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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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Netherlands Trial Register |
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Last refreshed on:
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28 April 2013 |
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Main ID: |
NTR2505 |
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Date of registration:
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14/09/2010 |
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Primary sponsor: |
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Public title:
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Implementation study ADHD-Tornadoproject.
Doelmatigheidsonderzoek Tornadopoli.
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Scientific title:
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Improving patient care for uncomplicated ADHD in children and adolescents by organisational redesign and enhanced collaboration between psychiatry and general practice. -
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Date of first enrolment:
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1/10/2010 |
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Target sample size:
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90 |
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Recruitment status: |
pending |
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URL:
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http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=2505 |
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Study type:
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intervention |
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Study design:
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Randomised: No; Masking: None; Control: Active; Group: Parallel; Type: 2 or more arms, non-randomized
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Countries of recruitment
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The Netherlands
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Contacts
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Name:
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Mijnke M.M.
Janssen |
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Address:
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Reinier Postlaan 12
6525 GC
Nijmegen
The Netherlands |
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Telephone:
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Email:
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m.janssen@karakter.com |
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Affiliation:
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Name:
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Mijnke M.M.
Janssen |
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Address:
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Reinier Postlaan 12
6525 GC
Nijmegen
The Netherlands |
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Telephone:
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Email:
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m.janssen@karakter.com |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: Children and adolescents (age 6-15 years) with, at referral by their GP, suspicion of uncomplicated ADHD (Attention Deficit Hyperativity Disorder, DSM-IV codes 314.01 and 314.00).
Exclusion criteria: Children and adolescents (age 6-15 years) with, at referral tot University Cluster of Karakter by their GP, suspicion of uncomplicated ADHD (Attention Deficit Hyperactivity
Disorder, DSM-IV codes 314.01 and 314.00) but who appear, after further study of their characteristics and complaints by the admission-coordinator, to have a more complicated (e.g. with psychiatrical or somatical co-morbidity and/of serious familyproblems) form of AHDH.
Age minimum:
Age maximum:
Gender:
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Health Condition(s) or Problem(s) studied
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Children, Adolescents, ADHD
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Intervention(s)
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Implementation intervention. The ADHD implementation program, which has been succesfully pilot tested in Nijmegen, focuses on children and adolescents with uncomplicated ADHD. It has two key components: Organisational redesign at the mental health centre, so that time between referral and start of treatment is substantially reduced; and enhanced collaboration between psychiatry and general practitioners, by providing short online courses for the GPs of referred patients. To make this intervention as recommended by the multidisciplinary ADHD guideline, the following procedures are implemented in patient care:
1. Triage of these referred patients to confirm the suspicion of uncomplicated ADHD;
2. Short procedures for diagnostical process (shorter than current usual care);
3. Start of appropriate pharmaceutical treatment and other treatment, by the child psychiatrist;
4. Monitoring and follow-up of the treatment results, by the child psycyhiatrist (usual care) or GP (intervention group);
5. Focused parent training in 4 sessions in the study centre.
Control-condition (care as usual for children and adolescents with ADHD): Referred patients suspected of uncomplicated ADHD are selected.
The following procedure will start:
1. They will get a regular intake and diagnostic proces in the outpatient clinic of Karakter. This standard procedures consists of: anamnese en hetero-anamnese with limited developmental anamnese, an assesment by a child and adolescent psychiatrist and;
2. When necessary an extended developmental anamnese, neuropsychological assesment, family assesment and contact with school about the school functioning of the child;
3. After these assesements there will be an appointment with the child and adolescent psychiatrist who will explain the results and give advice about further treatment. This diagnostical traject will take, in general, 6 to 12 weeks. 4. The child and adol
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Primary Outcome(s)
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Primary outcome: Time between referral to the mental health centre and start of treatment. We will examine:
1. Duration of waiting time, between referral and actual start of the diagnostic process;
2. Duration of run time/lead time of the diagnosis and the start of treatment.
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Secondary Outcome(s)
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1. ADHD status: The functional status of the patients will be measured with the HoNOSCA. The HoNOSCA provides a global measure of an individuals current mental health status. Time Points: T1,T2,T4,T5,T7;
2. Treatment adherence is measured by using the Morisky Adherence Scale to provide a brief screening
measurement of adherence with treatment response options. To measure the treatment adherence regarding the parent training, their appearance will be registered and parents will be asked ( by a brief, self-composed questionnaire at the end of the training) if they consider the parent-training useful and to what extend they apply what they learned in this training. Timepoints: T5, T6, T7;
3. Parents and patients are asked about their experiences (using the Trimbos Thermometer), study and control group are compared. Timepoints: T3 and T7;
4. Semi-strucured telephone interviews with GPs in the study group are done to assess their expiriences with the ADHD-programme. Focus will be on:
A. Their opinion and experience with respect to the referralprocess (forth and back), compared to ususal
care;
B. Do the involved GPs (in the ADHD-programme and control group) feel themselves competent enough
to prescribe abd monitor ADHD-medication?
C. Do the GPs involved in the ADHD-program think that the course, given by our ADHD-specialist, about
prescribing and monitoring medication for ADHD is effective? Is their a difference in their feeling of competence before and after the course?
Semi-structured interviews with the involved professionals in the Karakter University Cluster regarding their experiences in this programme, with particularly respect to the referralproces between general practiotioners and specialists, compared to care as usual. Timepoint: T7;
5. The clinical indicator measuring the ADHD symptoms before and after treatment by using the ADHD-Ratingscale
Timepoints: T1, T2, T4, T5, T7;
6. Economic evaluation:
Objectives: The economic evaluation aims to determine the efficiency of the ADHD-programme in comparison to the controlgroup for the observed period ( using observed costs and outcomes). The primary question is, what the cost consequences are per unit improvement on the primary outcome, that is reduction of time between referral and start of treatment. Indicators: EQ5D (child- and proxyversion) and Tic-P (proxy-version). Timepoints EQ5D: T1, T2, T4, T5, T6, T7. Timepoints Tic-P: T4 and T7.
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Secondary ID(s)
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80-823159710002
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Source(s) of Monetary Support
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ZON-MW, The Netherlands Organization for Health Research and Development
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