Treatment Drop-out and Missed Appointments Among Adults With ADHD

Attention-Deficit/Hyperactivity Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02226445
• Other study ID #: ADHD/DO/MA
• Status: Completed
• Phase: N/A
• First received: August 22, 2014
• Last updated: August 26, 2014
• Start date: September 2010
• Est. completion date: January 2013

Study information

• Verified date: August 2014
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Dataprotection AgencyDenmark: Danish Health and Medicines Authority
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 153
• Est. completion date: January 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 64 Years

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Attention Deficit Disorder with Hyperactivity
• Attention-Deficit/Hyperactivity Disorder
• Drop-out
• Hyperkinesis
• Non-adherence

Intervention

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.

Locations

Country	Name	City	State
Denmark	Psychiatric Research Unit West, Regional Psychiatric Services West	Herning

Sponsors (2)

Lead Sponsor	Collaborator
University of Aarhus	Central Denmark Region

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Treatment drop-out	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.	Patients will be followed for the duration of outpatient treatment at the ADHD Clinic, an expected average of 1 year	No
Primary	Missed appointments	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.	Patients will be followed for the duration of outpatient treatment at the ADHD Clinic, an expected average of 1 year	No