Personalizing Health Outcome in Epilepsy Now - An Introduction to Clinical Services (PHOENICS)
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|ClinicalTrials.gov Identifier: NCT01533649|
Recruitment Status : Unknown
Verified February 2012 by University Health Network, Toronto.
Recruitment status was: Not yet recruiting
First Posted : February 15, 2012
Last Update Posted : February 15, 2012
|Condition or disease||Intervention/treatment||Phase|
|Medically Intractable Epilepsy||Behavioral: Andrews/Reiter approach to epilepsy Behavioral: Relaxation/Meditation||Not Applicable|
Potential subjects will be systematically approached during a 3 years enrollment period to recruit a consecutive sample of the patient population receiving care at a tertiary care epilepsy center (Toronto Western Hospital). After an 8 week period to establish baseline measurements the proposed trial will allocate study subjects to an A/R intervention group or a relaxation/meditation control group or a usual care control group (N1=N2=N3=10) per their preference due to the fact that internalization of the therapeutic principles is an active process that requires continuous motivation and compliance of the patient with the intervention. If a subject displays high intrinsic motivation to engage in self-care enhancing activities but does not indicate a preference, he or she will get randomized to either the A/R intervention or the relaxation protocol. This trial design allows for measuring effect sizes in regard the potential effect of choice, and also whether there is any interaction between preference and treatment.
This trial will determine the following:
I. The fraction of (a) seizure-free subjects and (b) subjects with clinically meaningful, i.e. ≥ 90% or ≥ 50 reduction of seizure frequency, II. Changes of the subjective perception of disability as indicated by Subjective Handicap of Epilepsy Scale (SHE), III. Changes of seizure self-efficacy as indicated by Multidimensional Health Locus of Control (M-HLOC), Form C and Epilepsy Self-Efficacy Scale (ESES), IV. Changes in common psychopathologic comorbidities and stress as indicated by (a) Neurological Disorders Depression Inventory in Epilepsy (NDDI-E), (b) State Trait Anxiety Inventory (STAI), (c) Profile of Mood States (POMS brief), and (d) Perceived Stress Scale (PSS), V. Changes in quality of life as indicated by (a) Quality of Life in Epilepsy (QOLIE-89), (b) individually identified descriptors of various domains of life and (c) individually identified epilepsy-related distresses. Continuous measures (aims I and III b) will be obtained during months 9 and 10 after initial subject enrollment. All other measures will be obtained at the end of month 10.
Intervention Protocols: During months 3-5 the A/R intervention protocol devotes one face-to-face counseling session to each of the 11 chapters ("steps") of the workbook "Taking control of your epilepsy" which will be followed by weekly phone calls during months 6-8. A/R treatment plans include daily activities: Journaling (10 min), CD-guided relaxation (10-30 min), Workbook (10 min) to promote functional analysis of seizure context and development of coping strategies. The trial will be used for knowledge-translation as trainees delivering the intervention will be supervised by Donna Andrews, PhD, co-developer of the AR intervention. The relaxation and meditation protocol will consist of weekly 30 min session during months 3-5 and bi-weekly 60 min sessions during months 6-8.
All subjects are instructed to document seizure occurrences (number and type) and compliance with AEDs. They will continue to see their treating neurologist and adjustment of their antiepileptic medication will be made if necessary. Medication changes will be included in outcome analyses. Regular serum levels will be drawn to monitor drug compliance. Study subjects will be approached at 12, 24 and 36 months after the end of the pilot trial to obtain follow-up data. The sample size determination the investigators based on literature review, assuming the remission rate for the usual care group was 5% and 35% for the A/R intervention group and inflated by 30% to account for loss to non-compliance. Outcomes will be compared as found in groups as a whole.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Pilot Trial: Personalizing Health Outcome in Epilepsy Now - An Introduction to Clinical Services|
|Study Start Date :||April 2012|
|Estimated Primary Completion Date :||September 2013|
|Estimated Study Completion Date :||September 2013|
Experimental: A/R intervention
The A/R intervention will accommodate 10 study subjects who will participate in an epilepsy-specific counseling intervention.
Behavioral: Andrews/Reiter approach to epilepsy
The Andrews/Reiter approach to epilepsy is a systematic semi-directive, multi-modal counseling intervention that integrates conventional therapies, educational modules, psychological interventions and relaxation techniques in order to assist the individual in improving self-defined life quality. Face-to-face counseling sessions and supervision with telephone calls are based on a standardized workbook ("Taking Control of Your Epilepsy") as an on-going step-by-step guideline.
Other Name: A/R intervention
The relaxation group will accommodate 10 study subjects who will participate in a condition unspecific supportive relaxation intervention.
Subjects who participate in the relaxation control group will attend weekly relaxation sessions that will employ the following relaxation techniques: meditation, progressive muscle relaxation, autogenic training.
No Intervention: Usual care
10 Potential study subjects who are not interested in participating in either intervention will be asked to provide data as a usual care control group.
- Fraction of seizure free study subjects [ Time Frame: Change from baseline seizure frequency obtained during months 1 and 2 at months 9 and 10 after initial subject enrollment. ]The determination of the fraction of seizure-free study subjects will be the primary outcome measure of this pilot trial. Seizure freedom will be defined as absence of seizures (not auras) during months 9 and 10 after initial subject enrollment.
- Fraction of subjects achieving a clinically meaningful reduction of seizure frequency [ Time Frame: Change from baseline seizure frequency obtained during months 1 and 2 at months 9 and 10 after initial subject enrollment. ]The fraction of subjects achieving a clinically meaningful reduction of seizure frequency will be determined. Reduction of seizure frequency will be categorized as ≥ 90% reduction of seizures or ≥ 50% reduction of seizures
- Subjective Handicap of Epilepsy [ Time Frame: Change from baseline questionnaire scores obtained during month 1 at month 10 after initial subject enrollment ]Changes as indicated by the completion of the subjective Handicap of Epilepsy 32-item (SHE) scale at baseline and at the end of month 10 after subject enrollment.
- Health-related self-efficacy [ Time Frame: Change from baseline questionnaire scores and fraction of days with reported side effects obtained during months 1 and 2 at months 9 and 10 after initial subject enrollment. ]Changes as indicated by the completion of the 18-item Multidimensional Health Locus of Control (M-HLOC) Questionnaire.Different aspects of efficacy in the self-management of epilepsy will be measured using the 2000 version 33-item Epilepsy Self-Efficacy Scale (ESES). The fraction of days with reported medication side effects will be determined comparing documentations obtained during the initial 8 weeks of baseline measurement with adverse event documentation obtained during months 9 and 10 after initial subject enrollment.
- Psychopathologic disorders and stress [ Time Frame: Change from baseline questionnaire scores obtained during month 1 at month 10 after initial subject enrollment. ]Changes in the 6-item Neurological Disorders Depression Inventory in Epilepsy (NDDI-E), the State Trait Anxiety Inventory (STAI), the 30-item Profile of Mood States (POMS-Brief), and the 14-item Perceived Stress Scale (PSS)
- Quality of life [ Time Frame: Change from baseline questionnaire scores obtained during month 1 at month 10 after initial subject enrollment ]Changes in regard to 89-item Quality of Life in Epilepsy (OLIE-89) questionnaire.
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): NCT01533649
|Contact: Taufik A Valiante, MD PhD FRCS||647-261 ext firstname.lastname@example.org|
|Toronto Western Hospital||Not yet recruiting|
|Toronto, Ontario, Canada, M5T 2S8|
|Contact: Taufik A Valiante, MD PhD FRCS 416-603 ext 5460 email@example.com|
|Principal Investigator: Taufik A Valiante, MD PhD FRCS|
|Principal Investigator:||Taufik A Valiante, MD PhD FRCS||Toronto Western Hospital; University Health Networks|