Social Prescribing to Improve Access to Health and Care Services for People in Vulnerable Situations: An International, Multicentre, Pragmatic, Individually Randomised Controlled Basket Trial

Social Prescribing to Improve Access to Health and Care Services for People in Vulnerable Situations: An International, Multicentre, Pragmatic, Individually Randomised Controlled Basket Trial - SP-EU-RCT

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00038773

Enrollment

1776

Registered

2026-01-19

Start date

2026-05-07

Completion date

Unknown

Last updated

2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-Medical health related social needs (International Classification of Primary Care 3rd Edition, ICPC-3: ZC01-ZC99 “Social Problems”)

Interventions

Group 1: Social Prescribing (SP) is a structured, non-medical intervention. Eligible participants are referred by their general practitioner (GP) to a trained link worker. The link worker assesses the

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: - Presence of at least one non-medical, health-related social need according to Chapter ZC of the International Classification of Primary Care, 3rd Revision (ICPC-3) - Belonging to at least one of the following target groups: (1) LGBTQ+ persons, (2) refugees or first-generation migrants, or (3) older adults living alone (aged 65 years or older) - Ability to provide informed consent - Basic language skills sufficient to participate in the study

Exclusion criteria

Exclusion criteria: - Participation in another psychosocial intervention study or an existing social prescribing programme - Legal guardianship for health-related decisions - Another person from the same household already participating in the study - Study staff or employees of participating study centres and their immediate family members

Design outcomes

Primary

Measure	Time frame
The primary endpoint is collected via computer-assisted telephone interviews (CATI). - Utilization of non-medical, community-based support services within 6 months after randomisation, defined as the use of at least one such service, assessed using a self-developed 6-item patient-reported questionnaire with yes/no responses.	—

Secondary

Measure	Time frame
All secondary outcomes are collected via computer-assisted telephone interviews (CATI). - Utilization of non-medical, community-based support services at 12 months after randomisation, assessed using a self-developed 6-item patient-reported questionnaire (yes/no responses). - Number and types of non-medical, community-based services utilized at 6 and 12 months after randomisation, assessed via self-reported service utilization items (frequency and open-text type). - Health-related quality of life at 6 and 12 months after randomisation, assessed using the EQ-5D-5L questionnaire. - Capability and well-being at 6 and 12 months after randomisation, assessed using the ICECAP-A questionnaire. - Psychological well-being at 6 and 12 months after randomisation, assessed using the WHO-5 Well-Being Index. - General self-efficacy at 6 and 12 months after randomisation, assessed using the General Self-Efficacy Scale (GSE). - General life satisfaction at 6 and 12 months after randomisation, assessed using the Short Scale L-1 (SOEP). - Loneliness (emotional and social) at 6 and 12 months after randomisation, assessed using the De Jong Gierveld Loneliness Short Scales. - Social network size and social integration at 6 and 12 months after randomisation, assessed using the Lubben Social Network Scale (LSNS-6). - Health care and cross-sectoral resource utilization at 6 and 12 months after randomisation, assessed using the iMCQ and selected PECUNIA RUM modules. - Productivity loss and sick leave at 6 and 12 months after randomisation, assessed using the Productivity Cost Questionnaire (iPCQ).	—

Measure

Time frame

All secondary outcomes are collected via computer-assisted telephone interviews (CATI). - Utilization of non-medical, community-based support services at 12 months after randomisation, assessed using a self-developed 6-item patient-reported questionnaire (yes/no responses). - Number and types of non-medical, community-based services utilized at 6 and 12 months after randomisation, assessed via self-reported service utilization items (frequency and open-text type). - Health-related quality of life at 6 and 12 months after randomisation, assessed using the EQ-5D-5L questionnaire. - Capability and well-being at 6 and 12 months after randomisation, assessed using the ICECAP-A questionnaire. - Psychological well-being at 6 and 12 months after randomisation, assessed using the WHO-5 Well-Being Index. - General self-efficacy at 6 and 12 months after randomisation, assessed using the General Self-Efficacy Scale (GSE). - General life satisfaction at 6 and 12 months after randomisation, assessed using the Short Scale L-1 (SOEP). - Loneliness (emotional and social) at 6 and 12 months after randomisation, assessed using the De Jong Gierveld Loneliness Short Scales. - Social network size and social integration at 6 and 12 months after randomisation, assessed using the Lubben Social Network Scale (LSNS-6). - Health care and cross-sectoral resource utilization at 6 and 12 months after randomisation, assessed using the iMCQ and selected PECUNIA RUM modules. - Productivity loss and sick leave at 6 and 12 months after randomisation, assessed using the Productivity Cost Questionnaire (iPCQ).

—

Countries

Belgium, Croatia, Denmark, Germany, Poland, Portugal, Spain, Switzerland

Contacts

Public ContactWolfram J. Herrmann

Institut für Allgemeinmedizin

wolfram.herrmann@charite.de+49 30 450 514107

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Aug 10, 2026