NCT07708844

Brief Summary

The goal of this early phase clinical trial is to determine the impact of participation in planned social activities among adults 55 years of age or older, who report feelings of loneliness. The main questions the study aims to answer are:

  • With the availability of a personalized community activity plan, will patients with loneliness participate in two hours of social activity each week?
  • Will 2 hours/week of planned social activities in the community reduce individual reports of loneliness? Participants will meet with a community coordinator to identify community activities of interest to them and then participate, in-person or virtually, in these activities over a 6 month period. Patients will complete a series of surveys at the start of the study and then at 1, 3 and 6 months later.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
9mo left

Started May 2026

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress25%
May 2026May 2027

Study Start

First participant enrolled

May 1, 2026

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 13, 2026

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 16, 2026

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2027

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2027

Last Updated

July 17, 2026

Status Verified

July 1, 2026

Enrollment Period

11 months

First QC Date

July 13, 2026

Last Update Submit

July 16, 2026

Conditions

Keywords

Loneliness

Outcome Measures

Primary Outcomes (1)

  • Change in Loneliness score

    The primary dependent variable will be change in loneliness as measured by the six-item DeJong Loneliness Scale from baseline to six-months post-social prescription. Scale scores range from 0 to 6 with higher scores representing more loneliness.

    6 months

Study Arms (1)

Social Prescription

EXPERIMENTAL

Personalized Social Prescriptions will be determined from a broad menu of activities available in the community.

Behavioral: Prescribing of community activities; at least 2 hours per week

Interventions

Personalized Social Prescriptions will be determined from a broad menu of activities available in the community.

Social Prescription

Eligibility Criteria

Age55 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients 55 years of age or older attending an outpatient visit at an Endeavor Health primary care practice site in Evanston, IL.;
  • Screened positive for loneliness (often, some of the time, or occasionally) using the one-item Loneliness Screener;
  • Able to provide informed consent for study participation;
  • Speaks and understands English language.

You may not qualify if:

  • Prisoners, pregnant women, children
  • Persons those who are determined to be unable to provide consent
  • Non-English speakers

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Research Institute

Evanston, Illinois, 60201, United States

RECRUITING

Study Officials

  • Susan G Fisher, PhD

    Endeavor Health

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: This study will be a quasi-experimental pre-post design based on 'intention-to-treat' principles.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
VP, Healthcare Delivery Sciences

Study Record Dates

First Submitted

July 13, 2026

First Posted

July 16, 2026

Study Start

May 1, 2026

Primary Completion (Estimated)

March 31, 2027

Study Completion (Estimated)

May 1, 2027

Last Updated

July 17, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will share

De-identified data will be available upon request following final publication of study results

Shared Documents
SAP, ICF
Time Frame
June, 2027 to May, 2030
Access Criteria
All study documents and de-identified data will be available for 3 years post-study completion ang publication.
More information

Locations