Attention-Deficit/Hyperactivity DisorderNCT02226445
Treatment Drop-out and Missed Appointments Among Adults With ADHD
An observational study of Attention-Deficit/Hyperactivity Disorder and Drop-out, run by University of Aarhus at 1 site in Denmark.
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. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Attention-Deficit/Hyperactivity Disorder, Drop-out, Non-adherence
- What is being tested?
- Combined ADHD medication and psychosocial counseling
- How many people
- 153 participants
- Where
- 1 siteDenmark
- Study dates
- Sep 2010to Jan 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- No healthy volunteers
- Adult
Study population: Patients referred to a tertiary ADHD Clinic at Regional Psychiatric Services West, Central Denmark Region
Who may be able to join
- Referred to the ADHD Clinic and initiating assessment between September 1, 2010 and September 1, 2011
Who cannot join
- No ADHD diagnosis as assessed by the ADHD Clinic
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Psychiatric Research Unit West, Regional Psychiatric Services West
Herning, DK - 7400
About this study
Official title: 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.
Read more
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.
- Being tested
- Combined ADHD medication and psychosocial counseling
- Keywords
- Adults, Outpatients
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combined ADHD medication and psychosocial counselingOther
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.
| Study group | Role | What they receive |
|---|---|---|
| ADHD medication and psychosocial counseling | Not described Receives: Other: Combined ADHD medication and psychosocial counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Patients will be followed for the duration of outpatient treatment at the ADHD Clinic, an expected average of 1 year
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.
Measured: Patients will be followed for the duration of outpatient treatment at the ADHD Clinic, an expected average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2014 (estimated)
- Study startSep 2010
- Primary completionJan 2013
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Attention-Deficit/Hyperactivity DisorderStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 153 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- Central Denmark Region
- Responsible party
- Sponsor
- Investigators
- Hans Jørgen Søgaard, MD, Ph.d., Study chair, Psychiatric Research Unit West, Regional Psychiatric Services West, Central Denmark RegionHelle Møller Søndergaard, MSc, Principal investigator, Psychiatric Research Unit West, Regional Psychiatric Services West, Central Denmark RegionPer Hove Thomsen, Professor, Study chair, Center for Child and Adolescent Psychiatry, Aarhus University Hospital, Central Denmark RegionErik Pedersen, MD, Study chair, Regional Psychiatric Services West, Central Denmark Region
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02226445
- Sponsor's protocol ID
- ADHD/DO/MA
- Status last verified
- Aug 2014
- First submitted
- 22 Aug 2014
- Last updated
- 27 Aug 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 26761266
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment Drop-out and Missed Appointments Among Adults With Attention-Deficit/Hyperactivity Disorder: Associations With Patient- and Disorder-related Factors
- ClinicalTrials.gov ID
- NCT02226445
- Acronym / sponsor ID
- ADHD/DO/MA
- Keywords
- Adults, Outpatients
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 153 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- Central Denmark Region
- Study start
- Sep 2010
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 27 Aug 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ADHD medication and psychosocial counseling | – | Other: Combined ADHD medication and psychosocial counseling |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Patients referred to a tertiary ADHD Clinic at Regional Psychiatric Services West, Central Denmark Region
Key inclusion criteria (1 listed)
- Referred to the ADHD Clinic and initiating assessment between September 1, 2010 and September 1, 2011
Key exclusion criteria (1 listed)
- No ADHD diagnosis as assessed by the ADHD Clinic
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Combined ADHD medication and psychosocial counselingThe 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. | Other | ADHD medication and psychosocial counseling |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2014.
- Derived from this study: PubMed 26761266Soendergaard 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hans Jørgen Søgaard, MD, Ph.d. study chair
Psychiatric Research Unit West, Regional Psychiatric Services West, Central Denmark Region
Helle Møller Søndergaard, MSc principal investigator
Psychiatric Research Unit West, Regional Psychiatric Services West, Central Denmark Region
Per Hove Thomsen, Professor study chair
Center for Child and Adolescent Psychiatry, Aarhus University Hospital, Central Denmark Region
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Attention-Deficit/Hyperactivity Disorder and Drop-out, run by University of Aarhus at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02226445, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2014.