The CAG Bipolar the CAG Bipolar RCT

Bipolar Disorder Clinical Trial

Official title:

Effects of Specialized Treatment for Bipolar Disorder - the CAG Bipolar RCT

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04229875
• Other study ID #: H-19067248
• Status: Recruiting
• Phase: N/A
• Start date: January 13, 2020
• Est. completion date: January 13, 2025

Study information

• Verified date: March 2023
• Source: Mental Health Services in the Capital Region, Denmark
• Contact: Lars Vedel Kessing, Prof., MD, DMSc
• Phone: +4538647073
• Email: lars.vedel.kessing[@]regionh.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: January 13, 2025
• Est. primary completion date: November 13, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bipolar Disorder

Intervention

Other:
• CAG Bipolar
See description of CAG Bipolar

Locations

Country	Name	City	State
Denmark	Psychiatric Center Copenhagen	Copenhagen

Sponsors (3)

Lead Sponsor	Collaborator
Mental Health Services in the Capital Region, Denmark	Maria Faurholt-Jepsen, MD, DMSc, The Mental Health Services in the Capital Region of Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	Long-term register-based outcome measures: duration of hospitalization	Danish registry data with data available on number of longt-term days during hospitalizations	3, 5 and 10 years follow-up
Other	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
Other	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
Other	Long-term register-based outcome measures: somatic comorbidity	Danish registry data with data available on somatic diagnoses	3, 5 and 10 years follow-up
Other	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
Primary	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
Primary	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
Secondary	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
Secondary	Perceived stress according to Cohen's Perceived stress scale	Patient evaluated. Scores between 0-40. Higher score indicate higher perceived stress.	Baseline, 6 months and 12 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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