NCT04919070

Connect for Caregivers

Completed NA Results posted Last updated 29 December 2022

What this trial tests

NA trial testing Connect for Caregivers in Social Isolation in 5 participants. Completed in 27 August 2021.

Timeline

28 June 2021

Primary endpoint
27 August 2021

27 August 2021

Quick facts

Lead sponsor	University of Rochester
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	5
Start date	28 June 2021
Primary completion	27 August 2021
Estimated completion	27 August 2021
Sites	2 locations across United States

Drugs / interventions tested

• Connect for Caregivers

Conditions studied

• Social Isolation — all drugs for Social Isolation →
• Loneliness — all drugs for Loneliness →

Sponsor

University of Rochester

Who can join

50 and older, any sex, with Social Isolation or Loneliness. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Perceived Autonomy Primary · two weeks

This is a self-report measure that assesses a mechanism posited by Self-Determination Theory to increase motivation for healthy behaviors. It has 6 items, a range from 6-30, and higher scores indicate greater perceived autonomy.

Group	Value	95% CI
Connect for Caregivers	21.2	± 1.32

Perceived Competence Scale Primary · two weeks

This is a self-report measure that assesses a mechanism posited by Self-Determination Theory to increase motivation for healthy behaviors. It has 7 items, a range from 7-35, and higher scores indicate greater perceived competence.

Group	Value	95% CI
Connect for Caregivers	16.4	± 2

Knowledge of Social Engagement Secondary · two weeks

This is a self-report measure that assesses a subject's knowledge of the importance of social connections. It has 4 items, a range from 4-20, and higher scores indicate greater knowledge.

Group	Value	95% CI
Connect for Caregivers	15.6	± 2.3

Loneliness Secondary · two weeks

UCLA Loneliness Scale Version 3, which assesses self-reported loneliness. 20 items, rated as to how often the participant has felt a certain way in the prior month (e.g., "How often do you feel alone?") -- "never" (1), "rarely" (2), "sometimes" (3), or "often" (4). Higher scores indicate greater loneliness. Total scores range from 20 to 80, with higher scores representing a worse outcome (i.e., greater loneliness).

Group	Value	95% CI
Connect for Caregivers	53.4	± 6.11

Sponsor's own description

Connect for Caregivers is a intervention feasibility pilot study. The purpose of the study is to pilot test a newly developed single session behavioral intervention to help caregivers of individuals with Alzheimer's Disease or related dementias gain understanding of the importance of increasing social connectedness, awareness of their personal barriers to connectedness, and knowledge of local resources for promoting connectedness.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Connect for caregivers: an exemplar using the NIH Stage Model for behavioral intervention development.
   Norton SA, Carter RM, Moskow M, Bobry M, et al · · 2026 · PMID 41196573 · DOI 10.1080/13607863.2025.2581098