Haemophilia A or B Haematological Disorders
Conditions
Interventions
Ten nurse specialists based at 10 different UK NHS Haemophilia Comprehensive Care Centres will be randomised into either intervention or control groups
partcipants in the control group will be offered treatment as usual. Nurses based in the intervention groups will be provided with 5 days training in Haemophilia Adherence Therapy and will apply the t
this may be face to face or via the telephone as preferred. The participants will also be asked to complete some short treatment-related work books, which will be used to gather qualitative data about
Sponsors
Canterbury Christ Church University (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients with Haemophilia A or B being treated at one of the 10 haemophilia comprehensive care centres included in the trial 2. Aged 12 years or over who have been self-infusing clotting factor for a minimum of 6 months 3. Able to provide informed consent (or able to consent with parental/guardian agreement and signature) 4. With identified nonadherence issues (as determined by a score of =57 on the VERITASpro assessment measure) 5. English speaking and literate to a degree necessary to understand the PIS and the VERITASpro assessment measure and to complete the AnTHem workbook
Exclusion criteria
Exclusion criteria: 1. Patients that do not meet the abovementioned criteria 2. Patients identified as having nontransient inhibitors to factor VIII or IX 3. Patients who during the period of the research develop nontransient inhibitors to factor VIII or IX
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adherence to haemophilia therapy will be measured at baseline, post intervention and at 6 months follow-up using the 24-item VERITASpro tool (terminology adapted to suit the UK setting). The VERITASPro is a reliable and valid measure of adherence to prophylactic treatment of haemophilia. Internal consistency for the total VERITASPro score and all subscales was good to excellent; test-retest reliability correlations were very strong. Validation measures were strongly correlated with VERITASPro scores. This self-reported tool allows measurement of overall adherence to therapy, but also through the use of six subscales: differential scoring of timing, dosing, planning, remembering, skipping and communicating. Low scores represent greater levels of adherence to therapy. The literature utilising VERITASpro indicates a population range with 45 point median and 57 point high score (indicating a significant level of nonadherence). The study will therefore identify and recruit patients with a score of 57 and measure their adherence at the three time points. Participants will be asked to return the completed measures (at time points two and three) to a member of the research team who is blinded to treatment allocation. | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinician ratings of adherence will be measured at the three time points using Kemp's Composite measure of compliance. Kemp et al.'s (1998) observer rating of compliance uses a seven-point scale, ranging from 1 (complete refusal) to 7 (active participation in treatment). Concurrent validity has been established by correlating scores with the Hogan Drug Attitude Inventory (DAI30; Hogan, Awad, & Eastwood, 1983; Kemp et al., 1998). This quantitative data will be supplemented with thematically analysed qualitative excerpts from patient work books and staff logs in order to gain insights into both patient and clinician experiences of the AnTHem intervention. | — |
Countries
United Kingdom
Outcome results
None listed