In this study, we will conduct a randomized controlled pilot study to assess the effectiveness of the EQoL-intervention combined with standard of care versus standard of care alone.
ID
Source
Brief title
Condition
- Pigmentation disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Mean differences in emotion and functioning scores of the Skindex-29 between
baseline and 3 or 6 months in both study groups.
Secondary outcome
Secondary outcome measures are improvement on self-efficacy, coping strategies,
feelings of stigmatisation and symptoms of depression and anxiety.
Background summary
Vitiligo is an acquired cutaneous condition associated with depigmented macules
caused by destruction of melanocytes. Until this day there is no cure for
vitiligo and most therapies show rather disappointing results. Furthermore, the
quality of life is significantly impaired in vitiligo patients. Recent
guidelines recommend psychological interventions in vitiligo patients, however
no specific psychological therapeutic intervention could be recommended based
on current evidence. The psychosocial difficulties should be addressed and
psychological interventions can be beneficial in vitiligo patients.
Study objective
In this study, we will conduct a randomized controlled pilot study to assess
the effectiveness of the EQoL-intervention combined with standard of care
versus standard of care alone.
Study design
Prospective mono-centre observer-blinded randomized controlled trial.
Intervention
E-learning Quality of Life (EQoL); a Dutch web-based, educational, HRQoL
intervention for patients with a chronic skin disease. The EQoL will be
combined with standard of care in the intervention group and will be compared
to standard of care alone.
Study burden and risks
Subjects participating in the study will not experience any delay or
disadvantage in the medical care of vitiligo as the standard of care is
continued in both study groups. The treatment with the E-learning quality of
life has a hypothetically very low chance on adverse events and other risks.
However, patients need to invest a considerable amount of time in the
E-learning and this could be a burden for some patients. However, the
E-learning could substantially improve the quality of life. We consider the
burden due to participation in this study is in proportion with the expected
effect of the treatment.
Meibergdreef 9
Amsterdam 1100 DD
NL
Meibergdreef 9
Amsterdam 1100 DD
NL
Listed location countries
Age
Inclusion criteria
• Diagnosis of non-segmental vitiligo
• Patient visiting the NIPD during regular outpatient clinic visit and receives standard of care
• Skindex-29 emotions subscore of >= 35 and/or functioning subscores of >= 32 (moderate and severe impairment)
• Age of 18 years or older
• Patient is willing and able to give written consent
Exclusion criteria
• No access to a computer with internet connection
• Mental and/or physical impairment that could obstruct participation in the study
• Psychiatric comorbidity (e.g. depression, anxiety disorders)
• Insufficient mastery of Dutch
• Participation in another study with HRQoL as primary outcome.
• Currently receiving psychological and/or psychiatric treatment.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL55633.018.15 |