Treatment Drop-out and Missed Appointments Among Adults With ADHD
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| ClinicalTrials.gov Identifier: NCT02226445 |
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Recruitment Status :
Completed
First Posted : August 27, 2014
Last Update Posted : August 27, 2014
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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.
| Condition or disease | Intervention/treatment |
|---|---|
| Attention-Deficit/Hyperactivity Disorder Drop-out Non-adherence | Other: Combined ADHD medication and psychosocial counseling |
| Study Type : | Observational |
| Actual Enrollment : | 153 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Official Title: | Treatment Drop-out and Missed Appointments Among Adults With Attention-Deficit/Hyperactivity Disorder: Associations With Patient- and Disorder-related Factors |
| Study Start Date : | September 2010 |
| Actual Primary Completion Date : | January 2013 |
| Actual Study Completion Date : | January 2013 |
| 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. |
- 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.
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| Ages Eligible for Study: | 18 Years to 64 Years (Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02226445
| Denmark | |
| Psychiatric Research Unit West, Regional Psychiatric Services West | |
| Herning, Denmark, DK - 7400 | |
| 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 |
| Responsible Party: | University of Aarhus |
| ClinicalTrials.gov Identifier: | NCT02226445 |
| Other Study ID Numbers: |
ADHD/DO/MA |
| First Posted: | August 27, 2014 Key Record Dates |
| Last Update Posted: | August 27, 2014 |
| Last Verified: | August 2014 |
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Adults Outpatients |
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Hyperkinesis Attention Deficit Disorder with Hyperactivity Attention Deficit and Disruptive Behavior Disorders Neurodevelopmental Disorders |
Mental Disorders Dyskinesias Neurologic Manifestations Nervous System Diseases |