An interventional study of Educational Package in Hemophilia A, sponsored by Hampshire Hospitals NHS Foundation Trust. Completed at 1 site in United Kingdom. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-02-22.
Sponsored by Hampshire Hospitals NHS Foundation Trust · Not applicable, Interventional, and Other
Prospective, interventional study of pharmacokinetic (PK)-focused FVIII dosing discussions delivered as part of a patient education package.
The study will capture severe haemophilia A patient reported outcome measures before and after PK-focused dosing discussions, including a standardised patient education package, that include personalised PK-guided dosing suggestions from a computational predictive device (myPKFiT®). The pragmatic study design recognises the CE marked myPKFiT® device is being implemented into routine care nationally and consequently only requires a single additional clinic visit for the purpose of consenting.
There is a paucity of patient reported outcome data documenting the impact of PK focused prophylaxis discussions. This prospective, multicentre UK-PK trial will coincide with the initiation of the myPKFiT® device in the context of an enhanced clinical review. This will include a standardised patient education package using a short animated film explaining PK and personalised prophylaxis, followed by modelling of the patient's own PK using the myPKFiT® device and discussing the dosing options with the patient. The aim of the PK educational package is to educate and engage patients and ensure that their treatment regimens meet their individual needs. In addition, the study will capture the prophylaxis dosing strategy agreed upon by patients and the clinical team where treatment decisions are made jointly between patients and the clinical team (concordance). Looking forward, haemophilia clinical care team members need a marker to judge or predict patient engagement with this personalising medicine process. Successful consultation strategies may differ if the team can anticipate how an individual person with haemophilia (PWH) might respond to discussions about potential change. The primary outcome measure is the Patient Activation Measure (PAM) which gauges the knowledge, skills and confidence essential to managing one's own health and healthcare. A PAM score can predict healthcare outcomes including medication adherence, healthcare utilisation and hospital visits. It is hypothesized that a more activated patient will be more receptive to changes in their treatment regimen, education and information about their health condition.
In addition to patient activation, the study will assess a range of patient reported outcomes and psychological factors using validated tools. These will include patients' Haemophilia-related quality of life (HAEMO-QoL-A), beliefs about medicines (BMQ), self-reported adherence (VERITAS-Pro) and activity levels. These tools will provide clear patient reported outcomes for the haemophilia community, with accompanying EQ5D data, enabling robust health economic evaluation.
866 studies on the registry are indexed under Hemophilia A; 137 are open to participants now.
This study's enrollment of 59 is above the median of 28 across 512 interventional studies indexed under Hemophilia A.
Browse Hemophilia A studies →Hampshire Hospitals NHS Foundation Trust is the lead sponsor of 10 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients will receive a standardised PK focused educational package in the form of a short video film.
Behavioral: Educational Package
Patients will be invited to attend a PK educational session as part of the study protocol. This will form a discussion regarding clinical history and activity in the 6 months prior to study start, viewing of a short animated film giving additional detail on pharmacokinetics and prophylaxis in haemophilia A, followed by modelling of the patient's own PK and dose guidance based on 2 study blood samples.
Change in Patient Activation Measures
Change in the Patient Activation Measure (PAM) score over a 12 month time period.
Time frame: 12 months
Patients' perceptions of the PK educational package
Perceived threat, message quality, message acceptance/derogation. This will be measured qualitatively.
Time frame: 12 months
Health-related quality of life: EQ5D
Time frame: 12 months
Health-related quality of life: HAEMO-QoL-A
Time frame: 12 months
Self-reported adherence (VERITAS-pro)
Time frame: 12 months
Health-related quality of life: beliefs about medicines (BMQ)
Time frame: 12 months
Changes to participants' treatment regimen
Change to amount of FVIII used
Time frame: 12 months
Changes to accuracy and timeliness of entries on treatment log (Haemtrack or alternative treatment log).
Time frame: 12 months
Changes to patient adherence to treatment regimen
Actual changes as recorded on Haemtrack / equivalent.
Time frame: 12 months
This study is completed, as verified in Feb 2018. You cannot join it, but the record below documents what was studied.
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Hampshire Hospitals NHS Foundation Trust