Video-based First-contact Physiotherapy in Primary Care (VIPP)

Video-based First-contact Consultation With a Physiotherapist in Primary Care for Patients With Musculoskeletal Symptoms

This study aims to evaluate the effects and implications of using video-based first-contact consultation in primary care physiotherapy, compared with traditional in-person consultation for musculoskeletal symptoms. The participants with musculoskeletal symptoms will receive either a video-based first contact physiotherapy consultation or an in-person first-contact physiotherapy consultation and will be followed for up to two years. The project addresses clinical effectiveness, healthcare utilisation, cost-effectiveness, and carbon footprint, according to the following specific aims.

Objectives

• To evaluate whether a video-based first-contact consultation with a physiotherapist is not clinically inferior to an in-person first-contact consultation, using the Patient-Specific Functional Scale (PSFS) as the primary outcome measure and multiple secondary outcomes assessed over time.
• To analyse healthcare utilisation in primary and specialist care at 12 and 24 months following a video-based first-contact consultation, compared with an in-person first contact consultation.
• To evaluate whether a video-based first-contact consultation with a physiotherapist is cost-effective from a healthcare perspective and in terms of environmental impact compared with an in-person first contact consultation.

Study Overview

• Status: Not yet recruiting
• Conditions: Musculoskeletal Diseases
• Intervention / Treatment: Other: Video-based first-contact physiotherapy consultation; Other: In-person first-contact physiotherapy consultation

Detailed Description

Background The digitalisation of health care has accelerated in recent years, driven by the World Health Organisation's Global Strategy on Digital Health. Musculoskeletal conditions include diseases and disorders affecting the joints, bones, muscles and related connective tissues. These conditions can affect multiple body areas or systems. Furthermore, the conditions are often characterised by pain and limitations in mobility and activities of daily living. Globally, musculoskeletal conditions are estimated to affect 1.7 billion people. Musculoskeletal conditions represent approximately two-thirds of all adults requiring rehabilitation. Physiotherapy plays a central role in the management and rehabilitation of musculoskeletal conditions. When provided as first-line primary care, physiotherapy has proven both efficient and cost-effective . Furthermore, video-based physiotherapy has been associated with improved attendance and adherence, factors that are critical for treatment effectiveness.

Video-based assessment in physiotherapy has been shown to be partially valid and reliable, but the methods remain poorly standardised, and the use of approaches and technical tools varies considerably. Overall, the evidence is limited, and existing descriptions are insufficient to support implementation in clinical practice. The transition to video-based care is described as a paradigm shift, and the profession expresses uncertainty regarding its effectiveness.

Despite the promising potential of digital health encounters, several challenges remain. A substantial proportion of patients initially assessed via video subsequently require in-person visits. Moreover, the therapeutic relationship may be affected by the video-based format. Taken together, these factors highlight an urgent need for robust, long-term evaluations of video-based first-contact physiotherapy.

Methods Study design A pragmatic randomised controlled trial (RCT) with a non-inferiority design will be conducted. The study will evaluate whether a video-based first-contact consultation with a physiotherapy yields outcomes that are not clinically inferior to those of a standard in-person first-contact physiotherapy consultation in primary care. The study will be reported in accordance with the CONSORT 2010 Statement for non-inferiority trials.

A non-inferiority analysis will be conducted, as the study aims to determine whether video-based first-contact physiotherapy consultation is not clinically inferior to an in-person first-contact physiotherapy. The analysis will use a predefined margin (∆) based on both statistical considerations and clinical judgement. The minimal clinically important difference and change for the PSFS was considered to define the non-inferiority margin. Previous literature reports that the minimal clinically important change for the PSFS ranges from approximately 1.3 and 2.3 points, depending on the diagnostic area. To ensure that any potential difference between groups is not clinically relevant, the non-inferiority margin has been set at ∆ = 1.5 points, which is also consistent with previous research in digital physiotherapy. The standard deviation (SD) will be set to 2, based on previous studies .

Sample size calculations based on the primary outcome variable PSFS, with ∆ = 1.5, indicate that 78 participants per group are required to achieve 80% statistical power with a one-sided alpha of 2.5%. Assuming a 25 % dropout rate, 104 participants will be included in each group, for a total of 208 participants.

Participant Selection and Recruitment Participants aged 18 years or older with musculoskeletal symptoms will be recruited. The study will be conducted at approximately six regional primary care rehabilitation units in Region Västra Götaland, Sweden, representing both geographic and demographic variation.

Potential participants will be identified through advertisement via social media, through posters and telephone. Potential participants will be screened to ensure that they meet the inclusion and exclusion criteria. They will receive written participant information digitally, will have the opportunity to ask questions, and will be offered verbal information. Informed consent will be obtained digitally.

Participants will be stratified by age, randomised, and scheduled for the type of consultation (video or in-person) corresponding to their allocated group with participating physiotherapist. All collected data will be handled in accordance with the principal investigator's data management procedures and applicable legislation.

Procedures The video-based first-contact consultation and the in-person first-contact consultation will be conducted within routine care. Participating physiotherapists will undergo approximately five hours of training in a structured model for conducting video-based physiotherapeutic assessments.

Participants will complete digital questionnaires before the first consultation, immediately after the first consultation, and at 6 weeks, 3 months, 6 months, and 12 months. The estimated time required to complete the digital questionnaires is approximately 10-20 minutes. Medical records and registry data will be collected in 6, 12 and 24 months.

Statistical Analysis The analyses will be conducted using IBM SPSS Statistics for Windows, (IBM Corp., Armonk, NY, USA). Descriptive statistics will be presented as means, standard deviations, and medians for continuous variables, and as frequencies for categorical variables.

Comparisons of improvement levels will be conducted using regression models, controlling for potential confounders (e.g., age, gender, trust). Comparisons of proportions showing improvement will be performed using a two-proportion Z-test. Exploratory analyses will be conducted to identify predictors of outcomes within the video consultation group.

For the health economic analysis, QALYs will be calculated from EQ-5D-5L data, and cost data will be obtained from healthcare registers and patient records. Incremental cost-effectiveness ratios (ICERs) will be calculated, with uncertainty analyses performed using bootstrapping and cost-effectiveness acceptability curves.

Estimates of carbon dioxide emissions will be performed from a life-cycle perspective, based on patient travel and estimates from the Swedish Transport Administration, healthcare utilisation based on estimates from the National Health Service in England, and the use of digital technology.

Comparisons between groups and over time will be conducted using appropriate parametric or non-parametric tests and regression models, depending on the characteristics of the data. Matched analyses will be applied where relevant.

• Study Type: Interventional
• Enrollment (Estimated): 208
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Elvira Lange, PhD; Phone Number: +46 764-95 61 23; Email: elvira.m.lange@vgregion.se

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age 18 years or older.
• Musculoskeletal complaints.
• Sufficient linguistic and cognitive ability to read, understand, and complete a web-based application form and provide informed consent in Swedish.
• Willing to attend the clinic in person.

Exclusion Criteria:

• Ongoing treatment for the current condition with planned follow-up by a physiotherapist.
• Lack of access to technology capable of supporting video consultations (e.g., smartphone, computer, or tablet).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Video-based first-contact physiotherapy; Participants receive a video-based first-contact physiotherapy consultation. Following the first-contact consultation, participants will receive standard individualised physiotherapy treatment which falls outside the scope of the study.	Other: Video-based first-contact physiotherapy consultation; Participants receive a video-based first-contact physiotherapy consultation. Following the assessment, individualised standard physiotherapy treatment is provided as needed. During the video-based assessment, participants will be in a setting of their choice and will meet a physiotherapist via video. The physiotherapists will be trained in a structured model for conducting video-based physiotherapeutic assessments. The rehabilitation clinic's standard platform for real-time audio and video healthcare visits will be used. The estimated time will be approximately 30-45 minutes.
Active Comparator: Traditional in-person first-contact physiotherapy; Participants receive an in-person physiotherapy consultation at a primary care rehabilitation clinic. Following the first-contact consultation, participants will receive standard individualised physiotherapy treatment which falls outside the scope of the study.	Other: In-person first-contact physiotherapy consultation; Participants receive an in-person physiotherapy consultation at a primary care rehabilitation clinic. Following the assessment, individualised standard physiotherapy treatment is provided as needed. The traditional in-person consultation will be conducted at a rehabilitation clinic within the public healthcare system in Region Västra Götaland. The estimated time will be approximately 30-45 minutes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient-Specific Functional Scale (PSFS) at 6 weeks	Evaluates treatment outcomes by having the patient identify three activities limited by their condition and rate them on a scale from 0 to 10, where 0 = "unable to perform activity" and 10 = "able to perform activity at the same level as before injury or problem" (Stratford et al., 1995).	6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient-Specific Functional Scale (PSFS) at baseline	Evaluates treatment outcomes by having the patient identify three activities limited by their condition and rate them on a scale from 0 to 10, where 0 = "unable to perform activity" and 10 = "able to perform activity at the same level as before injury or problem" (Stratford et al., 1995).	Baseline
Patient-Specific Functional Scale (PSFS) at 3 months	Evaluates treatment outcomes by having the patient identify three activities limited by their condition and rate them on a scale from 0 to 10, where 0 = "unable to perform activity" and 10 = "able to perform activity at the same level as before injury or problem" (Stratford et al., 1995).	3 months
Patient-Specific Functional Scale (PSFS) at 6 months	Evaluates treatment outcomes by having the patient identify three activities limited by their condition and rate them on a scale from 0 to 10, where 0 = "unable to perform activity" and 10 = "able to perform activity at the same level as before injury or problem" (Stratford et al., 1995).	6 months
Patient-Specific Functional Scale (PSFS) at 12 months	Evaluates treatment outcomes by having the patient identify three activities limited by their condition and rate them on a scale from 0 to 10, where 0 = "unable to perform activity" and 10 = "able to perform activity at the same level as before injury or problem" (Stratford et al., 1995).	12 months
Pain intensity using Numeric Rating Scale (NRS) at baseline	Current pain is rated on a numeric scale from 0 to 10, where 0 represents no pain and 10 represents the worst imaginable pain (Hjermstad et al., 2011).	Baseline
Pain intensity using Numeric Rating Scale (NRS) at 6 weeks	Current pain is rated on a numeric scale from 0 to 10, where 0 represents no pain and 10 represents the worst imaginable pain (Hjermstad et al., 2011).	6 weeks
Pain intensity using Numeric Rating Scale (NRS) at 3 months	Current pain is rated on a numeric scale from 0 to 10, where 0 represents no pain and 10 represents the worst imaginable pain (Hjermstad et al., 2011).	3 months
Pain intensity using Numeric Rating Scale (NRS) at 6 months	Current pain is rated on a numeric scale from 0 to 10, where 0 represents no pain and 10 represents the worst imaginable pain (Hjermstad et al., 2011).	6 months
Pain intensity using Numeric Rating Scale (NRS) at 12 months	Current pain is rated on a numeric scale from 0 to 10, where 0 represents no pain and 10 represents the worst imaginable pain (Hjermstad et al., 2011).	12 months
Patient's Global Impression of Change (PGIC) at 6 weeks	The Patient's Global Impression of Change (PGIC) assesses the patient's perception of change. Patients rate their change since the start of treatment on a 7-point scale, where 1 indicates "very much improved" and 7 indicates "very much worse" (Hurst & Bolton, 2004).	6 weeks
Patient's Global Impression of Change (PGIC) at 3 months	The Patient's Global Impression of Change (PGIC) assesses the patient's perception of change. Patients rate their change since the start of treatment on a 7-point scale, where 1 indicates "very much improved" and 7 indicates "very much worse" (Hurst & Bolton, 2004).	3 months
Perceived quality of care, Quality from the Patient's Perspective (QPP) at day 1	Perceived quality of care will be assessed using the Quality from the Patient's Perspective (QPP) questionnaire, which measure patients 'experiences of healthcare quality from the patient's perspective across several domains/factors medical-technical competence, physical-technical conditions identity-oriented approach, socio-cultural atmosphere. Patients first rate their experience based on "this is how it was for me", which reflects the perceived reality. They then rate "this is how important it was for me", corresponding to subjective importance. Responses are provided using Likert scale. (Wilde Larsson & Larsson).	Day 1
Perceived quality of care, Quality from the Patient's Perspective (QPP) at 6 weeks	Perceived quality of care will be assessed using the Quality from the Patient's Perspective (QPP) questionnaire, which measure patients 'experiences of healthcare quality from the patient's perspective across several domains/factors medical-technical competence, physical-technical conditions identity-oriented approach, socio-cultural atmosphere. Patients first rate their experience based on "this is how it was for me", which reflects the perceived reality. They then rate "this is how important it was for me", corresponding to subjective importance. Responses are provided using Likert scale. (Wilde Larsson & Larsson).	6 weeks
Quality of life measured with EuroQol Dimensions - 5 Levels (EQ-5D-5L) at Baseline	The EQ-5D-5L is a health-related quality of life instrument consisting of two parts. The first part is a self-assessment of quality of life across five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, with each dimension rated on five levels of severity. The second part is a rating using a visual analogue scale (VAS) from 0 to 100, where 0 represents the worst imaginable health and 100 represents the best imaginable health (EuroQol Research Foundation, n.d.).	Baseline
Quality of life measured with EuroQol Dimensions - 5 Levels (EQ-5D-5L) at 6 weeks	The EQ-5D-5L is a health-related quality of life instrument consisting of two parts. The first part is a self-assessment of quality of life across five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, with each dimension rated on five levels of severity. The second part is a rating using a visual analogue scale (VAS) from 0 to 100, where 0 represents the worst imaginable health and 100 represents the best imaginable health (EuroQol Research Foundation, n.d.).	6 weeks
Quality of life measured with EuroQol Dimensions - 5 Levels (EQ-5D-5L) at 3 months	The EQ-5D-5L is a health-related quality of life instrument consisting of two parts. The first part is a self-assessment of quality of life across five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, with each dimension rated on five levels of severity. The second part is a rating using a visual analogue scale (VAS) from 0 to 100, where 0 represents the worst imaginable health and 100 represents the best imaginable health (EuroQol Research Foundation, n.d.).	3 months
Quality of life measured with EuroQol Dimensions - 5 Levels (EQ-5D-5L) at 6 months	The EQ-5D-5L is a health-related quality of life instrument consisting of two parts. The first part is a self-assessment of quality of life across five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, with each dimension rated on five levels of severity. The second part is a rating using a visual analogue scale (VAS) from 0 to 100, where 0 represents the worst imaginable health and 100 represents the best imaginable health (EuroQol Research Foundation, n.d.).	6 months
Quality of life measured with EuroQol Dimensions - 5 Levels (EQ-5D-5L) at 12 months	The EQ-5D-5L is a health-related quality of life instrument consisting of two parts. The first part is a self-assessment of quality of life across five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, with each dimension rated on five levels of severity. The second part is a rating using a visual analogue scale (VAS) from 0 to 100, where 0 represents the worst imaginable health and 100 represents the best imaginable health (EuroQol Research Foundation, n.d.).	12 months
Work Ability Index (WAI) at Baseline	Self-rated work ability will be measured with WAI. Questionnaire consisting of a total 10 questions of seven items, sometimes only one question is used. The index addresses demand of work, the worker's health status and resources (Illmarinen, 2007; Svenska WAI-nätverket, n.d.).	Baseline
Work Ability Index (WAI) at 6 weeks	Self-rated work ability will be measured with WAI. Questionnaire consisting of a total 10 questions of seven items, sometimes only one question is used. The index addresses demand of work, the worker's health status and resources (Illmarinen, 2007; Svenska WAI-nätverket, n.d.).	6 weeks
Work Ability Index (WAI) at 3 months	Self-rated work ability will be measured with WAI. Questionnaire consisting of a total 10 questions of seven items, sometimes only one question is used. The index addresses demand of work, the worker's health status and resources (Illmarinen, 2007; Svenska WAI-nätverket, n.d.).	3 months
Work Ability Index (WAI) at 6 months	Self-rated work ability will be measured with WAI. Questionnaire consisting of a total 10 questions of seven items, sometimes only one question is used. The index addresses demand of work, the worker's health status and resources (Illmarinen, 2007; Svenska WAI-nätverket, n.d.).	6 months
Work Ability Index (WAI) at 12 months	Self-rated work ability will be measured with WAI. Questionnaire consisting of a total 10 questions of seven items, sometimes only one question is used. The index addresses demand of work, the worker's health status and resources (Illmarinen, 2007; Svenska WAI-nätverket, n.d.).	12 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Demographic data	Background information such as age, sex, level of education and occupation.	Baseline
General self-efficacy	One question regarding participants general self-efficacy before the first-contact consultation (Di et al., 2023).	Baseline
Trust in digital care using Patient Trust Assessment Tool (PATAT)	To measure trust in telemedicine the Patient trust Assessment Tool (PATAT) will be used. PATAT is a self-reported instrument developed to measure patients' trust in healthcare services in the context of telemedicine or digital care. The instrument consists of 25 items, where the patient rate statements on a five-point Likert scale ranging from disagree (1) to agree (5). The questionnaire consisting of one question in each of five domains: trust in the healthcare organization, healthcare personnel, treatment, technology, and telemedicine (Van Velsen et al., 2017).	Baseline
Total travel time to the clinic	Total travel time to the clinic for the participant's first-contact consultation, or the estimated travel time to the clinic where an in-person visit would otherwise have taken place in the case of a video consultation. For participants receiving a video consultation, the travel time represents the time they would have spent travelling to an in-person consultation.	Day 1
Mode of transport to the clinic	Mode of transport used to travel to the clinic for the participant's first-contact consultation. For participants receiving a video consultation, the mode of transport they would have used to attend an in-person consultation will be recorded.	Day 1
Technology used for video consultation	Type of technology used by the participant to conduct the video consultation.	Day 1
Consultation duration	Duration of the physiotherapy first-contact consultation, measured in minutes.	Day 1
Administrative time	Duration of administrative activities associated with the physiotherapy consultation, measured in minutes.	Day 1
Number of adverse events	Number of adverse events occurring during the first-contact consultation.	Day 1
Physiotherapist-rated adherence to the structured approach	Physiotherapists rate the extent to which they followed the structured approach taught during the study training using a 0-10 numerical rating scale, where 0 = strongly disagree and 10 = strongly agree.	Day 1
Physiotherapist-rated sufficiency of information to proceed with treatment	Physiotherapists rate whether they obtained sufficient information from the first-contact consultation to proceed with treatment using a 0-10 numerical rating scale, where 0 = strongly disagree and 10 = strongly agree.	Day 1
Participant's areas of complaint	The participant's area of complaint as recorded by the physiotherapist at the first-contact consultation.	Day 1
Visit information -obtained from the physiotherapists	Consultation and administrative duration.; Adverse events.; Adherence to the structured video-based approach.; Whether sufficient information was obtained to proceed with treatment; Participant's area of complaint.	Day 1
Diagnostic code at the first-contact consultation	ICD-10 diagnosis code from the participant´s first-contact consultation with a physiotherapist at the rehabilitation clinic where the participant attended the first study visit. These data will be collected after all participants have been enrolled.	Approximately 6 months after study start
Procedure codes (KVÅ) at the first-contact consultation	Procedure codes (KVÅ) from the participant´s first-contact consultation with a physiotherapist at the rehabilitation clinic where the participant attended the first study visit. These data will be collected after all participants have been enrolled.	Approximately 6 months after study start
Number of previous rehabilitation visits	All visits and visit modalities at regional primary care rehabilitation clinics during the two years before the participant´s first visit in the study. These data will be collected after all participants have been enrolled.	Approximately 6 months after study start
Number of physiotherapy visits during the current episode of care, at 12 months	All physiotherapy visits related to the current episode of care, including visit modality (digital or in-person), from study start up to 12 months.	Approximately 12 months after study start
Number of physiotherapy visits during the current episode of care, at 24 months	All physiotherapy visits related to the current episode of care, including visit modality (digital or in-person), from study start up to 24 months.	Approximately 24 months after study start
Number of other Healthcare contacts, 12 months	All other healthcare contacts, including visit modality, within primary care, specialized outpatient care and inpatient care during the study period. The data will cover the period from study start until 12 months after the participant´s first-contact consultation.	Approximately 12 after study start
Number of other Healthcare contacts, 24 months	All other healthcare contacts, including visit modality, within primary care, specialized outpatient care and inpatient care during the study period. The data will cover the period from study start until 24 months after the participant´s first-contact consultation.	Approximately 24 months after study start
Total healthcare costs during 12 months	Information on healthcare costs associated with healthcare contacts recorded during the study period, to the extent that such information is available. Total healthcare costs will be calculated based on the recorded healthcare contacts and applicable unit costs and will be used for health economic and cost-effectiveness analyses.	Approximately 12 months after study start
Total healthcare costs during 24 months	Information on healthcare costs associated with healthcare contacts recorded during the study period, to the extent that such information is available. Total healthcare costs will be calculated based on the recorded healthcare contacts and applicable unit costs and will be used for health economic and cost-effectiveness analyses.	Approximately 24 months after study start
Number of physiotherapy visits related to the condition	Physiotherapy records may be reviewed during study period and up to one year after the first consultation in order to capture whether the visits were related to the current episode of care and to describe the content of assessments and treatments. The purpose is to ensure an accurate link between healthcare utilisation and the condition for which the participant is included in the study.	12 months

Collaborators and Investigators

• Sponsor: Vastra Gotaland Region
• Collaborators: The Swedish Research Council
• Investigators: Principal Investigator: Elvira Lange, PhD, Vastra Gotaland Region

Publications and helpful links

General Publications

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• Walin, M., Hansson, O., Bernhardsson, S., & Lange, E. (2025). Video-based musculoskeletal knee examination: A scoping review. JOSPT Open, 3(3), 263-276. https://doi.org/10.2519/josptopen.2025.0094
• Walsh NE, Halls S, Thomas R, Berry A, Liddiard C, Cupples ME, Gage H, Jackson D, Cramp F, Stott H, Kersten P, Jagosh J, Foster D, Williams P. First contact physiotherapy: an evaluation of clinical effectiveness and costs. Br J Gen Pract. 2024 Sep 26;74(747):e717-e726. doi: 10.3399/BJGP.2023.0560. Print 2024 Oct.
• Withers HG, Glinsky JV, Chu J, Jennings MD, Starkey I, Parmeter R, Boulos M, Cruwys JJ, Duong K, Jordan I, Wong D, Trang S, Duong M, Liu H, Hayes AJ, Lambert TE, Zadro JR, Sherrington C, Maher C, Lucas BR, Taylor D, Ferreira ML, Harvey LA. Remotely delivered physiotherapy is as effective as face-to-face physiotherapy for musculoskeletal conditions (REFORM): a randomised trial. J Physiother. 2024 Apr;70(2):124-133. doi: 10.1016/j.jphys.2024.02.016. Epub 2024 Mar 16.
• World Health Organization. (2021). Global strategy on digital health 2020-2025. World Health Organization.
• World Health Organization. (2022, July 14). Musculoskeletal conditions. https://www.who.int/news-room/fact-sheets/detail/musculoskeletal-conditions

Study record dates

Study Major Dates

• Study Start (Estimated): October 1, 2026
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2030

Study Registration Dates

• First Submitted: August 10, 2026
• First Submitted That Met QC Criteria: August 24, 2026
• First Posted (Actual): August 26, 2026

Study Record Updates

• Last Update Posted (Actual): August 26, 2026
• Last Update Submitted That Met QC Criteria: August 24, 2026
• Last Verified: August 1, 2026

More Information

Terms related to this study

• Keywords: Telemedicine; Remote Consultation; Digital Health; Physical Therapy Modalities
• Additional Relevant MeSH Terms: Musculoskeletal Diseases
• Other Study ID Numbers: VIPP; 2025 (U.S. NIH Grant/Contract: Faculty of Social Sciences Scientific Grant at the University of Gdańsk); 2025-07915 (Other Grant/Funding Number: Swedish Research Council)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Individual participant data (IPD) will not be publicly shared due to restrictions under the EU General data Protection Regulation (GDPR). However anonymised data may be made available upon reasonable request, provided the request complies with GDPR and Swedish data protection regulations.
• IPD Sharing Time Frame: After ethical approval. Anticipated date: Oktober 1st 2026. End: Available as long as R&D Project Database in Region Västra Götaland is available.
• IPD Sharing Access Criteria: Individual participant data (IPD) will be provided if the request complies with GDPR and Swedish data protection regulations.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No