Connect for Caregivers

NCT04919070 | Completed Results

• 2 other identifiers: 00004316P30AG064103
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Social Isolation; Loneliness

Keywords

Social Connectedness

Outcome Measures

Primary Outcomes (2)

• Perceived Autonomy

  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.

  two weeks

• Perceived Competence Scale

  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.

  two weeks

Secondary Outcomes (2)

• Knowledge of Social Engagement

  two weeks

• Loneliness

  two weeks

Study Arms (1)

Connect for Caregivers

EXPERIMENTAL

Connect for Caregivers is a single session behavioral intervention with three components: 1) psychoeducation on the importance of connectedness for health and well-being; a card sort-based discussion prioritization tool that systematizes and routinizes the process of identifying and prioritizing barriers to connectedness; 3) personalized resources to address the identified barriers and targets.

Behavioral: Connect for Caregivers

Interventions

Connect for Caregivers BEHAVIORAL

The intervention being studied is a single session guided behavioral intervention to improve social connectedness in caregivers of individuals with ADRD. The intervention, Connect for Caregivers, provides psychoeducation on the importance of social connectedness for health and well-being, includes a card-sort process to identify and prioritize barriers to connectedness, and provides personalized resources and strategies for caregivers to use to increase their social connectedness.

Connect for Caregivers

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 50 yrs;
• English speaking;
• Caregiver (age 50 or older) for a community-dwelling family member with ADRD, living with (or in close proximity to) family member with dementia;
• Elevated caregiving distress: Above population mean (\>11) on 10-item Perceived Stress Scale (PSS-10) and/or at least moderate caregiver strain (score \>= 5) on the Modified Caregiver Strain Index (MCSI).
• Social connectedness: UCLA Loneliness Scale: Short Form score of \>5.

You may not qualify if:

• Primary language is not English;
• Current non-alcohol psychoactive substance abuse (MINI Neuropsychiatric Interview), psychotic disorders (current and lifetime, MINI), bipolar disorder (MINI), and current mood disorder with psychotic features (MINI);
• Significant cognitive impairment (MOCA \<22); and
• Hearing problems that preclude completion of the intervention.

Sponsors & Collaborators

• University of Rochester: lead
• National Institute on Aging (NIA): collaborator

Study Sites (2)

University of Rochester

Rochester, New York, 14618, United States

Location

University of Rochester

Rochester, New York, 14642, United States

Location

Related Publications (1)

• Norton SA, Carter RM, Moskow M, Bobry M, Wittink MN, Heffner KL, Van Orden KA. Connect for caregivers: an exemplar using the NIH Stage Model for behavioral intervention development. Aging Ment Health. 2025 Nov 6:1-11. doi: 10.1080/13607863.2025.2581098. Online ahead of print.

  PMID: 41196573 DERIVED

MeSH Terms

Conditions

Social Isolation

Interventions

Caregivers

Condition Hierarchy (Ancestors)

Social Behavior; Behavior

Intervention Hierarchy (Ancestors)

Health Personnel; Health Care Facilities Workforce and Services

Results Point of Contact

• Title: Dr. Sally Norton
• Organization: University of Rochester

sally_norton@urmc.rochester.edu

5852759814

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 2, 2021
• First Posted: June 9, 2021
• Study Start: June 28, 2021
• Primary Completion: August 27, 2021
• Study Completion: August 27, 2021
• Last Updated: December 29, 2022
• Results First Posted: December 29, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Timetable to release the data: the data and referenced resources from publications will be made available by the on-line publication date.
• Access Criteria: The investigators will make the data and associated documentation available to users only under a data-sharing agreement as suggested by the NIH that provides for: (1) a commitment to using the data only for research purposes and not to identify any individual participant; (2) a commitment to securing the data using appropriate computer technology; and (3) a commitment to destroying or returning the data after analyses are completed. 4. De-identification of data from human subjects: A final complete database will be created to host all data which will be stripped of any identifiers and stored pursuant to UR Institutional Review Board protocols.

Locations

US (2)