Clinical trial NCT02226445: Treatment Drop-out and Missed Appointments Among Adults With ADHD
Official title: Treatment Drop-out and Missed Appointments Among Adults With Attention-Deficit/Hyperactivity Disorder: Associations With Patient- and Disorder-related Factors
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Attention-Deficit/Hyperactivity Disorder
Drop-out
Non-adherence
Keywords: Adults
Outpatients
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: Central Denmark Region
First posted: 2014-08-27
Enrollment: 153
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients referred to a tertiary ADHD Clinic at Regional Psychiatric Services West, Central Denmark Region

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.


Eligibility 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

Primary outcomes:
measure: Treatment drop-out
timeFrame: Patients will be followed for the duration of outpatient treatment at the ADHD Clinic, an expected average of 1 year
measure: Missed appointments
timeFrame: Patients will be followed for the duration of outpatient treatment at the ADHD Clinic, an expected average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Herning
country: Denmark
facility: Psychiatric Research Unit West, Regional Psychiatric Services West
Study officials:
affiliation: Psychiatric Research Unit West, Regional Psychiatric Services West, Central Denmark Region
name: Hans Jørgen Søgaard, MD, Ph.d.
role: STUDY_CHAIR
affiliation: Psychiatric Research Unit West, Regional Psychiatric Services West, Central Denmark Region
name: Helle Møller Søndergaard, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Center for Child and Adolescent Psychiatry, Aarhus University Hospital, Central Denmark Region
name: Per Hove Thomsen, Professor
role: STUDY_CHAIR
affiliation: Regional Psychiatric Services West, Central Denmark Region
name: Erik Pedersen, MD
role: STUDY_CHAIR
References:
citation: Soendergaard HM, Thomsen PH, Pedersen P, Pedersen E, Poulsen AE, Nielsen JM, Winther L, Henriksen A, Rungoe B, Soegaard HJ. Treatment dropout and missed appointments among adults with attention-deficit/hyperactivity disorder: associations with patient- and disorder-related factors. J Clin Psychiatry. 2016 Feb;77(2):232-9. doi: 10.4088/JCP.14m09270.