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Trial record 1 of 1 for:    NCT02226445
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Treatment Drop-out and Missed Appointments Among Adults With ADHD

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ClinicalTrials.gov Identifier: NCT02226445
Recruitment Status : Completed
First Posted : August 27, 2014
Last Update Posted : August 27, 2014
Sponsor:
Collaborator:
Central Denmark Region
Information provided by (Responsible Party):
University of Aarhus

Brief Summary:

The investigators knowledge of factors associated with treatment drop-out and missed appointments among adults with Attention-Deficit/Hyperactivity Disorder (ADHD) within a naturalistic, clinical setting is very limited. Drop-out rates among adult ADHD patients in randomised controlled trials (RCT´s) have been reported to be 26.6% - 50%, and similar rates are reported in two naturalistic studies of medication adherence.

Based on proposed hypotheses that past behaviour patterns are more predictive of current behaviours of treatment drop-out and missed appointments than are sociodemographic and clinical characteristics, the aim of the present study is to examine the associations of 1) sociodemographic variables, 2) clinical variables, 3) risk-taking behaviour 4) educational and occupational instability and 5) behaviours during primary/lower secondary school with treatment drop-out and number of missed appointments.

The target group of the study consists of all patients who initiates assessment at the adult ADHD Clinic at Regional Psychiatric Services West, Herning, Central Denmark Region in the period from September 1, 2010 to September 1, 2011. The patients are referred to this Clinic from general practitioners and specialised psychiatric authorities. The investigators study is designed as an observational, cohort study in which the patients are offered medical and non-manualised psychosocial treatment as it is usually offered in this tertiary ADHD Clinic from which the data are collected.

Data regarding sociodemography, clinical symptoms and impairments, risk-taking behaviour, educational and occupational instability and behaviours during primary/lower secondary school are collected using a semistructured protocol.

In the investigators study the investigators define treatment drop-out as premature termination of ongoing treatment, without any prior clinical or agreed resolution. No standardized definition of treatment drop-out is used through out the literature of adherence to treatment among patients in the psychiatric care system.


Condition or disease Intervention/treatment
Attention-Deficit/Hyperactivity Disorder Drop-out Non-adherence Other: Combined ADHD medication and psychosocial counseling

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Study Type : Observational
Actual Enrollment : 153 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Treatment Drop-out and Missed Appointments Among Adults With Attention-Deficit/Hyperactivity Disorder: Associations With Patient- and Disorder-related Factors
Study Start Date : September 2010
Actual Primary Completion Date : January 2013
Actual Study Completion Date : January 2013

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
ADHD medication and psychosocial counseling Other: Combined ADHD medication and psychosocial counseling

The patients are offered as well ADHD medication as non-standardized psychosocial treatment, the latter including psychoeducation (i.e. information about ADHD aetiology and symptoms plus management of symptoms) and counselling regarding emotional-, family- and social rehabilitation-related problems.

ADHD medication:

First choice of medication is methylphenidate immediate release, initially 5 mg 2-3 times a day increasing with 10-20 mg per week up to stabilization of symptoms.

When stabilized a shift to extended release methylphenidate. Alternatively dexamphetamine, initially 2.5 mg 2-3 times a day increasing with 5-10 mg per week up to stabilization of symptoms.

If there is no adequate effect of central stimulants then a shift to atomoxetine, initially 18 mg a day, increasing during a period of 6-10 weeks up to max. 100 mg a day.

If the patients have a substance use, an anxiety problem or other contraindications then first choice of medication is atomoxetine.





Primary Outcome Measures :
  1. Treatment drop-out [ Time Frame: Patients will be followed for the duration of outpatient treatment at the ADHD Clinic, an expected average of 1 year ]

    The outcome measure "treatment drop-out" is a binary outcome where participants at discharge are characterized as "drop-outs" or "non drop-outs".

    "Drop-outs" are defined as those participants, who terminate treatment without any prior clinical or agreed resolution.

    Logistic regression analyses is applied to calculate outcome odds ratios.


  2. Missed appointments [ Time Frame: Patients will be followed for the duration of outpatient treatment at the ADHD Clinic, an expected average of 1 year ]

    The outcome measure "missed appointments" is a binary outcome, dichomized into <3 missed appointments during treatment and ≥3 missed appointments during treatment.

    Logistic regression analyses is applied to calculate outcome odds ratios.




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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients referred to a tertiary ADHD Clinic at Regional Psychiatric Services West, Central Denmark Region
Criteria

Inclusion Criteria:

  • Referred to the ADHD Clinic and initiating assessment between September 1, 2010 and September 1, 2011

Exclusion Criteria:

  • No ADHD diagnosis as assessed by the ADHD Clinic

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02226445


Locations
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Denmark
Psychiatric Research Unit West, Regional Psychiatric Services West
Herning, Denmark, DK - 7400
Sponsors and Collaborators
University of Aarhus
Central Denmark Region
Investigators
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Study Chair: Hans Jørgen Søgaard, MD, Ph.d. Psychiatric Research Unit West, Regional Psychiatric Services West, Central Denmark Region
Principal Investigator: Helle Møller Søndergaard, MSc Psychiatric Research Unit West, Regional Psychiatric Services West, Central Denmark Region
Study Chair: Per Hove Thomsen, Professor Center for Child and Adolescent Psychiatry, Aarhus University Hospital, Central Denmark Region
Study Chair: Erik Pedersen, MD Regional Psychiatric Services West, Central Denmark Region
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT02226445    
Other Study ID Numbers: ADHD/DO/MA
First Posted: August 27, 2014    Key Record Dates
Last Update Posted: August 27, 2014
Last Verified: August 2014
Keywords provided by University of Aarhus:
Adults
Outpatients
Additional relevant MeSH terms:
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Hyperkinesis
Attention Deficit Disorder with Hyperactivity
Attention Deficit and Disruptive Behavior Disorders
Neurodevelopmental Disorders
Mental Disorders
Dyskinesias
Neurologic Manifestations
Nervous System Diseases