No registrations found.
ID
Source
Brief title
Health condition
Borrelia burgdorferi; Lyme disease; Lyme borreliosis; tick-borne disease; Post-treatment Lyme Disease Syndrome
Sponsors and support
Intervention
Outcome measures
Primary outcome
The health-related quality of life 5-8 years after participation in the randomized controlled trial on the effect of prolonged antibiotic treatment on persistent symptoms attributed to Lyme borreliosis (PLEASE).
Secondary outcome
- long-term impact of persistent symptoms attributed to Lyme borreliosis on (ability to) work and social costs;
- reported use of medical or complementary interventions or support after PLEASE participation, and their association with the course of symptoms, quality of life and ability to work.
Background summary
This study is a longitudinal follow-up study utilizing questionnaires, blood and urine sampling and – in selected subgroups – interviews and focus groups, among subjects who have participated 5-8 years ago in the randomized PLEASE trial (NL2362). The primary objective is to assess the long-term (5-8 years) quality of life in patients who previously participated in the placebo-controlled randomized controlled trial on the effect of prolonged antibiotic treatment on persistent symptoms attributed to Lyme borreliosis (PLEASE). The main secondary objectives are to investigate the long-term impact of persistent symptoms attributed to Lyme borreliosis on societal status and ability to work, to collect data on the additional medical or complementary care that patients have undergone after participation in PLEASE, and to correlate these data with their course of symptoms, quality of life and ability to work.
Study objective
Patients with persistent symptoms attributed to Lyme borreliosis report a substantial disease burden and a poor quality of life. Little is known about the long-term outcomes of patients with persistent symptoms attributed to Lyme borreliosis. The impact of these persistent symptoms on workability has not been investigated to date.
After completion of the study visits, many patients in the PLEASE cohort have followed other after long-term antibiotic treatment or complementary therapies.
We hypothesize that patients included in the PLEASE study may have ongoing symptoms during long-term follow-up, affecting their quality of life, workability and social costs. Furthermore, we hypothesize that specific interventions or supportive strategies that patients have undergone have an impact on long-term outcomes.
Study design
One time point, and in a subset of patients one or more additional time points for interviews and focus groups (upon additional consent).
Intervention
None
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. Inclusion criteria for PLEASE were: persistent symptoms 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 withdrawn informed consent to PLEASE participation, have not consented to receive PLEASE5+ study information, or who do not provide written informed consent to PLEASE5+ participation are excluded, as well as subjects who have died.
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL8224 |
| CCMO | NL71890.091.20 |
| OMON | NL-OMON50085 |