Survey on experiences with vitiligo treatment
| ISRCTN | ISRCTN86354475 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN86354475 |
- Submission date
- 22/01/2025
- Registration date
- 10/02/2025
- Last edited
- 04/02/2025
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Skin and Connective Tissue Diseases
Plain English Summary
Background and study aims
Vitiligo is a common autoimmune skin condition that causes white patches and can significantly affect a person’s quality of life. Treatment decisions for vitiligo vary depending on individual goals and circumstances, making it important for doctors and patients to work together to decide on the best approach. This study explores how patients feel about shared decision-making (SDM) when choosing their treatment and identifies any unmet needs they face during treatment. The study aims to understand how much patients feel involved in decision-making about their treatment. It will explore how factors like age, education, and ethnicity affect SDM and unmet needs, assess patients' uncertainty or conflict about decisions, and identify gaps in current vitiligo treatment.
Who can participate?
The study will include 100–150 patients per country who have a doctor-confirmed diagnosis of vitiligo, are 18 or older, and visited a dermatology department in the past two years.
What does the study involve?
A survey study will be conducted across three countries (Netherlands, Singapore, and Egypt) in collaboration with hospitals in these regions. The 10-minute survey asks about demographics, and unmet needs, and uses validated tools to measure SDM and decision-making challenges. The survey was developed and tested with input from vitiligo patients and translated into English and Arabic for use in all three countries.
What are the possible benefits and risks of participating?
This study aims to better understand how patients experience SDM and identify areas where vitiligo treatment can be improved. Insights will help improve patient-centred care for vitiligo globally. The study has a minimal burden for participants and has been cleared by the ethical committee.
Where is the study run from?
Amsterdam University Medical Centers, Netherlands
When is the study starting and how long is it expected to run for?
May 2024 to May 2025
Who is funding the study?
Amsterdam University Medical Centers, Netherlands
Who is the main contact?
Dr Marlide Jukema, m.jukema@amsterdamumc.nl
Contact information
Public, Scientific, Principal Investigator
Meibergdreef 9
Amsterdam
1105 AZ
Netherlands
| Phone | +31 020 566 9111 |
|---|---|
| a.wolkerstorfer@amsterdamumc.nl |
Study information
| Study design | Multinational cross-sectional exploratory survey study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cross sectional study |
| Study setting(s) | Internet/virtual |
| Study type | Other |
| Participant information sheet | 46717_PIS_v124July2024.pdf |
| Scientific title | Survey on experiences with vitiligo treatment |
| Study hypothesis | Vitiligo is a common autoimmune disorder characterised by depigmented macules which has a significant impact on patients’ quality of life. Treatment options vary based on individual factors and goals, making shared decision-making (SDM) crucial for aligning treatment with patient preferences. This study aims to investigate how patients experience shared decision-making in choosing their vitiligo treatment and which unmet needs they encounter in the treatment of vitiligo. |
| Ethics approval(s) |
Approved 13/08/2024, The Medical Ethics Committee of the Amsterdam University Medical Centers (Meibergdreef 9, Amsterdam, 1105 AZ, Netherlands; +31 020 566 9111; metc@amsterdamumc.nl), ref: 2024.0692 |
| Condition | Vitiligo |
| Intervention | This multinational, cross-sectional exploratory survey study will be conducted across three countries at the Amsterdam UMC, National University Singapore, Cairo University and Ain Shams University. The survey will be carried out using the free online survey tool ‘LimeSurvey’. The patients will be asked to fill out a questionnaire that will take about 10 minutes to complete. The questionnaire was developed with the input of three patients of the Dutch National Vitiligo Patient Association. It was also tested by three vitiligo patients who visited the dermatology department in Amsterdam UMC and was adjusted based on their feedback. The survey contains questions about demographic variables (such as educational level, ethnicity, etc.) and unmet needs during the treatment of vitiligo. Besides this, three validated questionnaires will be used: the 9-item Shared Decision-Making Questionnaire (SDM-Q-9) (Each item will be scored on a 6-point Likert scale ranging from 0 (no SDM) to 5 (optimal SDM). This results in a score ranging from 0 to 45, which will be converted to a scale of 0–100), the Control Preference Scale (CPS) and the Decisional Conflict Scale (DCS) for assessing the need for and extent of shared decision-making. The survey was translated into English and Arabic for the participating hospitals in Singapore and Egypt by a certified translation agency. The English survey and the Arabic survey will be reviewed in LimeSurvey by two doctors who are (near)-native speakers of these languages before sending the survey out to the patients. Data Collection and Analysis: Patients will receive an email with a secure link to the survey. Data will be anonymized and hosted securely by the Amsterdam University Medical Centre. Statistical analysis will summarize patient experiences and examine differences across countries and between demographic groups. |
| Intervention type | Other |
| Primary outcome measure | The following primary outcome measures are assessed at one time point after treatment: 1. The extent to which shared decision-making (SDM) is experienced will be measured using the validated nine-item Shared Decision-Making Questionnaire (SDM-Q) 2. The extent to which patients want to be involved in the SDM process will be measured using the validated Control Preference Scale 3. The uncertainty patients experience when making healthcare decisions will be measured using the Decisional Conflict Scale 4. Potential shortcomings patients may encounter during their treatment for vitiligo measured using a 5-point Likert scale (ranging from strongly disagree to strongly agree) |
| Secondary outcome measures | There are no secondary outcome measures |
| Overall study start date | 01/05/2024 |
| Overall study end date | 31/05/2025 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Mixed |
| Lower age limit | 18 Years |
| Upper age limit | 100 Years |
| Sex | Both |
| Target number of participants | The desired sample size is between 100-150 patients per country |
| Participant inclusion criteria | 1. Physician-based diagnosis of non-segmental vitiligo 2. Aged 18 years or above 3. Had a treatment visit at the dermatology department in the past 2 years |
| Participant exclusion criteria | Non segmental vitiligo |
| Recruitment start date | 26/11/2024 |
| Recruitment end date | 31/05/2025 |
Locations
Countries of recruitment
- Egypt
- Netherlands
- Singapore
Study participating centres
Amsterdam
1105 AZ
Netherlands
Singapore
119077
Singapore
Giza
12613
Egypt
Cairo
11566
Egypt
Sponsor information
Hospital/treatment centre
Meibergdreef 9
Amsterdam
1105 AZ
Netherlands
| Phone | +31 020 566 9111 |
|---|---|
| vitiligo-onderzoek@amsterdamumc.nl | |
| Website | https://www.amsterdamumc.org |
"ROR" |
https://ror.org/05grdyy37 |
Funders
Funder type
Hospital/treatment centre
Government organisation / Universities (academic only)
- Alternative name(s)
- Amsterdam UMC, Amsterdam University Medical Centres, AUMC
- Location
- Netherlands
Results and Publications
| Intention to publish date | 04/05/2026 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in peer-reviewed journal |
| IPD sharing plan | The datasets generated during and/or analysed during the current study will be available upon request from Dr Marlide Jukema, m.jukema@amsterdamumc.nl |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | version 124 | 24/07/2024 | 24/01/2025 | No | Yes |
| Protocol file | 24/01/2025 | No | No |
Additional files
Editorial Notes
04/02/2025: The study's existence confirmed by the Medical Ethics Committee of the Amsterdam University Medical Centers.
