Tailored intervention focussed on Self-Management and Acceptance to improve adherence in Severe Haemophilia (SMASH-study)

Completed

Conditions: bleeding disorder
haemophilia
10064477

Registration Number: NL-OMON47733

Lead Sponsor: Van Creveldkliniek

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 24

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

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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary endpoint:<br /><br>* Adherence, measured with a standardised interview asking about the adherence<br /><br>in the past two weeks, and/ or infusion logs over the last 3 months.<br /><br>Adherence was defined according to the Delphi definition:<br /><br>o Sub-optimally adherent: 15 to 25% prophylactic infusions missed, maximum 25%<br /><br>deviation in dose (IU) or more than 30% deviation in timing.<br /><br>o Non-adherent: more than 25% prophylactic infusions missed or more than 25%<br /><br>deviation in dose (IU), or a combination of both.<br /><br>Furthermore, the Veritas-Pro questionnaire will be administered during the<br /><br>pilot to verify the Delphi definition (max. 5 minutes time):<br /><br>* The Veritas-Pro is a validated questionnaire to measure adherence to<br /><br>prophylaxis in haemophilia. This questionnaire is about the adherence behaviour<br /><br>in the past three months in 21 items. Non-adherence as a score of >=57 points. </p><br>

Secondary Outcome Measures