bleeding disorder haemophilia
Conditions
Interventions
Acceptance intervention (Dutch: Leven met hemofilie)
* 8 group sessions (7 sessions, 1 follow-up session) based on Acceptance and
Commitment therapy, guided by a specially trained haemophilia health
* Focused on acceptance of haemophilia and prophylaxis
* Each session will require 2 hours.
Sponsors
Van Creveldkliniek
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Inclusion criteria In order to be eligible to participate in this study, a subject must meet all of the following criteria: - Adults (>18 years) with haemophilia with prophylactic treatment prescribed; - Self-reported problems with integrating haemophilia or prophylaxis in daily life; - Written and oral proficiency in Dutch.
Exclusion criteria
Exclusion criteria: Exclusion criteria: A potential subject who meets any of the following criteria will be excluded from participation in this study:;- Serious psychiatric disorders interfering with acceptance or self-management intervention.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary endpoint: * Adherence, measured with a standardised interview asking about the adherence in the past two weeks, and/ or infusion logs over the last 3 months. Adherence was defined according to the Delphi definition: o Sub-optimally adherent: 15 to 25% prophylactic infusions missed, maximum 25% deviation in dose (IU) or more than 30% deviation in timing. o Non-adherent: more than 25% prophylactic infusions missed or more than 25% deviation in dose (IU), or a combination of both. Furthermore, the Veritas-Pro questionnaire will be administered during the pilot to verify the Delphi definition (max. 5 minutes time): * The Veritas-Pro is a validated questionnaire to measure adherence to prophylaxis in haemophilia. This questionnaire is about the adherence behaviour in the past three months in 21 items. Non-adherence as a score of >=57 points. | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease specific outcomes, collected retrospectively over a period from at least 6 months to one year: * Annual number of minor bleeds (bleeds requiring a single infusion with clotting factor concentrate), collected from infusion logs/ clinic notes, including treatment per bleed (dosing). * Annual number of major bleeds (bleeds requiring a minimum of two infusions with clotting factor concentrate), collected from infusion logs/ clinic notes, including treatment per bleed (frequency, dosing). * Number of synovitis periods/yr, a synovitis is a clinical diagnosis consisting of chronic (minimum 2 weeks) painless swelling with only minimal loss of function, diagnosis made by physiotherapist and doctor, and treated according to the synovitis protocol (min. 6 weeks daily treatment). * Days lost from work/ school. * Nr of visits to the clinic. * Surgical procedures related to recent bleeding. * Hospital admissions related to recent bleeding. Patient reported outcomes: * Illness perception, measured with the Brief Illness Perception Questionnaire, 9 items (max. 5 minutes). * Health related quality of life (HR-Qol), measured with the SF-36 questionnaire, and utility calculated according to the Dutch tariff (max 5 minutes time). Direct medical costs: All costs are calculated according to the Dutch guideline for Cost research in health care: * Clotting factor consumption; collected from patient logs and pharmacy records (all patients receive their clotting factor through the haemophilia treatment centre only). * Treatment per bleed, collected from patient logs. * Days lost from work/school, self-reported, collected on CRF at the time of each evaluation. * Nr of visits to the haemophilia treatment centre. * Surgical procedures, only surgery related to recent bleeding will be included in the analysis. Other procedures or admissions are considered unrelated to the intervention. | — |
Countries
Netherlands
Outcome results
None listed