<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02226445</url>
  </required_header>
  <id_info>
    <org_study_id>ADHD/DO/MA</org_study_id>
    <nct_id>NCT02226445</nct_id>
  </id_info>
  <brief_title>Treatment Drop-out and Missed Appointments Among Adults With ADHD</brief_title>
  <official_title>Treatment Drop-out and Missed Appointments Among Adults With Attention-Deficit/Hyperactivity Disorder: Associations With Patient- and Disorder-related Factors</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Aarhus</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Central Denmark Region</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Aarhus</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The investigators knowledge of factors associated with treatment drop-out and missed&#xD;
      appointments among adults with Attention-Deficit/Hyperactivity Disorder (ADHD) within a&#xD;
      naturalistic, clinical setting is very limited. Drop-out rates among adult ADHD patients in&#xD;
      randomised controlled trials (RCT´s) have been reported to be 26.6% - 50%, and similar rates&#xD;
      are reported in two naturalistic studies of medication adherence.&#xD;
&#xD;
      Based on proposed hypotheses that past behaviour patterns are more predictive of current&#xD;
      behaviours of treatment drop-out and missed appointments than are sociodemographic and&#xD;
      clinical characteristics, the aim of the present study is to examine the associations of 1)&#xD;
      sociodemographic variables, 2) clinical variables, 3) risk-taking behaviour 4) educational&#xD;
      and occupational instability and 5) behaviours during primary/lower secondary school with&#xD;
      treatment drop-out and number of missed appointments.&#xD;
&#xD;
      The target group of the study consists of all patients who initiates assessment at the adult&#xD;
      ADHD Clinic at Regional Psychiatric Services West, Herning, Central Denmark Region in the&#xD;
      period from September 1, 2010 to September 1, 2011. The patients are referred to this Clinic&#xD;
      from general practitioners and specialised psychiatric authorities. The investigators study&#xD;
      is designed as an observational, cohort study in which the patients are offered medical and&#xD;
      non-manualised psychosocial treatment as it is usually offered in this tertiary ADHD Clinic&#xD;
      from which the data are collected.&#xD;
&#xD;
      Data regarding sociodemography, clinical symptoms and impairments, risk-taking behaviour,&#xD;
      educational and occupational instability and behaviours during primary/lower secondary school&#xD;
      are collected using a semistructured protocol.&#xD;
&#xD;
      In the investigators study the investigators define treatment drop-out as premature&#xD;
      termination of ongoing treatment, without any prior clinical or agreed resolution. No&#xD;
      standardized definition of treatment drop-out is used through out the literature of adherence&#xD;
      to treatment among patients in the psychiatric care system.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2010</start_date>
  <completion_date type="Actual">January 2013</completion_date>
  <primary_completion_date type="Actual">January 2013</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Treatment drop-out</measure>
    <time_frame>Patients will be followed for the duration of outpatient treatment at the ADHD Clinic, an expected average of 1 year</time_frame>
    <description>The outcome measure &quot;treatment drop-out&quot; is a binary outcome where participants at discharge are characterized as &quot;drop-outs&quot; or &quot;non drop-outs&quot;.&#xD;
&quot;Drop-outs&quot; are defined as those participants, who terminate treatment without any prior clinical or agreed resolution.&#xD;
Logistic regression analyses is applied to calculate outcome odds ratios.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Missed appointments</measure>
    <time_frame>Patients will be followed for the duration of outpatient treatment at the ADHD Clinic, an expected average of 1 year</time_frame>
    <description>The outcome measure &quot;missed appointments&quot; is a binary outcome, dichomized into &lt;3 missed appointments during treatment and ≥3 missed appointments during treatment.&#xD;
Logistic regression analyses is applied to calculate outcome odds ratios.</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">153</enrollment>
  <condition>Attention-Deficit/Hyperactivity Disorder</condition>
  <condition>Drop-out</condition>
  <condition>Non-adherence</condition>
  <arm_group>
    <arm_group_label>ADHD medication and psychosocial counseling</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Combined ADHD medication and psychosocial counseling</intervention_name>
    <description>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.&#xD;
ADHD medication:&#xD;
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.&#xD;
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.&#xD;
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.&#xD;
If the patients have a substance use, an anxiety problem or other contraindications then first choice of medication is atomoxetine.</description>
    <arm_group_label>ADHD medication and psychosocial counseling</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients referred to a tertiary ADHD Clinic at Regional Psychiatric Services West, Central&#xD;
        Denmark Region&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Referred to the ADHD Clinic and initiating assessment between September 1, 2010 and&#xD;
             September 1, 2011&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  No ADHD diagnosis as assessed by the ADHD Clinic&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>64 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Hans Jørgen Søgaard, MD, Ph.d.</last_name>
    <role>Study Chair</role>
    <affiliation>Psychiatric Research Unit West, Regional Psychiatric Services West, Central Denmark Region</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Helle Møller Søndergaard, MSc</last_name>
    <role>Principal Investigator</role>
    <affiliation>Psychiatric Research Unit West, Regional Psychiatric Services West, Central Denmark Region</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Per Hove Thomsen, Professor</last_name>
    <role>Study Chair</role>
    <affiliation>Center for Child and Adolescent Psychiatry, Aarhus University Hospital, Central Denmark Region</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Erik Pedersen, MD</last_name>
    <role>Study Chair</role>
    <affiliation>Regional Psychiatric Services West, Central Denmark Region</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Psychiatric Research Unit West, Regional Psychiatric Services West</name>
      <address>
        <city>Herning</city>
        <zip>DK - 7400</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <verification_date>August 2014</verification_date>
  <study_first_submitted>August 22, 2014</study_first_submitted>
  <study_first_submitted_qc>August 26, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 27, 2014</study_first_posted>
  <last_update_submitted>August 26, 2014</last_update_submitted>
  <last_update_submitted_qc>August 26, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 27, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Adults</keyword>
  <keyword>Outpatients</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hyperkinesis</mesh_term>
    <mesh_term>Attention Deficit Disorder with Hyperactivity</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02226445
org study id: ADHD/DO/MA
nct id: NCT02226445
lead sponsor: 
collaborator: 
has dmc: No
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.
observational model: Cohort
time perspective: Prospective
measure: 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
description: 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.
measure: Missed appointments
time frame: Patients will be followed for the duration of outpatient treatment at the ADHD Clinic, an expected average of 1 year
description: 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.
arm group label: ADHD medication and psychosocial counseling
intervention type: Other
intervention name: Combined ADHD medication and psychosocial counseling
description: 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.
arm group label: ADHD medication and psychosocial counseling
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 64 Years
healthy volunteers: No
last name: Hans Jørgen Søgaard, MD, Ph.d.
role: Study Chair
affiliation: Psychiatric Research Unit West, Regional Psychiatric Services West, Central Denmark Region
last name: Helle Møller Søndergaard, MSc
role: Principal Investigator
affiliation: Psychiatric Research Unit West, Regional Psychiatric Services West, Central Denmark Region
last name: Per Hove Thomsen, Professor
role: Study Chair
affiliation: Center for Child and Adolescent Psychiatry, Aarhus University Hospital, Central Denmark Region
last name: Erik Pedersen, MD
role: Study Chair
affiliation: Regional Psychiatric Services West, Central Denmark Region
facility: 
country: Denmark
responsible party type: Sponsor
mesh term: Hyperkinesis
mesh term: Attention Deficit Disorder with Hyperactivity