10 years follow-up |
| Long-term register-based outcome measures: rate of suicide and death | Danish registry data with the data available | 3, 5 and 10 years follow-up |