children, hemophilia, home treatment
Conditions
Interventions
Intervention is defined as 5-7 visits by an experienced hemophilia nurse during a total time span of two years. During each visit of one to two hours the nurse will instruct parents and patients in an
Sponsors
Erasmus MC - Sophia Children’ s Hospital
Eligibility
Inclusion criteria
Inclusion criteria: 1. Severe and moderately severe hemophilia A and B patients with a factor VIII or IX less than 5% on home treatment (prophylaxis) with factor VIII or IX for at least one year; 2. Aged 1 to 18 years old; 3. Registered in the Erasmus Medical Center-Sophia Children’s Hospital in Rotterdam or Academic Medical Center in Amsterdam-Emma Children’s Hospital.
Exclusion criteria
Exclusion criteria: 1. Patients unable to understand the Dutch language or in necessity of a translator for adequate understanding; 2. Patients on home treatment with bypassing products due to development of inhibitors.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| 1. Total clotting factor use (kg bw-1) before and after start intervention. Total number of bleeds before and after start intervention; 2. Adherence to treatment regimes (with attention to hygiene, storage of clotting factor, setting during infusion, vena puncture techniques, behavioural observations, adherence to prescribed therapy, documentation of infusion and knowledge of the disease). Adherence will be evaluated by the VERITAS-Pro questionnaire (Duncan et al. 2010) and self efficacy questionnaire as well as a standardized checklist. | — |
Primary
| Measure | Time frame |
|---|---|
| 1. Compliance to prescribed prophylactic treatment by comparison of prescribed prophylactic treatment dosages to actual infused units of clotting factor during prophylactic treatment as registered in the logbooks. Compliance will be quantified as a percentage of time spent in compliance with prescribed therapy (%); 2. Health related quality of life (HRQoL) and behavioural scores: A. Disease specific HRQoL questionnaires: i. Domain scores of Haemo-Qol, mainly physical health, family, interactions with others and coping. Parent form 4-7, 8-12 and 13-16 years and child form for children older than 12 years old. B. Generic HRQoL questionnaires: i. Domain scores of Infant/Toddles Quality of Life questionnaire (ITQOL, 2 months – 6 years, parent form), mainly: Physical functioning, growth and development, bodily pain, general health perceptions, parental impact (emotional and time); ii. Summary scores and domain scores of CHQ questionnaire (CHQ-PF50, parent form) and child form (CHQ-CF87) for children older than 12 years old), mainly Physical Summary Scale, Psychological Summary Scale, and physical functioning, bodily pain, general health perceptions and parental impact (emotional and time). C. Behavioural questionnaires: i. Total scores and domain scores of the strengths and difficulties questionnaire (SDQ, parent form, teacher form and child form for children older than 12 years old). | — |
Contacts
Public ContactJ. Lock
P.O. Box 2060
Outcome results
None listed