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NCT Number: NCT02226445

Treatment Drop-out and Missed Appointments Among Adults With ADHD

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.

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Key information

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Psychiatric Research Unit West, Regional Psychiatric Services West

Herning, DK - 7400, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Combined ADHD medication and psychosocial counseling

Other

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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Collaborators

  • Central Denmark Region

Registry information

Official study title

Treatment Drop-out and Missed Appointments Among Adults With Attention-Deficit/Hyperactivity Disorder: Associations With Patient- and Disorder-related Factors

Important dates

Study start
2010
Primary completion
2013
Study completion
2013
First posted
Aug 27, 2014
Registry last updated
Aug 27, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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