An RCT of a Patient-initiated Treatment Service for BEB and HFS
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|ClinicalTrials.gov Identifier: NCT02577224|
Recruitment Status : Unknown
Verified September 2016 by Moorfields Eye Hospital NHS Foundation Trust.
Recruitment status was: Active, not recruiting
First Posted : October 16, 2015
Last Update Posted : March 22, 2017
|Condition or disease||Intervention/treatment||Phase|
|Blepharospasm Hemi Facial Spasm||Other: Patient-initiated treatment||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||130 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Primary Purpose:||Health Services Research|
|Official Title:||A Randomised Controlled Trial to Explore the Effectiveness and Cost-effectiveness of a Patient-initiated Botulinum Toxin Treatment Model for Blepharospasm and Hemifacial Spasm Compared to Treatment as Usual|
|Actual Study Start Date :||August 2015|
|Estimated Primary Completion Date :||October 2017|
|Estimated Study Completion Date :||October 2017|
Participants randomized to the intervention group (patient-initiated treatment) will be asked to initiate their own treatment during the nine months they are taking part in the trial. Intervention group participants will receive information about when and how to initiate an appointment. Contact details for the service will be provided along with information on how quickly an appointment will be made, with whom and the procedure in the case of an emergency. All patients requesting an appointment will be booked in to the next available slot within the twice weekly ring‐fenced nurse-led clinics. Any subsequent scheduled appointments will be cancelled and all future treatment will be initiated by the patient.
Other: Patient-initiated treatment
Please see Intervention Arm
No Intervention: Control
Participants in the control group will receive treatment as usual. This consists of scheduled appointments in the hospital-based nurse-led botulinum toxin clinic. The frequency with which these appointments takes place are based on clinical judgement, but tend to range between every 6 weeks to every 4 months.
- Disease severity [ Time Frame: 18 months ]For patients with blepharospasm and hemifacial spasm, disease severity and frequency of symptoms will be assessed using the Jankovic Rating Scale (JRS), a clinician completed measure. The JRS consists of two subscales that measure severity and frequency separately. A 2-point improvement in the JRS sum score is considered a clinically relevant improvement. For patients with hemifacial spasm an additional rating scale for severity and frequency of cheek involvement will be included, which has been recommended by the questionnaire developers.
- Disability [ Time Frame: 18 months ]The Blepharospasm Disability Index (BSDI)© is a patient self-report measure which asks patients' about six daily activities: reading, driving a vehicle, watching TV, shopping, walking and doing everyday activities. The measure is also recommended for use when assessing the impact of Botulinum toxin in hemifacial spasm. The measure has been found to possess good convergent validity with the JRS, good internal consistency (Cronbach's alpha = 0.88) and adequate test-retest reliability by its developers.
- Patient satisfaction [ Time Frame: 18 months ]Patient satisfaction will be measured using the 8-item Client Satisfaction Questionnaire (CSQ). The scale has good internal reliability, with Cronbach's alpha ranging from 0.93 to 0.93 and good construct validity
- Side effects [ Time Frame: 18 months ]Individual side effects including ptosis, tearing, blurred vision, double vision, hematoma, foreign body sensation, will be recorded at each clinic visit. The total number of side effects will be recorded for each patient.
- Confidence in system of care [ Time Frame: 18 months ]Confidence in the system of care will be assessed using a 10cm visual analogue scale (VAS). Patients will be asked 'How confident are you that if you required treatment this system of care would be able to support you?' ranging from 'not at all confident' to 'completely confident'.
- Quality of life [ Time Frame: 18 months ]Quality of life will be measured using the Craniocervical dystonia questionnaire (CDQ-24) which was developed and validated in patients with blepharospasm, and has also been used with success in patients with hemifacial spasm. This 24 item measure assesses quality of life across five domains: stigma, emotional well-being, pain, activities of daily living and social/family life. The measure has been found to possess good internal consistency with Cronbach's alphas ranging from 0.77 to 0.89, good construct validity when compared who the SF-36, good discriminant validity and test retest reliability.
- Mood [ Time Frame: 18 months ]The Hospital Anxiety and Depression Scale (HADS) will be used to assess mood. The HADS is a 14-item self-screening questionnaire for depression and anxiety in patients with physical health problems. The two 7-item subscales measure how a person has been feeling in the past week. The scale provides cut-off scores for the presence of potentially clinical levels of anxiety and depression. A systematic review of the HADS has confirmed the factor structure, found the cut-off points to be valid against clinical interviews, reports excellent internal consistency (Cronbach's alpha: anxiety 0.68-0.93; depression 0.67-0.90)
- Illness perceptions [ Time Frame: 18 months ]Illness perceptions are cognitive representations or beliefs that a patient has about their illness. These concepts will be measured using the revised illness perceptions questionnaire (IPQ-R), which has been widely used and is a valid and reliable measure.
- Treatment beliefs [ Time Frame: 18 months ]Beliefs about botulinum toxin will be measured using the Treatment Representations Inventory (TRI). A 27-item measure, consisting of four subscales including 'treatment-value', 'treatment-concerns', 'decision-satisfaction' and 'cure'.
- Acceptability [ Time Frame: 18 months ]Acceptability of the new patient-initiated service and standard care will be measured using the 7-item Acceptability Questionnaire developed by the study team.
- Cost effectiveness [ Time Frame: 18 months ]An adapted version of the Client Service Receipt Inventory (CSRI) has been employed, which has been widely employed in previous studies, particularly in the mental health setting. The impact of the service on direct and indirect costs will be estimated at the end of the trial period.
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): NCT02577224
|Moorfields Eye Hospital NHS Foundation Trust|
|London, United Kingdom, EC1V 2PD|
|Principal Investigator:||Daniel Ezra, MD FRCOph||Moorfields Eye Hospital NHS Foundation Trust|