PLEASE5+: Long-term outcomes and quality of life of patients with symptoms attributed to Lyme borreliosis

Completed

Conditions: Lyme disease
Post-treatment Lyme borreliosis Syndrome (PTLBS)
10002252

Registration Number: NL-OMON50085

Lead Sponsor: Radboud Universitair Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 280

Inclusion Criteria

Subjects who have been randomized into the PLEASE study and not have
subsequently withdrawn informed consent for the PLEASE or PLEASE5+ study are
eligible. Inclusioncriteria for PLEASE were: persistent symptoms
(musculo-skeletal pain, arthritis, arthralgia, neuralgia, sensory disturbances,
dysesthesia, neuro-psychological disorders, or cognitive disorders, with or
without persistent fatigue) that were attributed to Lyme borreliosis, either
temporally related within 4 months to a physician-confirmed episode of erythema
migrans or otherwise proven symptomatic Lyme borreliosis manifestation (by
positive biopsy, PCR, culture, or intrathecal antibody production); or with a
positive B. burgdorferi IgG or IgM immunoblot.

Exclusion Criteria

Subjects who have died, subjects who have withdrawn informed consent to PLEASE
participation, have not consented to receive PLEASE5+ study information, and
who do not provide written informed consent to PLEASE5+ participation are
excluded.

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The main study endpoint is the health-related quality of life (QoL) 5-8 years<br /><br>after participation in PLEASE. Health-related QoL will be assessed by the<br /><br>physical component summary (PCS) score of the RAND-36 Health Status Inventory,<br /><br>as was measured in the PLEASE study at five time points. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary study endpoints are<br /><br>- differences in long-term outcomes between the three PLEASE treatment groups;<br /><br>- long-term impact of persistent symptoms attributed to Lyme borreliosis on<br /><br>(ability to) work, and social costs;<br /><br>- reported use of medical or complementary interventions or support after<br /><br>PLEASE participation, and their association with the course of symptoms,<br /><br>quality of life and ability to work;<br /><br>- determinants for the long-term course of symptoms and ability to work;<br /><br>- the relationship between severity and duration of symptoms before treatment,<br /><br>and long-term outcomes; and<br /><br>- the relationship between self-management strategies by patients and long-term<br /><br>outcomes and ability to work.</p><br>