Effectiveness Evaluation of Social Prescribing

NCT07029334 | Recruiting

• 1 other identifier: P-2024-17318
• Study Type: observational
• Target: 350
• Locations: 1 country
• Sites: 1

Brief Summary

Social Prescribing (SP), or Social Henvisning (SH) in Denmark, integrates healthcare with social and cultural services to address social determinants of health. The 'Social Prescribing Vesterbro-Sydhavnen' initiative, launched in fall 2024 as part of usual care, aims to involve general practitioners (GP) as primary prescribers to social services through a dedicated link worker, enhancing early intervention and connecting healthcare with community support. This evaluation aims to assess the effectiveness of the 'Social Prescribing Vesterbro-Sydhavnen' project as part of the Implementation Research Programme SHINE. The primary outcomes are: changes in contacts with general practice, unplanned hospital contacts and emergency calls (1813) as well as change in patients' perception of loneliness and health-related Quality of life.

Conditions

Loneliness; Health Related Quality of Life

Keywords

Social Prescribing; Public Health

Outcome Measures

Primary Outcomes (7)

• Rate ratios for change in contacts with GP

  Primary Outcome: • Change in contacts with general practice (all type of contacts)

  From the date the Link Worker received the social prescription to 3 and 9 months thereafter.

• Rate ratios for change in unplanned hospital contacts

  Primary Outcome: • Change in unplanned hospital contacts

  From the date the Link Worker received the social prescription to 3 and 9 months thereafter.

• Rate ratios for change in emergency calls (1813)

  Primary Outcome: • Change in emergency calls (1813)

  From the date the Link Worker received the social prescription to 3 and 9 months thereafter.

• Change in the perceived degree of loneliness assessed by T-ILS

  Primary Outcome: • Change in perception of loneliness - assessed by Three-Item Loneliness Scale (T-ILS). The scale uses three response categories: Hardly ever = score 1, Some of the time = score 2, Often = score 3. Higher scores means worse outcome.

  From the enrollment date to 3 and 9 months after the Link Worker has received the social prescription.

• Change in the perceived degree of loneliness - assessed by De Jong Gierveld Loneliness Scale

  Primary Outcome: • Change in perception of loneliness - assessed by De Jong Gierveld Loneliness Scale On the positively worded items, the neutral and negative answers are scored as "1" (Yes=0, More or less=1, and No=1). A higher score means a worse outcome.

  From the enrollment date to 3 and 9 months after the Link Worker has received the social prescription.

• Change in quality of life - assessed by EQ-5D-5L

  Primary Outcome: • Change in perception of Health-related Quality of Life (HRQoL) - assessed by EQ-5D-5L. The EQ-5D-5L instrument covers five dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) with five response levels: 1 = no problems, 2 = slight problems, 3 = moderate problems, 4 = severe problems, 5 = extreme problems; higher scores indicate worse outcomes. Dimension-level responses are aggregated into a single utility index using the Danish value set (range \< 0 \[health states worse than death\] to 1 \[full health\]); lower index scores reflect poorer health.

  From the enrollment date to 3 and 9 months after the Link Worker has received the social prescription.

• Change in quality of life - assessed by EQ-VAS (visual analog scale)

  Primary Outcome: • Change in perception of Health-related Quality of Life (HRQoL) - assessed by EQ-VAS (visual analog scale). Tthe minimum value = 0 and maximum value = 100. A higher scores mean a better outcome.

  From the enrollment date to 3 and 9 months after the Link Worker has received the social prescription.

Secondary Outcomes (1)

• Change in prescribed medication use (rate and dosage)

  6 months prior and 9 months after the date the Link Worker received the social prescription

Other Outcomes (3)

• Participation in the Social Prescribing intervention.

  Assessed 3 and 9 months after the link worker has received the SP referral from the GP

• Service types in Social Prescribing

  End of followup: 9 months after the link worker has received the SP referral from the GP

• Dropout of evaluation

  End of followup: 9 months after the link worker has received the SP referral from the GP

Study Arms (2)

SP participants

Participants in the intervention who has provided consent to participate in the effectiveness evaluation.

Other: Social Prescribing

SP participants - controls (registry data)

Matched controls (registry data) 1:4 selected from the same GP clinics and matched to cases based on age group, gender, and Charlson Comorbidity Index score.

Interventions

Social Prescribing OTHER

The SP intervention consists of a series of intervention components delivered across the SP pathways: Intervention components GP: 1. Social prescribing from physician to patient Link Worker: 2. Initial phone contact 3. Clarification and follow-up consultations 4. Personalized matching with local services and activities 5. Care coordination 6. Introductory visits to local services and activities 7. Accompanied (if needed) 8. Follow-up conversations 9. Concluding conversations 10. Group-based courses GP / Link Worker: 11. Re-prescribing (where appropriate) Each intervention component is described in detail in the TIDieR checklist

SP participants

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The GP´s work with the following inclusion and exclusion criteria when detecting eligible patients for the SP-intervention: INCLUSION CRITERIA * Citizens aged 18+ * In need of social support that can complement treatment in general practice or disease prevention * Motivated or can be motivated to participate. * Can be contacted via phone or email. * Reside in Vesterbro-Sydhavnen, Copenhagen Municipality EXCLUSION CRITERIA * Severe mental illness, other serious disabilities, or substance abuse that prevents the patient from participating in voluntary or municipal services. * Lack of basic language skills in Danish or English, which corresponds to levels A1-A2 of the Common European Framework of Reference for Languages (CEFR), indicating that the individual has very limited or no proficiency in the language.

Sponsors & Collaborators

• Hvidovre University Hospital: lead
• Volunteer Center Sydhavnen: collaborator
• GP cluster Vesterbro-Sydhavnen: collaborator

Study Sites (1)

Volunteer Center Sydhavnen

Copenhagen, 2450, Denmark

RECRUITING

Related Publications (1)

• Kirk JW, Oldrup LS, Lindstrom MB, Hansen JA, Broholm-Holst M, Andersen O. SHINE - social prescribing for adults and the elderly: the path to effective implementation. A study protocol. Implement Sci Commun. 2025 Oct 14;6(1):104. doi: 10.1186/s43058-025-00791-0.

  PMID: 41088466 DERIVED

Related Links

• Link to the paper used for the sample size calculation based on GP visit rates

Study Officials

• Ove Andersen, Professor, MD

  Department of Clinical Research, Copenhagen University Hospital, Hvidovre

  PRINCIPAL INVESTIGATOR

• Jeanette Wassar Kirk, PhD, Associate Professor

  Department of Clinical Research, Copenhagen University Hospital, Hvidovre

  STUDY CHAIR

Central Study Contacts

Mette B Lindstroem, MPH

CONTACT

+45 38623308; mlin0062@regionh.dk

Ove Andersen, Professor, MD

CONTACT

+45 38623335; ove.andersen@regionh.dk

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 9 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, MD, PhD

Study Record Dates

• First Submitted: June 3, 2025
• First Posted: June 19, 2025
• Study Start: July 4, 2025
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: July 24, 2025

Record last verified: 2025-07

Locations

DK (1)