Arts and culture on prescription
| ISRCTN | ISRCTN11875351 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN11875351 |
| Secondary identifying numbers | 2025-01138 |
- Submission date
- 29/07/2025
- Registration date
- 19/09/2025
- Last edited
- 07/10/2025
- Recruitment status
- Not yet recruiting
- Overall study status
- Ongoing
- Condition category
- Other
Plain English summary of protocol
Background and study aims
This study is exploring how cultural activities—like art workshops, music, dance, and theater—can support the health and well-being of older adults. The idea is to see whether taking part in these kinds of activities can help people feel better physically, mentally, and socially. Researchers want to find out if this approach could become a regular part of healthcare for older people.
Who can participate?
The study is open to people aged 65 and over who live in the Lugano area and have long-term health conditions such as obesity, diabetes, high blood pressure, chronic lung disease (COPD), or liver disease. People who are still working, have severe dementia or serious mobility issues, or who can’t take part in cultural activities won’t be able to join.
What does the study involve?
Participants will be split into two groups. Most will join the main group and take part in cultural activities like painting, music, photography, or theatre for six months. A smaller group will receive a free ticket to a cultural event like a museum or concert. Everyone will have health checks and fill out questionnaires at the start, after six months, and again after a year. A link worker will help match each person to the right activities for them.
What are the possible benefits and risks of participating?
Taking part could help improve your mood, health, and sense of connection with others. There are no major risks expected, but some people might find it tiring or challenging to take part in regular activities. The team will support participants throughout the study.
Where is the study run from?
The study is based in the municipality of Lugano, Switzerland.
When is the study starting and how long is it expected to run for?
Who is funding the study?
IBSA Foundation (Switzerland)
Who is the main contact?
Prof. Marta Fadda, marta.fadda@usi.ch
Dr Luca Gabutti, luca.gabutti@eoc.ch
Contact information
Public, Scientific, Principal investigator
Via Buffi 13
Lugano
6900
Switzerland
 ORCID ID |
0000-0002-1929-6759 |
|---|---|
| Phone | +41 91 811 84 65 |
| luca.gabutti@eoc.ch |
Scientific
Via Buffi 13
Lugano
6900
Switzerland
| Phone | +41 586664000 |
|---|---|
| marta.fadda@usi.ch |
Study information
| Study design | Double-arm feasibility study with a control group incorporating baseline and post-intervention assessments |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Community, GP practice |
| Study type | Quality of life, Efficacy |
| Scientific title | Arts and culture on prescription. The impact of cultural prescription on the health of the elderly population living in the Lugano municipality – A pilot project. |
| Study objectives | Primary objective: Explore programme feasibility and acceptability by assessing programme uptake, attendance rates, reasons for non-attendance, and barriers to engagement. Secondary objectives: Test whether there is any indication of an improvement in health orientation; compare health orientation and health outcomes of those participating in the programme versus the control group. |
| Ethics approval(s) |
Approved 15/07/2025, Ethics Committee of the Canton of Ticino (Via Orico 5, Bellinzona, 6501, Switzerland; +41 91 814 30 57; dss-ce@ti.ch), ref: 2025-01138 |
| Health condition(s) or problem(s) studied | Elderly health |
| Intervention | A link worker from the Città di Lugano will contact participants to provide detailed information about the available cultural offerings and the research procedure. The link worker will work closely with participants to understand their personal preferences and interests, ensuring that the selected cultural activities align with their tastes and needs. By tailoring the experience to each participant, the link worker will help identify the most appropriate events or activities that can enhance their engagement and overall well-being, while also supporting the goals of the study. Participants will receive up to six sessions with their link worker, which is a pragmatic allocation based on trial feasibility, though in real-world practice, individuals may receive additional support if needed. Each session will last up to one hour and will be conducted in person, over the phone, or via video call, depending on participant preference and accessibility. The control group will be offered a free ticket for a museum, concert or show. All cultural activities will be fully funded, ensuring that financial barriers do not limit participation. The available activities are part of a curated set designed specifically for this program, including drawing, painting, music, photography, museotherapy, dance, and theater. Link workers will not have complete autonomy over referrals but will guide participants toward these pre-selected activities that align with the research framework. Every activity includes up to 25 sessions lasting 1-2 hours each per week. The sessions take place at LAC. The total duration of follow-up for all study arms is 12 months. The randomisation process will be conducted using an online tool. |
| Intervention type | Behavioural |
| Primary outcome measure | Uptake and feasibility of recruitment and research procedures measured using attendance records (reported by facilitators and self-report), GP screening logs, and rates of completion of follow-up assessments at baseline, 6 months, and 12 months |
| Secondary outcome measures | 1. Health orientation measured using the Health Orientation Scale (HOS) at baseline, 6 months, and 12 months 2. Mental health and well-being measured using the following validated questionnaires at baseline, 6 months, and 12 months: 2.1. Generalized Anxiety Disorder Assessment-7 (GAD-7) 2.2. Patient Health Questionnaire-9 (PHQ-9) 2.3. Warwick-Edinburgh Mental Wellbeing Scale 2.4. Self-Compassion Scale Short Form (SCS-SF) 2.5. WHO-5 Well-Being Index 2.6. EQ-5D 2.7. Three-item UCLA Loneliness Scale 2.8. Medical Outcomes Study Social Support Survey 2.9. Bernese Sleep Health Questionnaire (BSHQ) 3. Physiological measures measured using clinical examination, wearable device (Garmin vívoactive® 5), and lab tests at baseline, 6 months, and 12 months: 3.1. Clinical: blood pressure, anthropometry, bioimpedance, Mini-Mental State Exam, and Clock Test 3.2. Wearable: heart rate variability (HRV), sleep quality, physical activity, stress (via smartwatch) 3.3. Laboratory: HbA1c, GGT, uric acid, ALAT, creatinine (blood); sodium, potassium, albumin, creatinine (urine) 4. Consultations and hospitalizations/emergency department accesses measured using a structured GP questionnaire (review of medical records) at 12 months |
| Overall study start date | 01/05/2024 |
| Completion date | 31/03/2027 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Senior |
| Lower age limit | 65 Years |
| Upper age limit | 99 Years |
| Sex | All |
| Target number of participants | 100 |
| Key inclusion criteria | 1. Aged 65 or older 2. Resident in the Lugano municipality 3. Having access to a GP 4. Diagnosed > six months with one or more of the following pathological conditions: Obesity (BMI ≥30); Obstructive sleep apnea syndrome; Type 2 Diabetes Mellitus; Chronic Obstructive Pulmonary Disease (COPD) (GOLD 2 or higher); Uncontrolled hypertension; Uncontrolled gouty arthritis; Metabolic dysfunction and alcohol-related liver disease (MetALD) |
| Key exclusion criteria | 1. Individuals who are still in employment (as the study focuses on retirees). Those who undertake occasional freelance work or small consultancies (e.g., fewer than 8 hours per week) may still be eligible, provided their professional activities do not interfere with participation in the study 2. Individuals diagnosed with moderate to severe dementia or cognitive impairment that affects their ability to provide informed consent 3. Individuals with significant mobility restrictions that would prevent engagement in artistic and cultural activities (unless safe accommodations can be arranged) |
| Date of first enrolment | 01/01/2026 |
| Date of final enrolment | 31/03/2027 |
Locations
Countries of recruitment
- Switzerland
Study participating centre
Lugano
6900
Switzerland
Sponsor information
Industry
Casa Carlo Cattaneo, Str. di Gandria 4
Lugano
6976
Switzerland
| Phone | +41 58 360 10 00 |
|---|---|
| info@ibsafoundation.org | |
| Website | https://www.ibsafoundation.org/en/ |
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | 01/01/2027 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Stored in publicly available repository |
| Publication and dissemination plan | IBSA Foundation will financially contribute to the study. The study follows a transparent publication policy, ensuring timely and open access dissemination of results in accordance with ethical and regulatory standards. Authorship will be determined based on substantial contributions to study design, data collection, analysis, and manuscript preparation, following recognized guidelines. Raw data access will be limited to authorized research team members, with data sharing considered upon reasonable request and in compliance with data protection regulations. Sex and gender analyses will be reported in the final study publication. If no effects are observed, this will also be explicitly stated. The sponsor will enter and publish a summary of the trial results in a public register as per ClinO Art. 65a within one year of study completion or discontinuation. If an interruption exceeds two years, the trial will be considered discontinued. Additionally, a lay summary of the results will be made available in BASEC in the national languages relevant to participant recruitment. The investigator will provide each participant with the lay summary at the end of the study and ensure that participants are informed about its availability in the patient information document. Potential conflicts of interest, including financial, intellectual, and proprietary considerations, will be disclosed in study publications. The study maintains independence from external influences, with data integrity and analysis remaining the responsibility of the research team. Additional contractual agreements related to publication and data sharing are outlined in separate study documents where applicable. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study will be stored in a publicly available repository (https://osf.io/). |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol file | version 1 | 02/06/2025 | 04/08/2025 | No | No |
Additional files
Editorial Notes
07/10/2025: Date of first enrolment was changed from 01/10/2025 to 01/01/2026.
04/08/2025: Trial's existence confirmed by the Ethics Committee of the Canton of Ticino.
