Schizophrenic Patients in Integrated Care

CARE II - Evaluation of Treatment Outcomes in Schizophrenic Patients Taking Part in the Integrated Care Program - a Single-country, Multi-centre Phase IV Study

Status

Terminated

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00681629

Acronym

CARE II

Enrollment

Registered

2008-05-21

Start date

2008-07-31

Completion date

2008-11-30

Last updated

2012-07-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Schizoaffective Disorder, Schizophrenia, Schizophreniform Disorder

Keywords

Schizophrenia, Integrated Care, Quetiapine

Brief summary

The purpose of the study is to investigate the well-being of schizophrenic patients treated with quetiapine XR combined with participation in the integrated care program compared to a treatment with quetiapine XR alone over a period of 18 month

Interventions

DRUGQuetiapine XR

400-800 mg, oral, bid

OTHERIntegrated Care Program (ICP)

Integrated care program (ICP), this is a legally based integrated care program covered by a contract according to §§ 140 a-d SGB-V (SGB: social security code); The ICP is not exclusively designed for this phase IV trial. Participation in the ICP is possible anytime for each patient in whom the services are covered by the individual health insurance.

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Inclusion criteria

* Patients with baseline SWN-K \<=70 * Provision of signed informed consent * Out-patients with schizophrenia, schizophreniform disorder or schizoaffective disorder, severe postpartum depressive disorders with psychotic symptoms and a minimum HAM-D cut off score of 20 points

Exclusion criteria

* Evidence of a clinical relevant disease, eg renal or hepatic impairment, significant coronary heart disease, hepatitis B or C, AIDS * Patients with known cardiovascular disease or other condition predisposing to hypotension or family history of QT prolongation * Patients who pose an imminent risk of suicide or danger to self or others

Design outcomes

Primary

Measure	Time frame	Description
Subjective Well-being in Patients Treated for Schizophrenia, Schizoaffective Disorder, Schizophreniform Disorder, Delusional Disorder or Psychotic Disorder Not Otherwise Specified Using the SWN-K (Subjective Well-being Under Neuroleptics) Scale	4 months	The SWN-K is comprised of 20 questions, each of which is rated using a 6 point scale ranging from 1 (not at all) to 6 (very much). Possible scores range from 20-120, with higher scores implying higher subjective well-being.

Secondary

Measure	Time frame	Description
Symptomatic Outcome Using CGI-S (Clinical Global Impression-Schizophrenia) Scale	4 month	With the CGI-S the rate of the severity of a patient's symptoms (positive, negative, cognitive, depressive and overall) using a scale ranging from 1 (normal, not ill) to 7 (among the most severely ill) is measured - higher scores implying higher severity.
Symptomatic Outcome Using the PANSS-8 Scales(Positive and Negative Symptoms) Scale Score	4 month	The schizophrenic symptomatology will be measured by the Positive and Negative Syndrome Scale (PANSS) providing 8 items of which each is rated on a severity scale ranging from 1-7, (1= absent - 7 = extreme severe. higher scores implying higher severity.
GAF (Global Assessment of Functioning) Scale Score	4 month	The GAF is a numeric rating scale used by clinicians for assessment of the social, occupational, psychological functioning of adult patients. The scale represents a hypothetical continuum of mental health illness providing a descending scoring code from 100 until 0. Higher scores indicate better patient condition and performance.
PSP (Personal and Social Performance) Scale Score	4 month	The '(PSP rating scale (100 until 0) used by clinicians for assessment of 4 main domains of functioning in adult patients acc. (a) socially useful activities including work and study, (b) personal and social relationships, (c) self-care, and (d) disturbing and aggressive behavior. Higher scores indicate better patient condition and performance.
EQ-5D (European Quality of Life Questionnaire) Score	4 month	The EQ-5D questionnaire is a generic measure of health status. It defines health in terms of five dimensions:1 (Mobility); 2 (Self-care); 3 (Usual activity); 4 (Pain/Discomfort); 5 (Anxiety/Depression). The minimum possible value is 5 (one point for each dimension) and the maximum possible values is 15 (3 points for each dimension). Each dimension has 3 levels of severity- no problems, some problems and extreme problems. Higher scores indicate more problems.
Vocational Occupational Index VOC Score	Up to 18 months (V1 Day 1, V2 Month 1, V3 Month 3, V4 Month 6, V5 Month 12, V6 Month 18)	The VOC index will assess the following 7 items: 1 fulltime gainful employment, 2 homemaker or student, 3 part-time gainful employment (20 hours per week or less), 4 retired, 5 full or part-time volunteer, 6 on medical or psychiatric leave of absence, 7 unemployed, whether or not expected to work. Results will be descriptively summarized. The VOC index will be completed at each visit. Difference from baseline of the index will be derived at each assessment
Assess Quality of Life Levels Using the Q-LES-Q-18 (Quality of Life Enjoyment and Satisfaction) Questionnaire	4 month	Q-LES-Q-18 will allow to generate a general QoL-index which will be used for the analysis and is defined as the average of the single scores for all 18 items. Scoring will be carried out from 1-5 per item (never / rarely / sometimes / frequently / all the time). Results will be descriptively summarized.
Assess Quality of Life Levels Using the RSM Scale (Riedel-Spellmann-Musil) Scale	4 month	The '(RSM is a new 36-item measure validated to assess the QoL in different dimensions of schizophrenic patient treated with antipsychotics. It will be rated on a four-point Likert scale (not / rather not / rather yes / yes) by the patient and the investigator. The total score ranges from min. 0 to max. of 108. Higher scores indicate higher QoL.
Assess Patient Engagement to Therapy Using the SES Scale (Service Engagement Scale)	4 month	The 'SES is a 14-item measure consisting of statements that assess the client specific engagement with services. It will be rated on a four-point Likert scale (not at all / rarely / sometimes / most of the time) by the investigator. The total score ranges from min. 0 to a max. of 42. Higher scores indicate lower engagement.
Subjective Well-being Using the SWN-K (Subjective Well-being Under Neuroleptics Scale) Total Score	4 month	The SWN-K is comprised of 20 questions, each of which is rated using a 6 point scale ranging from 1 (not at all) to 6 (very much). Possible scores range from 20-120, with higher scores implying higher subjective well-being.
Evaluate the Level of the Patients' (Subjective) Satisfaction Using the CSQ-8 Scale (Client Satisfaction Questionnaire)	4 month	The 'CSQ-8 is a brief, self-administered method to monitor the consumer's satisfaction with services in outpatient psychotherapy, showing high internal consistency. It is identified as a core subset of the general CSQ covering 8 Likert-type items with four response choices where '1' indicates the lowest and '4' the highest degree of satisfaction.
Assess Health Economy Improvements in Terms of a Reduction in Treatment Costs and Loss of Productivity by Determination of the Total Cost by Number of Days With Hospitalization	4 month	Any hospitalisation days in inpatients units and emergency ward stays will be recorded. At each hospitalisation, the number of days will be computed and at each visit, the cumulative total number of days will be used to calculate total costs. As higher the number of hospitalisation days as higher the costs per patient.
Assess Health Economy Improvements in Terms of a Reduction in Treatment Costs and Loss of Productivity by Determination of the Total Number of Days the Patient Was Not Able to Work or go to School or Complete Routine Daily Activities	4 month	The number of lost work days, lost school days or days without completing routine daily activities will be evaluated. With any number of lost workdays or lost school days or without completing routine daily activities, the costs will increase and the productivity will decrease.
Assess Health Economy Improvements in Terms of a Reduction in Treatment Costs and Loss of Productivity by Determination of the Need for Any Additional Antipsychotic Medication	4 month	Concomitant psychotropic drugs will be coded (ATC = Drug code) to allow a comparison of the number of drugs used per ATC class and per treatment visit. The drugs used will be listed by keeping their brand name for allowing to translate them into costs.
Evaluate Safety and Tolerability by Evaluation of Weight/Waist Circumference	4 month	Measuring of weight and waist circumference in centimeter.
Evaluate Safety and Tolerability by Evaluation of Laboratory Tests	4 month	Measuring of: B-Haemoglobin (g/dl), B-Haematocrit(%), B-Erythrocyte count(pl), B-Leucocytes count (nl), B-Platelet count(nl), Complete blood count (nl), B-Leucocytes differential count (%), B-HbA1c(%), S-ALAT (U/l), S-ASAT (U/l), S-GGT (U/l), P-Glucose (fasting)(mh/dl), S-prolactin level (ng/ml), S-Pregnancy test (IU/l), Qualitative analysis of urine with Stix®,Urine pregnancy. Comparing results with standard values.
Evaluate Safety and Tolerability by Evaluation of Concomitant Medication	4 month	Listing of all concomitant medication to show the efficacy and safety.
Evaluate Safety and Tolerability by Evaluation of the Incidence of Adverse Events	4 month	Listing of all adverse event or SAE´s to show the safety and tolerability.
Assess Compliance/Medication Adherence Using the MARS Scale (Medication Adherence Rating Scale)	4 month	The 'Medication Adherence Rating Scale' (MARS) is a reliable and valid self-reporting tool for investigation of the compliance in psychiatric patients also recognizing the complexity of compliance behaviour. 10 questions on medication attitude have to be answered by 'yes' or 'no' (8 times 1= no and Yes = 0 and twice 1= no, Yes =1). Results will be descriptively summarized. Summarized results minimum 0: low medication adherence, maximum 10: high medication adherence.

Countries

Germany

Participant flow

Recruitment details

Study period July 2008 to November 2008; Centre Dr. Lambert (Hamburg), Centre Dr. Dorn (Berlin)

Participants by arm

Arm	Count
Quetiapine XR With Integrated Care Program (ICP) Oral administration as 200 mg and 300 mg tablets allowing flexible dosing in 100 mg steps. Once daily in the evening. On day 1: 300 mg quetiapine XR, on day 2 : 600 mg, from day 3 onwards 400 to 800 mg at the centre-specific investigator´s discretion. Integrated Care Program (ICP) is a legally based integrated care program covered by a contract according to §§ 140 a-d SGB-V (SGB: social security code); The ICP is not exclusively designed for this phase IV trial. Participation in the ICP is possible anytime for each patient in whom the services are covered by the individual health insurance.	5
Quetiapine XR Alone Oral administration as 200 mg and 300 mg tablets allowing flexible dosing in 100 mg steps. Once daily in the evening. On day 1: 300 mg quetiapine XR, on day 2 : 600 mg, from day 3 onwards 400 to 800 mg at the centre-specific investigator´s discretion	2
Total	7

Withdrawals & dropouts

Period	Reason	FG000	FG001
Overall Study	Adverse Event	1	0
Overall Study	Study termination	4	2

Baseline characteristics

Characteristic	Quetiapine XR With Integrated Care Program (ICP)	Quetiapine XR Alone	Total
Age, Customized 18-65 years	5 Participants	2 Participants	7 Participants
Sex: Female, Male Female	5 Participants	0 Participants	5 Participants
Sex: Female, Male Male	0 Participants	2 Participants	2 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	— / —	— / —
other Total, other adverse events	2 / 5	1 / 2
serious Total, serious adverse events	0 / 5	0 / 2

Outcome results

Primary

Subjective Well-being in Patients Treated for Schizophrenia, Schizoaffective Disorder, Schizophreniform Disorder, Delusional Disorder or Psychotic Disorder Not Otherwise Specified Using the SWN-K (Subjective Well-being Under Neuroleptics) Scale

The SWN-K is comprised of 20 questions, each of which is rated using a 6 point scale ranging from 1 (not at all) to 6 (very much). Possible scores range from 20-120, with higher scores implying higher subjective well-being.

Time frame: 4 months