Treatment Drop-out and Missed Appointments Among Adults With ADHD

August 26, 2014 updated by: University of Aarhus

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

153

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Herning, Denmark, DK - 7400
        • Psychiatric Research Unit West, Regional Psychiatric Services West

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 64 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients referred to a tertiary ADHD Clinic at Regional Psychiatric Services West, Central Denmark Region

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Patients will be followed for the duration of outpatient treatment at the ADHD Clinic, an expected average of 1 year
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.
Patients will be followed for the duration of outpatient treatment at the ADHD Clinic, an expected average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Aarhus

Collaborators

Central Denmark Region

Investigators

  • 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 and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2010

Primary Completion (ACTUAL)

January 1, 2013

Study Completion (ACTUAL)

January 1, 2013

Study Registration Dates

First Submitted

August 22, 2014

First Submitted That Met QC Criteria

August 26, 2014

First Posted (ESTIMATE)

August 27, 2014

Study Record Updates

Last Update Posted (ESTIMATE)

August 27, 2014

Last Update Submitted That Met QC Criteria

August 26, 2014

Last Verified

August 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ADHD/DO/MA

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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