NCT02226445

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

Completed Last updated 26 August 2014

What this trial tests

trial testing Combined ADHD medication and psychosocial counseling in Attention-Deficit/Hyperactivity Disorder in 153 participants. Completed in 1 January 2013.

Timeline

1 September 2010

Primary endpoint
1 January 2013

1 January 2013

Quick facts

Lead sponsor	University of Aarhus
Status	Completed
Study type	OBSERVATIONAL
Enrollment	153
Start date	1 September 2010
Primary completion	1 January 2013
Estimated completion	1 January 2013
Sites	1 location across Denmark

Drugs / interventions tested

• Combined ADHD medication and psychosocial counseling

Conditions studied

• Attention-Deficit/Hyperactivity Disorder — all drugs for Attention-Deficit/Hyperactivity Disorder →
• Drop-out — all drugs for Drop-out →
• Non-adherence — all drugs for Non-adherence →

Sponsor

University of Aarhus

Who can join

Adults 18 to 64, any sex, with Attention-Deficit/Hyperactivity Disorder or Drop-out. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• 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.
• 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.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Treatment dropout and missed appointments among adults with attention-deficit/hyperactivity disorder: associations with patient- and disorder-related factors.
   Soendergaard HM, Thomsen PH, Pedersen P, Pedersen E, et al · · 2016 · cited 13× · PMID 26761266 · DOI 10.4088/jcp.14m09270